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Osteoporosis: HELP
Articles by Santiago Palacios
Based on 38 articles published since 2008

Between 2008 and 2019, S. Palacios wrote the following 38 articles about Osteoporosis.
+ Citations + Abstracts
Pages: 1 · 2
1 Guideline EMAS position statement: The ten point guide to the integral management of menopausal health. 2015

Neves-E-Castro, Manuel / Birkhauser, Martin / Samsioe, Goran / Lambrinoudaki, Irene / Palacios, Santiago / Borrego, Rafael Sanchez / Llaneza, Placido / Ceausu, Iuliana / Depypere, Herman / Erel, C Tamer / Pérez-López, Faustino R / Schenck-Gustafsson, Karin / van der Schouw, Yvonne T / Simoncini, Tommaso / Tremollieres, Florence / Rees, Margaret. ·Clinica da Menopausa, Av. Luis Bivar, 93c-1 Dt, Lisboa 1050-143, Portugal. · Gynaecological Endocrinology and Reproductive Medicine, University of Berne, Gartenstrasse 67, CH-4052 Basel, Switzerland. · Department of Clinical Sciences, SUS University Hospital Lund, Lund University, SE-221 85 Lund, Sweden. · Second Department of Obstetrics and Gynecology, National and Capodestrian University of Athens, Greece. · Instituto Palacios, Salud y Medicina de la Mujer, C/Antonio Acuña, 9, 28009 Madrid, Spain. · DIATROS, Clínica de Atención a la Mujer, Barcelona, Spain. · Department of Obstetrics and Gynecology, University Central Hospital of Asturias, University of Oviedo, 33011 Oviedo, Spain. · Department of Obstetrics and Gynecology, 'Carol Davila' University of Medicine and Pharmacy, Bucharest, Romania; Department of Obstetrics and Gynecology, 'Dr. I. Cantacuzino' Hospital, Bucharest, Romania. · Breast Clinic and Menopause Clinic, University Hospital, De Pintelaan 185, 9000 Gent, Belgium. · Department of Obstetrics and Gynecology, Istanbul University, Cerrahpasa School of Medicine, Valikonagi Cad. No: 93/4, Nisantasi, 34365 Istanbul, Turkey. · Department of Obstetrics and Gynecology, Zaragoza University Facultad de Medicina, Hospital Clínico, Zaragoza 50009, Spain. · Department of Medicine, Cardiology Unit, Centre for Gender Medicine, Karolinska Institutet and Karolinska University Hospital, Thorax N3:05, SE 17176 Stockholm, Sweden. · Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, The Netherlands. · Department of Clinical and Experimental Medicine, University of Pisa, Via Roma, 67, 56100 Pisa, Italy. · Menopause and Metabolic Bone Disease Unit, Hôpital Paule de Viguier, F-31059 Toulouse cedex 09, France. · Women's Centre, John Radcliffe Hospital, Oxford OX3 9DU, UK. Electronic address: margaret.rees@st-hildas.ox.ac.uk. ·Maturitas · Pubmed #25757366.

ABSTRACT: With increased longevity and more women becoming centenarians, management of the menopause and postreproductive health is of growing importance as it has the potential to help promote health over several decades. Women have individual needs and the approach needs to be personalised. The position statement provides a short integral guide for all those involved in menopausal health. It covers diagnosis, screening for diseases in later life, treatment and follow-up.

2 Editorial Association between vitamin D and falls in young postmenopausal women. 2016

Palacios, Santiago. ·Palacios Institute of Women's Health, Madrid, Spain. ·Menopause · Pubmed #26818014.

ABSTRACT: -- No abstract --

3 Editorial Antiresorptives and anabolic therapy in sequence or combination for postmenopausal osteoporosis. 2015

Palacios, S / Mejía, A. ·Palacios Institute of Women's Health , Madrid , Spain. ·Climacteric · Pubmed #25740608.

ABSTRACT: Osteoporosis is a chronic disease which may require treatment for many years and requires not only individual management but often sequential or combination treatments. Monotherapy with antiresorptives is usually the first choice. Sometimes, it is necessary to modify this option for therapeutic failure or for the time of use and risk of side-effects. Due to their different mode of action, therapy with anabolic drugs has increased our options in the treatment of osteoporosis. Postmenopausal women and men with severe and progressive osteoporosis despite antiresorptive treatment ('therapeutic failure') should be evaluated for treatment with an anabolic option. Moreover, anabolic agents are indicated for 18-24 months in patients at high risk. Then, sequential antiresorptive therapy is recommended to maintain drug increases in bone mass and support secondary mineralization of the newly formed bone. Combination therapies of antiresorptives and anabolic agents have shown a significant increase in bone mineral density compared to monotherapies. However, none of the combinations have been studied for the prevention of fractures. Combination therapy may not be recommended because of the possible increase in cost.

4 Review New options for menopausal symptoms after 15 years of WHI Study. 2017

Palacios, Santiago / Coronado, Pluvio J. ·Director of Instituto Palacios, Madrid, Spain - ipalacios@institutopalacios.com. · Department of Obstetrics and Gynecology, San Carlos Clinic Hospital, Madrid, Spain. ·Minerva Ginecol · Pubmed #27973466.

ABSTRACT: Menopausal symptoms include vasomotor symptoms (VMS), vulvar-vaginal atrophy, and loss of bone mass associated with an increased risk of fracture. Treatment of VMS consists of lifestyle changes, hormone treatment (estrogens with and without progestogens, tissue selective estrogens complex or conjugated estrogens and bazedoxifene [CE/BZA], progestogens, and tibolone), and nonhormonal treatments. Genitourinary symptoms due to vulvar-vaginal atrophy are treated with systemic and local hormones, moisturizer creams and gels, CE/BZA, and a selective estrogen receptor modulator (ospemifene). In addition to lifestyle changes, treatments for the risk of fragility fracture include calcium and vitamin D, hormone treatment, selective estrogen receptor modulators (raloxifene, BZA), bisphosphonates, strontium ranelate, denosumab, and teriparatide. This article reviews treatment options and provides treatment algorithms for women with menopausal symptoms.

5 Review The position of strontium ranelate in today's management of osteoporosis. 2015

Reginster, J-Y / Brandi, M-L / Cannata-Andía, J / Cooper, C / Cortet, B / Feron, J-M / Genant, H / Palacios, S / Ringe, J D / Rizzoli, R. ·Department of Public Health, Epidemiology and Health Economics, University of Liège, 4020, Liège, Belgium. jyreginster@ulg.ac.be. · Metabolic Bone Unit, Department of Internal Medicine, University of Florence, Florence, Italy. · Servicio de Metabolismo Óseo y Mineral, Hospital Universitario Central de Asturias, Universidad de Oviedo, Oviedo, Asturias, Spain. · MRC Lifecourse Epidemiology Unit and NIHR Nutrition Biomedical Research Centre, University of Southampton, Southampton, UK. · Service de Rhumatologie, Hôpital Roger Salengro, Lille, France. · Service de Chirurgie Orthopédique et Traumatologique, Hôpital Saint Antoine, UPMC, Paris, France. · Departments of Radiology, Medicine, Epidemiology and Orthopedic Surgery, University of California, San Francisco, CA, USA. · Instituto Palacios, Salud y Medicina de la Mujer, Madrid, Spain. · Med Klinik 4, Klinikum Leverkusen, Akadem, Lehrkrankenhaus, University of Cologne, Cologne, Germany. · Division of Bone Diseases, Faculty of Medicine, Geneva University Hospital, Geneva, Switzerland. ·Osteoporos Int · Pubmed #25868510.

ABSTRACT: Osteoporosis accounts for about 3 % of total European health-care spending. The low proportion of costs for the pharmacological prevention of osteoporotic fracture means that it is highly cost saving, especially in patient with severe osteoporosis or patients who cannot take certain osteoporosis medications due to issues of contraindications or tolerability. Following recent regulatory changes, strontium ranelate is now indicated in patients with severe osteoporosis for whom treatment with other osteoporosis treatments is not possible, and without contraindications including uncontrolled hypertension, established, current or past history of ischaemic heart disease, peripheral arterial disease, and/or cerebrovascular disease. We review here today's evidence for the safety and efficacy of strontium ranelate. The efficacy of strontium ranelate in patients complying with the new prescribing information (i.e. severe osteoporosis without contraindications) has been explored in a multivariate analysis of clinical trial data, which concluded that the antifracture efficacy of strontium ranelate is maintained in patients with severe osteoporosis without contraindications and also demonstrated how the new target population mitigates risk. Strontium ranelate is therefore an important alternative in today's management of osteoporosis, with a positive benefit-risk balance, provided that the revised indication and contraindications are followed and cardiovascular risk is monitored. The bone community should be reassured that there remain viable alternatives in patients in whom treatment with other agents is not possible and protection against the debilitating effects of fracture is still feasible in patients with severe osteoporosis.

6 Review Bazedoxifene/conjugated estrogens combination for the treatment of the vasomotor symptoms associated with menopause and for prevention of osteoporosis in postmenopausal women. 2015

Palacios, S / Mejía Ríos, A. ·Palacios Institute of Women's Health, Madrid, Spain. ipalacios@institutopalacios.com. · Palacios Institute of Women's Health, Madrid, Spain. ·Drugs Today (Barc) · Pubmed #25756066.

ABSTRACT: The decrease of estrogen in postmenopausal women has been associated with the presence of different symptoms such as vasomotor symptoms, vulvovaginal atrophy, bone loss, sleep disturbances, and mood and sexual activity alterations. Hormone replacement therapy with estrogen and progestins has been used to improve menopausal symptoms; however, there are still concerns regarding its safety and tolerability, as some progestins have been shown to increase breast cancer and cardiovascular risk. Bazedoxifene is a third-generation selective estrogen receptor modulator (SERM) used for osteoporosis management in postmenopausal women at fracture risk that has demonstrated a powerful antiestrogenic effect on the endometrium. Today we have a new alternative called the tissue-selective estrogen complex (TSEC), which combines bazedoxifene and conjugated estrogens and is designed not only to improve menopausal symptoms and vulvovaginal atrophy but also to prevent bone loss. Therefore, it maintains the benefits of estrogen therapy while antagonizing the stimulation effects on the endometrium and mammary gland without the effects associated with progestins.

7 Review [Inhibition of RANK-L in the pathophysiology of osteoporosis. Clinical evidences of its use]. 2013

Luis Neyro, José / Jesús Cancelo, María / Palacios, Santiago. ·Servicio de Ginecología y Obstetricia, Facultad de Medicina y Odontología, Grupo de trabajo de Osteoporosis de la Associación Española para el Estudio de la Menopausia, Universidad del País Vasco, EUH-UPV. jlneyro@sego.es ·Ginecol Obstet Mex · Pubmed #23672116.

ABSTRACT: The increase bone turnover is the most important fact at the physiopathology of postmenopausal osteoporosis. At the molecular level it is the increase of the RANK-L the principal mediator who allows the osteoclasts formation, survival and development of them. Multiple models have been in use in preclinical investigations for evaluating the effects of the inhibition of the RANKL, between which it is included on OPG's over-expression in mice and transgenic mouse and by means of other models that include the treatment with recombinant OPG. The results of these studies show that RANKL's inhibition improves the DMO as well as the geometry and resistance of the bone. Several references clinical trials have investigated the potential of denosumab as antiresorptive drug for the prevention and treatment of bone disease. It is a monoclonal antibody, the first fully human, which were recently published results of randomized clinical trials to eight years for increasing BMD in different locations and five years for the prevention of vertebral and hip fractures. We review the fundamentals of the mechanism of inhibition of RANK-L and the results of several clinical trials of Denosumab.

8 Review EMAS clinical guide: selective estrogen receptor modulators for postmenopausal osteoporosis. 2012

Palacios, Santiago / Brincat, Mark / Erel, C Tamer / Gambacciani, Marco / Lambrinoudaki, Irene / Moen, Mette H / Schenck-Gustafsson, Karin / Tremollieres, Florence / Vujovic, Svetlana / Rees, Margaret / Rozenberg, Serge. ·Palacios Institute of Woman's Health Antonio Acuna, Madrid, Spain. ipalacios@institutopalacios.com ·Maturitas · Pubmed #22176952.

ABSTRACT: Osteoporosis and the resulting fractures are major public health issues as the world population is ageing. Various therapies such as bisphosphonates, strontium ranelate and more recently denosumab are available. This clinical guide provides the evidence for the clinical use of selective estrogen modulators (SERMs) in the management of osteoporosis in postmenopausal women.

9 Review Bazedoxifene acetate for the management of postmenopausal osteoporosis. 2011

Palacios, S. ·Palacios Institute of Women's Health, Madrid, Spain. ipalacios@institutopalacios.com ·Drugs Today (Barc) · Pubmed #21494696.

ABSTRACT: Osteoporosis is a gender-related disease that is especially prevalent in postmenopausal women. New drugs have been developed led by issues of interest and concerns about this disease, each one striving to be more effective and safer than the previous one. Bazedoxifene acetate is a new, third-generation, selective estrogen receptor modulator. This drug is used to treat postmenopausal osteoporosis in women with a high risk of fracture. Bazedoxifene acetate significantly prevents bone mass loss at 20 mg/day in healthy postmenopausal women with normal or low bone mineral density. The risk of vertebral fractures in women with osteoporosis was reduced by 42% (P < 0.05) after 3 years in a pivotal study. Five years later, the reduction was still 35% (P = 0.014). Post hoc analysis in women with a high risk of fractures showed a 50% reduced risk of nonvertebral fractures (P = 0.02) after 3 years and a 37% reduction (P = 0.06) after 5 years. Bazedoxifene acetate shows anti-fracture potential in the first few years after menopause and a greater antiestrogen effect at the level of the uterus. This has made this compound an appropriate option in young postmenopausal women with osteoporosis and a risk of fractures.

10 Review Efficacy and safety of bazedoxifene, a novel selective estrogen receptor modulator for the prevention and treatment of postmenopausal osteoporosis. 2010

Palacios, Santiago. ·Instituto Palacios, Salud y Medicina de la Mujer, Madrid, Spain. ipalacios@institutopalacios.com ·Curr Med Res Opin · Pubmed #20429824.

ABSTRACT: OBJECTIVE: Osteoporosis affects millions of individuals, particularly postmenopausal women, and imposes a severe burden on patients and the healthcare system. Several therapeutic options are commercially available for the prevention and treatment of osteoporosis, including bisphosphonates, hormone therapy, and the selective estrogen receptor modulator (SERM), raloxifene. Because each of these agents has its own individual risk-benefit profile, their use should be tailored to specific patient populations. While many agents are approved for osteoporosis, new therapies are needed that maximize efficacy outcomes and minimize safety concerns. Several new SERMs are being evaluated in an effort to achieve an ideal tissue selectivity profile, with beneficial effects on bone without negative effects on the endometrium and breast. Bazedoxifene is a novel SERM that was recently approved in the European Union and is undergoing regulatory review in the United States for the prevention and treatment of postmenopausal osteoporosis. This article reviews the clinical efficacy and safety data for bazedoxifene in postmenopausal women with or at risk for osteoporosis. METHODS: The PubMed database and relevant congress abstract databases were searched to identify all pertinent literature on bazedoxifene for the prevention and/or treatment of postmenopausal osteoporosis. RESULTS: In phase 3 clinical studies, bazedoxifene has demonstrated significant reduction in the risk of new vertebral fracture versus placebo and positive effects on bone mineral density and bone turnover. Moreover, in a subgroup analysis of women at high risk for fracture, bazedoxifene significantly reduced the risk of nonvertebral fracture versus both placebo and raloxifene. Bazedoxifene was generally safe and well-tolerated in women with and at risk for osteoporosis, with no evidence of endometrial or breast stimulation. Data inclusion for this review article was limited by what was available in the public domain. CONCLUSION: The available clinical data suggest that bazedoxifene may offer a favorable risk-benefit profile for the prevention and treatment of postmenopausal osteoporosis.

11 Review Efficacy of ossein-hydroxyapatite complex compared with calcium carbonate to prevent bone loss: a meta-analysis. 2009

Castelo-Branco, Camil / Ciria-Recasens, Manel / Cancelo-Hidalgo, María J / Palacios, Santiago / Haya-Palazuelos, Javier / Carbonell-Abelló, Jordi / Blanch-Rubió, Josep / Martínez-Zapata, María J / Manasanch, José / Pérez-Edo, Lluís. ·Obstetrics and Gynaecology Unit, Hospital Clínic i Provincial, Barcelona, Spain. ·Menopause · Pubmed #19407667.

ABSTRACT: OBJECTIVE: There is increasing evidence to suggest that ossein-hydroxyapatite complex (OHC) is more effective than calcium supplements in maintaining bone mass. The aim of this meta-analysis was to determine whether OHC has a different clinical effect on bone mineral density (BMD) compared with calcium carbonate (CC). METHODS: A meta-analysis of randomized controlled clinical trials was carried out to evaluate the efficacy of OHC versus CC on trabecular BMD. We identified publications on clinical trials by a search of electronic databases, including MEDLINE (1966-November 2008), EMBASE (1974-November 2008), and the Cochrane Controlled Clinical Trials Register.The primary endpoint was percent change in BMD from baseline. Data were pooled in a random-effects model, and the weighted mean difference was calculated. A sensitivity analysis that excluded trials without full data was performed. RESULTS: Of the 18 controlled trials initially identified, 6 were included in the meta-analysis. There was no significant heterogeneity among the included trials. The percent change in BMD significantly favored the OHC group (1.02% [95% CI, 0.63-1.41], P < 0.00001). These results were confirmed in the sensitivity analysis. CONCLUSIONS: OHC is significantly more effective in preventing bone loss than CC.

12 Review Advances in hormone replacement therapy: making the menopause manageable. 2008

Palacios, Santiago. ·Palacios Institute of Women's Health, Calle Antonio Acuña, 9, 28009, Madrid, España. ipalacios@institutopalacios.com ·BMC Womens Health · Pubmed #19038018.

ABSTRACT: The importance of the results of some large, randomized controlled trials (RCTs) on Hormone Replacement Therapy (HRT) has modified the risk/benefit perception of HRT. Recent literature review supports a different management. The differences in age at initiation and the duration of HRT are key points. HRT appears to decrease coronary disease in younger women, near menopause; yet, in older women, HRT increases risk of a coronary event. Although HRT is a recognized method in the prevention and treatment of osteoporosis, it is not licensed for the prevention of osteoporosis as a first-line treatment. The effectiveness of low and ultra-low estrogen doses has been demonstrated for the treatment of vasomotor symptoms, genital atrophy and the prevention of bone loss, with fewer side-effects than the standard dose therapy. Further research, however, is needed to determine the effect both on fractures, as well as on cardiovascular and breast diseases. Newer progestins show effects that are remarkably different from those of other assays. The effectiveness of testosterone at improving both sexual desire and response in surgically and naturally postmenopausal women is shown by the testosterone patch. The intention, dose and regimen of HRT need to be individualized, based on the principle of choosing the lowest appropriate dose in relation to the severity of symptoms and the time and menopause age.

13 Clinical Trial Efficacy and tolerability of bazedoxifene in Mexican women with osteoporosis: a subgroup analysis of a randomized phase 3 trial. 2016

Palacios, Santiago / Williams, Robert / Mirkin, Sebastian / Pan, Kaijie / Arias, Lizbeth / Komm, Barry S. ·1Palacios Institute of Women's Health, Madrid, Spain 2Pfizer Inc, Collegeville, PA 3Pfizer Inc, Bosques de las Lomas, Mexico. ·Menopause · Pubmed #27116464.

ABSTRACT: OBJECTIVE: Bazedoxifene (BZA) is a selective estrogen receptor modulator that reduces fracture risk and bone turnover in postmenopausal women with osteoporosis. This analysis evaluated BZA's effects on bone mineral density (BMD) and bone turnover in Mexican women with osteoporosis from the global pivotal trial (Study Evaluating Bazedoxifene Acetate in Osteoporosis in Postmenopausal Women). METHODS: In this 3-year, phase 3, randomized, double-blind trial, healthy postmenopausal women with osteoporosis (N = 7,492) received BZA 20 or 40 mg/d, raloxifene 60 mg/d, or placebo. The subanalyses of Mexican women assessed serum concentrations of osteocalcin and collagen type 1 C-telopeptide, BMD, and tolerability with BZA 20 mg/d versus placebo. RESULTS: In the Mexican subgroup (BZA, n = 39; placebo, n = 37) at month 12, BZA 20 mg/d produced significant (P < 0.001) percentage decreases from baseline in osteocalcin (-40.5 vs -18.5) and C-telopeptide (-45.7 vs -29.4). For BZA versus placebo, percentage change in BMD from baseline to month 36 was 3.3 versus 0.64 for lumbar spine, -0.18 versus -1.8 for total hip, 0.21 versus -2.6 for femoral neck, and -0.55 versus -1.4 for femoral trochanter; differences were not statistically significant. Results were comparable to the overall study population in which differences were statistically significant. Common adverse events (≥20%) included arthralgia, back pain, gastritis, headache, influenza, and pain; none led to study withdrawal. CONCLUSIONS: In Mexican women with osteoporosis, BZA was well tolerated and seems to produce BMD changes comparable to the global phase 3 population, although differences versus placebo were not statistically significant in this smaller subgroup.

14 Clinical Trial The efficacy and safety of bazedoxifene in postmenopausal women by baseline kidney function status. 2014

Adami, S / Palacios, S / Rizzoli, R / Levine, A B / Sutradhar, S / Chines, A A. ·University of Verona , Verona , Italy. ·Climacteric · Pubmed #23937421.

ABSTRACT: INTRODUCTION: Two global, double-blind, placebo- and active-controlled, phase-3 studies (2-year prevention (n = 1583) and 3-year treatment (n = 7492)) have shown that bazedoxifene (BZA) is safe and effective for prevention and treatment of postmenopausal osteoporosis. OBJECTIVE: To evaluate the efficacy/safety of BZA according to baseline kidney function. METHODS: Data for the BZA 20- and 40-mg and placebo groups from both studies were integrated for assessment of bone turnover markers (BTMs), bone mineral density (BMD), and fracture incidence (treatment study only). Safety was assessed using integrated data for the BZA, placebo, and raloxifene 60-mg groups from both studies. Baseline glomerular filtration rate (GFR) was estimated by the Modification of Diet in Renal Disease Study equation; among subjects with baseline GFR, renal function categories were defined by GFR (ml/min per 1.73 m(2)): normal (GFR ≥ 90; n = 1982), mild impairment (60 ≤ GFR < 90; n = 6032), or moderate/severe impairment (GFR < 60; n = 723). RESULTS: Demographics were similar across treatment groups and within GFR subgroups. Across GFR subgroups, BZA 20 and 40 mg reduced BTM levels and improved lumbar spine and total hip BMD versus placebo. At month 24, there were significant treatment-by-GFR (p = 0.003) and treatment-by-serum creatinine (p = 0.034) interactions for the increase in lumbar spine BMD versus placebo. Fracture incidence was lower with BZA than placebo across all GFR categories, with no treatment-by-GFR interaction. There were no significant differences among treatment groups in incidences of overall, serious, or renal-related adverse events across GFR subgroups. CONCLUSIONS: Mild to moderate kidney impairment did not affect the efficacy and safety of BZA in postmenopausal women.

15 Clinical Trial Assessment of the safety of long-term bazedoxifene treatment on the reproductive tract in postmenopausal women with osteoporosis: results of a 7-year, randomized, placebo-controlled, phase 3 study. 2013

Palacios, Santiago / de Villiers, Tobie J / Nardone, Fiorenzo De Cicco / Levine, Amy B / Williams, Robert / Hines, Teresa / Mirkin, Sebastian / Chines, Arkadi A / Anonymous3611063. ·Palacios Institute of Women's Health, Calle Antonio Acuña, 9, 28009 Madrid, Spain. ipalacios@institutopalacios.com ·Maturitas · Pubmed #23871271.

ABSTRACT: OBJECTIVE: To evaluate the clinical safety of bazedoxifene (BZA) on the reproductive tract in postmenopausal women with osteoporosis over 7 years. STUDY DESIGN: This was a second, blinded, 2-year extension of a 3-year, randomized, double-blind, placebo (PBO)- and active-controlled phase 3 trial. In the core study, subjects were randomized to receive BZA 20 or 40mg, raloxifene 60mg, or PBO. During years 4-5, the raloxifene arm was discontinued and subjects receiving BZA 40mg were transitioned to BZA 20mg. Subjects continued to receive BZA 20mg or PBO during years 6-7. MAIN OUTCOME MEASURES: The primary endpoint was the incidence of new vertebral fractures at 7 years (reported separately). Reproductive tract safety findings at 7 years are reported here. Endometrial thickness was assessed by transvaginal ultrasonography for subjects in the endometrial safety substudy. Adverse events (AEs) were recorded throughout the study. RESULTS: At 7 years, the adjusted mean (±standard error) change in endometrial thickness was similar with BZA and PBO (-0.11 ± 0.21 and 0.07 ± 0.32 mm, respectively). The incidence of endometrial hyperplasia was low (0.1% for both groups). BZA showed significantly lower rates than PBO of endometrial carcinoma (0.1% vs. 0.4%; P=0.020) and vaginitis (6.1% vs. 7.6%; P=0.035). There were more cases of ovarian carcinoma with BZA (n=4 [0.1%]) than PBO (n=0); the difference was not statistically significant. Rates of breast-related and other gynecologic AEs were similar among groups. CONCLUSIONS: BZA was associated with a favorable reproductive safety profile in postmenopausal women with osteoporosis over 7 years.

16 Clinical Trial An evaluation of the Fracture Risk Assessment Tool (FRAX®) as an indicator of treatment efficacy: the effects of bazedoxifene and raloxifene on vertebral, nonvertebral, and all clinical fractures as a function of baseline fracture risk assessed by FRAX®. 2013

Kaufman, J-M / Palacios, S / Silverman, S / Sutradhar, S / Chines, A. ·Department of Endocrinology and Unit for Osteoporosis and Metabolic Bone Diseases, Ghent University Hospital, Ghent, Belgium, jean.kaufman@ugent.be. ·Osteoporos Int · Pubmed #23595562.

ABSTRACT: SUMMARY: The relationship between baseline Fracture Risk Assessment Tool (FRAX®) and treatment efficacy was evaluated using data from a pivotal phase 3 study. Relative risk of vertebral, nonvertebral, and all clinical fractures decreased with increasing probability of fracture for bazedoxifene (BZA) versus placebo but remained generally constant for raloxifene (RLX). INTRODUCTION: To determine whether the FRAX® predicts osteoporosis treatment efficacy, we evaluated reductions in fracture incidence associated with BZA and RLX according to baseline fracture risk determined by FRAX® using data from a phase 3 osteoporosis treatment study. METHODS: Hazard ratios (HRs) for effects of BZA and RLX versus placebo on incidence of vertebral, nonvertebral, and all clinical fractures were calculated using a Cox regression model. Cox regression analyses were performed in subgroups at or above 10-year fracture probability thresholds determined by FRAX®. RESULTS: HRs for the risk of vertebral, nonvertebral, and all clinical fractures versus placebo decreased with increasing 10-year fracture probability for BZA, while those for RLX remained stable. In all 10-year fracture probability subgroups, all BZA doses significantly reduced vertebral fracture risk versus placebo (HR = 0.22-0.66). BZA at 20, 40, and 20/40 mg significantly reduced risk of nonvertebral fractures (HR = 0.45, 0.44, and 0.45, respectively) and all clinical fractures (HR = 0.38, 0.41, and 0.40, respectively) for ≥20.0 % fracture probability. Vertebral fracture risk reductions for RLX 60 mg versus placebo were significant in subgroups at lower fracture probabilities (≥2.5- ≥ 10.0 %), but not higher (≥12.5 %), and in no subgroups for nonvertebral or all clinical fractures. CONCLUSION: The antifracture efficacy of BZA increased with increasing baseline FRAX® score, but there was no clear relationship between RLX and baseline FRAX®. These findings provide independent confirmation of current literature, suggesting that the relationship between FRAX® and treatment efficacy varies for different agents.

17 Clinical Trial Arzoxifene versus raloxifene: effect on bone and safety parameters in postmenopausal women with osteoporosis. 2012

Kendler, D L / Palacios, S / Cox, D A / Stock, J / Alam, J / Dowsett, S A / Zanchetta, J. ·University of British Columbia, 600-1285 West Broadway, Vancouver, BC, Canada V6H 3X8. kendler@ca.inter.net ·Osteoporos Int · Pubmed #21374068.

ABSTRACT: INTRODUCTION: To assess the effect of arzoxifene versus raloxifene on change in lumbar spine (LS) bone mineral density (BMD) in postmenopausal women with osteoporosis. METHODS: In this 12-month study (NEXT trial), participants were randomly assigned to arzoxifene 20 mg/day (N = 158) or raloxifene 60 mg/day (N = 162). All received daily calcium and vitamin D. Change in LS BMD was assessed by DXA. Secondary objectives included assessment of femoral neck (FN) and total hip BMD, serum bone turnover markers, and safety. RESULTS: Treatment groups were similar at baseline (mean age 63 years, mean LS BMD T-score -2.9). At 12 months, the increase in LS BMD with arzoxifene was greater than with raloxifene (+2.75% vs. +1.66%), as was FN and total hip BMD (P < 0.05). For LS and FN, this effect was also evident at 6 months. Arzoxifene reduced bone turnover to a greater extent than raloxifene at 3, 6, and 12 months (P < 0.05). The proportion of women reporting ≥ 1 adverse event did not differ between treatment groups, nor did vaginal bleeding. No cases of endometrial polyps, hyperplasia, or cancer were reported. Nasopharyngitis and bronchitis were reported more frequently with arzoxifene versus raloxifene (10.1% vs. 2.5%, and 5.1% vs. 0%, respectively) and new/worsening hot flushes were reported less frequently with arzoxifene (7.0% vs. 16.7%) (P < 0.05). CONCLUSIONS: Arzoxifene increased BMD and suppressed bone turnover to a greater extent than raloxifene and resulted in a lower incidence of new/worsening hot flushes. Based on subsequent findings from a fracture outcome study, this difference did not translate into improved fracture efficacy.

18 Clinical Trial Safety and tolerability of bazedoxifene in postmenopausal women with osteoporosis: results of a 5-year, randomized, placebo-controlled phase 3 trial. 2011

de Villiers, T J / Chines, A A / Palacios, S / Lips, P / Sawicki, A Z / Levine, A B / Codreanu, C / Kelepouris, N / Brown, J P. ·Panorama MediClinic and University of Stellenbosch, Room 118 Parow 7500, Cape Town, South Africa. Tobie@iafrica.com ·Osteoporos Int · Pubmed #20535606.

ABSTRACT: INTRODUCTION: We report safety and tolerability findings from a 5-year randomized, double-blind, phase 3 study of bazedoxifene in postmenopausal women with osteoporosis. METHODS: In the core study, healthy postmenopausal women with osteoporosis (N=7,492; mean age, 66.4 years) were randomized to daily doses of bazedoxifene 20 or 40 mg, raloxifene 60 mg, or placebo for 3 years. During the 2-year study extension, the raloxifene 60-mg treatment arm was discontinued after the 3-year database was finalized, and subjects receiving bazedoxifene 40 mg were transitioned in a blinded manner to bazedoxifene 20 mg (bazedoxifene 40-/20-mg group) after 4 years. Safety and tolerability data are reported for subjects in the bazedoxifene 20- and 40-/20-mg and placebo groups; efficacy findings are reported elsewhere. RESULTS: A total of 3,146 subjects in the bazedoxifene 20- and 40-mg and placebo groups were enrolled in the extension study (years 4 and 5). Overall, the 5-year incidence of adverse events (AEs), serious AEs, and discontinuations due to AEs were similar among groups. The incidence of hot flushes and leg cramps was higher with bazedoxifene compared with placebo. Venous thromboembolic events, primarily deep vein thrombosis, were more frequently reported in the bazedoxifene groups compared with the placebo group. Reports of cardiac disorders and cerebrovascular events were few and evenly distributed among groups. Bazedoxifene showed a neutral effect on the breast and endometrium. CONCLUSION: Bazedoxifene was associated with an overall favorable safety and tolerability profile in postmenopausal women with osteoporosis over 5 years of therapy, consistent with findings at 3 years.

19 Clinical Trial Safety of bazedoxifene in a randomized, double-blind, placebo- and active-controlled Phase 3 study of postmenopausal women with osteoporosis. 2010

Christiansen, Claus / Chesnut, Charles H / Adachi, Jonathan D / Brown, Jacques P / Fernandes, César E / Kung, Annie Wc / Palacios, Santiago / Levine, Amy B / Chines, Arkadi A / Constantine, Ginger D. ·Center for Clinical and Basic Research, Ballerup, Denmark. cc@Nordicbioscience.com ·BMC Musculoskelet Disord · Pubmed #20569451.

ABSTRACT: BACKGROUND: We report the safety findings from a 3-year phase 3 study (NCT00205777) of bazedoxifene, a novel selective estrogen receptor modulator under development for the prevention and treatment of postmenopausal osteoporosis. METHODS: Healthy postmenopausal osteoporotic women (N = 7,492; mean age, 66.4 years) were randomized to daily doses of bazedoxifene 20 or 40 mg, raloxifene 60 mg, or placebo for 3 years. Safety and tolerability were assessed by adverse event (AE) reporting and routine physical, gynecologic, and breast examination. RESULTS: Overall, the incidence of AEs, serious AEs, and discontinuations due to AEs in the bazedoxifene groups was not different from that seen in the placebo group. The incidence of hot flushes and leg cramps was higher with bazedoxifene or raloxifene compared with placebo. The rates of cardiac disorders and cerebrovascular events were low and evenly distributed among groups. Venous thromboembolic events, primarily deep vein thromboses, were more frequently reported in the active treatment groups compared with the placebo group; rates were similar with bazedoxifene and raloxifene. Bazedoxifene showed a neutral effect on the breast and an excellent endometrial safety profile. The incidence of fibrocystic breast disease was lower with bazedoxifene 20 and 40 mg versus raloxifene or placebo. Reductions in total and low-density lipoprotein levels and increases in high-density lipoprotein levels were seen with bazedoxifene versus placebo; similar results were seen with raloxifene. Triglyceride levels were similar among groups. CONCLUSION: Bazedoxifene showed a favorable safety and tolerability profile in women with postmenopausal osteoporosis. TRIAL REGISTRATION NUMBER: NCT00205777; Trial registration date: September 16, 2005.

20 Article Effects of Daily Intake of Calcium and Vitamin D-Enriched Milk in Healthy Postmenopausal Women: A Randomized, Controlled, Double-Blind Nutritional Study. 2018

Reyes-Garcia, Rebeca / Mendoza, Nicolas / Palacios, Santiago / Salas, Nancy / Quesada-Charneco, Miguel / Garcia-Martin, Antonia / Fonolla, Juristo / Lara-Villoslada, Federico / Muñoz-Torres, Manuel. ·1 Bone Metabolic Unit (CIBERFES), UGC Endocrinología y Nutrición, Hospital Universitario San Cecilio, Instituto de Investigación Biosanitario de Granada (Ibs. Granada) , Granada, Spain . · 2 Unidad de Endocrinología y Nutrición, Complejo Hospitalario Torrecardenas , Almeria, Spain . · 3 Department of Obstetrics and Gynecology, University of Granada , Granada, Spain . · 4 Palacios Institute of Women's Health , Madrid, Spain . · 5 Nutrition Department, Biosearch S.A., Granada, Spain . · 6 Research and Development Department, Lactalis Puleva, Granada, Spain . ·J Womens Health (Larchmt) · Pubmed #29676968.

ABSTRACT: OBJECTIVE: To determine the effect of the daily intake of calcium and vitamin D-enriched milk (with or without fructooligosaccharides [FOS]) on vitamin D, bone metabolism, and cardiovascular risk factors. MATERIALS AND METHODS: Two-year randomized controlled study, including 500 healthy postmenopausal women, assigned to 500 mL/day of skimmed milk to one of three groups: Low-dose (L): (120 mg/100 mL calcium, vitamin D RESULTS: After 24 months, vitamin D concentrations did not change in the control group, but increased in group A and group B, p < 0.001. We observed an increase in femoral neck BMD and an improvement in fasting plasma glucose, HbA CONCLUSIONS: Daily intake of milk enriched with calcium and vitamin D in postmenopausal healthy women induces a significant improvement in vitamin D status, a significant increase in BMD at femoral neck, and also favorable effects on glucose and lipid profile.

21 Article Effect of conjugated estrogens/bazedoxifene on postmenopausal bone loss: pooled analysis of two randomized trials. 2016

Gallagher, J Christopher / Palacios, Santiago / Ryan, Kelly A / Yu, Ching-Ray / Pan, Kaijie / Kendler, David L / Mirkin, Sebastian / Komm, Barry S. ·1Creighton University School of Medicine, Omaha, NE 2Instituto Palacios, Madrid, Spain 3Pfizer Inc, Collegeville, PA 4Pfizer Inc, New York, NY 5University of British Columbia, Vancouver, BC, Canada. ·Menopause · Pubmed #27404034.

ABSTRACT: OBJECTIVE: Conjugated estrogens/bazedoxifene reduces vasomotor symptoms and prevents postmenopausal bone loss without stimulating the breast and endometrium. We analyzed changes in bone mineral density (BMD) and bone markers using pooled data from two phase-3 trials. METHODS: Selective Estrogens, Menopause, and Response to Therapy (SMART)-1 and SMART-5 were randomized, double-blind, placebo- and active-controlled studies conducted in postmenopausal nonhysterectomized women. BMD and turnover marker data were pooled for women given conjugated estrogens (0.45 or 0.625 mg) plus bazedoxifene 20 mg or placebo over 12 months. Sensitivity analyses were conducted using baseline Fracture Risk Assessment Tool score, age, years since menopause, body mass index, race, and geographic region. RESULTS: There were 1,172 women, mean age 54.9 years, mean 6.21 years since menopause, mean lumbar spine, and total hip T scores -1.05 and -0.58; 58.8% had a Fracture Risk Assessment Tool score less than 5% indicating low fracture risk. At 12 months, adjusted differences (vs placebo) in BMD change in the groups taking conjugated estrogens 0.45 or 0.625 mg plus bazedoxifene 20 mg were 2.3% and 2.4% for lumbar spine, 1.4% and 1.5% for total hip, and 1.1% and 1.5% for femoral neck (all P < 0.001 vs placebo). These increases were unrelated to baseline Fracture Risk Assessment Tool score, age, years since menopause, body mass index, or geographic region. Both doses reduced bone turnover markers (P < 0.001). CONCLUSIONS: Conjugated estrogens/bazedoxifene significantly improved BMD and turnover in a large population of younger postmenopausal women at low fracture risk and is a promising therapy for preventing postmenopausal bone loss.

22 Article Treatment with denosumab reduces secondary fracture risk in women with postmenopausal osteoporosis. 2015

Palacios, S / Kalouche-Khalil, L / Rizzoli, R / Zapalowski, C / Resch, H / Adachi, J D / Gallagher, J C / Feldman, R G / Kendler, D L / Wang, A / Wagman, R B / Adami, S. ·a * Institute of Women's Health , Madrid , Spain. · b Amgen (Europe) GmbH , Zug , Switzerland. · c Geneva University Hospitals, Faculty of Medicine , Geneva , Switzerland. · d Amgen Inc. , Thousand Oaks , CA , USA. · e St Vincent Hospital , Vienna , Austria. · f St Joseph's Healthcare, McMaster University , Hamilton , ON , Canada. · g Creighton University Medical School , Omaha , NE , USA. · h Senior Clinical Trials Inc. , Laguna Hills , CA , USA. · i University of British Columbia , Vancouver , BC , Canada. · j University of Verona , Verona , Italy. ·Climacteric · Pubmed #26029985.

ABSTRACT: OBJECTIVES: A history of prior fracture is one of the strongest predictors of a future fragility fracture. In FREEDOM, denosumab significantly reduced the risk of new vertebral, non-vertebral, and hip fractures. We carried out a post-hoc analysis of FREEDOM to characterize the efficacy of denosumab in preventing secondary fragility fractures in subjects with a prior fracture. METHODS: A total of 7808 women aged 60-90 years with a bone mineral density T-score of less than - 2.5 but not less than - 4.0 at either the lumbar spine or total hip were randomized to subcutaneous denosumab 60 mg or placebo every 6 months for 36 months. The anti-fracture efficacy of denosumab was analyzed by prior fracture status, to assess secondary fragility fracture, and by subject age, prior fracture site and history of prior osteoporosis medication use. RESULTS: A prior fragility fracture was reported for 45% of the overall study population. Compared with placebo, denosumab significantly reduced the risk of a secondary fragility fracture by 39% (incidence, 17.3% vs. 10.5%; p < 0.0001). Similar results were observed regardless of age or prior fracture site. In the overall population, denosumab significantly reduced the risk of a fragility fracture by 40% (13.3% vs. 8.0%; p < 0.0001), with similar results observed regardless of history of prior osteoporotic medication use. CONCLUSIONS: Denosumab reduced the risk of fragility fractures to a similar degree in all risk subgroups examined, including those with prior fragility fractures. Identifying and treating high-risk individuals could help to close the current care gap in secondary fracture prevention.

23 Article Disability-adjusted-life-years losses in postmenopausal women with osteoporosis: a burden of illness study. 2015

Darbà, Josep / Kaskens, Lisette / Pérez-Álvarez, Nuria / Palacios, Santiago / Neyro, José Luis / Rejas, Javier. ·Department of Economics, Universitat de Barcelona, Diagonal 690, 08034, Barcelona, Spain. darba@ub.edu. · BCN Health Economics & Outcomes Research S.L., Travessera de Gracia 62, 5-6, 08006, Barcelona, Spain. lisette.kaskens@bcnhealth.com. · BCN Health Economics & Outcomes Research S.L., Travessera de Gracia 62, 5-6, 08006, Barcelona, Spain. nuria.perez@bcnhealth.com. · Instituto Palacios de Salud y Medicina de la Mujer, Calle Antonio Acuña, 9, 28009, Madrid, Spain. ipalacios@institutopalacios.com. · Department of Obstetrics and Gynaecology, Hospital Universitario Cruces, Gran Vía 81-4, 48011, Bilbao, Spain. doctor@neyro.com. · Health Economics and Outcomes Research Department, Pfizer, S.L.U., Avda. Europa 20B. Parque Empresarial la Moraleja, 28108, Alcobendas, Madrid, Spain. javier.rejas@pfizer.com. ·BMC Public Health · Pubmed #25880810.

ABSTRACT: BACKGROUND: To estimate the disability-adjusted life years (DALY) in a nationwide representative sample of postmenopausal women with osteoporosis. The effects of drug-based therapy and risk factors for osteoporotic bone fractures on DALY losses were also explored. METHODS: DALY were estimated based on participant's clinical characteristics and Health-Related Quality-of-Life (HRQoL) data obtained from a cross-sectional, epidemiological one-visit study (the GINERISK study). The study enrolled postmenopausal women (at least 12-months after their last menstrual period) with osteoporosis, above 18-years old, who attended Spanish outpatient Gynaecology clinics. HRQoL was assessed using the generic SF-12v2 questionnaire, which was used to derive disutility values. Mortality rates were extracted from the Spanish national statistics database. Factors explored to be associated with DALY losses were examined using ANOVA, ANCOVA and MANCOVA models. RESULTS: DALY could be computed in 2,782 (67%) out of 4,157 postmenopausal women, with a mean (95% CI) age of 61.0 (60.7-61.2) years. Overall individual undiscounted DALY per woman were 6.1 (5.9-6.2), resulting to be significantly higher in women with severe osteoporosis with prior bone fracture; 7.8 (7.2-8.4) compared to osteoporotic women [5.8 (5.6-6.0)] or postmenopausal women with a BMD > -2.5 T-score that received a drug-based therapy [6.2 (5.8-6.5)]; F = 27.0 (P < 0.01). Models explaining the variation in the levels of health based on the use of a selective estrogen receptor modulator (SERM) or possession of risk factors for osteoporotic BF were found (P < 0.05). CONCLUSIONS: DALY losses were considerable amongst postmenopausal women with osteoporosis. Not having a prior bone fracture, being older, using a SERM and having less osteoporotic risk factors were all linked to less DALY losses.

24 Article A 7-year randomized, placebo-controlled trial assessing the long-term efficacy and safety of bazedoxifene in postmenopausal women with osteoporosis: effects on bone density and fracture. 2015

Palacios, Santiago / Silverman, Stuart L / de Villiers, Tobie J / Levine, Amy B / Goemaere, Stefan / Brown, Jacques P / De Cicco Nardone, Fiorenzo / Williams, Robert / Hines, Teresa L / Mirkin, Sebastian / Chines, Arkadi A / Anonymous3360820. ·From the 1Palacios Institute of Women's Health, Madrid, Spain; 2Cedars-Sinai Medical Center and University of California, Los Angeles, CA; 3MediClinic Panorama and Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa; 4Pfizer Inc, Collegeville, PA; 5University Hospital, Ghent, Belgium; 6CHU de Québec Research Center, Laval University, Quebec City, QC, Canada; and 7Università Cattolica del Sacro Cuore, Rome, Italy. ·Menopause · Pubmed #25668306.

ABSTRACT: OBJECTIVE: In a 3-year randomized, double-blind, osteoporosis treatment study (N = 7,492), bazedoxifene 20 mg and bazedoxifene 40 mg significantly (P < 0.05) reduced the risk of new vertebral fractures by 42% and 37%, respectively, compared with placebo in postmenopausal women with osteoporosis. This study evaluated the long-term (7-y) efficacy and safety of bazedoxifene in generally healthy postmenopausal women with osteoporosis. METHODS: This was a second 2-year extension of the 3-year multicenter outpatient core study. During extension I (years 4-5), women receiving bazedoxifene 40 mg transitioned to bazedoxifene 20 mg. In extension II (years 6-7; N = 1,530), all bazedoxifene-treated women continued bazedoxifene 20 mg. Main outcome measures included year 7 endpoints: incidences of new vertebral and nonvertebral fractures, bone mineral density changes, and safety assessments. RESULTS: At 7 years, the cumulative incidences of new vertebral fractures were significantly lower in the bazedoxifene (6.4%) and bazedoxifene 20 mg (7.6%) groups than in the placebo group (9.9%); the relative risk reductions were 36.5% and 30.4%, respectively (both P < 0.001). Bazedoxifene had no effect on the overall incidence of nonvertebral fractures (bazedoxifene, 11.2%; bazedoxifene 20 mg, 12.0%; placebo, 10.8%). The mean changes from baseline in lumbar spine bone mineral density were 2.95%, 2.73%, and 2.19%, respectively. Seven-year decreases in total hip bone mineral density were significantly smaller in the bazedoxifene (-1.15%) and bazedoxifene 20 mg (-1.19%) groups than in the placebo group (-2.53%; P ≤ 0.002). Bazedoxifene showed a favorable safety/tolerability profile across 7 years, with similar adverse events, serious adverse events, and study discontinuations in all groups. CONCLUSIONS: Efficacy and safety of bazedoxifene are sustained across 7 years in postmenopausal women with osteoporosis.

25 Article Treatment satisfaction in postmenopausal women suboptimally adherent to bisphosphonates who transitioned to denosumab compared with risedronate or ibandronate. 2015

Palacios, Santiago / Agodoa, Irene / Bonnick, Sydney / Van den Bergh, Joop P / Ferreira, Irene / Ho, Pei-Ran / Brown, Jacques P. ·Instituto Palacios (S.P.), 9-28009 Madrid, Spain · Amgen (I.A., P.-R.H.), Thousand Oaks, California 91320 · Clinical Research Center of North Texas (S.B.), Denton, Texas 76210 · VieCuri Medical Center and Maastricht University (J.P.V.), 6200 MD Maastricht, Netherlands · Amgen (I.F.), Cambridge CB4 0WD, United Kingdom · and Laval University and CHU de Québec Research Centre (J.P.B.), Québec City, Canada G1V 4G2. ·J Clin Endocrinol Metab · Pubmed #25514106.

ABSTRACT: CONTEXT: For many patients, adhering to postmenopausal osteoporosis treatment is a challenge. Higher treatment satisfaction is associated with greater persistence with these therapies, which is associated with better outcomes. OBJECTIVE: This study aimed to evaluate the change in treatment satisfaction in postmenopausal women who were suboptimally adherent to daily or weekly oral bisphosphonates and who transitioned to denosumab vs a monthly oral bisphosphonate. DESIGN AND SETTING: Pooled data of outpatients from two international, multicenter, randomized, open-label studies were analyzed. PATIENTS: Postmenopausal women (n = 1703) age 55 years or greater with low bone mineral density who were suboptimally adherent with prior oral bisphosphonate therapy, as assessed by the Osteoporosis-Specific Morisky Medication Adherence Scale, were included in the study. INTERVENTIONS: Patients received denosumab, a fully human monoclonal antibody to receptor activator of nuclear factor-kappa B ligand, 60 mg s.c. every 6 months vs the oral bisphosphonates ibandronate or risedronate, 150 mg once monthly for 12 months. MAIN OUTCOME MEASURES: Change in treatment satisfaction scores from baseline to months 6 and 12 were measured using the Treatment Satisfaction Questionnaire for Medication (TSQM). The TSQM is a validated tool that measures perception of four domains of treatment satisfaction: effectiveness, side effects, convenience, and global satisfaction. RESULTS: Patients in both treatment groups showed improvement from baseline for all four TSQM domains at 6 and 12 months. However, the denosumab group had significantly (all P < .001) greater improvements among all four TSQM domains at 6 and 12 months compared with the oral bisphosphonate group. CONCLUSIONS: Women with low adherence to oral bisphosphonates reported greater treatment satisfaction when transitioned to denosumab vs switching to a monthly oral bisphosphonate.