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Osteoporosis: HELP
Articles by Dr. Paul Miller
Based on 92 articles published since 2008
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Between 2008 and 2019, Paul Miller wrote the following 92 articles about Osteoporosis.
 
+ Citations + Abstracts
Pages: 1 · 2 · 3 · 4
1 Guideline AMERICAN ASSOCIATION OF CLINICAL ENDOCRINOLOGISTS AND AMERICAN COLLEGE OF ENDOCRINOLOGY CLINICAL PRACTICE GUIDELINES FOR THE DIAGNOSIS AND TREATMENT OF POSTMENOPAUSAL OSTEOPOROSIS - 2016. 2016

Camacho, Pauline M / Petak, Steven M / Binkley, Neil / Clarke, Bart L / Harris, Steven T / Hurley, Daniel L / Kleerekoper, Michael / Lewiecki, E Michael / Miller, Paul D / Narula, Harmeet S / Pessah-Pollack, Rachel / Tangpricha, Vin / Wimalawansa, Sunil J / Watts, Nelson B. · ·Endocr Pract · Pubmed #27662240.

ABSTRACT: ABBREVIATIONS: AACE = American Association of Clinical Endocrinologists AFF = atypical femur fracture ASBMR = American Society for Bone and Mineral Research BEL = best evidence level BMD = bone mineral density BTM = bone turnover marker CBC = complete blood count CI = confidence interval DXA = dual-energy X-ray absorptiometry EL = evidence level FDA = U.S. Food and Drug Administration FLEX = Fracture Intervention Trial (FIT) Long-term Extension FRAX

2 Guideline AMERICAN ASSOCIATION OF CLINICAL ENDOCRINOLOGISTS AND AMERICAN COLLEGE OF ENDOCRINOLOGY CLINICAL PRACTICE GUIDELINES FOR THE DIAGNOSIS AND TREATMENT OF POSTMENOPAUSAL OSTEOPOROSIS - 2016--EXECUTIVE SUMMARY. 2016

Camacho, Pauline M / Petak, Steven M / Binkley, Neil / Clarke, Bart L / Harris, Steven T / Hurley, Daniel L / Kleerekoper, Michael / Lewiecki, E Michael / Miller, Paul D / Narula, Harmeet S / Pessah-Pollack, Rachel / Tangpricha, Vin / Wimalawansa, Sunil J / Watts, Nelson B. · ·Endocr Pract · Pubmed #27643923.

ABSTRACT: ABBREVIATIONS: AACE = American Association of Clinical Endocrinologists AFF = atypical femur fracture ASBMR = American Society for Bone and Mineral Research BEL = best evidence level BMD = bone mineral density BTM = bone turnover marker CBC = complete blood count CI = confidence interval DXA = dual-energy X-ray absorptiometry EL = evidence level FDA = U.S. Food and Drug Administration FLEX = Fracture Intervention Trial (FIT) Long-term Extension FRAX(®) = Fracture Risk Assessment Tool GFR = glomerular filtration rate GI = gastrointestinal HORIZON = Health Outcomes and Reduced Incidence with Zoledronic Acid Once Yearly IOF = International Osteoporosis Foundation ISCD = International Society for Clinical Densitometry IU = international units IV = intravenous LSC = least significant change NBHA = National Bone Health Alliance NOF = National Osteoporosis Foundation 25(OH)D = 25-hydroxy vitamin D ONJ = osteonecrosis of the jaw PINP = serum carboxy-terminal propeptide of type I collagen PTH = parathyroid hormone R = recommendation RANK = receptor activator of nuclear factor kappa-B RANKL = receptor activator of nuclear factor kappa-B ligand RCT = randomized controlled trial RR = relative risk S-CTX = serum C-terminal telopeptide SQ = subcutaneous VFA = vertebral fracture assessment WHO = World Health Organization.

3 Guideline National Osteoporosis Foundation 2008 Clinician's Guide to Prevention and Treatment of Osteoporosis and the World Health Organization Fracture Risk Assessment Tool (FRAX): what they mean to the bone densitometrist and bone technologist. 2008

Watts, Nelson B / Lewiecki, E Michael / Miller, Paul D / Baim, Sanford. · ·J Clin Densitom · Pubmed #18562228.

ABSTRACT: -- No abstract --

4 Guideline Quantitative ultrasound in the management of osteoporosis: the 2007 ISCD Official Positions. 2008

Krieg, Marc-Antoine / Barkmann, Reinhart / Gonnelli, Stefano / Stewart, Alison / Bauer, Douglas C / Del Rio Barquero, Luis / Kaufman, Jonathan J / Lorenc, Roman / Miller, Paul D / Olszynski, Wojciech P / Poiana, Catalina / Schott, Anne-Marie / Lewiecki, E Michael / Hans, Didier. ·Lausanne University Hospital, Lausanne, Switzerland. marc-antoine.krieg@chuv.ch ·J Clin Densitom · Pubmed #18442758.

ABSTRACT: Dual-energy X-ray absorptiometry (DXA) is commonly used in the care of patients for diagnostic classification of osteoporosis, low bone mass (osteopenia), or normal bone density; assessment of fracture risk; and monitoring changes in bone density over time. The development of other technologies for the evaluation of skeletal health has been associated with uncertainties regarding their applications in clinical practice. Quantitative ultrasound (QUS), a technology for measuring properties of bone at peripheral skeletal sites, is more portable and less expensive than DXA, without the use of ionizing radiation. The proliferation of QUS devices that are technologically diverse, measuring and reporting variable bone parameters in different ways, examining different skeletal sites, and having differing levels of validating data for association with DXA-measured bone density and fracture risk, has created many challenges in applying QUS for use in clinical practice. The International Society for Clinical Densitometry (ISCD) 2007 Position Development Conference (PDC) addressed clinical applications of QUS for fracture risk assessment, diagnosis of osteoporosis, treatment initiation, monitoring of treatment, and quality assurance/quality control. The ISCD Official Positions on QUS resulting from this PDC, the rationale for their establishment, and recommendations for further study are presented here.

5 Editorial Bone Density Testing Is the Best Way to Monitor Osteoporosis Treatment. 2017

Rothman, Micol S / Lewiecki, E Michael / Miller, Paul D. ·University of Colorado School of Medicine, Department of Medicine, Division of Endocrinology, Diabetes and Metabolism,Aurora, Colo. Electronic address: Micol.Rothman@ucdenver.edu. · New Mexico Clinical Research & Osteoporosis Center,Albuquerque, NM. · Colorado Center for Bone Research,Lakewood, Colo. ·Am J Med · Pubmed #28687261.

ABSTRACT: -- No abstract --

6 Editorial Skeletal health and bone strength: DXA and beyond growth for the Journal of Clinical Densitometry. 2008

Miller, Paul D. · ·J Clin Densitom · Pubmed #18442748.

ABSTRACT: -- No abstract --

7 Review Western Osteoporosis Alliance Clinical Practice Series: Evaluating the Balance of Benefits and Risks of Long-Term Osteoporosis Therapies. 2017

Hanley, David A / McClung, Michael R / Davison, K Shawn / Dian, Larry / Harris, Steve T / Miller, Paul D / Lewiecki, E Michael / Kendler, David L / Anonymous7240901. ·Departments of Medicine, Oncology, and Community Health Sciences, Cumming School of Medicine, University of Calgary, Alberta, Canada. Electronic address: dahanley@ucalgary.ca. · Oregon Osteoporosis Center, Portland; Institute of Health and Ageing, Australian Catholic University, Melbourne, Australia. · A Priori Medical Sciences Inc, Victoria, BC, Canada. · Department of Medicine, University of British Columbia, Vancouver, Canada. · Department of Medicine, University of California, San Francisco. · Colorado Center for Bone Research, Lakewood. · New Mexico Clinical Research & Osteoporosis Center, Albuquerque. · Department of Medicine, University of British Columbia, Vancouver. ·Am J Med · Pubmed #28359721.

ABSTRACT: Osteoporosis is a chronic disease that requires life-long strategies to reduce fracture risk. Few trials have investigated the balance of benefits and risk with long-term use of osteoporosis therapies, and fewer still have investigated the consequences of treatment discontinuation. The best available evidence suggests that up to 10 years of treatment with an oral bisphosphonate maintains the degree of fracture risk reduction observed in the 3-year registration trials. With denosumab, 10 years of therapy appears to provide fracture risk reduction similar to or better than that observed in the 3-year registration trial. Available data suggest an increasing but low risk of fractures with atypical features with increasing duration of bisphosphonate therapy. Published data linking duration of therapy to osteonecrosis of the jaw are lacking for bisphosphonates and denosumab. Other side effects associated with denosumab or bisphosphonates do not appear to be related to therapy duration. The antifracture benefits of long-term therapy with bisphosphonates and denosumab in appropriately selected patients outweigh the low risk of serious side effects.

8 Review Effects of ospemifene on bone parameters including clinical biomarkers in postmenopausal women. 2016

Constantine, Ginger D / Kagan, Risa / Miller, Paul D. ·1EndoRheum Consultants, LLC, Malvern, PA 2Department of Obstetrics, Gynecology, and Reproductive Sciences, University of California San Francisco East Bay Physicians Medical Group affiliated with Sutter East Bay Medical Foundation, Berkeley, CA 3University of Colorado Health Sciences Center, Colorado Center for Bone Research, Lakewood, CO. ·Menopause · Pubmed #27045700.

ABSTRACT: OBJECTIVE: Ospemifene is an estrogen-receptor agonist/antagonist (also known as a selective estrogen-receptor modulator) that is FDA approved for the treatment of moderate-to-severe dyspareunia, a symptom of vulvovaginal atrophy, due to menopause. Preclinical and clinical data suggest that ospemifene may also have an effect on bone health in postmenopausal women. METHODS: Relevant articles, including cellular and preclinical studies and clinical trials written in English pertaining to ospemifene and bone health, were identified from a database search of PubMed (from its inception to June 2015) and summarized in this comprehensive review. RESULTS: In vitro data suggest that ospemifene may mediate a positive effect on bone through osteoblasts. Ospemifene effectively reduced bone loss and resorption in ovariectomized rats, with activity comparable to estradiol and raloxifene. Clinical data from three phase 1 or 2 clinical trials (2 placebo- and 1 raloxifene-controlled) found ospemifene 60 mg/d to have a positive effect on the biochemical markers for bone turnover in healthy, postmenopausal women with significant improvements relative to placebo and comparable to raloxifene. CONCLUSIONS: Ospemifene 60 mg/d may have a protective effect on the bone health of women being treated for dyspareunia. The initial clinical data for ospemifene follows a trend similar to raloxifene and bazedoxifene, suggesting that ospemifene may have bone-protective effects in postmenopausal women. However, additional rigorous clinical trials are necessary to confirm any positive effects ospemifene may have on vertebral fractures and bone mineral density in healthy and osteoporotic women.

9 Review Management of severe osteoporosis. 2016

Miller, Paul D. ·a University of Colorado Health Sciences Center , Colorado Center for Bone Research , Lakewood , CO , USA. ·Expert Opin Pharmacother · Pubmed #26605922.

ABSTRACT: INTRODUCTION: Severe osteoporosis represents a disease of high mortality and morbidity. Recognition of what constitutes and causes severe osteoporosis and aggressive intervention with pharmacological agents with evidence to reduce fracture risk are outlined in this review. AREAS COVERED: This review is a blend of evidence obtained from literature searches from PubMed and The National Library of Medicine (USA), clinical experience and the author's opinions. The review covers the recognition of what constitutes severe osteoporosis, and provides up-to-date references on this sub-set of high risk patients. EXPERT OPINION: Severe osteoporosis can be classified by using measurements of bone densitometry, identification of prevalent fractures, and, knowledge of what additional risk factors contribute to high fracture risk. Once recognized, the potential consequences of severe osteoporosis can be mitigated by appropriate selection of pharmacological therapies and modalities to reduce the risk for falling.

10 Review Bone disease in CKD: a focus on osteoporosis diagnosis and management. 2014

Miller, Paul D. ·University of Colorado Health Sciences Center, Colorado Center for Bone Research, Lakewood, CO. Electronic address: millerccbr@aol.com. ·Am J Kidney Dis · Pubmed #24726630.

ABSTRACT: Osteoporosis is defined as a condition of impairment in bone strength due to low bone mineral density and poor bone quality and predisposes individuals to an increased risk of fractures. Osteoporosis may coexist with chronic kidney disease-mineral and bone disorder (CKD-MBD) and osteoporotic fractures occur in all stages of CKD. Management of osteoporosis in CKD should consider the pathophysiology of both disorders. Diagnosis and management of osteoporosis in patients with stages 1-3 CKD and patients without CKD are similar, but diagnosis and management decisions differ greatly once patients have stages 4-5 CKD. Discriminating between osteoporosis and CKD-MBD is best accomplished with quantitative bone histomorphometry. Biochemical markers, especially intact parathyroid hormone and bone-specific alkaline phosphatase, also may be helpful. When the diagnosis of osteoporosis is established, management in stages 4-5 CKD may include antiresorptive or anabolic agents, though evidence for efficacy is marginal in advanced CKD.

11 Review PINP as a biological response marker during teriparatide treatment for osteoporosis. 2014

Krege, J H / Lane, N E / Harris, J M / Miller, P D. ·Lilly USA, Indianapolis, IN, USA. ·Osteoporos Int · Pubmed #24599274.

ABSTRACT: Postmenopausal women with severe osteoporosis may require treatment with the bone anabolic drug teriparatide. While changes in bone mineral density (BMD) are one measure of response, BMD changes often require a minimum of one year to observe measureable changes. Biochemical markers of bone turnover change within 1 to 3 months of initiating osteoporosis therapy. Monitoring with a marker such as procollagen type I N propeptide (PINP), an osteoblast-derived protein, during teriparatide treatment may provide clinically useful information for managing patients with osteoporosis. Clinical trials have shown consistent increases in PINP within 3 months of initiating teriparatide, increases that are significantly greater than placebo and significantly different from baseline. Increases in PINP concentrations during teriparatide treatment correlate well with increases in skeletal activity assessed by radioisotope bone scans and quantitative bone histomorphometry parameters. Individuals treated with teriparatide in clinical trials usually experienced an increase in PINP > 10 mcg/L from baseline, while those given placebo usually did not. In the clinical setting, patients experiencing a significant increase in PINP > 10 mcg/L after initiating teriparatide therapy may receive an earlier confirmation of anabolic effect, while those who do not may be assessed for adherence, proper injection technique, or undetected secondary conditions that might mitigate an anabolic response. PINP monitoring may provide information supplemental to BMD monitoring and be a useful aid in managing patients receiving anabolic osteoporosis treatment in the same way that biochemical markers of bone resorption are useful in monitoring antiresorptive therapy. This review examines PINP as a biological response marker during teriparatide treatment for osteoporosis.

12 Review Chronic Kidney Disease-Mineral and Bone Disorders (CKD-MBDs): What the Endocrinologist Needs to Know. 2014

Zangeneh, Farhad / Clarke, Bart L / Hurley, Daniel L / Watts, Nelson B / Miller, Paul D. ·Endocrine, Diabetes & Osteoporosis Clinic (EDOC), Sterling, VA. · Division of Endocrinology, Diabetes, Metabolism and Nutrition, Mayo Clinic, Rochester, Minnesota. · Mercy Health Osteoporosis and Bone Health Services, Cincinnati, Ohio. · Colorado Center for Bone Research, University of Colorado Health Sciences Center. ·Endocr Pract · Pubmed #24325991.

ABSTRACT: OBJECTIVE: Chronic kidney disease-mineral and bone disorders (CKD-MBDs) are a spectrum of abnormalities involving skeletal hormones, minerals, and bone turnover and mineralization. This paper focuses on what the endocrinologist should know about the assessment and management of skeletal and metabolic disorders in CKD-MBDs. METHODS: Relevant literature was reviewed to (1) define disturbances of minerals and hormones in the course of CKD; (2) identify the variable radiographic and histomorphometric changes of CKD-MBDs; (3) review the association among CKD-MBDs, vascular calcification, cardiovascular disease (CVD), and mortality; and (4) clarify issues in CKD-MBDs therapy. RESULTS: Assessment and treatment of CKD-MBDs is complicated by progressive changes in bone minerals and skeletal regulatory hormones as kidney function declines. CKD-MBDs are associated with fracture risk, and studies demonstrate that bone mineral density can be used to assess bone loss and fracture risk in these patients. Treatment of CKD-MBDs continues to evolve. Use of calcium, phosphate binders, vitamin D, vitamin D-receptor analogs, and drugs for osteoporosis and CKD-MBDs treatment are discussed in the context of safety and efficacy for patients with CKD. CONCLUSION: The association of CKD with bone disease, vascular calcification, CVD, and mortality mandates earlier recognition and treatment of CKD-MBDs. Osteoporosis as a distinct entity can be diagnosed and managed in CKD, although assessment of osteoporosis becomes challenging in late (stage 4 to 5) CKD. Diabetes is common in early (stage 1 to 3) CKD. In addition, 96% of all individuals identified as having CKD have early CKD. The endocrinologist is uniquely positioned to address and treat both diabetes and many of the metabolic and skeletal disorders associated with early CKD-MBDs, including osteoporosis.

13 Review Understanding and communicating the benefits and risks of denosumab, raloxifene, and teriparatide for the treatment of osteoporosis. 2014

Lewiecki, E Michael / Miller, Paul D / Harris, Steve T / Bauer, Douglas C / Davison, K Shawn / Dian, Larry / Hanley, David A / McClung, Michael R / Yuen, Chui K / Kendler, David L. ·New Mexico Clinical Research and Osteoporosis Center, Albuquerque, NM, USA. Electronic address: mlewiecki@gmail.com. · Colorado Center for Bone Research, Lakewood, CO, USA. · Department of General Internal Medicine, University of California, San Francisco, CA, USA. · Faculty of Graduate Studies, University of Victoria, British Columbia, Canada. · Prohealth Clinical Research, University of British Columbia, Vancouver Canada. · Department of Medicine, University of Calgary, Calgary, Canada. · Oregon Osteoporosis Center, Portland, OR, USA. ·J Clin Densitom · Pubmed #24206867.

ABSTRACT: The number needed to treat is a valuable metric to determine the benefit of therapy, but it must be viewed against the respective number needed to harm. Denosumab and teriparatide (TPTD) have proven antifracture efficacy at vertebral and nonvertebral sites, whereas raloxifene has proven antifracture efficacy at the spine only. Denosumab use has been associated with a small, yet statistically significant, increased incidence of eczema and serious cellulitis. Raloxifene use has been associated with statistically significant increases in the risk of venous thromboembolism and possibly deadly stroke, although not an increase in total strokes. No significant, nontransient adverse events have been reported with TPTD use. When used for the treatment of postmenopausal osteoporosis, denosumab, raloxifene, and TPTD all generally have favorable risk-to-benefit profiles, but therapy-specific contraindications necessitate thoughtful consideration of all available clinical information and individualization of treatment decisions.

14 Review 2013 International Society for Clinical Densitometry Position Development Conference: Task Force on Normative Databases. 2013

Watts, Nelson B / Leslie, William D / Foldes, A Joseph / Miller, Paul D. ·Mercy Health Osteoporosis and Bone Health Services, Cincinnati, OH, USA. Electronic address: nelson.watts@hotmail.com. ·J Clin Densitom · Pubmed #24076161.

ABSTRACT: Following the standard protocol for development of Official Positions for the International Society for Clinical Densitometry, the Expert Panel heard the report and recommendations from the Task Force on Normative Databases; using the RAND methodology, agreement was reached on the following statements: 1. Manufacturers should continue to use their own databases for the lumbar spine as the reference standard for T-scores. 2. Manufacturers should continue to use National Health and Nutrition Examination Survey III data as the reference standard for femoral neck and total hip T-scores. 3. If local reference data are available, they should be used to calculate only Z-scores but not T-scores. 4. A uniform Caucasian (non-race adjusted) female reference database should be used to calculate T-scores for men of all ethnic groups.

15 Review Renal safety in patients treated with bisphosphonates for osteoporosis: a review. 2013

Miller, Paul D / Jamal, Sophie A / Evenepoel, Pieter / Eastell, Richard / Boonen, Steven. ·Colorado Center for Bone Research, University of Colorado Health Sciences Center, Lakewood, CO, USA. ·J Bone Miner Res · Pubmed #23907861.

ABSTRACT: Bisphosphonates are widely used for the treatment of osteoporosis and are generally well tolerated. However, the United States Food and Drug Administration safety reports have highlighted the issue of renal safety in bisphosphonate-treated patients. All bisphosphonates carry labeled "warnings" or a contraindication for use in patients with severe renal impairment (creatinine clearance <30 or <35 mL/min). Data from pivotal trials and their extension studies of bisphosphonates approved for the management of osteoporosis were obtained via PubMed, and were reviewed with support from published articles available on PubMed. Renal safety analyses of pivotal trials of oral alendronate, risedronate, and ibandronate for postmenopausal osteoporosis showed no short-term or long-term effects on renal function. Transient postinfusion increases in serum creatinine have been reported in patients receiving intravenous ibandronate and zoledronic acid; however, studies showed that treatment with these agents did not result in long-term renal function deterioration in clinical trial patients with osteoporosis. All bisphosphonate therapies have "warnings" for use in patients with severe renal impairment. Clinical trial results have shown that even in elderly, frail, osteoporotic patients with renal impairment, intravenous bisphosphonate therapy administration in accordance with the prescribing information did not result in long-term renal function decline. Physicians should follow guidelines for bisphosphonate therapies administration at all times.

16 Review Osteoporosis update from the 2012 Santa Fe Bone Symposium. 2013

Lewiecki, E Michael / Adler, Robert A / Bilezikian, John P / Bouxsein, Mary L / Marcus, Robert / McClung, Michael R / Miller, Paul D / Tanner, S Bobo / Randall, Susan. ·New Mexico Clinical Research & Osteoporosis Center, Albuquerque, NM, USA. Electronic address: mlewiecki@gmail.com. ·J Clin Densitom · Pubmed #23419827.

ABSTRACT: The core of the 2012 Santa Fe Bone Symposium consisted of plenary presentations on new developments in the fields of osteoporosis and metabolic bone disease, with a focus on current and future implications for patient care. These were complemented by oral abstracts, interactive discussions of challenging cases, a debate on benefits and risks of long-term bisphosphonate therapy, and a panel discussion of controversial issues in the management of osteoporosis. Other topics included a review of the most important scientific publications in the past year, new and emerging therapy for osteoporosis, the benefits and limitations of clinical practice guidelines in the care of individual patients, the effects of metallic elements on skeletal health, clinical applications of bone turnover markers, an engineering perspective of skeletal health and disease, and an update on the role of the International Society for Clinical Densitometry in education, certification, accreditation, and advocacy for high-quality bone density testing. The symposium was highlighted by an inaugural presentation of "2 Million 2 Many," a national campaign of the National Bone Health Alliance to increase awareness of osteoporosis.

17 Review Bisphosphonate therapy for osteoporosis: benefits, risks, and drug holiday. 2013

McClung, Michael / Harris, Steven T / Miller, Paul D / Bauer, Douglas C / Davison, K Shawn / Dian, Larry / Hanley, David A / Kendler, David L / Yuen, Chui Kin / Lewiecki, E Michael. ·Oregon Osteoporosis Center, Portland, OR 97213, USA. mmcclung@orost.com ·Am J Med · Pubmed #23177553.

ABSTRACT: The amino-bisphosphonates are first-line therapy for the treatment of most patients with osteoporosis, with proven efficacy to reduce fracture risk at the spine, hip, and other nonvertebral skeletal sites. Further, bisphosphonates have been associated with a significant decrease in morbidity and increase in survival. Following the use of bisphosphonates in millions of patients in clinical practice, some unexpected possible adverse effects have been reported, including osteonecrosis of the jaw, atypical femur fractures, atrial fibrillation, and esophageal cancer. Because bisphosphonates are incorporated into the skeleton and continue to exert an antiresorptive effect for a period of time after dosing is discontinued, the concept of a drug holiday has emerged, whereby the risk of adverse effects might be decreased while the patient still benefits from antifracture efficacy. Patients receiving bisphosphonates who are not at high risk for fracture are potential candidates for a drug holiday, while for those with bone mineral density in the osteoporosis range or previous history of fragility fracture, the benefits of continuing therapy probably far outweigh the risk of harm.

18 Review Unrecognized and unappreciated secondary causes of osteoporosis. 2012

Miller, Paul D. ·Colorado Center for Bone Research, 3190 South Wadsworth Boulevard, Lakewood, CO 80227, USA. millerccbr@aol.com ·Endocrinol Metab Clin North Am · Pubmed #22877432.

ABSTRACT: There are a substantial number of secondary causes of osteoporosis that can be identified through appropriate evaluation. Unrecognized celiac disease, Monoclonal gamopathy of undetermined significance (MGUS), impaired renal function, diabetes mellitus, and renal tubular acidosis are just a few of the more common secondary causes of osteoporosis. Through targeted laboratory tests, many secondary causes of osteoporosis can be identified.

19 Review Benefits and risks of bisphosphonate therapy for osteoporosis. 2012

Khosla, Sundeep / Bilezikian, John P / Dempster, David W / Lewiecki, E Michael / Miller, Paul D / Neer, Robert M / Recker, Robert R / Shane, Elizabeth / Shoback, Dolores / Potts, John T. ·College of Medicine, Mayo Clinic, 200 First Street SW, Rochester, Minnesota 55905, USA. khosla.sundeep@mayo.edu ·J Clin Endocrinol Metab · Pubmed #22523337.

ABSTRACT: CONTEXT: There has been considerable concern recently in the scientific and lay media regarding the benefits vs. the risks of bisphosphonates for the treatment of osteoporosis. Risks include possible associations with osteonecrosis of the jaw (ONJ) and atypical femur fractures. In this perspective, we review the use of bisphosphonates for the treatment of osteoporosis, including an objective assessment of the risks vs. the benefits of these drugs. EVIDENCE ACQUISITION: Authors' knowledge of the field and results of focused literature searches are presented. EVIDENCE SYNTHESIS: Bisphosphonates have proven efficacy in the prevention of bone loss and in the reduction of fractures in postmenopausal women and men with established osteoporosis. Although bisphosphonates, at doses used to treat osteoporosis, may be associated with an increased risk of ONJ and atypical femur fractures, many more fractures are prevented by the use of these drugs compared to the relatively low risk of these complications. Although oral bisphosphonates are associated with upper gastrointestinal side effects and iv bisphosphonates with acute phase reactions, the association of bisphosphonate use with esophageal cancer and atrial fibrillation is not well supported by current data. CONCLUSIONS: Bisphosphonates have been proven to prevent fractures in patients with established osteoporosis or those who are at high risk of fracture. In contrast, the incidence of major complications associated with bisphosphonate use, such as ONJ and atypical femur fractures, is very low.

20 Review Postmenopausal osteoporosis treatment with antiresorptives: effects of discontinuation or long-term continuation on bone turnover and fracture risk--a perspective. 2012

Boonen, Steven / Ferrari, Serge / Miller, Paul D / Eriksen, Erik F / Sambrook, Philip N / Compston, Juliet / Reid, Ian R / Vanderschueren, Dirk / Cosman, Felicia. ·Leuven University Center for Metabolic Bone Diseases, Katholieke Universiteit Leuven, Leuven, Belgium. ·J Bone Miner Res · Pubmed #22467094.

ABSTRACT: Osteoporosis may be a lifelong condition. Robust data regarding the efficacy and safety of both long-term osteoporosis therapy and therapy discontinuation are therefore important. A paucity of clinical trial data regarding the long-term antifracture efficacy of osteoporosis therapies necessitates the use of surrogate endpoints in discussions surrounding long-term use and/or discontinuation. Long-term treatment (beyond 3-4 years) may produce further increases in bone mineral density (BMD) or BMD stability, depending on the specific treatment and the skeletal site. Bisphosphonates, when discontinued, are associated with a prolonged reduction in bone turnover markers (BTMs), with a very gradual increase to pretreatment levels within 3 to 60 months of treatment cessation, depending on the bisphosphonate used and the prior duration of therapy. In contrast, with nonbisphosphonate antiresorptive agents, such as estrogen and denosumab, BTMs rebound to above pretreatment values within months of discontinuation. The pattern of BTM change is generally mirrored by a more or less rapid decrease in BMD. Although the prolonged effect of some bisphosphonates on BTMs and BMD may contribute to residual benefit on bone strength, it may also raise safety concerns. Adequately powered postdiscontinuation fracture studies and conclusive evidence on maintenance or loss of fracture benefit is lacking for bisphosphonates. Similarly, the effects of rapid reversal of bone turnover upon discontinuation of denosumab on fracture risk remain unknown. Ideally, studies evaluating the effects of long-term treatment and treatment discontinuation should be designed to provide head-to-head "offset" data between bisphosphonates and nonbisphosphonate antiresorptive agents. In the absence of this, a clinical recommendation for physicians may be to periodically assess the benefits/risks of continuation versus discontinuation versus alternative management strategies.

21 Review Bone and kidney disease: diagnostic and therapeutic implications. 2012

Jamal, Sophie A / West, Sarah L / Miller, Paul D. ·University of Toronto, Women's College Hospital, Ontario, Canada. sophie.jamal@utoronto.ca ·Curr Rheumatol Rep · Pubmed #22350608.

ABSTRACT: Fractures are common in patients with chronic kidney disease (CKD), but the diagnosis and treatment of bone disease in CKD are difficult due to the multiple etiologies of bone disease in these patients. Noninvasive imaging, including bone mineral density by dual energy x-ray absorptiometry, can be useful in diagnosing osteoporosis in predialysis CKD; however, consensus on the diagnosis of osteoporosis among those with advanced CKD-particularly stage 5 CKD patients on dialysis-is lacking. Treatments approved for osteoporosis in postmenopausal women may be used in patients with stage 1 to 3 CKD. Furthermore, post-hoc analyses show efficacy and safety of oral bisphosphonates, raloxifene, and denosumab in stage 4 CKD for short-term treatment. However, treatment decisions are more difficult in stage 5 CKD. Bone biopsy may be required, and most treatments, if used, would be off label. Overall, the diagnosis and treatment of bone disease in patients with CKD require further research.

22 Review Fracture risk assessment in patients with chronic kidney disease. 2012

Jamal, S A / West, S L / Miller, P D. ·Department of Medicine, University of Toronto, Toronto, ON, Canada. sophie.jamal@utoronto.ca ·Osteoporos Int · Pubmed #21901475.

ABSTRACT: Fractures are common in patients with chronic kidney disease (CKD) and associated with substantially high morbidity and mortality. Bone mass measurements are commonly used to assess fracture risk in the general population, but the utility of these measurements in patients with CKD, and specifically among those on hemodialysis, is unclear. This review will outline the epidemiology and etiology of fractures in patients with CKD with a particular emphasis on men and women on hemodialysis. As well, we will summarize the published data, which describes the association between risk factors for fracture (including bone mass measurements, biochemical markers of mineral metabolism, and muscle strength) and fractures in patients with CKD. Patients with CKD suffer from fractures due to impairments in bone quantity, bone quality, and abnormalities of neuromuscular function. There is a paucity of evidence on the associations between bone quality, bone turnover markers, neuromuscular function, and fractures in patients with CKD. Furthermore, the complex etiology of fractures combined with the technical limitations of bone mineral density testing, both by dual energy X-ray absorptiometry (DXA) and by peripheral quantitative tomography (pQCT), limits the clinical utility of bone mass measurements for fracture prediction in CKD; this is particularly true among patients with stages 4 and 5 CKD. Further prospective studies to identify noninvasive measures of bone strength that can be used for fracture risk assessment are needed.

23 Review Osteoporosis update from the 2010 santa fe bone symposium. 2011

Lewiecki, E Michael / Bilezikian, John P / Khosla, Sundeep / Marcus, Robert / McClung, Michael R / Miller, Paul D / Watts, Nelson B / Maricic, Michael. ·New Mexico Clinical Research & Osteoporosis Center, Albuquerque, NM 87106, USA. lewiecki@aol.com ·J Clin Densitom · Pubmed #21295739.

ABSTRACT: The 11th Santa Fe Bone Symposium was held in Santa Fe, NM, USA, on August 6-7, 2010. This annual event addresses clinically relevant advances in the fields of osteoporosis and metabolic bone disease. The venue includes plenary presentations by internationally recognized experts, oral presentations of abstracts, and interactive panel discussions of challenging cases and controversial issues. Attendees are active participants throughout the symposium program. Topics for the 2010 symposium included potential applications of novel technologies for the assessment of skeletal health for research and clinical practice; new and emerging treatments for osteoporosis; appropriate use of pharmacological agents to prevent osteoporosis; controversies with bisphosphonate therapy; practical applications of the World Health Organization fracture risk assessment tool (FRAX; World Health Organization Collaborating Centre for Metabolic Bone Diseases, University of Sheffield, UK); insights into the use of osteoanabolic agents to enhance fracture healing; and challenges in laboratory testing in the assessment of factors contributing to skeletal fragility. Concurrent sessions focused on critical thinking for technologists in the acquisition and analysis of data with dual-energy X-ray absorptiometry. The key messages from each presentation, including the best available medical evidence and potential current and future clinical applications, are provided here.

24 Review The kidney and bisphosphonates. 2011

Miller, Paul D. ·University of Colorado Health Sciences Center, Colorado Center for Bone Research, Lakewood, 80227, USA. millerccbr@aol.com ·Bone · Pubmed #21232648.

ABSTRACT: Bisphosphonates are eliminated from the human body by the kidney. Renal clearance is both by glomerular filtration and proximal tubular secretion. Bisphosphonates given rapidly in high doses in animal models have induced a variety of adverse renal effects, from glomerular sclerosis to acute tubular necrosis. Nevertheless in the doses that are registered for the management of postmenopausal osteoporosis (PMO), oral bisphosphonates have never been shown to adversely affect the kidney, even (in post-hoc analysis of clinical trial data) down to estimated glomerular filtration rates of 15 ml/min. In addition fracture risk reduction has also been observed in these populations with stage 4 chronic kidney disease (CKD) with age-related reductions in glomerular filtration rate (GFR). Intravenous zoledronic acid is safe when the infusion rate is no faster than 15 min though there have been short-term (days 9-11 post-infusion) increases in serum creatinine concentrations in a small sub-set of patients from the postmenopausal registration trials. For these reasons intravenous zoledronic acid should be avoided in patients with GFR levels <35 ml/min; and the patients should be well hydrated and have avoided the concomitant use of any agent that may impair renal function. Intravenous ibandronate has not to date been reported to induce acute changes in serum creatinine concentrations in the PMO clinical trial data, but the lack of head-to-head comparative data between ibandronate and zoledronic acid precludes knowing if one intravenous bisphosphonate is safer than the other. In patients with GFR levels <30-35 ml/min, the correct diagnosis of osteoporosis becomes more complex since other forms of renal bone disease, which require different management strategies than osteoporosis, need to be excluded before the assumption can be made that fractures and/or low bone mass are due to osteoporosis. In addition, in patients who may have pre-existing adynamic renal bone disease, there is a lack of evidence of any beneficial effect or harm by reducing bone turnover by any pharmacological agent, including bisphosphonates on bone strength or vascular calcification. Bisphosphonates are safe and effective for the management of osteoporosis when used in the right dose and in the right patient population for the right duration.

25 Review What is the best balance of benefits and risks among anti-resorptive therapies for postmenopausal osteoporosis? 2010

Miller, P D / Derman, R J. ·Colorado Center for Bone Research, 3190 South Wadsworth Blvd, Lakewood, CO 80227, USA. MillerCCBR@aol.com ·Osteoporos Int · Pubmed #20309524.

ABSTRACT: Pharmacologic osteoporosis therapy, particularly anti-resorptives, is recommended in postmenopausal women with clinical risk factors for fracture. Treatment decisions should be made based on the relative benefit-risk profile in different patient populations. Emerging options [e.g., selective estrogen receptor modulators (SERMs) and denosumab] may hold promise for providing protection from bone loss and for fracture risk reduction.Osteoporosis, the most common clinical disorder of bone metabolism, is characterized by low bone mineral density, deterioration of microarchitecture, and a consequent increase in bone fragility and risk of fracture. Pharmacologic therapy is recommended in postmenopausal women with clinical risk factors for fracture and includes anti-resorptive agents such as bisphosphonates, hormone therapy, SERMs, and calcitonin. The anabolic agent teriparatide (parathyroid hormone) is usually reserved for high-risk patients or those with glucocorticoid-induced osteoporosis. Strontium ranelate, available outside the USA, has both anti-resorptive and anabolic properties. Supplementation with calcium and vitamin D is recommended for all women aged 50 years and older. Bisphosphonates are often considered first-line therapy for osteoporosis and have the largest base of clinical trial data showing efficacy for global fracture risk reduction. Low-dose hormone therapy is appropriate for younger women who are experiencing other menopausal symptoms. In women for whom bisphosphonates are not appropriate or not tolerated or in younger postmenopausal women who have a low risk for hip fracture, SERMs are a suitable treatment option. Calcitonin is designated for patients who are unable or unwilling to tolerate other osteoporosis agents. Emerging options, including newer SERMs (e.g., bazedoxifene and lasofoxifene) and the monoclonal antibody denosumab, may hold promise for providing protection from bone loss and for fracture risk reduction. Because no single agent is appropriate for all patients, treatment decisions should be made on an individual basis, taking into account the relative benefits and risks in different patient populations.

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