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Osteoporosis: HELP
Articles by Gerd Möller
Based on 3 articles published since 2008

Between 2008 and 2019, Gerd Möller wrote the following 3 articles about Osteoporosis.
+ Citations + Abstracts
1 Article Denosumab treatment in postmenopausal women with osteoporosis does not interfere with fracture-healing: results from the FREEDOM trial. 2012

Adami, Silvano / Libanati, Cesar / Boonen, Steven / Cummings, Steven R / Ho, Pei-Ran / Wang, Andrea / Siris, Ethel / Lane, Joseph / Anonymous3440740 / Adachi, Jonathan D / Bhandari, Mohit / de Gregorio, Luiz / Gilchrist, Nigel / Lyritis, George / Möller, Gerd / Palacios, Santiago / Pavelka, Karel / Heinrich, Resch / Roux, Christian / Uebelhart, Daniel. ·Faculty of Medicine & Surgery, University of Verona, P. le Scuro 10, 37134, Verona, Italy. ·J Bone Joint Surg Am · Pubmed #23097066.

ABSTRACT: BACKGROUND: Fracture is the major complication of osteoporosis, and it allows the identification of individuals needing medical intervention for osteoporosis. After nonvertebral fracture, patients often do not receive osteoporosis medical treatment despite evidence that this treatment reduces the risk of subsequent fracture. In this pre planned analysis of the results of the three-year, placebo-controlled FREEDOM trial, we evaluated the effect of denosumab administration on fracture-healing to address theoretical concerns related to initiating or continuing denosumab therapy in patients presenting with a nonvertebral fracture. METHODS: Postmenopausal women aged sixty to ninety years with osteoporosis were randomized to receive 60 mg of denosumab (n = 3902) or a placebo (n = 3906) subcutaneously every six months for three years. Investigators reported complications associated with a fracture or its management and with fracture-healing for all nonvertebral fractures that occurred during the study. Delayed healing was defined as incomplete fracture-healing six months after the fracture. RESULTS: Six hundred and sixty-seven subjects (303 treated with denosumab and 364 who received a placebo) had a total of 851 nonvertebral fractures (386 in the denosumab group and 465 in the placebo group), including 199 fractures (seventy-nine in the denosumab group and 120 in the placebo group) that were treated surgically. Delayed healing was reported in seven subjects (two in the denosumab group and five in the placebo group), including one with subsequent nonunion (in the placebo group). Neither delayed healing nor nonunion was observed in any subject who had received denosumab within six weeks preceding or following the fracture. A complication associated with the fracture or intervention occurred in five subjects (2%) and twenty subjects (5%) in the denosumab and placebo groups,respectively (p = 0.009). CONCLUSIONS: Denosumab in a dose of 60 mg every six months does not seem to delay fracture-healing or contribute to other complications, even when it is administered at or near the time of the fracture.

2 Article Differences in persistence, safety and efficacy of generic and original branded once weekly bisphosphonates in patients with postmenopausal osteoporosis: 1-year results of a retrospective patient chart review analysis. 2009

Ringe, Johann D / Möller, Gerd. ·Medizinische Klink IV, Klinikum Leverkusen, University of Cologne, 51375 Leverkusen, Germany. ringe@klinikum-lev.de ·Rheumatol Int · Pubmed #19430791.

ABSTRACT: The objective of this study was to compare the changes on bone mineral density, and the effects on persistence and adverse events in patients treated for postmenopausal osteoporosis with generic alendronate or with branded alendronate (Fosamax®) or branded risedronate (Actonel®) once weekly. In this retrospective patient chart analysis, we reviewed the 1-year observational treatment results for 186 women (ITT population) with postmenopausal osteoporosis. Patients from our outpatient department, who had started with once-weekly bisphosphonate therapy between 36 and at least 12 months before this chart review, were included in this comparative three-arm study according to their treatment: A, Generic Alendonate 70 mg products; B, Branded Alendronate (Fosamax®) 70 mg once weekly and C, Branded Risedronate (Actonel®) 35 mg once weekly. All patients received basic therapy with 1,200 mg calcium and 800 IU vitamin D per day. Patient’s bone mineral density (BMD) at lumbar spine and total hip was below −2.5 T-score, and they were with or without prevalent vertebral and non-vertebral fractures. Data analysis regarding the 186 patients shows an average increase in LS-BMD after 12 months of 2.8, 5.2 and 4.8% for the groups A, B and C, respectively. The respective mean changes at total hip were 1.5, 2.9, and 3.1%. At both sites, the mean increases in BMD were not different between the two groups receiving branded bisphosphonates (B, C) but for both were significantly higher than for the group treated with generic alendronate (A). At 12 months, 68% of group A, 84% of group B and 94% of group C were still on bisphosphonate therapy. The persistence of patients treated with generic alendronate was significantly lower as compared to each of the two with branded bisphosphonate-treated groups. The total numbers of patients reporting gastrointestinal adverse events were 32, 15 and 9 for group A, group B, and group C, respectively. Significantly lower increases of lumbar spine and total hip BMD with generic alendronate once weekly as compared to the two branded bisphosphonate originals (Fosamax®, Actonel®) were observed. The reasons for the 40–50% lower BMD increase rates when using the generic compounds are not known yet. At least in part the lower efficacy can be explained by a significantly lower degree of persistence with generic alendronate, which could be related to a higher incidence of gastrointestinal adverse events. Other reasons could be lower bioavailability or potency of generic alendronate.

3 Article Value of a new fixed-combination pack of bisphosphonate, calcium and vitamin D in the therapy of osteoporosis: results of two quantitative patient research studies. 2009

Ringe, Johann D / Fardellone, Patrice / Kruse, Hans-Peter / Amling, Michael / van der Geest, Stefan A P / Möller, Gerd. ·Medizinische Klink IV, Klinikum Leverkusen, Teaching Hospital of the University of Cologne, Leverkusen, Germany. ringe@klinikum-lev.de ·Drugs Aging · Pubmed #19358619.

ABSTRACT: BACKGROUND: Osteoporotic patients with insufficient calcium intake and/or vitamin D insufficiency need adequate calcium and vitamin D supplementation with their bisphosphonate treatment. However, consistent intake and, therefore, the effectiveness of calcium/vitamin D supplementation may be impaired by several factors in the individual patient: low prescription rate or lack of advice to purchase calcium/vitamin D; reduced compliance because of the complexity of the regimen; or incorrect intake. There is a need to provide patients with a better way of taking bisphosphonate treatment with their calcium/vitamin D supplementation. To this end, a fixed-combination pack to help patients take the combination of bisphosphonate, calcium and vitamin D correctly and regularly has been developed. OBJECTIVE: To evaluate patients' understanding of administration instructions, preferences and their perceptions of compliance, convenience and completeness of a fixed-combination pack of bisphosphonate, calcium and vitamin D compared with those associated with separate packs. METHODS: The new monthly fixed-combination pack of bisphosphonate, calcium and vitamin D contains four weekly boxes. Each box contains a blister pack with one swallowable risedronate 35 mg film-coated tablet and six sachets of calcium/vitamin D effervescent granules (calcium 1000 mg and vitamin D(3) [colecalciferol] 880 IU) for dissolution in water as an oral solution, together constituting 1 week of therapy, accompanied by a patient information leaflet. Two quantitative patient research survey studies were conducted using standard questionnaires in face-to-face interviews with 400 postmenopausal women in several French cities. Participants were given the combined pack and two separate packs (risedronate 35 mg once weekly and calcium/vitamin D effervescent granules in sachets). In the first study, participants' understanding of administration instructions and preferences were evaluated. In the second study, participants' perception of compliance, convenience and completeness of the new combination pack of risedronate 35 mg plus calcium/vitamin D compared with two separate packs were evaluated. RESULTS: Participants asked about the combined pack answered a significantly higher proportion of questions about intake instructions correctly (80.3%) than participants asked about the two separate packs (70.7%) [p = 0.0004]. The combined pack was preferred by 72% of participants (p < 0.0001) for several reasons. Compared with separate packs, the combined pack was considered easier to use by 63% and easier to remember to use by 67% of participants. Participants believed that use of the combined pack would be more likely to help them take their bisphosphonate regularly (66%) and correctly (67%), and to take their calcium/vitamin D supplementation more regularly and correctly (68%), than use of separate packs. Seventy percent of participants believed that use of the combination pack would help them to not forget to take calcium/vitamin D supplementation. CONCLUSION: Use of the fixed-combination pack of risedronate 35 mg plus calcium/vitamin D once weekly could increase the likelihood that postmenopausal osteoporotic patients will receive a complete bisphosphonate, calcium and vitamin D therapy course and is likely to enhance correct intake of combination therapy. Use of this fixed-combination product will provide patients with a tool for improving adherence to recommended osteoporosis therapy and optimize the effectiveness of such treatment.