Eighteen Months of Treatment With Subcutaneous Abaloparatide Followed by 6 Months of Treatment With Alendronate in Postmenopausal Women With Osteoporosis

Cosman, Felicia; Miller, Paul D.; Williams, Gregory C.; Hattersley, Gary; Hu, Ming‐yi; Valter, Ivo; Fitzpatrick, Lorraine A.; Riis, Bente Juel; Christiansen, Claus; Bilezikian, John P.; Black, Dennis M.

doi:10.1016/j.mayocp.2016.10.009

Cited by 104 publications

(70 citation statements)

References 34 publications

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“…It is interesting to note that the BMD increments found with 18 months of Dmab treatment after 18 months of TPTD were quite large, especially in the spine and total hip. These BMD gains appear larger than those found in other studies when alendronate is administered after teriparatide or abaloparatide . Several other studies suggest that Dmab treatment enhances BMD gain after TPTD to a greater degree than bisphosphonates .…”

Section: Discussionmentioning

confidence: 52%

“…These BMD gains appear larger than those found in other studies when alendronate is administered after teriparatide (24) or abaloparatide. (25,26) Several other studies suggest that Dmab treatment enhances BMD gain after TPTD to a greater degree than bisphosphonates. (22,27,28) The explanation is likely due to a more potent antiresorptive effect of Dmab compared with bisphosphonates.…”

Section: Discussionmentioning

confidence: 99%

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Standard Versus Cyclic Teriparatide and Denosumab Treatment for Osteoporosis: A Randomized Trial

Cosman

McMahon

Dempster

et al. 2019

Journal of Bone and Mineral Research

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In the absence of an intervening antiresorptive agent, cyclic administration of teriparatide does not increase bone mineral density (BMD) more than standard daily therapy. Because denosumab is a potent antiresorptive agent with a rapid off‐effect, we hypothesized that it might be the optimal agent to help maximize bone gains with cyclic teriparatide. In this 3‐year protocol, 70 postmenopausal women with osteoporosis were randomized to 18 months of teriparatide followed by 18 months of denosumab (standard) or three separate 12‐month cycles of 6 months of teriparatide followed by 6 months of denosumab (cyclic). BMD (dual‐energy X‐ray absorptiometry [DXA]) measurements of lumbar spine (LS), total hip (TH), femoral neck (FN), and 1/3 radius (RAD) were performed every 6 months and total body bone mineral (TBBM) at 18 and 36 months. Baseline descriptive characteristics did not differ between groups except for a minimal difference in LS BMD but not T‐score (mean age 65 years, mean LS T‐score − 2.7). In the standard group, BMD increments at 36 months were: LS 16%, TH 4%, FN 3%, and TBBM 4.8% (all p < 0.001 versus baseline). In the cyclic group, 36‐month BMD increments were similar: LS 12%, TH 4%, FN 4%, and TBBM 4.1% (all p < 0.001 versus baseline). At 36 months, the LS BMD increase with standard was slightly larger than with cyclic (p = 0.04), but at 18 months, in the cyclic group, there was no decline in RAD or TBBM (p = 0.007 and < 0.001, respectively, versus standard). Although the cyclic regimen did not improve BMD compared with standard at 36 months, there appeared to be a benefit at 18 months, especially in the highly cortical skeletal sites. This could be clinically relevant in patients at high imminent risk of fracture, particularly at nonvertebral sites. © 2019 American Society for Bone and Mineral Research. © 2019 American Society for Bone and Mineral Research.

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Section: Discussionmentioning

confidence: 52%

Section: Discussionmentioning

confidence: 99%

Standard Versus Cyclic Teriparatide and Denosumab Treatment for Osteoporosis: A Randomized Trial

Cosman

McMahon

Dempster

et al. 2019

Journal of Bone and Mineral Research

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“…(43) Similarly, patients who have been treated with 18 months of abaloparatide experience further BMD gains and maintain a fracture-reduction benefit when switched to 6 months of alendronate (extended to 24 months in an unpublished abstract). (63) Finally, the effects of antiresorptive therapy after romosozumab has also been studied in large randomized trails with both alendronate and denosumab demonstrating the capacity to both increase BMD and maintain antifracture efficacy. (28,32) Taken together, these studies strongly suggest that antiresorptive drugs routinely be prescribed when a course of anabolic therapy is concluded.…”

Section: Antiresorptive Therapiesmentioning

confidence: 99%

“…Moreover, denosumab was also able to further increase BMD in patients who previously received 2 years of combined teriparatide/denosumab therapy . Similarly, patients who have been treated with 18 months of abaloparatide experience further BMD gains and maintain a fracture‐reduction benefit when switched to 6 months of alendronate (extended to 24 months in an unpublished abstract) . Finally, the effects of antiresorptive therapy after romosozumab has also been studied in large randomized trails with both alendronate and denosumab demonstrating the capacity to both increase BMD and maintain antifracture efficacy .…”

Section: Introductionmentioning

confidence: 98%

Optimizing Sequential and Combined Anabolic and Antiresorptive Osteoporosis Therapy

Leder

2018

JBMR Plus

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As osteoporosis therapy options have expanded, and clinical guidelines have begun to embrace the concept of limited treatment courses and “drug holidays,” the choices that physicians must make when initiating, electing to continue, or switching therapies have become more complex. As a result, one of the fundamental issues that must be carefully considered is whether, when, and in what sequence anabolic therapies should be utilized. This review evaluates the current evidence supporting the optimal sequence for the use of anabolic and antiresorptive drugs and assesses the expanding number of clinical trials favoring the initial use of anabolic therapy followed by an antiresorptive agent. This review also explores the evidence suggesting that the effectiveness of anabolic medications are diminished when used in patients that have been previously treated with specific antiresorptive drugs for prolonged periods. Finally, the recent advances in designing combination antiresorptive/anabolic treatment approaches are detailed, with a focus on combined denosumab/teriparatide regimens, which appear to provide the most substantial and clinically relevant skeletal benefits to patients with established osteoporosis. © 2018 The Authors. JBMR Plus is published by Wiley Periodicals, Inc. on behalf of the American Society for Bone and Mineral Research.

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“…Incorporating emerging evidence about osteoporosis and osteoporosis treatment in a new economic guideline is therefore important. Recent evidence includes the development of new osteoporosis treatments (e.g., abaloparatide [21] and romosozumab [22]), the value of sequential therapy [23, 24], effect after treatment discontinuation [25], new data about imminent risk after fractures [26], and the worldwide increase in the use of fracture risk algorithm such as FRAX® [27]. …”

Section: Introductionmentioning

confidence: 99%

Recommendations for the conduct of economic evaluations in osteoporosis: outcomes of an experts’ consensus meeting organized by the European Society for Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (ESCEO) and the US branch of the International Osteoporosis Foundation

et al. 2018

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SummaryEconomic evaluations are increasingly used to assess the value of health interventions, but variable quality and heterogeneity limit the use of these evaluations by decision-makers. These recommendations provide guidance for the design, conduct, and reporting of economic evaluations in osteoporosis to improve their transparency, comparability, and methodologic standards.IntroductionThis paper aims to provide recommendations for the conduct of economic evaluations in osteoporosis in order to improve their transparency, comparability, and methodologic standards.MethodsA working group was convened by the European Society for Clinical and Economic Aspects of Osteoporosis and Osteoarthritis to make recommendations for the design, conduct, and reporting of economic evaluations in osteoporosis, to define an osteoporosis-specific reference case to serve a minimum standard for all economic analyses in osteoporosis, to discuss methodologic challenges and initiate a call for research. A literature review, a face-to-face meeting in New York City (including 11 experts), and a review/approval by a larger group of experts worldwide (including 23 experts in total) were conducted.ResultsRecommendations on the type of economic evaluation, methods for economic evaluation, modeling aspects, base-case analysis and population, excess mortality, fracture costs and disutility, treatment characteristics, and model validation were provided. Recommendations for reporting economic evaluations in osteoporosis were also made and an osteoporosis-specific checklist was designed that includes items to report when performing an economic evaluation in osteoporosis. Further, 12 minimum criteria for economic evaluations in osteoporosis were identified and 12 methodologic challenges and need for further research were discussed.ConclusionWhile the working group acknowledges challenges and the need for further research, these recommendations are intended to supplement general and national guidelines for economic evaluations, improve transparency, quality, and comparability of economic evaluations in osteoporosis, and maintain methodologic standards to increase their use by decision-makers.

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Eighteen Months of Treatment With Subcutaneous Abaloparatide Followed by 6 Months of Treatment With Alendronate in Postmenopausal Women With Osteoporosis

Abstract: clinicaltrials.gov Identifier: NCT01657162.

Cited by 104 publications

References 34 publications

Standard Versus Cyclic Teriparatide and Denosumab Treatment for Osteoporosis: A Randomized Trial

Standard Versus Cyclic Teriparatide and Denosumab Treatment for Osteoporosis: A Randomized Trial

Optimizing Sequential and Combined Anabolic and Antiresorptive Osteoporosis Therapy

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