Monthly oral ibandronate therapy in postmenopausal osteoporosis: 1-year results from the MOBILE study.
Paul D. Miller,Michael R. McClung,Liviu Macovei,J. A. Stakkestad,Marjorie M. Luckey,B. Bonvoisin,Jean-Yves Reginster,Robert R. Recker,C. Hughes,E. Michael Lewiecki,Dieter Felsenberg,Pierre D. Delmas,David L. Kendler,M. A. Bolognese,N. Mairon,Cyrus Cooper +15 more
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TLDR
Once‐monthly (50/50, 100, and 150 mg) and daily (2.5 mg; 3‐year vertebral fracture risk reduction: 52%) oral ibandronate regimens were compared in 1609 women with postmenopausal osteoporosis.Abstract:
Once-monthly (50/50, 100, and 150 mg) and daily (2.5 mg; 3-year vertebral fracture risk reduction: 52%) oral ibandronate regimens were compared in 1609 women with postmenopausal osteoporosis. At least equivalent efficacy and similar safety and tolerability were shown after 1 year. Introduction: Suboptimal adherence to daily and weekly oral bisphosphonates can potentially compromise therapeutic outcomes in postmenopausal osteoporosis. Although yet to be prospectively shown in osteoporosis, evidence from randomized clinical trials in several other chronic conditions shows that reducing dosing frequency enhances therapeutic adherence. Ibandronate is a new and potent bisphosphonate with antifracture efficacy proven for daily administration and also intermittent administration with a dose-free interval of >2 months. This report presents comparative data on the efficacy and safety of monthly and daily oral ibandronate regimens. Materials and Methods: MOBILE is a 2-year, randomized, double-blind, phase III, noninferiority trial. A total of 1609 women with postmenopausal osteoporosis were assigned to one of four oral ibandronate regimens: 2.5 mg daily, 50 mg/50 mg monthly (single doses, consecutive days), 100 mg monthly, or 150 mg monthly. Results: After 1 year, lumbar spine BMD increased by 3.9%, 4.3%, 4.1%, and 4.9% in the 2.5, 50 /50, 100, and 150 mg arms, respectively. All monthly regimens were proven noninferior, and the 150 mg regimen superior, to the daily regimen. All monthly regimens produced similar hip BMD gains, which were larger than those with the daily regimen. All regimens similarly decreased serum levels of C-telopeptide, a biochemical marker of bone resorption. Compared with the daily regimen, a significantly larger proportion of women receiving the 100 and 150 mg monthly regimens achieved predefined threshold levels for percent change from baseline in lumbar spine (6%) or total hip BMD (3%). All regimens were similarly well tolerated. Conclusions: Monthly ibandronate is at least as effective and well tolerated as the currently approved daily ibandronate regimen in postmenopausal osteoporosis.read more
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Clinician’s Guide to Prevention and Treatment of Osteoporosis
Felicia Cosman,S. J. de Beur,Meryl S. LeBoff,E. M. Lewiecki,B. Tanner,S. Randall,Robert Lindsay +6 more
TL;DR: The Clinician’s Guide to Prevention and Treatment of Osteoporosis was developed by an expert committee of the National Osteiporosis Foundation in collaboration with a multispecialty council of medical experts in the field of bone health convened by NOF.
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Once-yearly zoledronic acid for treatment of postmenopausal osteoporosis
Dennis M. Black,Pierre D. Delmas,Richard Eastell,Ian R. Reid,Steven Boonen,Jane A. Cauley,Felicia Cosman,Peter L. Lakatos,Ping Chung Leung,Z. Man,Carlos Mautalen,Peter Mesenbrink,Huilin Hu,John Caminis,Karen Tong,Theresa Rosario-Jansen,Joel S. Krasnow,Trisha F. Hue,Deborah E. Sellmeyer,Erik Fink Eriksen,Steven R. Cummings +20 more
TL;DR: Treatment with zoledronic acid reduced the risk of morphometric vertebral fracture by 70% during a 3-year period, as compared with placebo.
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Osteoporosis: trends in epidemiology, pathogenesis and treatment
P. N. Sambrook,Cyrus Cooper +1 more
TL;DR: Clinical assessment will probably evolve from decisions mainly being made on the basis of bone densitometry, to use of algorithms of absolute fracture risk, and other diagnostic and therapeutic approaches, including biological agents, are likely to become more widespread.
Journal ArticleDOI
Markers of bone turnover for the prediction of fracture risk and monitoring of osteoporosis treatment: a need for international reference standards
Samuel D Vasikaran,Samuel D Vasikaran,Richard Eastell,Olivier Bruyère,A. J. Foldes,P. Garnero,Andrea Griesmacher,Michael R. McClung,Howard A. Morris,Stuart L. Silverman,Tommaso Trenti,D. A. Wahl,Cyrus Cooper,Cyrus Cooper,John A. Kanis +14 more
TL;DR: BTM hold promise in fracture risk prediction and for monitoring treatment and Uncertainties over their clinical use can be in part resolved by adopting international reference standards.
Journal ArticleDOI
American Association of Clinical Endocrinologists and American College of Endocrinology clinical practice guidelines for the diagnosis and treatment of postmenopausal osteoporosis — 2016
Pauline M. Camacho,Steven M. Petak,Neil Binkley,Dima L. Diab,Leslie S. Eldeiry,Azeez Farooki,Steven T. Harris,Daniel L. Hurley,Jennifer J. Kelly,E. Michael Lewiecki,Rachel Pessah-Pollack,Michael R. McClung,Sunil J. Wimalawansa,Nelson B. Watts +13 more
TL;DR: A large number of the patients in this study had atypical femur fracture and the results confirmed the need for further investigation into the mechanisms leading to and effects of these fractures.
References
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Osteoporosis prevention, diagnosis, and therapy
Anne Klibanski,Lucile L. Adams-Campbell,Tamsen Bassford,Steven N. Blair,Scott D. Boden,Kay Dickersin,David R. Gifford,Lou Glasse,Steven R. Goldring,Keith A. Hruska,Susan R. Johnson,Laurie K. McCauley,William E. Russell +12 more
TL;DR: Though prevalent in white postmenopausal women, osteoporosis occurs in all populations and at all ages and has significant physical, psychosocial, and financial consequences.
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Randomised trial of effect of alendronate on risk of fracture in women with existing vertebral fractures
Dennis M. Black,Steven R. Cummings,David B. Karpf,Jane A. Cauley,Desmond E. Thompson,Michael C. Nevitt,Douglas C. Bauer,Harry K. Genant,William L. Haskell,Robert Marcus,Susan M. Ott,James C. Torner,Sara A. Quandt,Theodore F. Reiss,Kristine E. Ensrud +14 more
TL;DR: Among women with low bone mass and existing vertebral fractures, alendronate is well tolerated and substantially reduces the frequency of morphometric and clinical vertebra fractures, as well as other clinical fractures.
Journal ArticleDOI
Effects of Risedronate Treatment on Vertebral and Nonvertebral Fractures in Women With Postmenopausal Osteoporosis: A Randomized Controlled Trial
Steven T. Harris,Nelson B. Watts,Harry K. Genant,Clark D. McKeever,Thomas N. Hangartner,Michael Keller,Charles H. Chesnut,Jacques P. Brown,Erik Fink Eriksen,Mohammad S. Hoseyni,Douglas Wayne Axelrod,Paul D. Miller +11 more
TL;DR: Risedronate, a potent bisphosphonate, has been shown to be effective in the treatment of Paget disease of bone and other metabolic bone diseases, but, to the knowledge, it has not been evaluated in this article.
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A systematic review of the associations between dose regimens and medication compliance
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Journal ArticleDOI
Effect of risedronate on the risk of hip fracture in elderly women. Hip Intervention Program Study Group.
Michael R. McClung,Piet Geusens,Paul D. Miller,Hartmut Zippel,William G. Bensen,Christian Roux,Silvano Adami,Ignac Fogelman,Terrence H. Diamond,Richard Eastell,Pierre J. Meunier,Richard D. Wasnich,Maria Greenwald,Jean-Marc Kaufman,C Chesnut,Jean-Yves Reginster +15 more
TL;DR: In this paper, the authors found that risedronate increases bone mineral density in elderly women, but whether it prevents hip fracture is not known, and the women were randomly assigned to receive treatment with either oral risingronate (2.5 or 5.0 mg) or placebo for three years.
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