Treatment of postmenopausal osteoporosis with delayed-release risedronate 35 mg weekly for 2 yearsReportar como inadecuado

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Osteoporosis International

, Volume 24, Issue 1, pp 301–310

First Online: 19 October 2012Received: 15 July 2012Accepted: 12 September 2012


SummaryBone mineral density response to once weekly delayed-release formulation of risedronate, given before or following breakfast, was non-inferior to that seen with traditional immediate-release risedronate given daily before breakfast. Delayed-release risedronate is a convenient dosing regimen for oral bisphosphonate therapy that might avoid poor compliance.

IntroductionThis 2-year, randomized, controlled, non-inferiority study assessed the efficacy and safety of a delayed-release DR 35-mg weekly oral formulation of risedronate that allows subjects to take their weekly risedronate dose before or immediately after breakfast. Results from the first year of the study were published previously McClung et al. Osteoporos Int 231:267-276, 2012; we now report the final results after 2 years.

MethodsWomen with postmenopausal osteoporosis were randomly assigned to receive risedronate 5 mg immediate-release IR daily n = 307 at least 30 min before breakfast, or risedronate 35 mg DR weekly, either immediately following breakfast FB, n = 307 or at least 30 min before breakfast BB, n = 308. Bone mineral density BMD, bone turnover markers BTMs, fractures, adverse events, and bone histomorphometry were evaluated.

ResultsA total of 248 subjects 80.8 % in the IR daily group, 234 subjects 76.2 % in the DR FB weekly group, and 240 subjects 77.9 % in the DR BB weekly group completed the 2-year study. After 2 years of treatment, BMD increases at the lumbar spine and total hip with the weekly DR doses similar to or greater than that with the IR daily dose. Decreases in BTMs were similar or significantly lower in the DR groups. Bone histomorphometry results did not differ among the DR weekly and the IR daily formulations. The three regimens were similarly well tolerated.

ConclusionsRisedronate 35 mg DR weekly is as effective and as well tolerated as risedronate 5 mg IR daily, and will allow subjects to take their weekly risedronate dose immediately after breakfast.

KeywordsBone mineral density Delayed-release Enteric-coated Histomorphometry Osteoporosis Risedronate Weekly Trial Identifier: NCT00541658

This study was funded and supported by Warner Chilcott formerly Procter and Gamble Pharmaceuticals, Inc. and Sanofi for the design and conduct of the study; collection, management, analysis, and interpretation of the data; and editorial assistance for the manuscript.

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Autor: M. R. McClung - A. Balske - D. E. Burgio - D. Wenderoth - R. R. Recker


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