Efficacy and safety of risedronate 150-mg once a month in the treatment of postmenopausal osteoporosis: 2-year dataReportar como inadecuado




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Osteoporosis International

, Volume 24, Issue 1, pp 293–299

First Online: 30 June 2012Received: 11 May 2012Accepted: 06 June 2012

Abstract

SummaryThis study showed that risedronate 150-mg once a month provides similar efficacy and safety at 2 years compared with risedronate 5-mg daily for the treatment of postmenopausal osteoporosis. This adds to the range of risedronate dosing options and provides an alternative for patients who prefer once-a-month dosing.

IntroductionRisedronate is effective in the treatment of postmenopausal osteoporosis in oral daily, weekly, or on two consecutive days per month doses. This 2-year randomized, double-blind, multicenter study assesses the efficacy and safety of a single risedronate 150-mg once-a-month oral dose compared with the 5-mg daily regimen.

MethodsWomen with postmenopausal osteoporosis were randomly assigned to receive risedronate 5-mg daily n = 642 or 150-mg once a month n = 650 for 2 years. Bone mineral density BMD, bone turnover markers, new vertebral fractures, and adverse events were evaluated. The primary efficacy endpoint was the mean percent change from baseline in lumbar spine BMD after 1 year.

ResultsFour hundred ninety-eight subjects in the daily group 77.6 % and 513 subjects in the once-a-month group 78.9 % completed the study. After 24 months, the mean percent change in lumbar spine BMD was 3.9 % 95 % confidence interval CI, 3.43 to 4.42 % and 4.2 % 95 % CI, 3.68 to 4.65 % in the daily and once-a-month groups, respectively. The once-a-month regimen was determined to be non-inferior to the daily regimen. The mean percent changes in BMD at the hip were similar in both dose groups, as were changes in biochemical markers of bone turnover. The incidence of adverse events, adverse events leading to withdrawal, and upper gastrointestinal tract adverse events were similar in the two treatment groups.

ConclusionsAfter 2 years, treatment with risedronate 150-mg once a month provided similar efficacy and tolerability to daily dosing and provides an alternative for patients who prefer once-a-month oral dosing.

KeywordsBone mineral density Fracture risk Monthly Osteoporosis Risedronate AbbreviationsAEAdverse event

BALPBone-specific alkaline phosphatase

BMDBone mineral density

CIConfidence interval

CrCreatinine

CTXC-terminal crosslinking telopeptide of type I collagen

DXADual x-ray absorptiometry

ITTIntent to treat

MedDRAMedical Dictionary for Regulatory Activities

NTXN-terminal crosslinking telopeptide of type I collagen

ClinicalTrials.gov identifier: NCT00247273

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Autor: M. R. McClung - J. R. Zanchetta - A. Racewicz - C. Roux - C.-L. Benhamou - Z. Man - R. A. Eusebio - J. F. Beary - D. 

Fuente: https://link.springer.com/



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