Treatment With Once-Weekly Alendronate 70 mg Compared With Once-Weekly Risedronate 35 mg in Women With Postmenopausal Osteoporosis: A Randomized Double-Blind Study

University of Maryland, Baltimore, Baltimore, Maryland, United States
Journal of Bone and Mineral Research (Impact Factor: 6.83). 01/2005; 20(1):141-51. DOI: 10.1359/JBMR.040920
Source: PubMed


Once-weekly alendronate 70 mg and once-weekly risedronate 35 mg are indicated for the treatment of postmenopausal osteoporosis. These two agents were compared in a 12-month head-to-head trial. Greater gains in BMD and greater reductions in markers of bone turnover were seen with alendronate compared with risedronate with similar tolerability.
The nitrogen-containing bisphosphonates, alendronate and risedronate, are available in once-weekly (OW) formulations for the treatment of postmenopausal osteoporosis. A 12-month, head-to-head study was performed to compare these agents in the treatment of postmenopausal women with low BMD.
A total of 1053 patients from 78 U.S. sites were randomized to OW alendronate 70 mg (N = 520) or risedronate 35 mg (N = 533), taken in the morning after fasting. Endpoints included BMD changes over 6 and 12 months at the hip trochanter, total hip, femoral neck, and lumbar spine (LS); percent of patients with predefined levels of change in trochanter and LS BMD at 12 months; and change in biochemical markers of bone turnover at 3, 6, and 12 months. Tolerability was evaluated by adverse experience (AE) reporting.
Significantly greater increases in hip trochanter BMD were seen with alendronate (3.4%) than risedronate (2.1%) at 12 months (treatment difference, 1.4%; p < 0.001) as well as 6 months (treatment difference, 1.3%; p < 0.001). Significantly greater gains in BMD were seen with alendronate at all BMD sites measured (12-month difference: total hip, 1.0%; femoral neck, 0.7%; LS, 1.2%). Significant differences were seen as early as 6 months at all sites. A greater percentage of patients had > or =0% (p < 0.001) and > or =3% (p < 0.01) gain in trochanter and spine BMD at 12 months with alendronate than risedronate. Significantly greater (p < 0.001) reductions in all biochemical markers of bone turnover occurred with alendronate compared with risedronate by 3 months. No significant differences were seen between treatment groups in the incidence of upper gastrointestinal AEs or AEs causing discontinuation.
In this 12-month, head-to-head trial of alendronate and risedronate, given in accordance with the approved OW regimens for treatment of osteoporosis in postmenopausal women, alendronate produced greater gains in BMD and greater reductions in markers of bone turnover than risedronate. The greater antiresorptive effect of alendronate was seen as early as 3 months, and the tolerability profiles were similar.

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Available from: Risa Kagan, Feb 13, 2015
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    • "The effect of the BPs on postmenopausal osteoporosis was evaluated with the biochemical markers and the CTX value decreased 70–80% compared to the baseline values after 3 months of medication and remained at the decreased level for 12 or 24 months after the BP treatment [27]. bALP was also decreased by 40–50% after 6 months of BP treatment and remained at that level for 12 or 24 months [28] [29]. The control patients also showed a similar pattern found in previous reports. "
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    ABSTRACT: Objective This study aimed to analyze the difference in biochemical markers of patients with osteoporosis taking bisphosphonates (BPs) who developed bisphosphonate-related osteonecrosis of the jaw (BRONJ) vs those who did not develop BRONJ.Patients & methodsForty-one BRONJ patients and 76 control patients who had been treated with alendronate or risedronate were investigated. Bone turnover markers [C-terminal telopeptide (CTX) and bone-specific alkaline phosphatase (bALP)] and inflammatory activity markers [erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP) level] were evaluated. In BRONJ patients, radiographic severity and its relation with the serological data and BRONJ staging were analyzed.ResultsCTX and bALP level after the long-term BPs treatment in the control patients was similar to the level of the BRONJ patients at the time of diagnosis. The BRONJ patients showed a significantly higher ESR than the control patients with BPs. BRONJ score were not correlated with CTX and bALP. The severity of BRONJ in alendronate-treated group was strongly correlated with ESR and CRP.Conclusions Bone turnover markers such as serum CTX level has limitation in reflecting BRONJ status. Increased level of inflammatory markers in BRONJ patients implies the importance of inflammation in BRONJ progression.
    Full-text · Article · Apr 2013
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    • "This contrasts with the histomorphometric results with alendronate and denosumab that demonstrated absent tetracycline labels in many subjects [29, 30]. This apparent difference in the level of turnover observed on treatment is consistent with the study by Rosen and colleagues in which the approved dose of alendronate (70 mg weekly) reduced markers of bone turnover significantly more than did the approved dose of risedronate IR (35 mg weekly) [31]. The clinical implications of the reported differences among different drugs on indices of bone turnover are not known, but knowing that bone remodeling is not “over suppressed” with risedronate is reassuring. "
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    ABSTRACT: Bone 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. Introduction This 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 23(1):267-276, 2012); we now report the final results after 2 years. Methods Women 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. Results A 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. Conclusions Risedronate 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.
    Full-text · Article · Oct 2012 · Osteoporosis International
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    • "J Bone Miner Res. 2005;20(1):141–151.20 "
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