1.
Two-year efficacy and tolerability of risedronate once a week for the treatment of women with postmenopausal osteoporosis.
Harris, ST, Watts, NB, Li, Z, Chines, AA, Hanley, DA, Brown, JP
Current medical research and opinion. 2004;(5):757-64
Abstract
OBJECTIVE The efficacy and tolerability of risedronate once-a-week dosing (35 and 50mg) were compared with risedronate daily dosing (5mg) in a 2-year study in women with osteoporosis. DESIGN AND METHODS This was a randomized, double-blind, active-control study with lumbar spine bone mineral density (BMD) as the primary efficacy endpoint at 1 year. Subjects were women aged 50 years or older, postmenopausal for at least 5 years, and had either a BMD T-score of -2.5 or lower (lumbar spine or total proximal femur) or a T-score lower than -2 and at least one prevalent vertebral fracture. In addition to risedronate treatment, the subjects received 1000 mg daily of elemental calcium supplementation and received vitamin D if the baseline serum 25-hydroxyvitamin D(3) level was low. RESULTS The results after 1 year of treatment were previously published. Of the 1456 women who were randomized and received study medication, 1127 (77%) completed the 2-year study. Over the 2 years of treatment, the incidence of both new vertebral fractures (2.9, 1.5, and 1.7% for the 5, 35, and 50 mg groups, respectively; for women with postmenopausal osteoporosis who p = 0.298) and osteoporosis-related non-vertebral fractures reported as adverse events (5.0, 4.9, and 4.5% for the 5, 35, and 50 mg groups, respectively; p = 0.918) was similar for all 3 treatment groups. The reduction from baseline at Month 24 in bone turnover markers was similar based on an analysis of variance for the 5 mg daily and the 35 mg once-a-week groups. The mean percentage change in lumbar spine BMD after 24 months was 5.17, 4.74, and 5.47% for the 5, 35, and 50 mg groups, respectively. Both the 35 and 50 mg once-a-week treatment groups met the pre-specified criterion of non-inferiority to the 5 mg daily treatment group. No apparent difference in the pattern or distribution of serious and upper gastrointestinal adverse events was observed. CONCLUSIONS The 2-year data agree with the 1-year results demonstrating that the risedronate once-a-week doses are comparable in efficacy and safety to the 5 mg daily dose. Risedronate 35 mg once a week is considered the optimal dose want a once-a-week dosing regimen.
2.
Tolerability of risedronate in postmenopausal women intolerant of alendronate.
Adachi, JD, Adami, S, Miller, PD, Olszynski, WP, Kendler, DL, Silverman, SL, Licata, AA, Li, Z, Gomez-Panzani, E
Aging (Milan, Italy). 2001;(5):347-54
Abstract
Bisphosphonates are effective treatments for osteoporosis, but some have been associated with upper gastrointestinal intolerance. This randomized, double-blind study assessed the upper gastrointestinal tolerability of risedronate in postmenopausal women who had discontinued alendronate treatment because of upper gastrointestinal adverse events. Sixty-six women who had previously discontinued treatment with alendronate 10 mg/day because of upper gastrointestinal symptoms received placebo (N=31) or risedronate 5 mg (N=35) daily for 3 months. The primary outcome was the rate of discontinuation due to upper gastrointestinal adverse events: 5/31 (16.1%) in the placebo group, and 4/35 (11.4%) in the risedronate group. Discontinuation rates were also similar in the two treatment groups among subgroups of patients with a history of gastrointestinal disorder, prior use of acid suppression drugs, and concomitant use of NSAIDs. The overall incidence of upper gastrointestinal events was comparable between the placebo (19.4%) and risedronate (20.0%) groups. Overall, risedronate 5 mg/day for 3 months was as well tolerated as placebo in patients who could not tolerate alendronate 10 mg. These results are consistent with, and complement those from previous studies showing that risedronate 5 mg has a gastrointestinal tolerability similar to that of placebo.