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Efficacy and safety of risedronate 150 mg once a month in the treatment of postmenopausal osteoporosis.
Bone. 2008 Jan; 42(1):36-42.BONE

Abstract

INTRODUCTION

Risedronate has been shown to be effective in the treatment of postmenopausal osteoporosis when given orally in daily or weekly doses or on 2 consecutive days per month. This randomized, double-blind, multi-center study was designed to assess the efficacy and safety of a single 150 mg risedronate once-a-month oral dose compared with the 5 mg daily regimen.

METHODS

Women with postmenopausal osteoporosis were randomly assigned to receive risedronate 5 mg daily (n=642) or 150 mg once a month (followed by daily placebo) (n=650) in a double-blind fashion for 2 years. Study drug was taken on an empty stomach at least 30 min before breakfast. Bone mineral density, bone turnover markers, fractures, and adverse events were evaluated. The primary efficacy endpoint was the mean percent change from baseline in lumbar spine bone mineral density after 1 year.

RESULTS

538 patients in the daily group (83.8%) and 556 patients in the once-a-month group (85.5%) completed 1 year. The mean percent change in lumbar spine bone mineral density was 3.4% (95% confidence interval, 3.03% to 3.82%) in the daily group and 3.5% (95% confidence interval, 3.15% to 3.93%) in the once-a-month group. The difference between groups was -0.1% (95% confidence interval, -0.51% to 0.27%). The once-a-month regimen was determined to be non-inferior to the daily regimen based on prospectively defined criteria. The mean percent changes in bone mineral density at sites in the hip (total proximal femur, femoral neck, femoral trochanter) were also similar in both dose groups, as were the 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 2 treatment groups. Both regimens were well tolerated; the percent of patients who withdrew from treatment as a result of an adverse event was 9.5% in the daily group and 8.6% in the once-a-month group.

CONCLUSIONS

Risedronate 150 mg once a month is similar in efficacy and safety to daily dosing and may provide an alternative for patients who prefer once-a-month oral dosing.

Authors+Show Affiliations

INSERM Research Unit 831 and University of Lyon, Lyon, France. delmas@lyon.inserm.frNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

17920005

Citation

Delmas, Pierre D., et al. "Efficacy and Safety of Risedronate 150 Mg once a Month in the Treatment of Postmenopausal Osteoporosis." Bone, vol. 42, no. 1, 2008, pp. 36-42.
Delmas PD, McClung MR, Zanchetta JR, et al. Efficacy and safety of risedronate 150 mg once a month in the treatment of postmenopausal osteoporosis. Bone. 2008;42(1):36-42.
Delmas, P. D., McClung, M. R., Zanchetta, J. R., Racewicz, A., Roux, C., Benhamou, C. L., Man, Z., Eusebio, R. A., Beary, J. F., Burgio, D. E., Matzkin, E., & Boonen, S. (2008). Efficacy and safety of risedronate 150 mg once a month in the treatment of postmenopausal osteoporosis. Bone, 42(1), 36-42.
Delmas PD, et al. Efficacy and Safety of Risedronate 150 Mg once a Month in the Treatment of Postmenopausal Osteoporosis. Bone. 2008;42(1):36-42. PubMed PMID: 17920005.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy and safety of risedronate 150 mg once a month in the treatment of postmenopausal osteoporosis. AU - Delmas,Pierre D, AU - McClung,Michael R, AU - Zanchetta,José R, AU - Racewicz,Artur, AU - Roux,Christian, AU - Benhamou,Claude-Laurent, AU - Man,Zulema, AU - Eusebio,Rachelle A, AU - Beary,John F, AU - Burgio,David E, AU - Matzkin,Ellen, AU - Boonen,Steven, Y1 - 2007/09/08/ PY - 2007/07/19/received PY - 2007/08/31/revised PY - 2007/09/04/accepted PY - 2007/10/9/pubmed PY - 2008/4/4/medline PY - 2007/10/9/entrez SP - 36 EP - 42 JF - Bone JO - Bone VL - 42 IS - 1 N2 - INTRODUCTION: Risedronate has been shown to be effective in the treatment of postmenopausal osteoporosis when given orally in daily or weekly doses or on 2 consecutive days per month. This randomized, double-blind, multi-center study was designed to assess the efficacy and safety of a single 150 mg risedronate once-a-month oral dose compared with the 5 mg daily regimen. METHODS: Women with postmenopausal osteoporosis were randomly assigned to receive risedronate 5 mg daily (n=642) or 150 mg once a month (followed by daily placebo) (n=650) in a double-blind fashion for 2 years. Study drug was taken on an empty stomach at least 30 min before breakfast. Bone mineral density, bone turnover markers, fractures, and adverse events were evaluated. The primary efficacy endpoint was the mean percent change from baseline in lumbar spine bone mineral density after 1 year. RESULTS: 538 patients in the daily group (83.8%) and 556 patients in the once-a-month group (85.5%) completed 1 year. The mean percent change in lumbar spine bone mineral density was 3.4% (95% confidence interval, 3.03% to 3.82%) in the daily group and 3.5% (95% confidence interval, 3.15% to 3.93%) in the once-a-month group. The difference between groups was -0.1% (95% confidence interval, -0.51% to 0.27%). The once-a-month regimen was determined to be non-inferior to the daily regimen based on prospectively defined criteria. The mean percent changes in bone mineral density at sites in the hip (total proximal femur, femoral neck, femoral trochanter) were also similar in both dose groups, as were the 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 2 treatment groups. Both regimens were well tolerated; the percent of patients who withdrew from treatment as a result of an adverse event was 9.5% in the daily group and 8.6% in the once-a-month group. CONCLUSIONS: Risedronate 150 mg once a month is similar in efficacy and safety to daily dosing and may provide an alternative for patients who prefer once-a-month oral dosing. SN - 8756-3282 UR - https://www.unboundmedicine.com/medline/citation/17920005/Efficacy_and_safety_of_risedronate_150_mg_once_a_month_in_the_treatment_of_postmenopausal_osteoporosis_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S8756-3282(07)00678-3 DB - PRIME DP - Unbound Medicine ER -