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The efficacy and tolerability of risedronate once a week for the treatment of postmenopausal osteoporosis.
Calcif Tissue Int. 2002 Aug; 71(2):103-11.CT

Abstract

This study evaluated the efficacy and tolerability of risedronate once a week (35 mg and 50 mg) compared with risedronate 5 mg once daily in women with osteoporosis. We conducted a randomized, double-blind, active-controlled, 2-year study; the primary efficacy assessment was performed after 1 year. Subjects were women aged 50 years or older who had been postmenopausal for at least 5 years, with either a bone mineral density (BMD) T-score of -2.5 or lower (lumbar spine or proximal femur) or a T-score lower than -2 and at least one prevalent vertebral fracture. Subjects received risedronate 5 mg once daily, 35 mg once a week or 50 mg once a week. All subjects also received 1 g daily of elemental calcium supplementation and supplemental vitamin D if the baseline serum levels were low. The primary efficacy measure was percent change in lumbar spine BMD at 12 months. A total of 1,456 women were randomized and received medication; 1,209 (83%) women completed 12 months. The mean percent change (SE) in lumbar spine BMD after 12 months was 4.0% (0.2%) in the 5 mg daily group, 3.9% (0.2%) in the 35 mg group, and 4.2% (0.2%) in the 50 mg group; each once-a-week treatment was determined to be as effective as the daily treatment. Outcomes of the secondary efficacy measurements and safety assessments were also similar in all 3 groups after 12 months. Risedronate 35 mg and 50 mg once a week provide the same efficacy and safety as the daily 5 mg regimen; therefore, the lower dose, 35 mg once a week, is considered optimal for women with postmenopausal osteoporosis who desire a once-a-week regimen.

Authors+Show Affiliations

Brown JP
Le Centre de recherche du CHUL, Laval University, Sainte-Foy, Québec, Canada. Jacques.Brown@crchul.ulaval.ca
Kendler DL
No affiliation info available
McClung MR
No affiliation info available
Emkey RD
No affiliation info available
Adachi JD
No affiliation info available
Bolognese MA
No affiliation info available
Li Z
No affiliation info available
Balske A
No affiliation info available
Lindsay R
No affiliation info available

MeSH

Administration, OralAgedBiomarkersBone DensityBone ResorptionCalcium Channel BlockersDose-Response Relationship, DrugDouble-Blind MethodDrug Administration ScheduleEtidronic AcidFemaleFemur NeckHumansLumbar VertebraeMiddle AgedOsteoporosis, PostmenopausalRisedronic AcidSpinal FracturesStomachTreatment Outcome

Pub Type(s)

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

Language

eng

PubMed ID

12085156

Citation

Brown, J P., et al. "The Efficacy and Tolerability of Risedronate once a Week for the Treatment of Postmenopausal Osteoporosis." Calcified Tissue International, vol. 71, no. 2, 2002, pp. 103-11.
Brown JP, Kendler DL, McClung MR, et al. The efficacy and tolerability of risedronate once a week for the treatment of postmenopausal osteoporosis. Calcif Tissue Int. 2002;71(2):103-11.
Brown, J. P., Kendler, D. L., McClung, M. R., Emkey, R. D., Adachi, J. D., Bolognese, M. A., Li, Z., Balske, A., & Lindsay, R. (2002). The efficacy and tolerability of risedronate once a week for the treatment of postmenopausal osteoporosis. Calcified Tissue International, 71(2), 103-11.
Brown JP, et al. The Efficacy and Tolerability of Risedronate once a Week for the Treatment of Postmenopausal Osteoporosis. Calcif Tissue Int. 2002;71(2):103-11. PubMed PMID: 12085156.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - The efficacy and tolerability of risedronate once a week for the treatment of postmenopausal osteoporosis. AU - Brown,J P, AU - Kendler,D L, AU - McClung,M R, AU - Emkey,R D, AU - Adachi,J D, AU - Bolognese,M A, AU - Li,Z, AU - Balske,A, AU - Lindsay,R, Y1 - 2002/06/27/ PY - 2002/01/25/received PY - 2002/04/15/accepted PY - 2002/6/27/pubmed PY - 2003/2/5/medline PY - 2002/6/27/entrez SP - 103 EP - 11 JF - Calcified tissue international JO - Calcif Tissue Int VL - 71 IS - 2 N2 - This study evaluated the efficacy and tolerability of risedronate once a week (35 mg and 50 mg) compared with risedronate 5 mg once daily in women with osteoporosis. We conducted a randomized, double-blind, active-controlled, 2-year study; the primary efficacy assessment was performed after 1 year. Subjects were women aged 50 years or older who had been postmenopausal for at least 5 years, with either a bone mineral density (BMD) T-score of -2.5 or lower (lumbar spine or proximal femur) or a T-score lower than -2 and at least one prevalent vertebral fracture. Subjects received risedronate 5 mg once daily, 35 mg once a week or 50 mg once a week. All subjects also received 1 g daily of elemental calcium supplementation and supplemental vitamin D if the baseline serum levels were low. The primary efficacy measure was percent change in lumbar spine BMD at 12 months. A total of 1,456 women were randomized and received medication; 1,209 (83%) women completed 12 months. The mean percent change (SE) in lumbar spine BMD after 12 months was 4.0% (0.2%) in the 5 mg daily group, 3.9% (0.2%) in the 35 mg group, and 4.2% (0.2%) in the 50 mg group; each once-a-week treatment was determined to be as effective as the daily treatment. Outcomes of the secondary efficacy measurements and safety assessments were also similar in all 3 groups after 12 months. Risedronate 35 mg and 50 mg once a week provide the same efficacy and safety as the daily 5 mg regimen; therefore, the lower dose, 35 mg once a week, is considered optimal for women with postmenopausal osteoporosis who desire a once-a-week regimen. SN - 0171-967X UR - https://www.unboundmedicine.com/medline/citation/12085156/The_efficacy_and_tolerability_of_risedronate_once_a_week_for_the_treatment_of_postmenopausal_osteoporosis_ DB - PRIME DP - Unbound Medicine ER -