A novel monthly dosing regimen of risedronate for the treatment of postmenopausal osteoporosis: 2-year data

Michael R. McClung, Claude Laurent Benhamou, Zulema Man, Witold Tlustochowicz, Jose R. Zanchetta, Rachelle Eusebio, Ana M. Balske, Ellen Matzkin, Wojciech P. Olszynski, Robert Recker, Pierre D. Delmas

Research output: Contribution to journalArticle

4 Scopus citations

Abstract

This 2-year trial evaluated the efficacy and tolerability of a monthly oral regimen of risedronate. Postmenopausal women with osteoporosis were randomly assigned to double-blind treatment with risedronate 75 mg on 2 consecutive days each month (2CDM) or 5 mg daily. The primary end point was the percentage change from baseline in lumbar spine bone mineral density (BMD) at 12 months. Secondary end points included the change in BMD of the lumbar spine and proximal femur and in bone turnover markers as well as the number of subjects with at least one new vertebral fracture over 24 months. Among 1,229 patients who were randomized and received at least one dose of risedronate, lumbar spine BMD was increased in both treatment groups: mean percentage change from baseline was 4.2 ± 0.19 and 4.3 ± 0.19 % in the 75 mg 2CDM and 5 mg daily groups, respectively, at month 24. The treatment difference was 0.17 (95 % confidence interval -0.35 to 0.68). There were no statistically significant differences between treatment groups on any secondary efficacy parameters. Both treatment regimens were well tolerated. Risedronate 75 mg 2CDM was noninferior in BMD efficacy and did not show a difference in tolerability compared to 5 mg daily after 24 months of treatment in women with postmenopausal osteoporosis. This monthly regimen may provide a more convenient dosing schedule to some patients with postmenopausal osteoporosis.

Original languageEnglish (US)
Pages (from-to)59-67
Number of pages9
JournalCalcified Tissue International
Volume92
Issue number1
DOIs
StatePublished - Jan 1 2013

    Fingerprint

All Science Journal Classification (ASJC) codes

  • Endocrinology, Diabetes and Metabolism
  • Orthopedics and Sports Medicine
  • Endocrinology

Cite this

McClung, M. R., Benhamou, C. L., Man, Z., Tlustochowicz, W., Zanchetta, J. R., Eusebio, R., Balske, A. M., Matzkin, E., Olszynski, W. P., Recker, R., & Delmas, P. D. (2013). A novel monthly dosing regimen of risedronate for the treatment of postmenopausal osteoporosis: 2-year data. Calcified Tissue International, 92(1), 59-67. https://doi.org/10.1007/s00223-012-9668-4