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Randomized Controlled Trial
. 2013 Jan;92(1):59-67.
doi: 10.1007/s00223-012-9668-4. Epub 2012 Nov 13.

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

Michael R McClung  1 , 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
Affiliations
Randomized Controlled Trial

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

Michael R McClung et al. Calcif Tissue Int. 2013 Jan.

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.

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Figures

Fig. 1
Fig. 1
Subject disposition. 2CDM two consecutive days each month. One subject in each of the treatment groups missed their month 12 visit but continued on to year 2. These two subjects were not counted in month 12 visit but were included in the month 24 visit
Fig. 2
Fig. 2
LS mean (±SE) percentage change from baseline in a lumbar spine and b total hip BMD by visit. 2CDM two consecutive days each month, BMD bone mineral density, LS least squares
Fig. 3
Fig. 3
LS mean (±SE) percentage change from baseline in a uNTX/creatinine and b sBAP. 2CDM two consecutive days each month, sBAP serum bone-specific alkaline phosphatase, uNTX urinary N-telopeptide
See this image and copyright information in PMC

References

    1. Emkey R, Koltun W, Beusterien K, Seidman L, Kivitz A, Devas V, Masanauskaite D. Patient preference for once-monthly ibandronate versus once-weekly alendronate in a randomized, open-label, cross-over trial: the Boniva Alendronate Trial in Osteoporosis (BALTO) Curr Med Res Opin. 2005;21:1895–1903. doi: 10.1185/030079905X74862. - DOI - PubMed
    1. Recker RR, Gallagher R, MacCosbe PE. Effect of dosing frequency on bisphosphonate medication adherence in a large longitudinal cohort of women. Mayo Clin Proc. 2005;80:856–861. doi: 10.4065/80.7.856. - DOI - PubMed
    1. Cooper A, Drake J, Brankin E, PERSIST Investigators Treatment persistence with once-monthly ibandronate and patient support vs once-weekly alendronate: results from the PERSIST study. Int J Clin Pract. 2006;60:896–905. doi: 10.1111/j.1742-1241.2006.01059.x. - DOI - PMC - PubMed
    1. Harris ST, Watts NB, Genant HK, McKeever CD, Hangartner T, Keller M, Chesnut CH, 3rd, Brown J, Eriksen EF, Hoseyni MS, Axelrod DW, Miller PD, Vertebral efficacy with risedronate therapy (VERT) study group Effects of risedronate treatment on vertebral and nonvertebral fractures in women with postmenopausal osteoporosis: a randomized controlled trial. JAMA. 1999;282:1344–1352. doi: 10.1001/jama.282.14.1344. - DOI - PubMed
    1. Reginster J, Minne HW, Sorensen OH, Hooper M, Roux C, Brandi ML, Lund B, Ethgen D, Pack S, Roumagnac I, Eastell R, Vertebral efficacy with risedronate therapy (VERT) study group Randomized trial of the effects of risedronate on vertebral fractures in women with established postmenopausal osteoporosis. Osteoporos Int. 2000;11:83–91. doi: 10.1007/s001980050010. - DOI - PubMed

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