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Monthly dosing with risedronate 50 mg on three consecutive days a month compared with daily dosing with risedronate 5 mg: a 6-month pilot study.
Curr Med Res Opin. 2007 Dec; 23(12):3079-89.CM

Abstract

OBJECTIVE

Risedronate 5 mg daily significantly reduces the incidence of vertebral and non-vertebral osteoporotic fractures in postmenopausal women. We compared the efficacy and tolerability of risedronate 50 mg administered on 3 consecutive days per month, with and without a loading dose, with those of risedronate 5 mg daily in a randomized, double-blind study.

METHODS

Subjects were postmenopausal women 65-80 years old with low bone mineral density (BMD) (T-score < or = -2). Subjects received risedronate 5 mg daily for 6 months (n = 48), risedronate 150 mg (50-mg doses on 3 consecutive days) monthly for 6 months (n = 50), or a loading dose of risedronate 15 mg daily for 1 month followed by 150 mg (50-mg doses on 3 consecutive days) monthly for 5 months (n = 52).

RESULTS

Within 1 week, statistically significant reductions in urine N-telopeptide, the primary efficacy measure, were observed in all three groups. After 6 months, the least squares (LS) mean differences (95% confidence intervals [CI]) from the change in the 5 mg daily group (-39.88) were -3.54% (-15.71; 8.64) for the 150 mg monthly and -2.02% (-14.13;10.10) for the loading dose + 150 mg monthly groups. Mean percent changes in serum alpha-C-telopeptide, bone-specific alkaline phosphatase, and BMD, secondary efficacy measures, after 6 months were also similar for the three groups. The LS mean differences (95% CI) from the mean percent change in BMD in the 5 mg daily group (3.22%) were 0.20 (-1.15; 1.55) for the 150 mg monthly and -0.58 (-1.93; 0.76) for the loading dose + 150 mg monthly groups. The safety profile of the monthly regimens was similar to that of the 5 mg daily regimen and consistent with product labeling.

CONCLUSIONS

A monthly regimen of risedronate 50 mg on 3 consecutive days per month was similar to risedronate 5 mg daily with respect to its effect in suppressing bone turnover and increasing BMD and its safety profile in women with postmenopausal osteoporosis. This study was not powered to be a confirmatory trial for non-inferiority; therefore, additional study is needed.

Authors+Show Affiliations

NZOZ Centrum Medyczne, BiaBystok, Poland. osteo_medic_bial@op.plNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

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

Language

eng

PubMed ID

17971285

Citation

Racewicz, Artur J., et al. "Monthly Dosing With Risedronate 50 Mg On Three Consecutive Days a Month Compared With Daily Dosing With Risedronate 5 Mg: a 6-month Pilot Study." Current Medical Research and Opinion, vol. 23, no. 12, 2007, pp. 3079-89.
Racewicz AJ, Schofield PJ, Cahall DL, et al. Monthly dosing with risedronate 50 mg on three consecutive days a month compared with daily dosing with risedronate 5 mg: a 6-month pilot study. Curr Med Res Opin. 2007;23(12):3079-89.
Racewicz, A. J., Schofield, P. J., Cahall, D. L., Cline, G. A., & Burgio, D. E. (2007). Monthly dosing with risedronate 50 mg on three consecutive days a month compared with daily dosing with risedronate 5 mg: a 6-month pilot study. Current Medical Research and Opinion, 23(12), 3079-89.
Racewicz AJ, et al. Monthly Dosing With Risedronate 50 Mg On Three Consecutive Days a Month Compared With Daily Dosing With Risedronate 5 Mg: a 6-month Pilot Study. Curr Med Res Opin. 2007;23(12):3079-89. PubMed PMID: 17971285.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Monthly dosing with risedronate 50 mg on three consecutive days a month compared with daily dosing with risedronate 5 mg: a 6-month pilot study. AU - Racewicz,Artur J, AU - Schofield,Pamela J, AU - Cahall,David L, AU - Cline,Gary A, AU - Burgio,David E, PY - 2007/11/1/pubmed PY - 2008/2/23/medline PY - 2007/11/1/entrez SP - 3079 EP - 89 JF - Current medical research and opinion JO - Curr Med Res Opin VL - 23 IS - 12 N2 - OBJECTIVE: Risedronate 5 mg daily significantly reduces the incidence of vertebral and non-vertebral osteoporotic fractures in postmenopausal women. We compared the efficacy and tolerability of risedronate 50 mg administered on 3 consecutive days per month, with and without a loading dose, with those of risedronate 5 mg daily in a randomized, double-blind study. METHODS: Subjects were postmenopausal women 65-80 years old with low bone mineral density (BMD) (T-score < or = -2). Subjects received risedronate 5 mg daily for 6 months (n = 48), risedronate 150 mg (50-mg doses on 3 consecutive days) monthly for 6 months (n = 50), or a loading dose of risedronate 15 mg daily for 1 month followed by 150 mg (50-mg doses on 3 consecutive days) monthly for 5 months (n = 52). RESULTS: Within 1 week, statistically significant reductions in urine N-telopeptide, the primary efficacy measure, were observed in all three groups. After 6 months, the least squares (LS) mean differences (95% confidence intervals [CI]) from the change in the 5 mg daily group (-39.88) were -3.54% (-15.71; 8.64) for the 150 mg monthly and -2.02% (-14.13;10.10) for the loading dose + 150 mg monthly groups. Mean percent changes in serum alpha-C-telopeptide, bone-specific alkaline phosphatase, and BMD, secondary efficacy measures, after 6 months were also similar for the three groups. The LS mean differences (95% CI) from the mean percent change in BMD in the 5 mg daily group (3.22%) were 0.20 (-1.15; 1.55) for the 150 mg monthly and -0.58 (-1.93; 0.76) for the loading dose + 150 mg monthly groups. The safety profile of the monthly regimens was similar to that of the 5 mg daily regimen and consistent with product labeling. CONCLUSIONS: A monthly regimen of risedronate 50 mg on 3 consecutive days per month was similar to risedronate 5 mg daily with respect to its effect in suppressing bone turnover and increasing BMD and its safety profile in women with postmenopausal osteoporosis. This study was not powered to be a confirmatory trial for non-inferiority; therefore, additional study is needed. SN - 1473-4877 UR - https://www.unboundmedicine.com/medline/citation/17971285/Monthly_dosing_with_risedronate_50_mg_on_three_consecutive_days_a_month_compared_with_daily_dosing_with_risedronate_5_mg:_a_6_month_pilot_study_ L2 - https://www.tandfonline.com/doi/full/10.1185/030079907X242665 DB - PRIME DP - Unbound Medicine ER -