The efficacy and safety of weekly 35-mg risedronate dosing regimen for Chinese postmenopausal women with osteoporosis or osteopenia: 1-year data.

Abstract

AIM:

Oral risedronate is effective in the treatment of postmenopausal osteoporosis when administered daily, weekly, or monthly. In this 1-year, randomized, double-blind, multicenter study we compared the weekly 35-mg and daily 5-mg risedronate dosing regimens in the treatment of Chinese postmenopausal women with osteoporosis or osteopenia.

METHODS:

Postmenopausal women with primary osteoporosis or osteopenia were randomly assigned to the weekly group or daily group (n=145 for each) that received oral risedronate 35 mg once a week or 5 mg daily, respectively, for 1 year. The subjects' bone mineral densities (BMDs), bone turnover markers (P1NP and β-CTX), new vertebral fractures, and adverse events were assessed at baseline and during the treatments.

RESULTS:

All subjects in the weekly group and 144 subjects in the daily group completed the study. The primary efficacy endpoint after 1 year, ie the mean percent changes in the lumbar spine BMD (95% CI) were 4.87% (3.92% to 5.81%) for the weekly group and 4.35% (3.31% to 5.39%) for the daily group. The incidences of clinical adverse events were 48.3% in the weekly group and 54.2% in the daily group.

CONCLUSION:

The weekly 35-mg and daily 5-mg risedronate dosing regimens during 1 year of follow-up show similar efficacy in improving BMDs and biochemical markers of bone turnover in Chinese postmenopausal women with osteoporosis or osteopenia. Moreover, the two dosing regimens exhibit similar safety and tolerability.

• Authors: Jie-mei Gu, Li Wang, Hua Lin, De-cai Chen, Hai Tang, Xiao-lan Jin, Wei-bo Xia, Yun-qiu Hu, Wen-zhen Fu, Jin-wei He, Hao Zhang, Chun Wang, Hua Yue, Wei-wei Hu, Yu-juan Liu, Zhen-lin Zhang
• Journal: Acta pharmacologica Sinica (Acta Pharmacol Sin) Vol. 36 Issue 7 Pg. 841-6 (Jul 2015) ISSN: 1745-7254 [Electronic] United States
• PMID: 26051110 (Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Bone Density Conservation Agents
• Risedronic Acid

Topics

• Aged
• Asian People
• Bone Density (drug effects)
• Bone Density Conservation Agents (administration & dosage, adverse effects)
• Bone Diseases, Metabolic (diagnosis, drug therapy, epidemiology)
• China (epidemiology)
• Double-Blind Method
• Drug Administration Schedule
• Female
• Follow-Up Studies
• Gastrointestinal Diseases (chemically induced)
• Humans
• Middle Aged
• Osteoporosis, Postmenopausal (diagnosis, drug therapy, epidemiology)
• Prospective Studies
• Risedronic Acid (administration & dosage, adverse effects)
• Time Factors
• Treatment Outcome