The Safety and Efficacy of Early-Stage Bi-Weekly Alendronate to Improve Bone Mineral Density and Bone Turnover in Chinese Post-Menopausal Women at Risk of Osteoporosis

• Published in: Journal of international medical research 2011-02, Vol.39 (1), p.302-310
• Main Authors: You, L, Sheng, Z-Y, Chen, J-Y, Pan, L, Chen, L
• Format: Article
• Language: English
• Subjects: Adult; Aged; Alendronate - administration & dosage; Alendronate - therapeutic use; Alkaline Phosphatase - blood; Asian Continental Ancestry Group; Biomarkers - blood; Bone Density - drug effects; Bone Density Conservation Agents - administration & dosage; Bone Density Conservation Agents - therapeutic use; Calcium - blood; Collagen Type I - blood; Drug Administration Schedule; Female; Fractures, Bone - prevention & control; Humans; Hydroxycholecalciferols - administration & dosage; Hydroxycholecalciferols - therapeutic use; Lumbar Vertebrae - drug effects; Lumbar Vertebrae - physiology; Middle Aged; Osteoporosis, Postmenopausal - blood; Osteoporosis, Postmenopausal - physiopathology; Osteoporosis, Postmenopausal - prevention & control; Peptides - blood; Postmenopause - drug effects; Postmenopause - physiology; Prospective Studies; Risk Factors; Treatment Outcome
• ISSN: 0300-0605; 1473-2300
• DOI: 10.1177/147323001103900133

The efficacy and safety of early, low frequency antiresorptive drug intervention for osteopaenia on bone mineral density (BMD) and bone turnover in Chinese post-menopausal women at risk of developing osteoporosis were investigated. A total of 180 women aged 40 − 70 years were enrolled and equally randomized to receive either 70 mg alendronate once every 2 weeks plus 0.5 μg alfacalcidol daily (treatment group) or alfacalcidol 0.5 μg daily alone (control group) for 12 months. In the treatment group, lumbar spine and total hip BMD at 12 months had increased significantly from baseline and compared with the control group. There were also significant reductions in serum levels of the bone turnover biomarkers, bone-specific alkaline phosphatase and C-terminal telopeptide of type I collagen, compared with the control. No serious adverse events were observed in either group and safety profiles were similar. It was concluded that early intervention with 70 mg alendronate once every 2 weeks was safe, well tolerated and more effective than alfacalcidol alone (control) in increasing BMD and reducing bone turnover, and might prevent serious outcomes, such as fragility fractures, reduce rates of adverse effects and improve patient compliance.