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Abstract
Introduction/Objective: We conducted a Cochrane systematic review to determine the efficacy of alendronate therapy at preventing bone loss and fractures in postmenopausal women. These results are being incorporated into a cost-effectiveness analysis of alendronate compared to hormone replacement therapy.
Methods: A literature search was conducted in MEDLINE, Embase, Current Contents and the Cochrane Controlled Trials Registry up to May 1998 according to the methods suggested by Haynes et al. Two independent reviewers selected randomized controlled trials (RCTs) which met predetermined inclusion criteria. These two reviewers independently extracted data using predetermined forms and assessed trial quality using Jadad's scale. Statistical Analysis: For dichotomous outcomes, relative risks were calculated using fixed effects models. For continuous data, weighted mean differences (WMD) of the percentage change from baseline were calculated. Where heterogeneity existed (determined by a Chi square test), random effects models were used.
Results: Seven RCTs met the inclusion criteria. The trials had a mean methodologic score of 2.57. For secondary prevention the WMD was 7.35 (95% Cl: 6.72, 7.97) for the lumbar spine and 4.18 (95% Cl: 3.27,5.09) for femoral neck with two years of treatment. For primary prevention, 2 years of treatment the WMD was 5.44 (95% Cl: 4.92, 5.94) for the spine and 3.36 (95% Cl: 2.2, 4.5) for the femoral neck. Alendronate successfully reduced vertebral fractures RR 0.54 (95% Cl: 0.43, 0.68) and non-vertebral fractures 0.77 (95% Cl: 0.64, 0.93). The results of the cost-effectiveness analysis are forthcoming.
Discussion: Alendronate is effective at increasing bone density in both early postmenopausal women and those with established osteoporosis. In patients with pre-existing bone loss, alendronate is effective at reducing both vertebral and non-vertebral fractures.
Methods: A literature search was conducted in MEDLINE, Embase, Current Contents and the Cochrane Controlled Trials Registry up to May 1998 according to the methods suggested by Haynes et al. Two independent reviewers selected randomized controlled trials (RCTs) which met predetermined inclusion criteria. These two reviewers independently extracted data using predetermined forms and assessed trial quality using Jadad's scale. Statistical Analysis: For dichotomous outcomes, relative risks were calculated using fixed effects models. For continuous data, weighted mean differences (WMD) of the percentage change from baseline were calculated. Where heterogeneity existed (determined by a Chi square test), random effects models were used.
Results: Seven RCTs met the inclusion criteria. The trials had a mean methodologic score of 2.57. For secondary prevention the WMD was 7.35 (95% Cl: 6.72, 7.97) for the lumbar spine and 4.18 (95% Cl: 3.27,5.09) for femoral neck with two years of treatment. For primary prevention, 2 years of treatment the WMD was 5.44 (95% Cl: 4.92, 5.94) for the spine and 3.36 (95% Cl: 2.2, 4.5) for the femoral neck. Alendronate successfully reduced vertebral fractures RR 0.54 (95% Cl: 0.43, 0.68) and non-vertebral fractures 0.77 (95% Cl: 0.64, 0.93). The results of the cost-effectiveness analysis are forthcoming.
Discussion: Alendronate is effective at increasing bone density in both early postmenopausal women and those with established osteoporosis. In patients with pre-existing bone loss, alendronate is effective at reducing both vertebral and non-vertebral fractures.