FPIN's Help Desk Answers
Duration of Bisphosphonate Therapy
Am Fam Physician. 2018 Apr 1;97(7):online.
What is the optimal duration of bisphosphonate therapy for the treatment of osteoporosis in post-menopausal women?
Oral bisphosphonates significantly reduce clinical fracture risk at four years in women with postmenopausal osteoporosis (T-score less than −2.5). (Strength of Recommendation [SOR]: B, based on a randomized controlled trial [RCT] with subgroup analysis.) Treatment beyond five years is associated with further reductions in fractures in women with persistent femoral neck T-scores less than −2.5. (SOR: C, based on a post-hoc analysis of RCTs.) Treatment beyond five years in other women with osteopenia or osteoporosis does not result in further decreases in rates of clinical vertebral fractures, nonvertebral fractures, or mortality. (SOR: C, based on a meta-analysis of two small RCTs reporting fracture as a secondary outcome.)
A 2011 meta-analysis of three RCTs in post-menopausal women with primary osteoporosis (N = 1,443) evaluated continual oral bisphospho-nate treatment vs. discontinuation at five years.1 Study participants had a bone mineral density (BMD) of 0.68 g per cm2 or less (corresponding to a T-score of −1.6) in one trial or a T-score of −2.5 or less in two trials, or a history of fracture. Oral bisphosphonates included alendronate (Fosamax), 5 or 10 mg per day, or etidronate (Didronel), 400 mg per day. Outcomes included change in BMD, rates of bone turnover, mortality, and adverse events. Fracture rates were reported but were not primary outcomes in any of the trials. Comparing a discontinuation group (patients who stopped bisphosphonate therapy after five years) with a continuation group (extended bisphosphonate treatment for seven to 10 years), pooled analysis of two of the trials (N = 1,346) showed no difference in the risk of vertebral fracture (relative risk [RR] = 0.61; 95% confidence interval [CI], 0.32 to 2.1), nonvertebral fracture (RR = 0.91; 95% CI, 0.77 to 1.2) or mortality (RR
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1. Fraser LA, Vogt KN, Adachi JD, Thabane L. Fracture risk associated with continuation versus discontinuation of bisphosphonates after 5 years of therapy in patients with primary osteoporosis: a systematic review and meta-analysis. Ther Clin Risk Manag. 2011;7:157–166.
2. Cummings SR, Black DM, Thompson DE, et al. Effect of alendronate on risk of fracture in women with low bone density but without vertebral fractures: results from the Fracture Intervention Trial. JAMA. 1998;280(24):2077–2082.
3. Schwartz AV, Bauer DC, Cummings SR, et al.; FLEX Research Group. Efficacy of continued alendronate for fractures in women with and without prevalent vertebral fracture: the FLEX trial. J Bone Miner Res. 2010;25(5):976–982.
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