Bisphosphonates and osteoporotic fractures: a cross-design synthesis of results among compliant/persistent postmenopausal women in clinical practice versus randomized controlled trials
- First Online:
- 219 Downloads
In a cross-design synthesis, total fractures were similarly reduced by bisphosphonates among postmenopausal women in randomized trials (23.8%) and highly compliant/persistent patients in observational studies of large databases from routine practice (20.3%). Bisphosphonates also reduced nonvertebral, vertebral and hip fractures in randomized trials and observational studies. In the real-word setting, compliant/persistent patients can gain a benefit from bisphosphonates comparable to that of randomized trial participants.
The purpose of the study was to determine whether clinical fracture risk reduction by bisphosphonate treatment in women with postmenopausal osteoporosis differs between randomized controlled trials and routine practice.
Randomized trials comparing bisphosphonate with placebo and observational studies comparing highly compliant/persistent with less compliant/persistent patients were sought by electronic searches and ancillary methods. Clinical fracture data were extracted from the study reports and quantitatively combined by random effects metaanalysis.
The odds ratio (OR) for all clinical fractures in randomized trials of 0.762, with a 95% confidence interval (CI) of 0.680–0.855, was closely similar to that in the observational studies (OR, 0.797; CI, 0.748–0.850). Pooled clinical fracture reduction across both study designs was 22%. Nonvertebral, vertebral, and hip fractures were also significantly reduced by bisphosphonate treatment in both randomized trials and observational studies.
Compliant/persistent patients in the “real-world” setting benefit from bisphosphonate treatment to a similar extent as patients in randomized trials.
KeywordsBisphosphonates Compliance Fractures Osteoporosis Persistence
- 16.Harris ST, Watts NB, Genant HK et al (1999) Effects of risedronate treatment on vertebral and nonvertebral fractures in women with postmenopausal osteoporosis: a randomized controlled trial. Vertebral Efficacy With Risedronate Therapy (VERT) Study Group. JAMA 282:1344–1352CrossRefPubMedGoogle Scholar
- 17.Pols HA, Felsenberg D, Hanley DA et al (1999) Multinational, placebo-controlled, randomized trial of the effects of alendronate on bone density and fracture risk in postmenopausal women with low bone mass: results of the FOSIT study. Fosamax International Trial Study Group. Osteoporos Int 9:461–468CrossRefPubMedGoogle Scholar
- 42.Ettinger B, Black DM, Mitlak BH et al (1999) Reduction of vertebral fracture risk in postmenopausal women with osteoporosis treated with raloxifene: results from a 3-year randomized clinical trial. Multiple Outcomes of Raloxifene Evaluation (MORE) Investigators. JAMA 282:637–645CrossRefPubMedGoogle Scholar