Ten-year fracture probability identifies women who will benefit from clodronate therapy--additional results from a double-blind, placebo-controlled randomised study

• Published in: Osteoporosis international Vol. 20; no. 5; pp. 811 - 817
• Main Authors: McCloskey, E. V, Johansson, H, Oden, A, Vasireddy, S, Kayan, K, Pande, K, Jalava, T, Kanis, J. A
• Format: Journal Article
• Language: English
• Published: London London : Springer-Verlag 01.05.2009; Springer-Verlag; Springer; Springer Nature B.V
• Subjects: Absorptiometry, Photon; Aged; Aged, 80 and over; Algorithms; Biological and medical sciences; Bisphosphonate; BMD; Bone density; Bone Density - drug effects; Bone Density Conservation Agents - therapeutic use; Bones, joints and connective tissue. Antiinflammatory agents; Clodronate; Clodronic Acid - therapeutic use; Diseases of the osteoarticular system; Double-Blind Method; Drug therapy; Efficacy; Endocrinology; Endocrinology and Diabetes; Endokrinologi och diabetes; Female; Fracture probability; Fractures; Fractures, Bone - epidemiology; Fractures, Bone - prevention & control; Fysiologi; Hip Joint - diagnostic imaging; Humans; Injuries of the limb. Injuries of the spine; Medical sciences; Medicine; Medicine & Public Health; Original Article; Orthopedics; Osteoporosis; Osteoporosis, Postmenopausal - drug therapy; Osteoporosis, Postmenopausal - epidemiology; Osteoporosis. Osteomalacia. Paget disease; Pharmacology. Drug treatments; Physiology; Prescription drugs; Probability; Rheumatology; Risk Assessment; Risk Factors; Traumas. Diseases due to physical agents; Treatment Outcome; United Kingdom - epidemiology; Women; Osteoporosis; Bisphosphonate; Fracture probability; Fractures; BMD; Efficacy; Clodronate; Risk factors; Human; Antiosteoporotic; Diseases of the osteoarticular system; Rheumatology; Fracture; Trauma; Bisphosphonates; Clodronic acid; Fractures; Fracture probability; Treatment; Antiosteoclastic agent; Risk factor; Double blind study; Woman
• ISSN: 0937-941X; 1433-2965; 1433-2965
• DOI: 10.1007/s00198-008-0786-9

Summary Fracture risk prediction can be enhanced by the concurrent assessment of other clinical risk factors. This study demonstrates that the estimation of an individual's 10-year probability of fracture by the FRAX® algorithm identifies patients at high risk of fracture who will respond to bisphosphonate therapy. Introduction Treatments for osteoporosis are targeted largely to patients with low bone density (BMD) or a prior fragility fracture. Fracture risk prediction can be enhanced by the concurrent assessment of other clinical risk factors, but it is important to determine whether the risk so identified can be reduced by intervention. We determined the effect of a bisphosphonate on fracture rates when risk was calculated using a new risk algorithm (FRAX®). Methods Women aged 75 years or more were recruited to a randomised, double-blind controlled trial of 800 mg oral clodronate (Bonefos®) daily over 3 years. Baseline clinical risk factors were entered in the FRAX® model to compute the 10-year probability of major osteoporotic fractures with or without input of femoral neck BMD. The interaction between fracture probability and treatment efficacy was examined by Poisson regression. Results In 3,974 women, the interaction between fracture probability and treatment efficacy was significant when probability was assessed without BMD (p = 0.043), but not when BMD was included (p = 0.10). Efficacy was more evident in those deemed at highest risk. For example women lying at the 75th percentile of fracture probability in the absence of BMD (10-year probability 24%) treatment reduced fracture risk by 27% (HR 0.73, 95%CI 0.58-0.92). In those with a fracture probability of 30% (90th percentile), the fracture risk reduction was 38% (HR 0.62, 0.46-0.84). Conclusions The estimation of an individual's 10-year probability of fracture by the FRAX® algorithm identifies patients at high risk of fracture who will respond to bisphosphonate therapy.