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Denosumab reduces the risk of osteoporotic fractures in postmenopausal women, particularly in those with moderate to high fracture risk as assessed with FRAX.
J Bone Miner Res. 2012 Jul; 27(7):1480-6.JB

Abstract

Denosumab has been shown to reduce the incidence of vertebral, nonvertebral, and hip fractures. The aim of the current study was to determine whether the antifracture efficacy of denosumab was dependent on baseline fracture probability assessed by FRAX. The primary data of the phase 3 FREEDOM study of the effects of denosumab in women with postmenopausal osteoporosis were used to compute country-specific probabilities using the FRAX tool (version 3.2). The outcome variable comprised all clinical osteoporotic fractures (including clinical vertebral fractures). Interactions between fracture probability and efficacy were explored by Poisson regression. At baseline, the median 10-year probability of a major osteoporotic fracture (with bone mineral density) was approximately 15% and for hip fracture was approximately 5% in both groups. In the simplest model adjusted for age and fracture probability, treatment with denosumab over 3 years was associated with a 32% (95% confidence interval [CI] 20% to 42%) decrease in clinical osteoporotic fractures. Denosumab reduced fracture risk to a greater extent in those at moderate to high risk. For example, at 10% probability, denosumab decreased fracture risk by 11% (p = 0.629), whereas at 30% probability (90th percentile of study population) the reduction was 50% (p = 0.001). The reduction in fracture was independent of prior fracture, parental history of hip fracture, or secondary causes of osteoporosis. A low body mass index (BMI) was associated with greater efficacy. Denosumab significantly decreased the risk of clinical osteoporotic fractures in postmenopausal women. Overall, the efficacy of denosumab was greater in those at moderate to high risk of fracture as assessed by FRAX.

Authors+Show Affiliations

WHO Collaborating Centre for Metabolic Bone Diseases, University of Sheffield, Sheffield, United Kingdom. e.v.mccloskey@shef.ac.ukNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

22431426

Citation

McCloskey, Eugene V., et al. "Denosumab Reduces the Risk of Osteoporotic Fractures in Postmenopausal Women, Particularly in Those With Moderate to High Fracture Risk as Assessed With FRAX." Journal of Bone and Mineral Research : the Official Journal of the American Society for Bone and Mineral Research, vol. 27, no. 7, 2012, pp. 1480-6.
McCloskey EV, Johansson H, Oden A, et al. Denosumab reduces the risk of osteoporotic fractures in postmenopausal women, particularly in those with moderate to high fracture risk as assessed with FRAX. J Bone Miner Res. 2012;27(7):1480-6.
McCloskey, E. V., Johansson, H., Oden, A., Austin, M., Siris, E., Wang, A., Lewiecki, E. M., Lorenc, R., Libanati, C., & Kanis, J. A. (2012). Denosumab reduces the risk of osteoporotic fractures in postmenopausal women, particularly in those with moderate to high fracture risk as assessed with FRAX. Journal of Bone and Mineral Research : the Official Journal of the American Society for Bone and Mineral Research, 27(7), 1480-6. https://doi.org/10.1002/jbmr.1606
McCloskey EV, et al. Denosumab Reduces the Risk of Osteoporotic Fractures in Postmenopausal Women, Particularly in Those With Moderate to High Fracture Risk as Assessed With FRAX. J Bone Miner Res. 2012;27(7):1480-6. PubMed PMID: 22431426.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Denosumab reduces the risk of osteoporotic fractures in postmenopausal women, particularly in those with moderate to high fracture risk as assessed with FRAX. AU - McCloskey,Eugene V, AU - Johansson,Helena, AU - Oden,Anders, AU - Austin,Matt, AU - Siris,Ethel, AU - Wang,Andrea, AU - Lewiecki,E Michael, AU - Lorenc,Roman, AU - Libanati,Cesar, AU - Kanis,John A, PY - 2012/3/21/entrez PY - 2012/3/21/pubmed PY - 2012/11/9/medline SP - 1480 EP - 6 JF - Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research JO - J Bone Miner Res VL - 27 IS - 7 N2 - Denosumab has been shown to reduce the incidence of vertebral, nonvertebral, and hip fractures. The aim of the current study was to determine whether the antifracture efficacy of denosumab was dependent on baseline fracture probability assessed by FRAX. The primary data of the phase 3 FREEDOM study of the effects of denosumab in women with postmenopausal osteoporosis were used to compute country-specific probabilities using the FRAX tool (version 3.2). The outcome variable comprised all clinical osteoporotic fractures (including clinical vertebral fractures). Interactions between fracture probability and efficacy were explored by Poisson regression. At baseline, the median 10-year probability of a major osteoporotic fracture (with bone mineral density) was approximately 15% and for hip fracture was approximately 5% in both groups. In the simplest model adjusted for age and fracture probability, treatment with denosumab over 3 years was associated with a 32% (95% confidence interval [CI] 20% to 42%) decrease in clinical osteoporotic fractures. Denosumab reduced fracture risk to a greater extent in those at moderate to high risk. For example, at 10% probability, denosumab decreased fracture risk by 11% (p = 0.629), whereas at 30% probability (90th percentile of study population) the reduction was 50% (p = 0.001). The reduction in fracture was independent of prior fracture, parental history of hip fracture, or secondary causes of osteoporosis. A low body mass index (BMI) was associated with greater efficacy. Denosumab significantly decreased the risk of clinical osteoporotic fractures in postmenopausal women. Overall, the efficacy of denosumab was greater in those at moderate to high risk of fracture as assessed by FRAX. SN - 1523-4681 UR - https://www.unboundmedicine.com/medline/citation/22431426/Denosumab_reduces_the_risk_of_osteoporotic_fractures_in_postmenopausal_women_particularly_in_those_with_moderate_to_high_fracture_risk_as_assessed_with_FRAX_ L2 - https://doi.org/10.1002/jbmr.1606 DB - PRIME DP - Unbound Medicine ER -