Denosumab reduces the risk of osteoporotic fractures in postmenopausal women, particularly in those with moderate to high fracture risk as assessed with FRAX.
Artikel i vetenskaplig tidskrift, 2012

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.

Risk Assessment

Probability

prevention & control

Female

Risk

80 and over

Proportional Hazards Models

Middle Aged

Bone Density Conservation Agents

Monoclonal

Fracture Healing

Algorithms

Aged

therapeutic use

Osteoporotic Fractures

Humans

Postmenopause

Placebos

drug therapy

Body Mass Index

Osteoporosis

Antibodies

Humanized

Författare

Eugene V McCloskey

Helena Johansson

Matt Austin

Ethel Siris

Andrea Wang

E Michael Lewiecki

Roman Lorenc

Cesar Libanati

John A Kanis

Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research

1523-4681 (ISSN)

Vol. 27 1480-6

Ämneskategorier

Endokrinologi och diabetes

DOI

10.1002/jbmr.1606

PubMed

22431426