Baseline Characteristics and Changes in Bone Mineral Density T-Scores of Bulgarian Women with Postmenopausal Osteoporosis Receiving Denosumab in Routine Clinical Practice.

Abstract

BackgroundPostmenopausal osteoporosis (PMO) is common among women over 50 years of age and is associated with an increased risk of fracture. Bone-targeted agents, such as denosumab, can reduce fracture risk in patients with PMO.ObjectiveThe aim was to describe baseline characteristics and changes in bone mineral density (BMD) T-scores among women with PMO receiving denosumab in Bulgaria.MethodsThis multicenter chart review included women with PMO receiving denosumab for ≥1 year in Bulgaria (October 2011–August 2013). Participants were required to have a baseline BMD T-score of ≤−2.5 standard deviations (SDs) at one or more skeletal sites.ResultsOverall, 222 women were included. The mean (SD) age at denosumab initiation was 64.2 (8.5) years; 26.6% reported a previous osteoporotic fracture and 6.8% a previous hip fracture. Only half of those reporting a previous fracture (49.2%) had received prior osteoporosis therapy. At baseline, mean (SD) BMD T-scores were lumbar spine −3.2 SD (0.6 SD), total hip −2.3 SD (0.8 SD), and femoral neck −2.7 SD (0.7 SD). After 1 year of denosumab treatment, scores increased significantly at all three sites, reaching −2.7 SD (0.6 SD), −2.1 SD (0.9 SD), and −2.4 SD (0.7 SD), respectively (all p < 0.0001 vs. baseline). No serious adverse drug reactions were identified.ConclusionDenosumab is usually prescribed in women with PMO at high fracture risk. In the patients who were persistent with treatment at 1 year, denosumab was well tolerated and effective at increasing BMD T-scores at several skeletal sites.