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

BACKGROUND: Postmenopausal 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. OBJECTIVE: The aim was to describe baseline characteristics and changes in bone mineral density (BMD) T-scores among women with PMO receiving denosumab in Bulgaria. METHODS: This 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. RESULTS: Overall, 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. CONCLUSION: Denosumab 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.