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

Drugs R D. 2017 Mar;17(1):125-132. doi: 10.1007/s40268-016-0159-3.

Abstract

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.

Publication types

  • Multicenter Study

MeSH terms

  • Aged
  • Bone Density / drug effects*
  • Bulgaria
  • Denosumab / administration & dosage
  • Denosumab / pharmacology*
  • Denosumab / therapeutic use*
  • Female
  • Humans
  • Middle Aged
  • Osteoporosis, Postmenopausal / diagnosis
  • Osteoporosis, Postmenopausal / drug therapy*
  • Retrospective Studies

Substances

  • Denosumab