Abstract

SummaryPersistence with osteoporosis therapy is critical for fracture risk reduction. This observational study evaluated medication-taking behaviour of women with postmenopausal osteoporosis receiving denosumab or oral ibandronate in real-world clinical practice in Bulgaria. Compared with ibandronate, densoumab was associated with a lower discontinuation rate and greater increases in bone mineral density.PurposePersistence with osteoporosis therapy is critical for fracture risk reduction and the effectiveness of such treatments may be reduced by low persistence. Alternative therapies such as denosumab may improve persistence. This study aimed to describe medication-taking behaviour in women with osteoporosis, prescribed denosumab or oral ibandronate, in Bulgarian clinical practice.MethodsThis retrospective, observational, multicentre chart review (with up to 24 months follow-up) enrolled postmenopausal women initiating 6-monthly denosumab injection or monthly oral ibandronate treatment for osteoporosis between 1 October 2011 and 30 September 2012.ResultsOverall, 441 women were enrolled (224 had initiated denosumab, 217 had initiated ibandronate). At baseline, more women in the denosumab group than in the ibandronate group had a previous fracture (25.5 vs 17.5%; p = 0.043) and past exposure to osteoporosis therapy (19.6 vs 12.0%; p = 0.028). At 24 months, 4.5% of women receiving denosumab had discontinued therapy compared with 56.2% of women receiving ibandronate. Median time to discontinuation was longer in the denosumab group (729 days; interquartile range (IQR), 728.3–729.0) than in the ibandronate group (367 days; IQR, 354.0–484.8; p < 0.001). At 24 months, there were significantly greater changes in BMD T-scores at the lumbar spine (p < 0.001) and femoral neck (p < 0.001) in patients receiving denosumab than in those receiving ibandronate. At 24 months, persistence with denosumab was 98.7%.ConclusionThis real-world study demonstrates there is a low discontinuation rate and high persistence with denosumab. Denosumab was associated with greater BMD increases than ibandronate, which could reduce fracture risk.

Highlights

  • Osteoporosis is characterised by low bone mineral density (BMD) and disruption of bone architecture, which leads to an increased risk of fractures [1, 2]

  • We examined the first real-world estimates of 12, 18- and 24-month persistence with denosumab for Bulgaria

  • The proportion of women with previous exposure to postmenopausal osteoporosis therapy was greater in the denosumab group than in the ibandronate group (19.6 vs 12.0%, respectively; p = 0.028)

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Summary

Introduction

Osteoporosis is characterised by low bone mineral density (BMD) and disruption of bone architecture, which leads to an increased risk of fractures [1, 2]. A more recent population-based study estimated that approximately 26.6% of Bulgarian women aged 50 years or older have osteoporosis of at least one bone site [4]. A consequence of the increasing prevalence of osteoporosis is that a growing number of women are at risk of fractures, which are associated with considerable pain and disability, as well as substantial healthcare costs [1, 5]. The estimated 10year absolute fracture risk for women with osteoporosis in Bulgaria is 13.4% for major fractures and 2.8% for hip fractures [3]. This equated to 21,476 fractures among 1.6 million Bulgarian women aged 50 years or older in 2010 [1]. Data on patient outcomes following antiresorptive therapy are required to improve understanding of their value, in terms of osteoporosis treatment and fracture prevention in Bulgaria

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