Real-world Management of Women with Postmenopausal Osteoporosis Treated with Denosumab: A Prospective Observational Study in the Czech Republic and Slovakia.

INTRODUCTION: Osteoporosis is characterized by low bone mineral density (BMD) and an increased risk of fracture. In randomized controlled trials, denosumab has been shown to significantly reduce the fracture risk in women with osteoporosis. However, little is known about the real-world management of women who are prescribed denosumab. METHODS: This multicenter, prospective, observational real-world study in the Czech Republic and Slovakia evaluated the baseline characteristics and clinical management of women with postmenopausal osteoporosis prescribed denosumab for 24 months. RESULTS: A total of 600 women were included (300 in each country). In the Czech Republic and Slovakia, respectively, mean age at enrollment was 69.0 and 64.3 years, 67.7% and 30.0% of patients had a previous osteoporotic fracture, and 85.0% and 48.7% had previously received osteoporosis medication. In both countries, 'low BMD T score' and 'a history of osteoporotic fracture' were the main reasons for prescribing denosumab. Most patients received all four post-baseline denosumab injections (Czech Republic, 82.0%; Slovakia, 81.0%), and more than 98% of patients in both countries received all injections at the prescribing center. At 24 months, most patients experienced an increase in BMD T score for the lumbar spine, total hip, or femoral neck (Czech Republic, 69.7-91.7%; Slovakia, 67.1-92.9%). Adverse drug reactions were consistent with the known safety profile of denosumab. CONCLUSION: Baseline characteristics of patients receiving denosumab in the Czech Republic and Slovakia reflect the reimbursement criteria for this agent in each country. The findings of our study in patients who are at high risk for fracture are consistent with the growing body of evidence demonstrating the effectiveness of denosumab in real-world clinical practice. TRIAL REGISTRATION: ClinicalTrials.gov identifier, NCT01652690. FUNDING: Amgen Inc.

Therapeutic adherence to osteoporosis treatment.

OBJECTIVE: Adherence of patients to therapy is a major determinant of therapeutic success, which is not included in most clinical studies. This is especially true for chronic diseases with few subjective symptoms, such as osteoporosis. The aim of our study was to describe and to analyze the therapeutic adherence to several widely used anti-osteoporotic medications in real-world medicine in Slovakia. METHODS: Using a retrospective approach, data about drug prescriptions for 8,223 patients from 3 consecutive years were analyzed regarding compliance and persistence. Compliance was measured as medication possession ratio-ratio between the supply of the drugs in the treatment time according to the prescriptions and the time of observation. Persistence was assessed as the percentage of patients who used the drug without a gap for the given time period. RESULTS: The average compliance was 70%, 59%, and 4% for 6, 12, and 24 months, respectively. Average persistence was very low with 54%, 42%, and 22% for 6, 12, and 24 months, respectively. Total average persistence was only 9.8 months. Medications with lower frequency of application tended to be associated with higher adherence. CONCLUSION: In conclusion, the therapeutic adherence to anti-osteoporotic treatments varies between the available drugs and drug regimens. In general, the adherence is very low but comparable to previously published studies from other countries. This variability of adherence should be considered in clinical decision making together with the variability of therapeutic efficiency found in clinical studies.