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

Abstract

IntroductionOsteoporosis 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.MethodsThis 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.ResultsA 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.ConclusionBaseline 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 RegistrationClinicalTrials.gov identifier, NCT01652690.FundingAmgen Inc.Electronic supplementary materialThe online version of this article (10.1007/s12325-018-0779-9) contains supplementary material, which is available to authorized users.

Osteoporosis treatment with denosumab in routine clinical practice in Poland

“…The prevalence of risk factors for fracture observed in our study population, such as smoking status [15], mean BMI [16,17], the number and type of comorbidities [18,19], age, and cause of menopause onset [17,18,20], was similar to previous studies, validating these risk factors.…”

“…These data reflect the local reimbursement criteria at the time of the study [13]. Studies from the Czech Republic and Slovakia also reported that reimbursement criteria for denosumab impacted the baseline characteristics of enrolled patients [17].…”

“…For example, more patients were enrolled from Type I centres than from Type II centres, suggesting that specialists prescribe denosumab more frequently than general practitioners [20]. Conversely, a study in neighbouring countries reported that internists and rheumatologist prescribed denosumab with similar frequency; however, the authors did not compare the characteristic of patients enrolled in the different study centres [17].…”

Effect of denosumab treatment on bone mineral density and bone turnover markers in osteoporotic patients: real-life experience 2-year follow-up

“…In conclusion, this is the first study of real-life results of denosumab treatment in osteoporotic Turkish population in real-life setting of denosumab treatment. These studies further give information about drug adherence and effectiveness in the real-life setting [19][20][21]26]. According to the results of this current study, denosumab is an effective treatment for osteoporosis with similar effectivity in different comorbid conditions with non-significant side effects.…”

“…In recent real-life persistence data about denosumab, persistence was 71% in a 7.5 year of follow-up, which was higher from other studies. The authors attributed this to positive motivation practices by describing the results of treatment with patients during outpatient control [21]. The osteoclastic effects of denosumab reverse with cessation of treatment and increase in fracture risk was shown with studies [13,14].…”