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Summary: Persistence 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. Purpose: Persistence 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. Methods: This 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. Results: Overall, 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%. Conclusion: This 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. [ABSTRACT FROM AUTHOR]

Summary: This retrospective database study assessed 2-year persistence with bisphosphonates or denosumab in a large German cohort of women with a first-time prescription for osteoporosis treatment. Compared with intravenous or oral bisphosphonates, 2-year persistence was 1.5-2 times higher and risk of discontinuation was significantly lower ( P < 0.0001) with denosumab. Introduction: Persistence with osteoporosis therapies is critical for fracture risk reduction. Detailed data on long-term persistence (≥2 years) with bisphosphonates and denosumab are sparse. Methods: From the German IMS® database, we included women aged 40 years or older with a first-time prescription for bisphosphonates or denosumab between July 2010 and August 2014; patients were followed up until December 2014. The main outcome was treatment discontinuation, with a 60-day permissible gap between filled prescriptions. Two-year persistence was estimated using Kaplan-Meier survival curves, with treatment discontinuation as the failure event. Denosumab was compared with intravenous (i.v.) and oral bisphosphonates separately. Cox proportional hazard ratios (HRs) for the 2-year risk of discontinuation were calculated, with adjustment for age, physician specialty, health insurance status, and previous medication use. Results: Two-year persistence with denosumab was significantly higher than with i.v. or oral bisphosphonates (39.8 % [ n = 21,154] vs 20.9 % [i.v. ibandronate; n = 20,472] and 24.8 % [i.v. zoledronic acid; n = 3966] and 16.7-17.5 % [oral bisphosphonates; n = 114,401]; all P < 0.001). Patients receiving i.v. ibandronate, i.v. zoledronic acid, or oral bisphosphonates had a significantly increased risk of treatment discontinuation than did those receiving denosumab (HR = 1.65, 1.28, and 1.96-2.02, respectively; all P < 0.0001). Conclusions: Two-year persistence with denosumab was 1.5-2 times higher than with i.v. or oral bisphosphonates, and risk of discontinuation was significantly lower with denosumab than with bisphosphonates. A more detailed understanding of factors affecting medication-taking behavior may improve persistence and thereby reduce rates of fracture. [ABSTRACT FROM AUTHOR]

Summary: The objectives of this study were to estimate persistence with denosumab and put these results in context by conducting a review of persistence with oral bisphosphonates. Persistence with denosumab was found to be higher than with oral bisphosphonates. Purpose: This study had two objectives: to analyse persistence in Swedish women initiating denosumab for treatment of postmenopausal osteoporosis (PMO) and to put these findings in context by conducting a literature review and meta-analysis of persistence data for oral bisphosphonates. Methods: The study used the Swedish Prescribed Drug Register and included women aged at least 50 years initiating denosumab between May 2010 and July 2012. One injection of denosumab was defined as 6-month persistence. Women were considered persistent for another 6 months if they filled their next prescription within 6 months + 56 days and survival analysis applied to the data. A literature search was conducted in PubMed to identify retrospective studies of persistence with oral bisphosphonates and pooled persistence estimates were calculated using a random-effects model. Results: The study identified 2,315 women who were incident denosumab users. Mean age was 74 years and 61 % had been previously treated for PMO. At 12 and 24 months, persistence with denosumab was 83 % (95 % CI, 81-84 %) and 62 % (95 % CI, 60-65 %), respectively. The literature search identified 40 articles for inclusion in the meta-analysis. At 12 and 24 months, persistence with oral bisphosphonates ranged from 10 % to 78 % and from 16 % to 46 %, with pooled estimates of 45 % and 30 %, respectively. Conclusion: These data from the Swedish Prescribed Drug Register and literature review suggest that persistence was higher with denosumab than with oral bisphosphonates. [ABSTRACT FROM AUTHOR]

Summary: This database analysis of over 4,000 German women prescribed oral bisphosphonates between December 2004 and November 2007 showed that compliance and persistence with oral bisphosphonates in German women with osteoporosis were inadequate. Introduction: GRAND is a database analysis designed to investigate persistence and compliance with oral bisphosphonate regimens, and their association with fracture incidence, in women with osteoporosis. Methods: Diagnostic, treatment and fracture data were obtained from the IMS® Disease Analyzer patient database in Germany. Women with osteoporosis prescribed one of six specified oral bisphosphonates between December 2004 and November 2007 with no similar prescription for at least 1 year beforehand were eligible for analysis. Those treated with intravenous bisphosphonates were excluded. Persistence (prescription refill gap of ≤30 days or change of treatment frequency) and compliance (medication possession ratio) were measured for 2 years from therapy start. Results: Data from 4,147 women were evaluable, with a median oral bisphosphonate treatment duration of 145.5 days. Persistence rates after 1 and 2 years were 27.9% and 12.9%, respectively, and 66.3% of women were compliant. As expected, persistence rates were higher when the refill gap was increased to 60 or 90 days. No significant differences in 1-year persistence between patients on weekly or monthly treatment regimens were observed (28.6% and 29.4%, respectively), although 1-year persistence with daily treatment was only 7.2%. After 24 months of therapy, compliant women had fewer fractures than non-compliant women (88.1% and 85.0% fracture-free, respectively; p = 0.0147). In multivariate Cox regression analysis, treatment compliance was the only factor that significantly decreased fracture risk ( p = 0.0034). Conclusions: Compliance and persistence with oral bisphosphonates in German women with osteoporosis were inadequate. Better compliance and persistence can prevent fractures in these women. [ABSTRACT FROM AUTHOR]