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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.

Using Swedish and Dutch registry data for women initiating bisphosphonates, we evaluated two methods of comparing the real-world effectiveness of osteoporosis treatments that attempt to adjust for differences in patient baseline characteristics. Each method has advantages and disadvantages; both are potential complements to clinical trial analyses., Purpose: We evaluated methods of comparing the real-world effectiveness of osteoporosis treatments that attempt to adjust for both observed and unobserved confounding., Methods: Swedish and Dutch registry data for women initiating zoledronate or oral bisphosphonates (OBPs; alendronate/risedronate) were used; the primary outcome was fracture. In adjusted direct comparisons (ADCs), regression and matching techniques were used to account for baseline differences in known risk factors for fracture (e.g., age, previous fracture, comorbidities). In an own-control analysis (OCA), for each treatment, fracture incidence in the first 90 days following treatment initiation (the baseline risk period) was compared with fracture incidence in the 1-year period starting 91 days after treatment initiation (the treatment exposure period)., Results: In total, 1196 and 149 women initiating zoledronate and 14,764 and 25,058 initiating OBPs were eligible in the Swedish and Dutch registries, respectively. Owing to the small Dutch zoledronate sample, only the Swedish data were used to compare fracture incidences between treatment groups. ADCs showed a numerically higher fracture incidence in the zoledronate than in the OBPs group (hazard ratio 1.09-1.21; not statistically significant, p > 0.05). For both treatment groups, OCA showed a higher fracture incidence in the baseline risk period than in the treatment exposure period, indicating a treatment effect. OCA showed a similar or greater effect in the zoledronate group compared with the OBPs group., Conclusions: ADC and OCA each possesses advantages and disadvantages. Combining both methods may provide an estimate of real-world treatment efficacy that could potentially complement clinical trial findings.

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.

Unlabelled: 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., Competing Interests: Compliance with Ethical Standards Conflicts of interest This study was supported by Amgen GmbH. MS, MI, and TS are Amgen employees and shareholders. EP was an Amgen employee and shareholder at the time of conducting this study and manuscript preparation. PH has received honoraria, unrestricted educational grants, and research funding from Amgen, AstraZeneca, Eli Lilly, GlaxoSmithKline, Novartis, Pfizer, Procter & Gamble, and Roche. IK has received honoraria, unrestricted educational grants, and funding from Amgen. LH has received honoraria, unrestricted educational grants, and research funding from Amgen, Eli Lilly, and Novartis. CN has received honoraria, unrestricted educational grants, and research funding from Amgen, Eli Lilly, Merck Sharp & Dohme, and UCB Pharma. PHK received honoraria, unrestricted grants, and research funding from Amgen, Eli Lilly, GlaxoSmithKline, Ipsen, Novo Nordisk, Novartis, Pfizer, Procter & Gamble, Roche, and Sanofi Aventis. HS has received honoraria and unrestricted educational grants from Prüfungseinrichtungen Baden-Württemberg, KV Baden-Württemberg, AOK, BEK, DAK, TKK, BKK’s, IKK, LKK, BK, Heilfürsorge, BG, Ärztekammer Baden-Württemberg, Patienten, Diverse Kliniken, Amgen, Anwerina, Astra, Daichi, Glaxo, Grünenthal, Janssen, Kade, Lilly, Medi, Medtronic, Omnia-Med, Orion, Medical Tribune, MSD, Mundipharma, Novartis, Nycomed, Pfizer, Procter & Gamble, Roche, Servier, and Teva. AAK has received honoraria, unrestricted educational grants, and research funding from Amgen, Baxter, Biomet, Boehringer Ingelheim, Dfine, Eli Lilly, GlaxoSmithKline, Novartis, Pfizer, Procter & Gamble, and Roche. FT has received honorarium by Lilly, Amgen, Boehringer, and Takeda.

This study assessed persistence and compliance with anti-osteoporosis therapies, and associations between compliance and clinical outcomes (fracture, fracture-related hospitalization and death), in Hungarian women with postmenopausal osteoporosis. The study used the Hungarian National Health Insurance Fund Administration database and included women with PMO aged at least 50 years, for whom a prescription for anti-osteoporosis medication had been filled between 1 January 2004 and 31 December 2013 (index event). Persistence (prescription refilled within 8 weeks of the end of the previous supply) was evaluated over 2 years; good compliance (medication possession ratio ≥ 80 %) was evaluated at 1 year. Associations between compliance and clinical outcomes (data collected for up to 6 years) were assessed with adjustment for baseline covariates. A total of 296,300 women met the inclusion criteria (524,798 index events). Persistence and compliance were higher for less frequent and parenteral therapies (1- and 2-year persistence: half-yearly [parenteral] vs. daily/weekly/monthly [oral and parenteral], 81 and 38 % vs. 21-34 and 10-18 %, respectively; parenteral vs. oral, 75 and 36 % vs. 32 and 16 %; good compliance: half-yearly vs. daily/weekly/monthly, 70 vs. 24-39 %; parenteral vs. oral 78 vs. 36 %). Good compliance significantly reduced the risks of fracture, fracture-related hospitalization and death (relative risk vs. non-compliance [95 % confidence interval]: 0.77 [0.70-0.84], 0.72 [0.62-0.85] and 0.57 [0.51-0.64], respectively; P < 0.01). Improving compliance through long-interval parenteral therapies may result in clinical benefits for patients.

Unlabelled: 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.

Unlabelled: 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.