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Summary: This 7-year prospective observational study determined the predictors of re-fracture amongst 234 patients managed within a Secondary Fracture Prevention programme. Poor compliance, multiple co-morbidities, corticosteroid therapy, low hip bone mineral density (BMD) or low body weight were all significantly associated with re-fracture in patients commenced on long-term anti-resorptive therapy. Introduction: Risk factors for osteoporotic fracture amongst treatment-naïve patients are well established. In contrast, predictors of re-fracture in patients optimally managed within a Secondary Fracture Prevention (SFP) programme are ill-defined. Methods: This prospective observational study included 234 subjects with incident osteoporotic fractures managed long-term by the Concord SFP programme. Using Cox proportional hazards models, predictors of re-fracture were analysed separately for patients commenced on specific pharmacotherapy (group 1, N = 171) and subjects receiving calcium and/or vitamin D supplements only (group 2, N = 63). Relevant anthropometric, clinical and technical data were documented at each visit. Compliance and persistence were analysed as time-varying covariates. Results: During a mean follow-up of 5.2 (range 3.5-7.3) years, 20.9 % of all subjects re-fractured (26.3 % in group 1, 6.3 % in group 2). Multivariate predictors of re-fracture in group 1 were significant co-morbidity (HR 2.04 if >3, 95 % CI 1.10-3.79, p = 0.024), corticosteroid use (HR 1.75, 95 % CI 1.12-2.73, p = 0.013) and total hip BMD (HR 1.36 per 0.1 g/cm decrease, 95 % CI 1.08-1.70, p = 0.008). In contrast, gender, prevalent fractures and lumbar spine BMD were not associated with re-fracture. Amongst patients with complete compliance data, a medication possession ratio of ≤ 50 % (HR 3.36, 95 % CI 1.32-8.53, p = 0.011) and low body weight (HR 1.04 per 1-kg decrease, 95 % CI 1.003-1.08, p = 0.032) were significantly associated with re-fracture. Conclusions: Amongst patients managed within a dedicated SFP programme, poor compliance, multiple co-morbidities, corticosteroid therapy, low hip BMD or low body weight are all associated with increased risk of re-fracture. This subgroup of patients therefore require intensive management including strategies to improve compliance. [ABSTRACT FROM AUTHOR]

Summary: Following initiation of oral bisphosphonate therapy through a secondary fracture prevention program, 2-year treatment compliance and persistence remained high and were similar in patients randomised to follow-up by either the program or primary care physician. Thus, community-based and specialist management are equally effective in supporting compliance and persistence with anti-osteoporotic treatments. Introduction: The purpose of this study was to determine whether management by a secondary fracture prevention (SFP) program (aka 'fracture liaison service') results in better compliance and persistence to oral bisphosphonate therapy than follow-up by the primary care physician, after initiation within an SFP program. Methods: This prospective RCT included 102 patients with incident osteoporotic fractures referred to a SFP program in Sydney, Australia. Following oral bisphosphonate therapy initiation, patients were randomised to either 6-monthly follow-up with the SFP program (group A) or referral to their primary care physician with a single SFP program visit at 24 months (group B). Compliance and persistence to treatment were measured using pharmaceutical claims data. Predictors of compliance and persistence and associations between compliance and persistence, and changes in bone mineral density (BMD) or bone resorption marker, urinary deoxypyridinoline over 24 months were analysed. Results: The median medication possession ratio at 24 months was 0.78 (IQR, 0.50-0.93) in group A and 0.79 (IQR, 0.48-0.96) in group B ( p = 0.68). Persistence at 24 months was also similar in both groups (64 vs. 61 %, respectively; p = 0.75). After adjusting for confounders, patients in group A were not more likely to be compliant (OR, 1.06; 95 % CI, 0.46-2.47) or persistent (HR, 0.83; 95 % CI, 0.27-1.67) than those randomised to group B. Time-based changes in BMD or bone turnover were not associated with compliance or persistence. Conclusion: Compliance and persistence to oral bisphosphonate therapy remain high amongst patients initiated within an SFP program, with community-based and SFP program management being equally effective in maintaining therapeutic compliance and persistence over 2 years. These results indicate that one of the main functions of an SFP program may be the initiation of therapy rather than continuous patient monitoring. [ABSTRACT FROM AUTHOR]

We report on the clinical and biochemical outcomes in two adult patients with active polyostotic fibrous dysplasia (FD) treated with the RANK-L inhibitor, denosumab, following unsatisfactory responses to prior long-term bisphosphonate therapy. A 44-year-old female (case 1) who had received a cumulative dose of 20 mg zoledronic acid over 2.5 years and a 48-year-old male (case 2) who had received a cumulative dose of 45 mg zoledronic acid over 8 years both experienced minimal reductions in pain scores and markers of bone turnover. Following initiation of denosumab 60 mg sc, changes in bone pain, bone turnover [assessed by serum amino-terminal propeptide of type I collagen (PINP) and urinary deoxypyridinoline] were monitored over a period of 20 and 8 months, respectively. Following administration of denosumab, both patients demonstrated a rapid and pronounced biochemical response: Within 4-7 weeks, bone turnover markers fell to levels within the respective reference range, and one patient reported a reduction in pain. Treatment with denosumab was well tolerated. However, transient asymptomatic hypocalcaemia and/or hypophosphatemia associated with a transient two to threefold increase in serum PTH levels was observed in both patients. Dosing intervals for denosumab varied significantly between the two patients, depending on disease activity at baseline. Denosumab appears to be effective in reducing bone turnover in adult patients with active FD. However, caution should be exercised, and patients should be monitored carefully as significant fluctuations in biochemical and hormonal indices can occur. [ABSTRACT FROM AUTHOR]

Most people presenting with incident osteoporotic fractures are neither assessed nor treated for osteoporosis to reduce their risk of further fractures, despite the availability of effective treatments. We evaluated the effectiveness of published models of care for the secondary prevention of osteoporotic fractures. We searched eight medical literature databases to identify reports published between 1996 and 2011, describing models of care for secondary fracture prevention. Information extracted from each publication included study design, patient characteristics, identification strategies, assessment and treatment initiation strategies, as well as outcome measures (rates of bone mineral density (BMD) testing, osteoporosis treatment initiation, adherence, re-fractures and cost-effectiveness). Meta-analyses of studies with valid control groups were conducted for two outcome measures: BMD testing and osteoporosis treatment initiation. Out of 574 references, 42 articles were identified as analysable. These studies were grouped into four general models of care-type A: identification, assessment and treatment of patients as part of the service; type B: similar to A, without treatment initiation; type C: alerting patients plus primary care physicians; and type D: patient education only. Meta-regressions revealed a trend towards increased BMD testing ( p = 0.06) and treatment initiation ( p = 0.03) with increasing intensity of intervention. One type A service with a valid control group showed a significant decrease in re-fractures. Types A and B services were cost-effective, although definition of cost-effectiveness varied between studies. Fully coordinated, intensive models of care for secondary fracture prevention are more effective in improving patient outcomes than approaches involving alerts and/or education only. [ABSTRACT FROM AUTHOR]

Summary: In the present prospective controlled observational study, we investigated the effect of a coordinated intervention program on 4-year refracture rates in patients with recent osteoporotic fractures. Compared to standard care, targeted identification, and management significantly reduced the risk of refracture by more than 80%. Introduction: The risk of refracture following an incident osteoporotic fracture is high. Despite the availability of treatments that reduce refracture and mortality rates, most patients with minimal trauma fracture (MTF) are not managed appropriately. The present prospective controlled observational study investigated the effect of a coordinated intervention program on 4-year refracture rates and time to refracture in patients with recent osteoporotic fractures. Methods: Patients presenting with a non-vertebral MTF were actively identified and offered referral to a dedicated intervention program. Patients attending the clinic underwent a standardized set of investigations, were treated as indicated and reviewed at 12-monthly intervals ('MTF group'). Patients who elected to follow-up with their primary care physician were assigned to the concurrent control group. Results: Groups were balanced for baseline anthropometric, socio-economic, and clinical risk factors. Over 4 years, 10 out of 246 patients (4.1%) in the MTF group and 31 of 157 patients (19.7%) in the control group suffered a new fracture, with a median time to refracture of 26 and 16 months, respectively ( p < 0.01). Compared to the intervention group, the risk of refracture was increased by 5.3-fold in the control group (95% CI: 2.8-12.2, p < 0.01), and remained elevated (HR 5.63, 95%CI 2.73-11.6, p < 0.01) after adjustment for other significant predictors of refracture such as age and body weight. Conclusions: In patients presenting with a minimal trauma non-vertebral fracture, active identification and management significantly reduces the risk of refracture (Australian New Zealand Clinical Trials Registry ACTRN 12606000108516). [ABSTRACT FROM AUTHOR]