The osteoporotic fracture prevention programme in rural areas
- Conditions
- S22Fracture of rib(s), sternum and thoracic spineFracture of femurS12S32S42S52S72S82Fracture of neck
- Registration Number
- DRKS00009000
- Lead Sponsor
- Robert Bosch Gesellschaft für medizinische Forschung mbH (RBMF)
- Brief Summary
Background: Fractures are a major health problem in aging societies. Preventive approaches combining bone health and fall prevention are rare. The osteoporotic fracture prevention program in rural areas (OFRA) is a health care fund-driven program for older people in randomly selected districts in Germany. The components of the program were falls prevention exercise classes, examination of bone health by a dual-energy X-ray absorptiometry (DXA) scan, and a consultation about “safety in the living environment.” The aim of this study was to evaluate this complex preventive intervention in a routine health care setting. Methods: This cluster-randomized trial was performed from October 2015 to October 2018 and took place in 186 administrative districts in five federal states, 47 districts served as intervention districts, and 139, as controls. Within these districts, we included (a) all community-living women and men aged 70–85 years with prior fragility fractures and (b) all community-living women aged 75–80 years. The analysis used routine data collected by a health insurance company. The primary endpoint was all fragility fractures combined. Fracture types, mortality, and nursing home admission were explorative endpoints. Cox frailty models were used for comparative analyses with a median follow-up time of 365 days (interquartile range: 0 days). Results: Nine thousand four hundred eight individuals were approached to participate in one of the program components, 27,318 individuals served as controls. The mean age was 78.7 years. Of those approached to participate, nearly 30% joined the exercise classes. DXA measurement was reimbursed for 13.6%, and 51.8% received advice about measures to increase “safety in the living environment.” The incidence of fragility fractures did not differ between the intervention and the control group (HR 0.94; 95% CI 0.80–1.11). However, femoral fractures, the most frequent fracture type, were reduced in the intervention group (HR 0.76; 95% CI 0.59–0.99). Mortality and nursing home admission did not differ between the intervention and the control group. Conclusions: A comprehensive fracture prevention program for older people living in rural areas was implemented. The program did not affect the primary endpoint of all fragility fractures combined. It has to be considered that we used a modified intention to treat approach based on geographic randomization and information about endpoints relied exclusively on routine data of the health care insurance.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 36726
All …
• community-living women and men aged 70- <85 years with a fragility fracture in the last 5 years;
• community-living women aged 75- <80 years
… who are insured at the Landwirtschaftliche Krankenversicherung (LKK) within the Sozialversicherung für Landwirtschaft, Forsten und Gartenbau (SVLFG) and live in one of the intervention districts (complete sampling).
1. Insured persons not living at home (residents of nursing homes). 2. Insured persons with being categorized in a level of care 2 or 3 (Pflegestufe 2 oder 3) according to the German long term care insurance.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Osteoporotic fractures (ICD-10 S12, S22, S32, S42, S52, S72, S82, kombiniert), which require a hospitalisation (main admission or discharge diagnosis) - as recorded in the routine health claims database of the insurance after recruitment and an additional year of follow-up (30.09.2018).
- Secondary Outcome Measures
Name Time Method 1. Attendance of a physical exercise Group, 2. Referral to a bone mass density measurement (DXA), 3. Specific anti-resorptive drug therapy (e.g. bisphosphonates); point 1 to 3 six months after the first contact.<br>Data collection partly by routine data (DXA; drugs) and partly by as-sessment by the telecentres (attendance of a physical exercise group).<br>4. Cost-effectiveness of the Programme. <br>A cost-effectiveness analysis of the programme will be performed one year after the end of recruitment . Based on routine data of the health care fund fracture-related costs of acute care, rehabilitation and care-giving expenses are calculated in the intervention and control group.<br>