The osteoporotic fracture prevention program in rural areas (OFRA): a protocol for a cluster-randomized health care fund driven intervention in a routine health care setting.

BACKGROUND: Fragility fractures are one of the leading causes for disability in old people. The main underlying mechanisms are osteoporosis and falls. Evidence-based measures to prevent either falls or fractures are available. However, coordinated preventive approaches combining bone health and fall prevention are rare. The objective of the study is to evaluate a health care fund driven program, which encourages insured persons to adhere to national guidelines regarding bone health and physical activity and falls prevention. The health care fund cooperates with the 'German Association of Rural Women' and the 'German Gymnastics Association'. The program consists of mobility and falls prevention classes, the examination of bone health by a DXA scan, and a consultation about 'safety in the living environment'.

METHODS: Cluster-randomized study in 47 intervention and 143 control districts in 5 federal states of Germany. The program is offered to a) community-living women and men aged 70 to <85 years with a prior fragility fracture or b) community-living women aged 75 to <80 years. Within two years more than 10,000 persons will be directly contacted and motivated to make use of the components of the program. The primary outcome is a combined measure of incident osteoporotic fractures. Secondary outcomes include the rate of referrals to a mobility and falls prevention class or a bone mass density measurement. An economic evaluation will be conducted.

DISCUSSION: The study evaluates a complex preventive intervention in a routine health care setting which may serve as model for similar approaches in other areas or countries.

TRIAL REGISTRATION: DRKS-ID: DRKS00009000 ; date of registration: 06.08.2015.