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Randomized Controlled Trial
. 2022 Feb 4;20(1):49.
doi: 10.1186/s12916-021-02226-8.

Effect of an osteoporotic fracture prevention program on fracture incidence in routine care: a cluster-randomized trial

Kilian Rapp  1 , Sarah E Lamb  2 , Patrick Roigk  1 , Clemens Becker  1 , Claudia Konnopka  3 , Hans-Helmut König  3 , Raphael S Peter  4 , Dietrich Rothenbacher  4 , Gisela Büchele  5
Affiliations
Randomized Controlled Trial

Effect of an osteoporotic fracture prevention program on fracture incidence in routine care: a cluster-randomized trial

Kilian Rapp et al. BMC Med. .

Abstract

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.

Trial registration: German Clinical Trials Register DRKS-ID: 00009000.

Keywords: DXA; Falls; Mobility and falls prevention exercise classes; Osteoporotic fractures; Prevention; Rural area.

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Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Flow-chart of A the number of included districts (cluster of randomization) and B the number of included individuals
Fig. 2
Fig. 2
Effect of OFRA on all “fragility fractures combined” and on fractures of femur, spine, forearm, shoulder/upper arm, lower leg, and pelvis during 12 months of follow-up. N, number; HR, hazard ratio; CI, confidence interval; Frag. Fractures comb., fragility fractures combined
Fig. 3
Fig. 3
Effect of OFRA on all “fragility fractures combined” stratified by sex, age, and fracture history and on death and nursing home admission during 12 months of follow-up. N, number; HR, hazard ratio; CI, confidence interval; FU, follow-up
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