Top

Published in:

Open Access 01-12-2022 | Femoral Fracture | Research article

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

Authors: Kilian Rapp, Sarah E. Lamb, Patrick Roigk, Clemens Becker, Claudia Konnopka, Hans-Helmut König, Raphael S. Peter, Dietrich Rothenbacher, Gisela Büchele

Published in: BMC Medicine | Issue 1/2022

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

Available only for authorised users

Cummings SR, Melton LJ. Epidemiology and outcomes of osteoporotic fractures. Lancet Lond Engl. 2002;359(9319):1761–7. https://doi.org/10.1016/S0140-6736(02)08657-9.CrossRef

Bleibler F, Konnopka A, Benzinger P, Rapp K, König H-H. The health burden and costs of incident fractures attributable to osteoporosis from 2010 to 2050 in Germany--a demographic simulation model. Osteoporos Int. 2013;24(3):835–47. https://doi.org/10.1007/s00198-012-2020-z.CrossRefPubMed

Kanis JA, Cooper C, Rizzoli R, Reginster J-Y. Scientific Advisory Board of the European Society for Clinical and Economic Aspects of Osteoporosis (ESCEO) and the Committees of Scientific Advisors and National Societies of the International Osteoporosis Foundation (IOF). European guidance for the diagnosis and management of osteoporosis in postmenopausal women. Osteoporos Int. 2019;30(1):3–44. https://doi.org/10.1007/s00198-018-4704-5.CrossRefPubMed

Grisso JA, Kelsey JL, Strom BL, Chiu GY, Maislin G, O’Brien LA, et al. Risk factors for falls as a cause of hip fracture in women. The Northeast Hip Fracture Study Group. N Engl J Med. 1991;324(19):1326–31. https://doi.org/10.1056/NEJM199105093241905.CrossRefPubMed

Sherrington C, Fairhall NJ, Wallbank GK, Tiedemann A, Michaleff ZA, Howard K, et al. Exercise for preventing falls in older people living in the community. Cochrane Database Syst Rev. 2019;1(1):CD012424. https://doi.org/10.1002/14651858.CD012424.pub2.CrossRefPubMed

Clemson L, Mackenzie L, Ballinger C, Close JCT, Cumming RG. Environmental interventions to prevent falls in community-dwelling older people: a meta-analysis of randomized trials. J Aging Health. 2008;20(8):954–71. https://doi.org/10.1177/0898264308324672.CrossRefPubMed

McClung MR, Grauer A, Boonen S, Bolognese MA, Brown JP, Diez-Perez A, et al. Romosozumab in postmenopausal women with low bone mineral density. N Engl J Med. 2014;370(5):412–20. https://doi.org/10.1056/NEJMoa1305224.CrossRefPubMed

Benzinger P, Becker C, Todd C, Bleibler F, Rothenbacher D, König H-H, et al. The impact of preventive measures on the burden of femoral fractures - a modelling approach to estimating the impact of fall prevention exercises and oral bisphosphonate treatment for the years 2014 and 2025. BMC Geriatr. 2016;16(1):75. https://doi.org/10.1186/s12877-016-0247-9.CrossRefPubMedPubMedCentral

Giangregorio L, Papaioannou A, Cranney A, Zytaruk N, Adachi JD. Fragility fractures and the osteoporosis care gap: an international phenomenon. Semin Arthritis Rheum. 2006;35(5):293–305. https://doi.org/10.1016/j.semarthrit.2005.11.001.CrossRefPubMed

10.

Akesson K, Marsh D, Mitchell PJ, McLellan AR, Stenmark J, Pierroz DD, et al. Capture the fracture: a best practice framework and global campaign to break the fragility fracture cycle. Osteoporos Int. 2013;24(8):2135–52. https://doi.org/10.1007/s00198-013-2348-z.CrossRefPubMedPubMedCentral

11.

Rapp K, Kampe K, Roigk P, Kircheisen H, Becker C, Lindlbauer I, et al. 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. BMC Musculoskelet Disord. 2016;17(1):458. https://doi.org/10.1186/s12891-016-1308-0.CrossRefPubMedPubMedCentral

12.

Campbell AJ, Robertson MC, Gardner MM, Norton RN, Tilyard MW, Buchner DM. Randomised controlled trial of a general practice programme of home based exercise to prevent falls in elderly women. BMJ. 1997;315(7115):1065–9. https://doi.org/10.1136/bmj.315.7115.1065.CrossRefPubMedPubMedCentral

13.

Robertson MC, Campbell AJ, Gardner MM, Devlin N. Preventing injuries in older people by preventing falls: a meta-analysis of individual-level data. J Am Geriatr Soc. 2002;50(5):905–11. https://doi.org/10.1046/j.1532-5415.2002.50218.x.CrossRefPubMed

14.

Winkler J, Regelin P. Standfest und Stabil: Kursmanual. 2., Auflage. Aachen: Meyer & Meyer Sport; 2015. p. 184.

15.

Roigk P, Büchele G, Kampe K, Rupp K, Rapp K. The osteoporotic fracture prevention program in rural areas (OFRA): analysis of 1092 mobility courses in rural areas. Z Gerontol Geriatr. 2019;52(1):68–74. https://doi.org/10.1007/s00391-018-1434-4.CrossRefPubMed

16.

Roigk P, Büchele G, Rehm M, Schulz C, König H-H, Becker C, et al. Uptake of an exercise class and use of bone density measurement after advice by the health insurance fund: results from the osteoporotic fracture prevention program in rural areas (OFRA). Aging Clin Exp Res. 2020;32(7):1255–62. https://doi.org/10.1007/s40520-020-01506-2.CrossRefPubMed

17.

El-Khoury F, Cassou B, Charles M-A, Dargent-Molina P. The effect of fall prevention exercise programmes on fall induced injuries in community dwelling older adults: systematic review and meta-analysis of randomised controlled trials. BMJ. 2013;347:f6234.PubMedPubMedCentral

18.

Lamb SE, Bruce J, Hossain A, Ji C, Longo R, Lall R, et al. Screening and intervention to prevent falls and fractures in older people. N Engl J Med. 2020;383(19):1848–59. https://doi.org/10.1056/NEJMoa2001500.CrossRefPubMed

19.

Jaglal SB, Donescu OS, Bansod V, Laprade J, Thorpe K, Hawker G, et al. Impact of a centralized osteoporosis coordinator on post-fracture osteoporosis management: a cluster randomized trial. Osteoporos Int. 2012;23(1):87–95. https://doi.org/10.1007/s00198-011-1726-7.CrossRefPubMed

20.

Mitchell P, Åkesson K, Chandran M, Cooper C, Ganda K, Schneider M. Implementation of models of care for secondary osteoporotic fracture prevention and orthogeriatric models of care for osteoporotic hip fracture. Best Pract Res Clin Rheumatol. 2016;30(3):536–58. https://doi.org/10.1016/j.berh.2016.09.008.CrossRefPubMed

21.

Goltz L, Degenhardt G, Maywald U, Kirch W, Schindler C. Evaluation of a program of integrated care to reduce recurrent osteoporotic fractures. Pharmacoepidemiol Drug Saf. 2013;22(3):263–70. https://doi.org/10.1002/pds.3399.CrossRefPubMed

22.

Dell R, Greene D, Schelkun SR, Williams K. Osteoporosis disease management: the role of the orthopaedic surgeon. J Bone Joint Surg Am. 2008;90(Suppl 4):188–94. https://doi.org/10.2106/JBJS.H.00628.CrossRefPubMed

23.

Shepstone L, Lenaghan E, Cooper C, Clarke S, Fong-Soe-Khioe R, Fordham R, et al. Screening in the community to reduce fractures in older women (SCOOP): a randomised controlled trial. Lancet Lond Engl. 2018;391(10122):741–7. https://doi.org/10.1016/S0140-6736(17)32640-5.CrossRef

Title: Effect of an osteoporotic fracture prevention program on fracture incidence in routine care: a cluster-randomized trial
Authors: Kilian Rapp
Sarah E. Lamb
Patrick Roigk
Clemens Becker
Claudia Konnopka
Hans-Helmut König
Raphael S. Peter
Dietrich Rothenbacher
Gisela Büchele
Publication date: 01-12-2022
Publisher: BioMed Central
Keywords: Femoral Fracture
Care
Published in: BMC Medicine / Issue 1/2022
Electronic ISSN: 1741-7015
DOI: https://doi.org/10.1186/s12916-021-02226-8

At a glance: The ONWARDS insulin icodec trials

Springer Medicine

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

Abstract

Background

Methods

Results

Conclusions

Trial registration

At a glance: The ONWARDS insulin icodec trials

Springer Medicine

Abstract

Background

Methods

Results

Conclusions

Trial registration

Please log in to get access to this content

Other articles of this Issue 1/2022

A cost-effectiveness analysis of capecitabine maintenance therapy versus routine follow-up for early-stage triple-negative breast cancer patients after standard treatment from a perspective of Chinese society

Non-alcoholic fatty liver is associated with increased risk of irritable bowel syndrome: a prospective cohort study

The effectiveness of the Structured Health Intervention For Truckers (SHIFT): a cluster randomised controlled trial (RCT)

The association of neurodevelopmental abnormalities, congenital heart and renal defects in a tuberous sclerosis complex patient cohort

Predictive validity of the Stopping Elderly Accidents, Deaths & Injuries (STEADI) program fall risk screening algorithms among community-dwelling Thai elderly

A multicenter, double-blind, randomized, parallel-group, placebo-controlled study to evaluate the efficacy and safety of camostat mesilate in patients with COVID-19 (CANDLE study)