Design of the SALT Osteoporosis Study: a randomised pragmatic trial, to study a primary care screening and treatment program for the prevention of fractures in women aged 65 years or older

BMC Musculoskeletal Disorders

Study Protocol

M. W. Heymans¹  F. Rutters¹  N. M. van Schoor¹  H. E. van der Horst²  A. A. van der Heijden²  T. Merlijn²  W. van Hout²  B. C. van der Zwaard²  P. J. M. Elders²  K. M. A. Swart³  J. C. Netelenbos⁴  P. Lips⁴  C. Niemeijer⁵ 

[1] Department of Epidemiology and Biostatistics, VU University Medical Center, Amsterdam Public Health research institute, Amsterdam, The Netherlands;Department of General Practice and Elderly Care Medicine, VU University Medical Center, Amsterdam Public Health research institute, Amsterdam, The Netherlands;Department of General Practice and Elderly Care Medicine, VU University Medical Center, Amsterdam Public Health research institute, Amsterdam, The Netherlands;Stichting ArtsenLaboratorium en Trombosedienst, Koog aan de Zaan, The Netherlands;Department of Internal Medicine, Endocrine Section, VU University Medical Center, Amsterdam Public Health research institute, Amsterdam, The Netherlands;Stichting ArtsenLaboratorium en Trombosedienst, Koog aan de Zaan, The Netherlands;

关键词: Osteoporosis;    Fractures;    Primary care;    Randomised pragmatic trial;    Screening;    Bisphosphonates;   

DOI  :  10.1186/s12891-017-1783-y

 received in 2017-04-06, accepted in 2017-10-15,  发布年份 2017

来源: Springer

【 摘 要 】

BackgroundSeveral drugs have become available for the treatment of osteoporosis. However, screening and treatment of patients with a high fracture risk is currently not recommended in the Netherlands, because the effectiveness of bone sparing drugs has not been demonstrated in the general primary care population. Here we describe the design of the SALT Osteoporosis study, which aims to examine whether the screening and treatment of older, female patients in primary care can reduce fractures, in comparison to usual care.MethodsA randomised pragmatic trial has been designed using a stepwise approach in general care practices in the Netherlands. Women aged ≥65 years, who are not prescribed bone sparing drugs or corticosteroids are eligible for the study. First, women with at least one clinical risk factor for fractures, as determined by questionnaires, are randomly assigned to the intervention or control group. Second, women in the intervention group having a high fracture risk according to our screening program, including an adapted fracture risk assessment (FRAX) tool, combined with dual-energy x-ray absorptiometry (DXA), and instant vertebral assessment (IVA), are offered a structured treatment program. The women in the control group receive care as usual and will undergo the same screening as the intervention group at the end of the trial. The follow-up duration will be three years and the primary outcome is time to first incident fracture and the total number of fractures.DiscussionThe results of the current study will be very important for underpinnings of the prevention strategy of the osteoporosis guidelines.Trial registrationID NTR2430. Registered 26 July 2010.

【 授权许可】

CC BY   
© The Author(s). 2017