TY - JOUR
T1 - 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
AU - Elders, P. J.M.
AU - Merlijn, T.
AU - Swart, KMA
AU - Van Hout, W.
AU - Van Der Zwaard, B. C.
AU - Niemeijer, C.
AU - Heymans, M. W.
AU - Van Der Heijden, A. A.
AU - Rutters, F.
AU - Van Der Horst, H. E.
AU - Lips, P.
AU - Netelenbos, J. C.
AU - Van Schoor, N. M.
PY - 2017/10/27
Y1 - 2017/10/27
N2 - © 2017 The Author(s). Background: Several 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. Methods: A 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. Discussion: The results of the current study will be very important for underpinnings of the prevention strategy of the osteoporosis guidelines. Trial registration: ID NTR2430. Registered 26 July 2010.
AB - © 2017 The Author(s). Background: Several 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. Methods: A 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. Discussion: The results of the current study will be very important for underpinnings of the prevention strategy of the osteoporosis guidelines. Trial registration: ID NTR2430. Registered 26 July 2010.
KW - Bisphosphonates
KW - Fractures
KW - Osteoporosis
KW - Primary care
KW - Randomised pragmatic trial
KW - Screening
UR - http://www.scopus.com/inward/record.url?scp=85032444275&partnerID=8YFLogxK
U2 - https://doi.org/10.1186/s12891-017-1783-y
DO - https://doi.org/10.1186/s12891-017-1783-y
M3 - Article
C2 - 29078762
SN - 1471-2474
VL - 18
JO - BMC musculoskeletal disorders
JF - BMC musculoskeletal disorders
IS - 1
ER -