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

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Abstract

© 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.
Original languageEnglish
JournalBMC Musculoskeletal Disorders
Volume18
Issue number1
DOIs
Publication statusPublished - 27 Oct 2017

Cite this

@article{746b32cabc724cbab2f165488c12cf66,
title = "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",
abstract = "{\circledC} 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.",
keywords = "Bisphosphonates, Fractures, Osteoporosis, Primary care, Randomised pragmatic trial, Screening",
author = "Elders, {P. J.M.} and T. Merlijn and KMA Swart and {Van Hout}, W. and {Van Der Zwaard}, {B. C.} and C. Niemeijer and Heymans, {M. W.} and {Van Der Heijden}, {A. A.} and F. Rutters and {Van Der Horst}, {H. E.} and P. Lips and Netelenbos, {J. C.} and {Van Schoor}, {N. M.}",
year = "2017",
month = "10",
day = "27",
doi = "10.1186/s12891-017-1783-y",
language = "English",
volume = "18",
journal = "BMC Musculoskeletal Disorders",
issn = "1471-2474",
publisher = "BioMed Central",
number = "1",

}

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 - 10.1186/s12891-017-1783-y

DO - 10.1186/s12891-017-1783-y

M3 - Article

VL - 18

JO - BMC Musculoskeletal Disorders

JF - BMC Musculoskeletal Disorders

SN - 1471-2474

IS - 1

ER -