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BMC Musculoskeletal Disorders
Published in: BMC Musculoskeletal Disorders 1/2017

Open Access 01-12-2017 | Study protocol

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

Authors: P. J. M. Elders, T. Merlijn, K. M. A. Swart, W. van Hout, B. C. van der Zwaard, C. Niemeijer, M. W. Heymans, A. A. van der Heijden, F. Rutters, H. E. van der Horst, P. Lips, J. C. Netelenbos, N. M. van Schoor

Published in: BMC Musculoskeletal Disorders | Issue 1/2017

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Abstract

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.
Literature
1.
Genant HK, Cooper C, Poor G, et al. Interim report and recommendations of the World Health Organization task-force for osteoporosis. Osteoporos Int. 1999;10:259–64.CrossRefPubMed
2.
Seeley DG, Browner WS, Nevitt MC, Genant HK, Scott JC, Cummings SR. Which fractures are associated with low appendicular bone mass in elderly women? The study of osteoporotic fractures research group. Ann Intern Med. 1991;115:837–42.CrossRefPubMed
3.
Lotters FJ, van den Bergh JP, de Vries F, Rutten-van Molken MP. Current and future incidence and costs of osteoporosis-related fractures in The Netherlands: combining claims data with BMD measurements. Calcif Tissue Int. 2016;98:235–43.CrossRefPubMedPubMedCentral
4.
Lips P, van Schoor NM. Quality of life in patients with osteoporosis. Osteoporos Int. 2005;16:447–55.CrossRefPubMed
5.
Wells G, Cranney A, Peterson J, Boucher M, Shea B, Robinson V, Coyle D, Tugwell P. Risedronate for the primary and secondary prevention of osteoporotic fractures in postmenopausal women. Cochrane Database Syst Rev. 2008;1:CD004523.
6.
Wells GA, Cranney A, Peterson J, Boucher M, Shea B, Robinson V, Coyle D, Tugwell P. Alendronate for the primary and secondary prevention of osteoporotic fractures in postmenopausal women. Cochrane Database Syst Rev. 2008;1:CD001155.
7.
Wells GA, Cranney A, Peterson J, Boucher M, Shea B, Robinson V, Coyle D, Tugwell P. Etidronate for the primary and secondary prevention of osteoporotic fractures in postmenopausal women. Cochrane Database Syst Rev. 2008;1:CD003376.
8.
Serrano AJ, Begona L, Anitua E, Cobos R, Orive G. Systematic review and meta-analysis of the efficacy and safety of alendronate and zoledronate for the treatment of postmenopausal osteoporosis. Gynecol Endocrinol. 2013;29:1005–14.CrossRefPubMed
9.
Briot K, Cortet B, Thomas T, et al. 2012 update of French guidelines for the pharmacological treatment of postmenopausal osteoporosis. Joint Bone Spine. 2012;79:304–13.CrossRefPubMed
10.
Compston J, Bowring C, Cooper A, et al. Diagnosis and management of osteoporosis in postmenopausal women and older men in the UK: National Osteoporosis Guideline Group (NOGG) update 2013. Maturitas. 2013;75:392–6.CrossRefPubMed
11.
Elders PJM, Dinant GJ, van Geel T, Maartens LWF, Merlijn T, Geijer RMM, Geraets JJXR. NHG-Standaard Fractuurpreventie (tweede herziening). Huisarts Wet. 2012;55:452–8.CrossRef
12.
Kanis JA, McCloskey EV, Johansson H, Cooper C, Rizzoli R, Reginster JY. European guidance for the diagnosis and management of osteoporosis in postmenopausal women. Osteoporos Int. 2013;24:23–57.CrossRefPubMed
13.
Mendoza N, Sanchez-Borrego R, Villero J, et al. 2013 up-date of the consensus statement of the Spanish menopause society on postmenopausal osteoporosis. Maturitas. 2013;76:99–107.CrossRefPubMed
14.
Watts NB, Bilezikian JP, Camacho PM, et al. American Association of Clinical Endocrinologists Medical Guidelines for clinical practice for the diagnosis and treatment of postmenopausal osteoporosis. Endocr Pract. 2010;16(Suppl 3):1–37.CrossRefPubMedPubMedCentral
15.
Yeap SS, Hew FL, Lee JK, Goh EM, Chee W, Mumtaz M, Damodaran P, Lim HH, Chan SP. The Malaysian clinical guidance on the management of postmenopausal osteoporosis, 2012: a summary. Int J Rheum Dis. 2013;16:30–40.CrossRefPubMed
16.
17.
18.
Kanis JA, Johnell O, Oden A, Johansson H, McCloskey E. FRAX and the assessment of fracture probability in men and women from the UK. Osteoporos Int. 2008;19:385–97.CrossRefPubMedPubMedCentral
19.
Kanis JA, McCloskey EV, Johansson H, Oden A, Strom O, Borgstrom F. Development and use of FRAX in osteoporosis. Osteoporos Int. 2010;21(Suppl 2):S407–13.CrossRefPubMed
20.
Kanis JA, McCloskey EV, Johansson H, Strom O, Borgstrom F, Oden A. Case finding for the management of osteoporosis with FRAX--assessment and intervention thresholds for the UK. Osteoporos Int. 2008;19:1395–408.CrossRefPubMed
21.
Kanis JA, Johansson H, Johnell O, Oden A, De Laet C, Eisman JA, Pols H, Tenenhouse A. Alcohol intake as a risk factor for fracture. Osteoporos Int. 2005;16:737–42.CrossRefPubMed
22.
Kanis JA, Johnell O, Oden A, et al. Smoking and fracture risk: a meta-analysis. Osteoporos Int. 2005;16:155–62.CrossRefPubMed
23.
Kanis JA, Oden A, Johnell O, et al. The use of clinical risk factors enhances the performance of BMD in the prediction of hip and osteoporotic fractures in men and women. Osteoporos Int. 2007;18:1033–46.CrossRefPubMed
24.
Pongchaiyakul C, Nguyen ND, Jones G, Center JR, Eisman JA, Nguyen TV. Asymptomatic vertebral deformity as a major risk factor for subsequent fractures and mortality: a long-term prospective study. J Bone Miner Res. 2005;20:1349–55.CrossRefPubMed
25.
Black DM, Arden NK, Palermo L, Pearson J, Cummings SR. Prevalent vertebral deformities predict hip fractures and new vertebral deformities but not wrist fractures. Study of Osteoporotic Fractures Research Group. J Bone Miner Res. 1999;14:821–8.CrossRefPubMed
26.
CBO KvdG (2011) Richtlijn Osteoporose en fractuurpreventie, derde herziening.
27.
Parkkari J, Kannus P, Palvanen M, Natri A, Vainio J, Aho H, Vuori I, Jarvinen M. Majority of hip fractures occur as a result of a fall and impact on the greater trochanter of the femur: a prospective controlled hip fracture study with 206 consecutive patients. Calcif Tissue Int. 1999;65:183–7.CrossRefPubMed
28.
Hoogendijk EO, Deeg DJ, Poppelaars J, et al. The longitudinal aging study Amsterdam: cohort update 2016 and major findings. Eur J Epidemiol. 2016;31:927–45.CrossRefPubMedPubMedCentral
29.
Martineau P, Leslie WD. Trabecular bone score (TBS): Method and applications. Bone. 2017;104:66–72.
30.
Genant HK, Wu CY, van Kuijk C, Nevitt MC. Vertebral fracture assessment using a semiquantitative technique. J Bone Miner Res. 1993;8:1137–48.CrossRefPubMed
31.
Peeters GM, Elders PJM, Lips P, Deeg DJ. Snelle inschatting van de kans op herhaald vallen bij ouderen. Huisarts Wet. 2011;54:186–91.CrossRef
32.
van Wijngaarden JP, Swart KM, Enneman AW, et al. Effect of daily vitamin B-12 and folic acid supplementation on fracture incidence in elderly individuals with an elevated plasma homocysteine concentration: B-PROOF, a randomized controlled trial. Am J Clin Nutr. 2014;100:1578–86.CrossRefPubMed
Metadata
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
Authors
P. J. M. Elders
T. Merlijn
K. M. A. Swart
W. van Hout
B. C. van der Zwaard
C. Niemeijer
M. W. Heymans
A. A. van der Heijden
F. Rutters
H. E. van der Horst
P. Lips
J. C. Netelenbos
N. M. van Schoor
Publication date
01-12-2017
Publisher
BioMed Central
Published in
BMC Musculoskeletal Disorders / Issue 1/2017
Electronic ISSN: 1471-2474
DOI
https://doi.org/10.1186/s12891-017-1783-y

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