A pragmatic randomised controlled trial of screening for osteoporosis in older women

Lead Research Organisation: University of East Anglia
Department Name: Norwich Medical School

Abstract

Osteoporosis is a common disease affecting around 20% of women aged over 50 years. The condition causes a ?thinning? of the bones making a sufferer prone to fractures. These fractures, particularly hip fractures, can lead to disability, a loss of independent living and even death. Current treatment for osteoporosis can reduce the risk of fracture by around 35% to 50%. However, predicting which women are at high risk of fracture and therefore would most likely benefit from treatment has so far not been conducted in a comprehensive and systematic manner. This study sets out to trial a method of screening all women aged between 70 and 85 for risk of fracture. Women in that age group recruited to the study will either be screened or managed as usual. Those screened and considered at high risk will be offered treatment by their GPs. All women will be followed for 5 years and, at the end of that period, a comparison of the fractures in the screened group will be made with those in the non-screened group. It is hoped that screening will reduce the number of fractures by around 20%.

Technical Summary

The proposed randomised controlled trial aims to evaluate the effectiveness and cost-effectiveness of a community based screening program for osteoporosis in women aged 70 to 85. Those women randomised to the screening arm of the trial will provide information on clinical risk factors followed by bone mineral density (BMD) measurements where this information would be deemed useful. Based upon this information, a 10-year absolute risk for fracture will be calculated. This information will be given to study subjects? GPs with an indication of whether this risk exceeds a pre-determined treatment threshold or not. Those women in the control arm will be treated ?as usual?. The primary effiacy outcome, to be ascertained from hospital records will be fracture at any site. The follow up period will be 5 years and a sample size of 11 500 women will be sufficient to provided 90% power to detect a 18% relative reduction in fractures.

Publications

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Bell K (2016) Enclosing a pen reduced time to response to questionnaire mailings. in Journal of clinical epidemiology

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Curtis EM (2019) Gestational Vitamin D Supplementation Leads to Reduced Perinatal RXRA DNA Methylation: Results From the MAVIDOS Trial. in Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research

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Farre-Garros R (2019) Quadriceps miR-542-3p and 5p are elevated in COPD and reduce function by inhibiting ribosomal and protein synthesis. in Journal of applied physiology (Bethesda, Md. : 1985)

 
Description Efficacy and Mechanisms Evaluation
Amount £180,384 (GBP)
Funding ID G0601019 
Organisation National Institute for Health Research 
Sector Public
Country United Kingdom
Start 04/2014 
End 06/2015
 
Description NIHR Research for Patient Benefit
Amount £152,839 (GBP)
Organisation National Institute for Health Research 
Department Research for Patient Benefit
Sector Public
Country United Kingdom
Start 01/2008 
End 06/2013
 
Title Fracture data collection methods 
Description The SCOOP RCT has used an approach to data collection for fracture outcome that is being duplicated in at least one other RCT. It makes use of self-report and readily available data through the NHS. 
Type Of Material Improvements to research infrastructure 
Year Produced 2011 
Provided To Others? Yes  
Impact Little at present. Now being used by another trial and, informally, suggested as the main method for the primary outcome data collection for a second. 
 
Title SCOOP cohort database 
Description The SCOOP trial has provide a database of over 12000 older women followed up for more than 5 years. These have been recruited from the general community (rather than disease or condition specific) and have comprehensive data on osteoporosis medications and fractures, amongst other things. This should prove a good asset for future work. 
Type Of Material Database/Collection of data 
Provided To Others? No  
Impact None to date but this database will be of use to other groups once the trial and associated papers are complete. Data are now being released to the wider research team to pursue secondary research questions. In addition, an application has been submitted to the HTA for further funding to keep data collection going for a further five years. If successful this will be a very valuable database. 
 
Description Osteoporosis Dorset Meeting (invited speaker), December 4th 2017 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach Regional
Primary Audience Professional Practitioners
Results and Impact This was a presentation of the main SCOOP results on invitation to the annual 'Osteoporosis Dorset' meeting. The group is a regional charity with a mixed audience of practitioner, patients and charity supporters, numbering around 100. A number of questions and discussions arose in light of the talk.
Year(s) Of Engagement Activity 2018
URL http://www.osteodorset.org.uk/
 
Description Osteoporosis Information Day 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Type Of Presentation Keynote/Invited Speaker
Geographic Reach Local
Primary Audience Participants in your research and patient groups
Results and Impact Around 100 people for the local area with an interest in osteoporosis. Organised by the local trust and local NOS.

Impossible to say.
Year(s) Of Engagement Activity 2013