A pragmatic randomised controlled trial of the effectiveness and cost-effectiveness of screening for osteoporosis in older women for the prevention of fractures
| ISRCTN | ISRCTN55814835 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN55814835 |
| Secondary identifying numbers | MRC ref: G0601019 |
- Submission date
- 14/05/2007
- Registration date
- 19/06/2007
- Last edited
- 15/02/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English Summary
Background and study aims
Osteoporosis is a condition that weakens the bones, making them fragile and more likely to break (fracture). Osteoporotic fractures – in particular hip fractures – have major adverse effects on quality of life in terms of pain and disability. Around 50% of hip fracture patients lose the ability to live independently and 20% die within a year of their fracture. The aim of this study is to investigate whether a community-based screening programme for osteoporosis reduces the incidence of fractures, and is cost effective, in older women (aged 70 - 85 years).
Who can participate?
Women aged 70 to 85 who are not currently on prescription medication to prevent osteoporotic fractures.
What does the study involve?
Participants are randomly allocated to either the screening group or the control group. Those in the screening group have their risk of fracture calculated using data from a questionnaire and, for some participants, results from a DXA (x-ray) scan. Participants above an age-dependent threshold are recommended for treatment (typically bisphosphonate tablets), and to continue treatment for the duration of the study. The risk of fracture is not calculated for participants in the control group, who receive usual care. Participants are followed-up 6 months later and then annually by postal questionnaires and checking of medical records. The proportion of participants sustaining fractures is measured for each group, along with hip fracture rate. Cost-effectiveness is also assessed, as well as the acceptability of the DXA scanning and risk assessment process.
What are the possible benefits and risks of participating?
Participants in the screening group have the opportunity to discuss treatment with their GP that would reduce their fracture risk. In addition, everyone taking part in the study will be helping to determine whether screening would be beneficial in older women. Taking part in this study will involve some time to complete questionnaires. If a participant in the screening group is invited to have a DXA bone density scan this would involve a single appointment lasting about 15 to 30 minutes with the DXA provider (usually at an NHS hospital trust). The DXA scanner uses much less radiation than a normal x-ray, such as a chest x-ray, and is equivalent to a few days of natural background radiation.
Where is the study run from?
University of East Anglia (UK)
When is the study starting and how long is it expected to run for?
February 2007 to December 2015
Who is funding the study?
1. Medical Research Council (MRC) (UK)
2. Arthritis Research Campaign (UK)
Who is the main contact?
Prof. Lee Shepstone
l.shepstone@uea.ac.uk
Contact information
Scientific
MED Building
University of East Anglia
Norwich
NR4 7TJ
United Kingdom
| l.shepstone@uea.ac.uk |
Study information
| Study design | Two-group pragmatic randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | A pragmatic randomised controlled trial of the effectiveness and cost-effectiveness of Screening for Osteoporosis in Older women for the Prevention of fractures (SCOOP) |
| Study acronym | SCOOP |
| Study hypothesis | To investigate whether a community-based screening programme for osteoporosis reduces the incidence of fractures, and is cost effective, in older women (aged 70 - 85 years). |
| Ethics approval(s) | The North West Research Ethics Committee, 20/09/2007 |
| Condition | Musculoskeletal Diseases: Osteoporosis |
| Intervention | Intervention subjects will have a 10-year absolute risk of fracture calculated from a World Health Organization (WHO) risk algorithm based on data from a screening questionnaire and, for some subjects, results from a Dual energy X-ray Absorptiometry (DXA) scan. GPs will be advised of those at high risk and whether to consider treatment. The control group will have usual care. Both intervention and control groups will be provided with lifestyle advice through an Arthritis Research Campaign (ARC) booklet on osteoporosis. |
| Intervention type | Other |
| Primary outcome measure | All osteoporosis-related fractures (excluding those of hands, feet, nose and skull), assessed at the annual follow-up visits for 5 years post randomisation. |
| Secondary outcome measures | 1. All clinical fractures (including hip fractures) 2. Quality of life, assessed by the European Quality of life (EQ-5D) and Short Form 12 (SF-12) questionnaires at baseline (immediately prior to randomisation), 6 and 12 months and then annually for 5 years post randomisation 3. Psychological anxiety, assessed by the State-Trait Anxiety Index at baseline, 6 and 12 months and then annually for 5 years post randomisation 4. Mortality (assessed annually for 5 years post randomisation) A process measure will be treatment adherence as ascertained by an ad-hoc questionnaire at follow-up visits. |
| Overall study start date | 01/02/2007 |
| Overall study end date | 30/12/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Female |
| Target number of participants | 11,580 |
| Participant inclusion criteria | 1. Female 2. Aged 70 to 85 years 3. Able to provide informed consent |
| Participant exclusion criteria | 1. Currently known to be on treatment for osteoporosis (other than calcium and vitamin D) 2. Any known co-morbidity that would make entry to the trial inadvisable, in GP's opinion |
| Recruitment start date | 01/02/2007 |
| Recruitment end date | 01/07/2009 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
NR4 7TJ
United Kingdom
United Kingdom
United Kingdom
United Kingdom
United Kingdom
United Kingdom
United Kingdom
Sponsor information
University/education
Research Enterprise & Engagement
University of East Anglia
Norwich
NR4 7TJ
England
United Kingdom
| H.Ings@uea.ac.uk | |
"ROR" |
https://ror.org/026k5mg93 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- Medical Research Council (United Kingdom), UK Medical Research Council, MRC
- Location
- United Kingdom
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | To be confirmed at a later date. |
| IPD sharing plan | The trialists plan to make data available on request, subject to terms of data sharing agreement drawn up by University of East Anglia. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 01/10/2012 | Yes | No | |
| Results article | results | 24/02/2018 | Yes | No |
Editorial Notes
15/02/2018: Internal review.
19/12/2017: Publication references added
08/03/2016: The overall trial end date was changed from 30/06/2015 to 30/12/2015.
02/10/2014: The overall trial end date was changed from 30/04/2014 to 30/06/2015.
