| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN55814835 |
| Date ISRCTN assigned | 19/06/2007 |
| Local reference number(s) | To be confirmed |
| Public 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) |
| Scientific title |
|
| Acronym | SCOOP |
| Disease/condition/study domain | Musculoskeletal Diseases |
| 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). |
| Design/methodology | Two group, pragmatic randomised controlled trial. |
| Research ethics review | To be submitted as of 14/05/2007. |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | 1. Female
2. Aged 70 to 85 years
3. Able to provide informed consent |
| Participants - 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 |
| Patient information material |
|
| Anticipated start date | 01/02/2007 |
| Anticipated end date | 30/04/2014 |
| Status of trial | Ongoing |
| Target number of participants | 11,580 |
| Interventions | 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.
|
| Primary outcome measure(s) | All osteoporosis-related fractures (excluding those of hands, feet, nose and skull), assessed at the annual follow-up visits for five years post randomisation. |
| Secondary outcome measure(s) | 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. |
| Sources of funding | Co-funded by Medical Research Council (G0601019, UK) and Arthritis Research Campaign (UK) |
| Sponsor name | University of East Anglia (UK) |
| Sponsor details | Research & Business Services
University of East Anglia
Norwich
United Kingdom
NR4 7TJ |
| Sponsor email | Sue.steel@uea.ac.uk |
| Contact name | Dr Lee Shepstone |
| Contact details | Elizabeth Fry Building,
University of East Anglia
Norwich
United Kingdom
NR4 7TJ |
| Contact email | l.shepstone@uea.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN55814835 |
| Date last extracted from ISRCTN register | 17/04/2008 |
