A pragmatic randomised controlled trial of the effectiveness and cost-effectiveness of screening for osteoporosis in older women for the prevention of fractures

Not Applicable

Completed

• Conditions: Musculoskeletal Diseases: Osteoporosis; Musculoskeletal Diseases; Osteoporosis

• Registration Number: ISRCTN55814835
• Lead Sponsor: niversity of East Anglia (UK)

Brief Summary

2012 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/22314936 2017 results in: https://www.ncbi.nlm.nih.gov/pubmed/29254858

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-06-19
• Study Completion: 2015-12-30
• Last Update Posted: 19 March 2018

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 11580

Inclusion Criteria

1. Female
2. Aged 70 to 85 years
3. Able to provide informed consent

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
1. All clinical fractures (including hip fractures)<br>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<br>3. Psychological anxiety, assessed by the State-Trait Anxiety Index at baseline, 6 and 12 months and then annually for 5 years post randomisation<br>4. Mortality (assessed annually for 5 years post randomisation)<br><br>A process measure will be treatment adherence as ascertained by an ad-hoc questionnaire at follow-up visits.