A randomised trial of nurse led clinics to promote increased use of calcium with vitamin D supplements for fracture prevention in women over 70 years

ISRCTN ISRCTN26118436
DOI https://doi.org/10.1186/ISRCTN26118436
Secondary identifying numbers RCHA251
Submission date
23/01/2004
Registration date
23/01/2004
Last edited
01/09/2022
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Injury, Occupational Diseases, Poisoning
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr David Torgerson
Scientific

University of York
Dept of Health Studies & Centre for Health Economics
Heslington
York
YO10 5DQ
United Kingdom

Phone +44 (0)1904 434 129
Email djt6@york.ac.uk

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific titleA randomised trial of nurse led clinics to promote increased use of calcium with vitamin D supplements for fracture prevention in women over 70 years
Study objectivesTo assess whether supplementation with calcium and cholecaliferol (vitamin D3) reduces the risk of fracture in women with one or more risk factors for fracture of the hip.randomised controlled trial
Ethics approval(s)Ethical approval for the study was obtained from the Northern and Yorkshire multicentre research ethics committee and relevant local research ethics committees.
Health condition(s) or problem(s) studiedInjury, occupational diseases, poisoning: Musculoskeletal injury
InterventionDaily oral supplementation using 1000 mg calcium with 800 IU cholecaliferol and information leaflet on dietary calcium intake and prevention of falls, or leaflet only (control group).
Intervention typeOther
Primary outcome measureAll clinical fractures
Secondary outcome measures1. Adherence to treatment
2. Falls
3. Quality of life (measured with the 12-item short form health survey [SF-12])
Overall study start date09/01/2001
Completion date03/01/2004

Eligibility

Participant type(s)Patient
Age groupSenior
SexFemale
Target number of participants3314
Key inclusion criteria3314 women aged 70 and over with one or more risk factors for hip fracture:
1. Any previous fracture
2. Low body weight (less than 58 kg)
3. Smoker
4. Family history of hip fracture
5. Fair or poor self reported health
Key exclusion criteria1. Cognitive impairment
2. A life expectancy of less than six months
Date of first enrolment09/01/2001
Date of final enrolment03/01/2004

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

University of York
York
YO10 5DQ
United Kingdom

Sponsor information

NHS R&D Regional Programme Register - Department of Health (UK)
Government

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Phone +44 (0)20 7307 2622
Email dhmail@doh.gsi.org.uk
Website http://www.doh.gov.uk

Funders

Funder type

Government

NHS Executive Northern and Yorkshire (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing planNot provided at time of registration

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article 30/04/2005 Yes No
Results article 26/10/2005 Yes No

Editorial Notes

01/09/2022: Internal review.