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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 10.1186/ISRCTN26118436
ClinicalTrials.gov identifier
EudraCT number
Public title 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
Scientific title
Acronym N/A
Serial number at source RCHA251
Study hypothesis To 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
Lay summary
Ethics approval Ethical approval for the study was obtained from the Northern and Yorkshire multicentre research ethics committee and relevant local research ethics committees.
Study design Randomised controlled trial
Countries of recruitment United Kingdom
Disease/condition/study domain Injury, occupational diseases, poisoning: Musculoskeletal injury
Participants - inclusion criteria 3314 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
Participants - exclusion criteria 1. Cognitive impairment
2. A life expectancy of less than six months
Anticipated start date 09/01/2001
Anticipated end date 03/01/2004
Status of trial Completed
Patient information material
Target number of participants 3314
Interventions Daily 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).
Primary outcome measure(s) All clinical fractures
Secondary outcome measure(s) 1. Adherence to treatment
2. Falls
3. Quality of life (measured with the 12-item short form health survey [SF-12])
Sources of funding NHS Executive Northern and Yorkshire (UK)
Trial website
Publications Results in:
1. http://www.ncbi.nlm.nih.gov/pubmed/15860827
2. http://www.ncbi.nlm.nih.gov/pubmed/16250910
Contact name Dr  David  Torgerson
  Address University of York
Dept of Health Studies & Centre for Health Economics
Heslington
  City/town York
  Zip/Postcode YO10 5DQ
  Country United Kingdom
  Tel +44 (0)1904 434 129
  Fax +44 (0)1904 434 102
  Email djt6@york.ac.uk
Sponsor NHS R&D Regional Programme Register - Department of Health (UK)
  Address The Department of Health
Richmond House
79 Whitehall
  City/town London
  Zip/Postcode SW1A 2NL
  Country United Kingdom
  Tel +44 (0)20 7307 2622
  Fax +44 (0)20 7307 2623
  Email dhmail@doh.gsi.org.uk
  Sponsor website: http://www.doh.gov.uk
Date applied 23/01/2004
Last edited 19/02/2008
Date ISRCTN assigned 23/01/2004
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