Contact information
Type
Scientific
Primary contact
Dr David Torgerson
ORCID ID
Contact details
University of York
Dept of Health Studies & Centre for Health Economics
Heslington
York
YO10 5DQ
United Kingdom
+44 (0)1904 434 129
djt6@york.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
RCHA251
Study information
Scientific title
Acronym
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
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
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Injury, occupational diseases, poisoning: Musculoskeletal injury
Intervention
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).
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
All clinical fractures
Secondary outcome measures
1. Adherence to treatment
2. Falls
3. Quality of life (measured with the 12-item short form health survey [SF-12])
Overall trial start date
09/01/2001
Overall trial end date
03/01/2004
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Senior
Gender
Female
Target number of participants
3314
Participant exclusion criteria
1. Cognitive impairment
2. A life expectancy of less than six months
Recruitment start date
09/01/2001
Recruitment end date
03/01/2004
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University of York
York
YO10 5DQ
United Kingdom
Sponsor information
Organisation
NHS R&D Regional Programme Register - Department of Health (UK)
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
NHS Executive Northern and Yorkshire (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
Results in:
1. http://www.ncbi.nlm.nih.gov/pubmed/15860827
2. http://www.ncbi.nlm.nih.gov/pubmed/16250910
Publication citations
-
Porthouse J, Cockayne S, King C, Saxon L, Steele E, Aspray T, Baverstock M, Birks Y, Dumville J, Francis R, Iglesias C, Puffer S, Sutcliffe A, Watt I, Torgerson DJ, Randomised controlled trial of calcium and supplementation with cholecalciferol (vitamin D3) for prevention of fractures in primary care., BMJ, 2005, 330, 7498, 1003, doi: 10.1136/bmj.330.7498.1003.
-
Cockayne S, Torgerson DJ, A randomised controlled trial to assess the effectiveness of offering study results as an incentive to increase response rates to postal questionnaires [ISRCTN26118436]., BMC Med Res Methodol, 2005, 5, 34, doi: 10.1186/1471-2288-5-34.