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
Protocol serial number	RCHA251
Sponsor	NHS R&D Regional Programme Register - Department of Health (UK)
Funder	NHS Executive Northern and Yorkshire (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

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

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific 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
Study objectives	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(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) studied	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
Primary outcome measure(s)	All clinical fractures
Key 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])
Completion date	03/01/2004

Participant type(s)	Patient
Age group	Senior
Sex	Female
Target sample size at registration	3314
Key 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
Key exclusion criteria	1. Cognitive impairment 2. A life expectancy of less than six months
Date of first enrolment	09/01/2001
Date of final enrolment	03/01/2004

University of York

York
YO10 5DQ
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan	Not provided at time of registration

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

01/09/2022: Internal review.