title: Randomised controlled trial of calcium and supplementation with cholecalciferol (vitamin D3) for prevention of fractures in primary care.
abstract: OBJECTIVE
  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.
  
  
  METHODS
  Pragmatic open randomised controlled trial.
  
  
  METHODS
  Practice nurse led clinics in primary care.
  
  
  METHODS
  3314 women aged 70 and over with one or more risk factors for hip fracture: any previous fracture, low body weight (< 58 kg), smoker, family history of hip fracture, or fair or poor self reported health.
  
  
  METHODS
  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).
  
  
  METHODS
  Primary outcome measure was all clinical fractures and secondary outcome measures were adherence to treatment, falls, and quality of life (measured with the SF-12).
  
  
  RESULTS
  69% of the women who completed the follow-up questionnaire at 24 months were still taking supplements (55% with inclusion of randomised participants known to be alive). After a median follow-up of 25 months (range 18 to 42 months), clinical fracture rates were lower than expected in both groups but did not significantly differ for all clinical fractures (odds ratio for fracture in supplemented group 1.01, 95% confidence interval 0.71 to 1.43). The odds ratio for hip fracture was 0.75 (0.31 to 1.78). The odds of a woman having a fall at six and 12 months was 0.99 and 0.98, respectively. Quality of life did not significantly differ between the groups.
  
  
  CONCLUSIONS
  We found no evidence that calcium and vitamin D supplementation reduces the risk of clinical fractures in women with one or more risk factors for hip fracture. Registration ISRCTN26118436, controlled trials registry.
authors.affiliation: York Trials Unit, Department of Health Sciences, University of York, York YO10 5DD.
authors.forename: Jill
authors.initials: J
authors.lastname: Porthouse
authors.forename: Sarah
authors.initials: S
authors.lastname: Cockayne
authors.forename: Christine
authors.initials: C
authors.lastname: King
authors.forename: Lucy
authors.initials: L
authors.lastname: Saxon
authors.forename: Elizabeth
authors.initials: E
authors.lastname: Steele
authors.forename: Terry
authors.initials: T
authors.lastname: Aspray
authors.forename: Mike
authors.initials: M
authors.lastname: Baverstock
authors.forename: Yvonne
authors.initials: Y
authors.lastname: Birks
authors.forename: Jo
authors.initials: J
authors.lastname: Dumville
authors.forename: Roger
authors.initials: R
authors.lastname: Francis
authors.forename: Cynthia
authors.initials: C
authors.lastname: Iglesias
authors.forename: Suezann
authors.initials: S
authors.lastname: Puffer
authors.forename: Anne
authors.initials: A
authors.lastname: Sutcliffe
authors.forename: Ian
authors.initials: I
authors.lastname: Watt
authors.forename: David J
authors.initials: DJ
authors.lastname: Torgerson
mesh_terms: D000284:Administration, Oral; D000368:Aged; D002762:Cholecalciferol / Q000008:administration & dosage*; D005260:Female; D006620:Hip Fractures / Q000517:prevention & control*; D006801:Humans; D010865:Pilot Projects; D012307:Risk Factors; D016896:Treatment Outcome; D014807:Vitamin D / Q000008:administration & dosage*
chemical_list: D014807:Vitamin D; D002762:Cholecalciferol