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Calcium and Vitamin D Supplementation Did Not Reduce Fractures in Women [Greater Than or Equal To] 70 Years of Age

Posted on: Tuesday, 22 November 2005, 03:02 CST

By Porthouse, J; Cockayne, S; King, C; Et al

Porthouse J, Cockayne S, King C, et al. Randomised controlled trial of calcium and suplementation with cholecalciferol (vitamin D3) for prevention of fractures in primary care. BMJ. 2005;330:1003.

Clinical impact ratings: GIM/FP/GP ******* Geriatrics *******

QUESTION

Do calcium and vitamin D reduce the risk for fracture in at-risk community-dwelling older women?

METHODS

Design: Randomized controlled trial.

Allocation: Concealed.*

Blinding: Unblinded.*

Follow-up period: Median 25 months.

Setting: Nurse-led clinics in England, UK.

Patients: 3454 women ≥ 70 years of age (mean age 77 y) with ≥ 1 risk factor for hip fracture (body weight < 58 kg, previous fracture, maternal history of hip fracture, smoking, and poor to fair health). Exclusion criteria were calcium supplementation > 500 mg/d, history of kidney or bladder stones, renal failure, hypercalcemia, cognitive impairment, or life expectancy < 6 months.

Intervention: Information leaflet alone (n = 1993) or 6-month supply of calcium, 1000 mg, and cholecalciferol (vitamin D), 800 IU daily, taken as 2 tablets (Calcichew D, Forte, Hampshire, UK); lifestyle advice on how to reduce fracture risk; and an information leaflet on prevention of falls and calcium and vitamin D intake (n = 1321).

Outcomes: Any fracture (excluding ribs, digits, face, and skull). Secondary outcomes were hip fracture, quality of life (12-item Short Form Health Survey), death, hospital admissions and doctor visits, falls, and fear of falling. The study had 80% power to detect a 34% reduction in fracture.

Patient follow-up: 140 patients were excluded directly after randomization. 3314 patients (96%) were included in the intention- to-treat analysis.

MAIN RESULTS

During follow-up, 149 fractures were reported. Calcium and vitamin D supplementation did not reduce fractures (Table). Groups did not differ for quality of life, death, hospital admissions and doctor visits, and falls. The adjusted odds ratio for falling was 0.99 (95% CI 0.8 to 1.20) at 6 months and 0.93 (CI 0.79 to 1.20) at 12 months.

Calcium and vitamin D supplementation vs no supplementation in older women at risk for fracture median 25 months[dagger]

CONCLUSION

Supplementation with calcium and vitamin D for 2 years did not reduce the risk for fracture in at-risk community-dwelling older women.

Sources of funding: Northern and Yorkshire NHS Research and Development; Healthy Ageing Programme; Shire; Nycomed.

For correspondence: Dr. D.J. Torgerson, University of York, York, England, UK. E-mail djt6@york.ac.uk.

* See Glossary.

Copyright American College of Physicians Nov/Dec 2005

Source: ACP Journal Club

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