Vitamin D3 and calcium reduced hip and nonvertebral fractures in elderly women
ACP J Club. 1993 May-June;118:66. doi:10.7326/ACPJC-1993-118-3-066
Related Content in the Archives
• Vitamin D supplementation did not reduce fractures in the elderly
• Calcium and vitamin D reduced nonvertebral fractures and bone loss
Chapuy MC, Arlot ME, Duboeuf F, et al. Vitamin D3 and calcium to prevent hip fractures in elderly women. N Engl J Med. 1992 Dec 3;327:1637-42.
To determine whether vitamin D3 and calcium supplements reduce the incidence of hip and nonvertebral fractures in elderly women living in nursing homes.
18-month, randomized, double-blind, placebo-controlled trial.
180 nursing homes and apartments for elderly persons in France.
3270 women (mean age 84 y, range 69 to 106 y) with life expectancy ≥ 18 months, who were ambulatory, had no serious illnesses, and had not been taking fluoride salts, vitamin D, calcium, or other drugs known to alter bone metabolism. Follow-up was 97%.
1634 women were randomly assigned to receive calcium (1.2 g of elemental calcium in the form of tricalcium phosphate powder in an aqueous suspension) and oral vitamin D3, 800 IU (20 mg), with their noon meal. The 1636 women in the placebo group received 2 pills and an aqueous solution of lactose, kaolin, and starch.
Main outcome measures
Clinical status, calcium intake, side effects, and fracture data were collected at clinic visits done every 6 months. Clinical findings identified fractures that were confirmed by radiograph. Serum analysis and femoral bone mineral density were done for a subgroup of women.
In an intention-to-treat analysis, the active-treatment group compared with the placebo group had fewer nonvertebral fractures (P < 0.001) and fewer hip fractures (P = 0.004) (Table). The odds ratio for nonvertebral fractures among women in the placebo group was 1.4 (95% CI 1.4 to 2.1) and for hip fractures was 1.7 (CI 1.0 to 2.8). The groups did not differ for mortality (258 vs 274 deaths), side effects, serum creatinine, phosphorus, osteocalcin, or total protein concentrations. Femoral bone density increased 2.7% in the active group and decreased 4.6% in the placebo group.
Supplementation with vitamin D3 and calcium decreased the risk for hip and nonvertebral fractures among elderly women living in nursing homes.
Sources of funding: Caisse Nationale d'Assurance Maladie des Travailleurs Salariés-INSERM; Ministère de la Recherche et de l'Enseignement Supérieur-Aliment 2000; Duphar Laboratories (vitamin D3); Merck-Clevenot Laboratories (tricalcium phosphate).
For article reprint: Dr. M.C. Chapuy, Institut National de la Santé et de la Recherche Médicale (INSERM), Unité 403, Pavillon F, Hôpital Edouard Herriot, 69437 Lyon, Cedex 3 France. FAX 33-472-117483.
Table. Vitamin D3 and calcium vs placebo for fractures*
|Outcomes at 18 months||Vitamin D3 and calcium||Placebo||RRR (95% CI)||NNT (CI)|
|Nonvertebral fracture||11.5%||15.3%||25% (9 to 38)||26 (16 to 79)|
|Hip fracture||5.8%||7.8%||26% (3 to 44)||48 (25 to 488)|
*Abbreviations defined in Glossary; RRR, NNT, and CI calculated from data in article
Clinicians caring for elderly persons who are at risk for osteoporotic fractures frequently experience frustration because therapeutic options seem limited. Prevention of falls remains one of the most effective strategies. Dietary deficiencies in calcium and vitamin D3 among nursing home residents have, however, been well established, suggesting that supplementation may have protective effects (1, 2).
The study by Chapuy and colleagues is the largest, most ambitious clinical trial of calcium and vitamin D3 replacement in a vulnerable elderly population. The high percentage of deaths (16%), noncompliance (16%), dropouts for other illnesses (3%), and losses to follow-up (3%) highlight the difficulties in doing these trials. Because the numbers of participants in the different comparisons varied, the data were analyzed and reported in 3 different ways: for only those women completing 18 months of follow-up, for women only while on active treatment, and for all women according to assignment, whether on treatment or not. All 3 methods of analysis gave similar results. At baseline, the treatment group showed 2% fewer fallers (women who had fallen in the 3 months before the study), which was not statistically significant. It is peculiar, however, that the intention-to-treat analysis showed a 2% decrease in fractures. Perhaps the difference in fallers at baseline could explain the difference in fracture rates.
The effects of calcium and vitamin D3 on fracture incidence, bone density, and biochemical markers support the routine use of these supplements for elderly persons in institutions, although the optimal dose and formulation of vitamin D3 have not been established. The reduction of fractures evident after only 18 months of therapy suggests that the major effect of this regimen is to correct osteomalacia, a reversible disorder, in elderly persons who are institutionalized.
Douglas P. Kiel, MD, MPH
Harvard Medical SchoolBoston, Massachusetts, USA
1. Webb AR, Pilbeam C, Hanafin N, Holick MF. An evaluation of the relative contribution of exposure to sunlight and of diet to the circulating concentrations of 25-hydroxyvitamin D in an elderly nursing home population in Boston. Am J Clin Nutr. 1990;51:1075-81.