Oral vitamin D3 and calcium for secondary prevention of low-trauma fractures in elderly people (Randomised Evaluation of Calcium Or vitamin D, RECORD): a randomised placebo-controlled trial
Grant AM, Avenell A, Campbell MK, McDonald AM, MacLennan GS, McPherson GC, Anderson FH, Cooper C, Francis RM, Donaldson C, Gillespie WJ, Robinson CM, Torgerson DJ, Wallace WA, RECORD Trial Group
Lancet (London, England) · 571 citas
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Cómo se estudió
- Diseño
- Ensayo controlado aleatorizado (indexado por PubMed)
- Estudiado en
- Personas
- Resultado principal
- Eventos clínicos como enfermedad o muerte
Quién lo pagó
- Financiación
- Financiación no declarada
Publicación
- Publicado
- 2005-04-30 · Lancet · vol. 365 · número 9471 · págs. 1621–1628
- Editorial
- Elsevier BV
- Citado
- 970 citas · más que el 100% de estudios similares · 64.7× el promedio de su campo
- Impacto
- Entre el 10 % más citado de su campo
- Referencias
- 30 trabajos
- Acceso
- De pago
- Áreas de investigación
- Vitamin D Research Studies · Bone health and osteoporosis research · Hip and Femur Fractures
- Palabras clave
- vitamin D3 supplementation, calcium supplementation, secondary fracture prevention, fragility fractures, hip fracture, older adults, osteoporosis, fracture risk, falls, quality of life, medication adherence, falls in older adults, RECORD trial, factorial design, bone mineral density, bone turnover markers
- MeSH
- humans, osteoporosis, calcium, cholecalciferol, administration, oral, accidental falls, aged, female, male, fractures, bone
14 autores
- A. Grant🇬🇧University of Aberdeen
- Alison Avenell
- Marion Campbell
- A M McDonald
- Graeme MacLennan
- Gladys C. McPherson
- Frazer H. Anderson
- Cyrus C. Cooper
- R. M. Francis
- CHARLES L. DONALDSON
- William John Gillespie
- C. M. Robinson
- David John Torgerson
- William Angus Wallace
Resumen
El texto original del estudio, en el idioma en que se publicó.
Background
Elderly people who have a fracture are at high risk of another. Vitamin D and calcium supplements are often recommended for fracture prevention. We aimed to assess whether vitamin D3 and calcium, either alone or in combination, were effective in prevention of secondary fractures.
Methods
In a factorial-design trial, 5292 people aged 70 years or older (4481 [85%] of whom were women) who were mobile before developing a low-trauma fracture were randomly assigned 800 IU daily oral vitamin D3, 1000 mg calcium, oral vitamin D3 (800 IU per day) combined with calcium (1000 mg per day), or placebo. Participants who were recruited in 21 UK hospitals were followed up for between 24 months and 62 months. Analysis was by intention-to-treat and the primary outcome was new low-energy fractures.
Findings
698 (13%) of 5292 participants had a new low-trauma fracture, 183 (26%) of which were of the hip. The incidence of new, low-trauma fractures did not differ significantly between participants allocated calcium and those who were not (331 [12.6%] of 2617 vs 367 [13.7%] of 2675; hazard ratio (HR) 0.94 [95% CI 0.81-1.09]); between participants allocated vitamin D3 and those who were not (353 [13.3%] of 2649 vs 345 [13.1%] of 2643; 1.02 [0.88-1.19]); or between those allocated combination treatment and those assigned placebo (165 [12.6%] of 1306 vs 179 [13.4%] of 1332; HR for interaction term 1.01 [0.75-1.36]). The groups did not differ in the incidence of all-new fractures, fractures confirmed by radiography, hip fractures, death, number of falls, or quality of life. By 24 months, 2886 (54.5%) of 5292 were still taking tablets, 451 (8.5%) had died, 58 (1.1%) had withdrawn, and 1897 (35.8%) had stopped taking tablets but were still providing data for at least the main outcomes. Compliance with tablets containing calcium was significantly lower (difference: 9.4% [95% CI 6.6-12.2]), partly because of gastrointestinal symptoms. However, potentially serious adverse events were rare and did not differ between groups.
Interpretation
The findings do not support routine oral supplementation with calcium and vitamin D3, either alone or in combination, for the prevention of further fractures in previously mobile elderly people.
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