Supplementen van Calcium (1000 mg) en Vitamine D (800 IE) zouden bij ouderen met osteoporose geen bescherming bieden tegen het risico op breuken (heupfractuur), aldus een Engelse studie bij meer dan 5.000 personen van 70 jaar en ouder. Het ging om mensen met een verhoogd risico op breuken (laag gewicht, roken, reeds voordien een breuk...) aldus The Lancet.

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

Summary

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 By 24 months, 2886 (54·5%) of 5292 were still taking tablets, 451 (8·5%) had died, 58 (1·1%) had withdrawn, and 1897 (35·8%) had stopped taking tablets but were still providing data for at least the main outcomes.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. (The Lancet)

(Opm. Andere deskundigen hebben zo hun twijfels over de conclusie en plaatsten de volgende opmerkingen:

-          Bijna de helft van de deelnemers is onderweg afgehaakt.

-          Voor de aanvang van de studie zijn van geen deelnemer bloedwaarden Vitamine D gemeten

-          Alleen de controlegroep was informatie verstrekt over het voorkomen van vallen en breuken

-          De resultaten laten geen verschil zien in het aantal fracturen in beide groepen.)

( Mei 2005)

 

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