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Atorvastatin has no effect on bone mineral density (BMD) or biochemical markers of bone turnover in postmenopausal women with dyslipidaemia, a study has concluded.
The results of the double-blind, placebo-controlled dose-ranging trial have just been published in the Journal of Clinical Endocrinology and Metabolism.
The study prompted by findings from observational studies that statins may have a beneficial effect on osteoporosis or fracture risk.
However, the possibility of bias in such trials is considerable, and some researchers have concluded that the apparent effect of statins is attributable to unmeasured confounding factors.
In addition, trials aimed mainly at assessing lipid-lowering effects have yielded inconsistent results.
The study appears to be the first prospective investigation specifically designed to assess whether statins have a beneficial effect on bone metabolism, and the findings were negative.
The study involved 626 postmenopausal women with LDL cholesterol levels of 3.4–4.9mmol/l, who were randomised to treatment with 10, 20, 40 or 80mg of atorvastatin daily, or to placebo.
At 52 weeks there was no significant reduction from baseline or any difference versus placebo for any atorvastatin group in lumbar (L1–L4) spine BMD (primary endpoint) or BMD at any other site, or in biochemical markers of bone turnover.
The authors conclude that “clinically relevant doses of atorvastatin that lower lipid levels had no effect on bone mineral density or biochemical indices of bone metabolism in this study, suggesting that such oral agents are not useful in the prevention or treatment of osteoporosis”.