Wednesday, February 14, 2007

Questions Surrounding Avandia® and its Effect on Bone


A small study to be published in an upcoming issue of the Journal of Clinical Endocrinology & Metabolism found that postmenopausal women who took Avandia® (rosiglitazone) at 8mg/day for 14 weeks had greater reductions in hip bone density than women in a control group:
  • - Total hip bone density fell in the Avandia group by 1.9%
  • - Total hip bone density fell in the placebo group by 0.2%
Leading authors to conclude:
"Short-term therapy with rosiglitazone exerts detrimental skeletal effects, by inhibiting bone formation."

A reduction in bone density could increase the risk of fractures. That won't be welcome news to women with diabetes who already experience an increased risk of fractures - a finding reported by this journal last year.

Reuters reported:
"Morgan Stanley said in a note that an osteoporosis warning was now "very likely" to be added to the drug's label."

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Avandia study, free author manuscript (pdf):
The peroxisome-proliferator-activated receptor-gamma agonist rosiglitazone decreases bone formation and one mineral density in healthy postmenopausal women: a randomized, controlled trial

Avandia study, abstract:
The peroxisome-proliferator-activated receptor-gamma agonist rosiglitazone decreases bone formation and bone mineral density in healthy postmenopausal women: a randomized, controlled trial

Reuters news summary:
New study fuels bone fears over Glaxo's Avandia

JCEM's diabetes and bone fracture study, abstract:
Risk of Fracture in Women with Type 2 Diabetes: the Women’s Health Initiative Observational Study