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Concern about public safety in osteoporosis clinical trial

12th June 2013

Concerns about public safety in osteoporosis clinical trial

‘Women’s Health Action is concerned that an osteoporosis drug trial run by University of Auckland has exaggerated the risk of osteoporosis to attract women participants and downplayed the risks associated with the trial drug’ says Gill Sanson from Women’s Health Action Trust.

‘Healthy New Zealand women aged 50 to 60 are being randomly selected from the electoral roll and mailed an invitation to participate in the ten year clinical drug trial measuring osteoporosis-related fracture. The drug, Zoledronate (Aclasta) is administered by injection in a single dose considered sufficient for up to five years. Once in the body, the drug cannot be removed. Zoledronate was approved by PHARMAC in 2010 for the prevention of osteoporosis in older high-risk patients who had a history of osteoporotic fracture, not well women with little risk of osteoporosis’, says Gill Sanson.

‘It doesn’t make sense for the trial to target younger well postmenopausal women whose risk of osteoporosis is extremely low, especially when the women will be exposing themselves to the long-term effects of a potent drug without understanding the potential for serious risk’ says Gill Sanson.

‘Zoledronate suppresses normal bone remodelling and permanently alters bone composition.  Evidence is accumulating that long term use may result in brittle bones that fracture more easily. The US Food and Drug Administration have issued a label warning to this effect, and additional warnings for kidney failure, severe incapacitating joint bone and muscle pain, and osteonecrosis (bone death) of the jaw. These risks are not made clear in the patient information’ says Gill Sanson.

For a full copy of the article ‘Concerns about patient safety in osteoporosis clinical trial’ see http://www.womens-health.org.nz/uploads/Womens%20Health%20Updates%20PDF/2013/WHU%20June%202013.pdf

ENDS

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