NICE Doesn't Change Its Mind About Strontium Ranelate

January 26, 2011

NICE, the UK-based institute, published an updated final guidance on osteoporosis fractures prompted by an appeal regarding strontium ranelate.

, the UK-based institute, published an updated final guidance on preventing osteoporotic fractures following a reconsideration of the use of strontium ranelate (Protelos).

The two pieces of guidance for both primary and secondary prevention of osteoporotic fractures recommend that strontium ranelate be used in circumstances where patients are unable to tolerate oral bisphosphonates, and who are at high risk of osteoporotic fractures.

This guidance has been produced following a court ruling. The Court did not find that NICE had made the wrong decision but that NICE should have done more to explain its decision on a specific analysis of hip fractures from a research study carried out by the manufacturer of strontium ranelate.

The subsequent thorough reconsideration of the analysis has resulted in no change to the recommendations on strontium ranelate, compared with the guidance issued in 2008 and updated in January 2010. The guidance published today updates the previous guidance.

Dr. Carole Longson, Director of the NICE Centre for Health Technology Evaluation, commented: "We're pleased that these appraisals on preventing osteoporotic fracture have concluded and we can now provide clarity for health professionals and patients on the place of strontium ranelate in the treatment pathway amongst other recommended drugs.

The update to the guidance relates only to the reconsideration of strontium ranelate; our recommendations on the use of other drugs for osteoporosis were not questioned by the Court. Women at risk of osteoporotic fractures continue to have access to all of these treatments on the NHS, as recommended in the previous version of the guidance.

Dr. Carole Longson, director of the NICE Centre for Health Technology Evaluation, commented, in a press release:

"We're pleased that these appraisals on preventing osteoporotic fracture have concluded and we can now provide clarity for health professionals and patients on the place of strontium ranelate in the treatment pathway amongst other recommended drugs. The update to the guidance relates only to the reconsideration of strontium ranelate; our recommendations on the use of other drugs for osteoporosis were not questioned by the Court. Women at risk of osteoporotic fractures continue to have access to all of these treatments on the NHS, as recommended in the previous version of the guidance.

"NICE has complied fully with the Court's judgement - having examined the evidence on strontium ranelate again very carefully, the new independent committee reached the same conclusions as the original committee, and so the recommendations on strontium ranelate remain unchanged from those published originally. Along with the separate guidance published in October 2010 recommending the use of denosumab, today's final guidance completes a suite of options for preventing osteoporotic fracture in post-menopausal women."

The previous guidance on preventing osteoporotic fracture suggested Strontium ranelate be used as a treatment option for postmenopausal women who cannot take the recommended first line treatment alendronate, and who have specified risk factors. The manufactures of strontium ranelate, Servier, issued an appeal to have NICE reconsider the guidance on the use of the product.

Servier desired further explanation from NICE on its descision based on a specific analysis of hip fractures from a research study carried out by the company. The court required that NICE reassess the analysis relating to strontium ranelate and produce a fresh decision on the drug's use. NICE complied but its decision remains unchanged.

Source: NICE--

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