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The National Institute for Health and Clinical Excellence (NICE) last week published 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 should 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 as it includes an in-depth explanation of the reconsideration.

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.

“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.”

Notes to Editors

About NICE guidance on preventing osteoporotic fracture

1. View the primary prevention guidance and the secondary prevention guidance. This guidance was originally published in October 2008, with an update in January 2010 after consultation on the economic model (the recommendations remained unchanged).

Strontium ranelate was already recommended in this guidance as a treatment option for postmenopausal women who cannot take the recommended first line treatment alendronate, and who have specified risk factors.

2. Following a Court of Appeal hearing applied for by Servier, the manufacturer of strontium ranelate, NICE was asked by the Court of Appeal to reconsider the guidance on the use of strontium ranelate. The Court ruling did not find that NICE had made the wrong decision, but it found 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 Courtrequired that NICE should reassess the analysis relating to strontium ranelate, and produce a fresh decision on the drug's use. NICE has complied fully with the Court's judgement, having asked our independent Appraisal Committee to look afresh at the specific analysis relating to the effect of strontium ranelate on hip fracture. This reconsideration is included in the final guidance published on 26 January 2011. These final recommendations relating to strontium ranelate remain unchanged from the previous updated guidance issued in January 2010.

3. NICE has also separately recommended denosumab (Prolia) as a treatment option for certain postmenopausal women¹ who are at increased risk of primary and secondary osteoporotic fractures if other treatments available on the NHS are unsuitable. This guidance was published in October 2010: http://guidance.nice.org.uk/TA204 .

4. Summary of the recommendations for all drugs featured in the guidance:

Primary prevention

Alendronate is recommended as a treatment option for primary prevention of osteoporotic fragility fractures in women aged 70 years or older who have an independent clinical risk factor for fracture or an indicator of low bone mineral density (BMD) and are confirmed to have osteoporosis (a T-score of -2.5 SD or below). In women aged 75 years or older who have two or more independent risk factors for fracture or low BMD, a DXA scan may not be required if considered inappropriate or unfeasible.

Alendronate is also recommended for primary prevention of osteoporotic fragility fractures in postmenopausal women younger than 70 years who have confirmed osteoporosis and:

• an independent clinical risk factor for fracture for those aged 65-69 years
• an independent clinical risk factor for fracture and at least one additional indicator of low BMD for those younger than 65 years.

If alendronate is unsuitable, risedronate and etidronate are recommended alternative options. Strontium ranelate is a recommended option for women considered unsuitable for alendronate, risedronate and etidronate. Raloxifene is not recommended as a treatment option.

Secondary prevention

Alendronate is recommended in all postmenopausal women who have confirmed osteoporosis. Women aged 75 years or older may not need a DXA scan if considered clinically inappropriate. For women who cannot take alendronate, risedronate and etidronate are recommended. For women who cannot take alendronate, risedronate and etidronate, strontium ranelate and raloxifene are recommended options. Teriparatide is a recommended alternative for women who can't take any of the previous recommended options or who've had an unsatisfactory response to alendronate, risedronate or etidronate.

Background to this ruling

5. The Appeal judgement was given on 31 March 2010. It ruled that NICE should reassess the analysis relating to strontium ranelate and make a fresh decision on its use in primary and secondary of osteoporotic fracture. Today's guidance (Jan 2011) is the result of the reassessment of the analysis.

6. The appeal was heard on 17 December 2009 at the Appeal Court. Servier challenged part of an earlier ruling of the High Court from 19 February 2009 on NICE's guidance on the use of various drugs to prevent osteoporotic fractures.

7. On 19 February 2009 the High Court ruled in favour of NICE on 2 of the 3 grounds brought against the Institute in this case.

8. The High Court ruled in favour of NICE on the two grounds of discrimination and handling clinical data. The High Court judge respected NICE's scientific judgment on the trial data and ruled that the reasons why NICE made the recommendations it did were properly explained in the guidance. It is this point that Servier challenged.

9. Regarding the 3rd point the judge agreed that NICE was correct in not releasing “in confidence” information but nevertheless considered that, although NICE had asked for permission to release the information, NICE could have done more to arrange for that information to be available.

NICE has since obtained agreement for the confidential information to be released, and has made this information and the executable model available to our consultees for comment. (This resulted in the updated guidance published in January 2010.)

About NICE

10. The National Institute for Health and Clinical Excellence (NICE) is the independent organisation responsible for providing national guidance and standards on the promotion of good health and the prevention and treatment of ill health.

11. NICE produces guidance in three areas of health:

• public health - guidance on the promotion of good health and the prevention of ill health for those working in the NHS, local authorities and the wider public and voluntary sector
• health technologies - guidance on the use of new and existing medicines, treatments, medical technologies (including devices and diagnostics) and procedures within the NHS
• clinical practice - guidance on the appropriate treatment and care of people with specific diseases and conditions within the NHS.

12. NICE produces standards for patient care:

• quality standards - these reflect the very best in high quality patient care, to help healthcare practitioners and commissioners of care deliver excellent services
• Quality and Outcomes Framework - NICE develops the clinical and health improvement indicators in the QOF, the Department of Health scheme which rewards GPs for how well they care for patients.

13. NICE provides advice and support on putting NICE guidance and standards into practice through its implementation programme, and it collates and accredits high quality health guidance, research and information to help health professionals deliver the best patient care through NHS Evidence.

Footnotes

1. Defined for primary prevention by a combination of low bone mineral density, age and a number of other clinical risk factors such as parental history of hip fracture, high alcohol intake and rheumatoid arthritis.

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