Final draft guidance recommends osteoporosis treatment as a new option for women at increased risk of fractures
Postmenopausal women who are at increased risk of osteoporotic fractures should be treated with denosumab if treatment with the currently available oral bisphosphonates alendronate, and either risedronate or etidronate is unsuitable, according to draft guidance published today (Wednesday 15 September) by NICE.
Denosumab (Prolia, Amgen) is licensed to treat postmenopausal women at increased risk of osteoporotic fractures. It is given by injection twice a year and works by reducing bone breakdown and increasing bone mass and strength.
Most postmenopausal women at increased risk of osteoporotic fractures are treated with oral bisphosphonates, but for some women these drugs may be unsuitable. Reasons for unsuitability are that a woman is unable to comply with the special instructions for the administration of oral bisphosphonates (for instance she may not be able to remain standing or sitting upright for half an hour after taking the drugs), or has a contraindication to, or is intolerant of bisphosphonates. Denosumab should be one of the options for these women if they are judged to be at increased risk of fractures, according to the draft NICE guidance.
Dr Carole Longson, Health Technology Evaluation Centre Director at NICE said: “Our independent Appraisal Committee felt that there was good quality evidence to show that denosumab is a useful addition to the treatment options available for women who can't have oral bisphosphonates. It should help to prevent a first fracture in women at increased risk and also help prevent further fractures in women who have already experienced one. We believe that older women at increased risk of osteoporotic fractures who cannot take alendronate, and either risedronate and etidronate should be considered for this drug alongside the other options available in order to help prevent the misery of breaking a bone.”
Consultees now have until 29 September to appeal against the recommendations via the NICE website. NICE has not yet issued final guidance to the NHS; these decisions may change after appeal. Final guidance is expected to be published later this year. Until then, NHS bodies should make decisions locally on the funding of specific treatments.
Notes to Editors
About the guidance
- View the final appraisal determination (FAD) on Osteoporotic fractures - denosumab from Wednesday 15 September 2010. NICE expects to publish final guidance on denosumab later this year.
- The final appraisal determination states:
1.1 Denosumab is recommended as a treatment option for the primary prevention of osteoporotic fragility fractures only in postmenopausal women at increased risk of fractures:
- who are unable to comply with the special instructions for administering alendronate and either risedronate or etidronate, or have an intolerance of, or a contraindication to, those treatments and
- who also have a combination of T-score, age and number of independent clinical risk factors for fracture (see section 1.3) as indicated in the following table:
T-scores (SD) at (or below) which denosumab is recommended when alendronate and either risedronate or etidronate are unsuitable
|Age (years)||Number of independent clinical risk factors for fracture|
|75 or older||−4.0||−4.0||−3.0|
|a Treatment with denosumab is not recommended.|
1.2 Denosumab is recommended as a treatment option for the secondary prevention of osteoporotic fragility fractures only in postmenopausal women at increased risk of fractures who are unable to comply with the special instructions for administering alendronate and either risedronate or etidronate, or have an intolerance of, or a contraindication to, those treatments
1.3 For the purposes of this guidance, independent clinical risk factors for fracture are parental history of hip fracture, alcohol intake of 4 or more units per day, and rheumatoid arthritis.
1.4 People currently receiving denosumab for the primary or secondary prevention of osteoporotic fragility fractures who do not meet the criteria specified in recommendations 1.1 or 1.2 should have the option to continue treatment until they or their clinician consider it appropriate to stop.
- Denosumab is administered as a single subcutaneous injection into the thigh, abdomen or the back of the arm. The recommended dosage is 60mg once every six months.
- Each dose costs £183, which means that the annual cost of treatment with denosumab is £366. Costs may vary in different settings because of negotiated procurement discounts.
1. The National Institute for Health and Care Excellence (NICE) is the independent organisation responsible for providing national guidance on the promotion of good health and the prevention and treatment of ill health.
2. 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 and procedures within the NHS
- clinical practice - guidance on the appropriate treatment and care of people with specific diseases and conditions within the NHS.
‘ Increased risk' is defined 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.
 T-score relates to the measurement of bone mineral density (BMD) using central (hip and/or spine) double-energy x-ray (DXA) scanning, and is expressed as the number of standard deviations (SD) below peak BMD.
This page was last updated: 15 September 2010