Raloxifene for the primary prevention of osteoporotic fragility fractures in postmenopausal women

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Osteoporosis - primary prevention: scope

NATIONAL INSTITUTE FOR CLINICAL EXCELLENCE

Health Technology Appraisal

Prevention and Treatment of Osteoporosis

Scope

 

Objective: To establish the clinical and cost effectiveness of selective oestrogen receptor modulators (SERMs), bisphosphonates, and parathyroid hormone (subject to licensing) for the prevention and treatment of osteoporosis and the prevention of osteoporotic fractures in post-menopausal women, and to provide guidance to the NHS in England and Wales.1

Background: Osteoporosis is defined as a skeletal disorder characterised by compromised bone strength predisposing a person to an increased risk of fractures. Bone strength primarily reflects the integration of bone density and bone quality.2 Fractures occur most commonly in the hip, wrist and spine, and are associated with a substantial burden of disability and pain. The diagnosis of osteoporosis centres around the measurement of bone mineral density (BMD) at the spine, hip, or forearm, expressed as standard deviation units called T-scores.3

Although current diagnostic definitions for osteoporosis are based around BMD, other factors need to be considered when assessing overall risk of fracture (see below).

While osteoporosis can occur in all populations at all ages, it is most prevalent in caucasian post-menopausal women. It is estimated that in women over the age of 50, the lifetime risk of vertebral fracture is about one in three, and that for hip fracture is approximately one in six.4 One tenth to one fifth of women who have a hip fracture die within the following year.5 The social and acute care costs of osteoporotic fractures in post-menopausal women in the UK is estimated to be in the region of £1030 million.6 7

Technoloy: Three pharmacological classes of intervention will be appraised: selective oestrogen receptor modulators (SERMs), bisphosphonates, and parathyroid hormone (subject to licensing). SERMS and biphosphonates act to inhibit bone resorption whereas parathyroid hormone acts to stimulate bone formation.

 

Interventions

Any agents in the following pharmacological classes (with calcium & vitamin D supplementation if required), licensed for prevention and treatment of osteoporosis, or prevention of related fractures, in women considered at risk:

  • SERMs: raloxifene
  • Bisphosphonates: alendronate, etidronate & risedronate
  • Parathyroid hormone (subject to licensing): teriparatide
Populations

Post-menopausal women at risk of developing osteoporosis or having a related fracture. Risk factors include: low bone mineral density, smoking, low body mass index, early menopause, family history of osteoporosis, untreated hypogonadism, corticosteroid therapy, other diseases which affect bone metabolism.

Comparators
  1. Head to head comparisons of the classes of interventions listed above where feasible
  2. Comparisons of the interventions listed above with other treatments given separately or in combination, including:
  • Oestrogens & oestrogen-like molecules
  • Vitamin D & calcitriol· Calcium (pharmacological doses)
  • Exercise interventions
  • No treatment
Other considerations

Avoidance of fractures and quality of life should be the primary outcomes measures.

If the evidence allows NICE will provide guidance on how treatments could be best targeted to those most likely to benefit.

 

1 Remit from Department of Health: To advise on the clinical and cost effectiveness of licensed treatments for the prevention and treatment of osteoporosis and prevention of osteoporotic fractures in post-menopausal women in the following pharmacological classes: Selective (o)estrogen receptor modulators (SERMs); Bisphosphonates; Parathyroid hormone (subject to licensing) relative to commonly-used treatments; and to advise if the evidence allows on how any recommended treatments could be best be targeted on those most likely to benefit.

2 Consensus development panel on osteoporosis prevention, diagnosis and therapy. JAMA 2001;285: 785-789

3 WHO has made the following definitions relating to osteoporosis:

  • Normal: T-score of -1 or above
  • Osteopenia: T-score between and -1 and -2.5
  • Osteoporosis: T-score of less than -2.5
  • Established osteoporosis: T-score of less than -2.5 with one or more documented low trauma or fragility fractures

4 National Osteoporosis Society www.nos.org.uk

5 Soloman CG. NEJM 2002; 346: 642

6 Dolan P, Torgeson DJ. The cost of treating osteoporotic fractures in the UK female population. Osteoporosis Int 1998; 8: 611-617

7 Dolan P, Torgerson DJ
  Letter: The cost of treating osteoporotic fractures in the United Kingdom female population. Osteoporosis Int 2000 11:551-552

This page was last updated: 30 March 2010