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Osteoporosis - secondary prevention

The clinical effectiveness and cost effectiveness of technologies for the secondary prevention of osteoporotic fractures in postmenopausal women

Guidance type:  Technology appraisal
Date issued:  January 2005

We will consult on our review plans for this guidance in October 2007.

Reference:  TA87

Summary

NICE has made the following recommendations about the use of bisphosphonates, raloxifene and teriparatide.

The recommendations concern the use of these medicines to reduce the risk of further osteoporosis-related fractures (broken bones) in women who have gone through the menopause and who have already had an osteoporosis-related fracture. They do not cover the treatment of women who have osteoporosis as a result of taking medicines called corticosteroids.

Bisphosphonates

Bisphosphonates (alendronate, etidronate and risedronate) are recommended by NICE to be used in postmenopausal women

  • aged 75 and older, without the need for a DEXA scan
  • aged between 65 and 74, if osteoporosis is confirmed with a DEXA scan
  • aged under 65, only if their bone mineral density is very low (a T-score of –3 SD or below), or if they have a confirmed diagnosis of osteoporosis and have one or more of the following risk factors:
    • they are very underweight; this means that they have a ‘body mass index’ or BMI of less than 19 kg/m2 – the BMI is calculated by measuring someone’s weight in relation to their height
    • they had a mother who had a hip fracture before the age of 75
    • they had an early menopause that was untreated
    • they have a medical condition that increases the risk of osteoporosis – for example, rheumatoid arthritis, chronic inflammatory bowel disease, hyperthyroidism or coeliac disease
    • they have a medical condition that doesn’t allow them to move.

When discussing which bisphosphonate should be used, the woman and her doctor should consider the evidence for how well the medicine works and its possible side effects.

Raloxifene

NICE recommends that raloxifene should be given to any of the following women:

  • women who are currently taking other medicines that may be affected by the bisphosphonates or have another medical condition that means bisphosphonates cannot be used
  • women who are unable to physically manage the way a bisphosphonate has to be taken –for example, taking it with a certain amount of water, having to avoid eating for certain periods before or after taking it, and having to remain upright for certain periods after taking it
  • women who have already been treated for a year with a bisphosphonate but it hasn’t worked. For instance, another fracture has occurred and bone density has decreased to a level lower than when treatment started
  • women who are unable to take bisphosphonate because of the side effects. Side effects can include inflammation or ulceration of the oesophagus, and diarrhoea.

Teriparatide

Teriparatide should be used in women aged 65 and older:

  • when bisphosphonates haven’t worked (which means that after 1 year of treatment with a bisphosphonate, another fracture has occurred and bone density has decreased to a level lower than when treatment started) or for women who are unable to take bisphosphonates because of the side effects and
  • who have a very high risk of fracture, as indicated by:
    • T-score of –4 SD or below or
    • a T-score of –3 SD or below and more than two fractures and at least one of the additional risk factors listed above for bisphosphonates, except for women who have a medical condition that is independently associated with bone loss.
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