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NICE guidance - bisphosphonates , raloxifene and strontium ranelate for the primary prevention of fragility fractures in postmenopausal women with osteoporosis

Last reviewed dd mmm yyyy. Last edited dd mmm yyyy

Authoring team

  • this provides a summary of the main features from the NICE guideline (1). For more detailed information then consult the full guidline
    • guidance relates only to treatments for the primary prevention of fragility fractures in postmenopausal women who have osteoporosis
      • osteoporosis is defined by a T-score of -2.5 standard deviations (SD) or below on dual-energy X-ray absorptiometry (DXA) scanning
      • however, the diagnosis may be assumed in women aged 75 years or older if the responsible clinician considers a DXA scan to be clinically inappropriate or unfeasible
    • guidance assumes that women who receive treatment have an adequate calcium intake and are vitamin D replete. Unless clinicians are confident that women who receive treatment meet these criteria, calcium and/or vitamin D supplementation should be considered.
  • Bisphosphonates
    • alendronate is recommended as a treatment option for the primary prevention of osteoporotic fragility fractures in the following groups:
      • women aged 70 years or older who have an independent clinical risk factor for fracture or an indicator of low BMD and who are confirmed to have osteoporosis (that is, a T-score of -2.5 SD or below). In women aged 75 years or older who have two or more independent clinical risk factors for fracture or indicators of low BMD, a DXA scan may not be required if the responsible clinician considers it to be clinically inappropriate or unfeasible
      • women aged 65-69 years who have an independent clinical risk factor for fracture and who are confirmed to have osteoporosis (that is, a T-score of -2.5 SD or below)
      • postmenopausal women younger than 65 years who have an independent clinical risk factor for fracture and at least one additional indicator of low BMD and who are confirmed to have osteoporosis (that is, a T-score of -2.5 SD or below). When the decision has been made to initiate treatment with alendronate, the preparation prescribed should be chosen on the basis of the lowest acquisition cost available.
    • risedronate and etidronate are recommended as alternative treatment options for the primary prevention of osteoporotic fragility fractures in postmenopausal women:
      • who are unable to comply with the special instructions for the administration of alendronate, or have a contraindication to or are intolerant of alendronate and
      • who also have a combination of T-score, age and number of independent clinical risk factors for fracture as indicated in the following table 

Age (years)

0 independent clinical risk factors for fracture

1 independent clinical risk factors for fracture

2 independent clinical risk factors for fracture

65-69

Treatment with risedronate or etidronate is not recommended

-3.5

-3.0

70-74

-3.5

-3.0

-2.5

>75

-3.0

-3.0

-3.0

  • if a woman aged 75 years or older who has two or more independent clinical risk factors for fracture or indicators of low BMD has not previously had her BMD measured, a DXA scan may not be required if the responsible clinician considers it to be clinically inappropriate or unfeasible
  • in deciding between risedronate and etidronate, clinicians and patients need to balance the overall proven effectiveness profile of the drugs against their tolerability and adverse effects in individual patients
  • strontium ranelate
    • recommended as an alternative treatment option for the primary prevention of osteoporotic fragility fractures in postmenopausal women:
      • who are unable to comply with the special instructions for the administration of alendronate and either risedronate or etidronate, or have a contraindication to or are intolerant of alendronate and either risedronate or etidronate and
      • who also have a combination of T-score, age and number of independent clinical risk factors for fracture as indicated in the following table
        • T-scores (SD) at (or below) which strontium ranelate is recommended when alendronate and either risedronate or etidronate cannot be taken

Age (years)

0 independent clinical risk factors for fracture

1 independent clinical risk factors for fracture

2 independent clinical risk factors for fracture

65-69

Treatment strontium ranelate is not recommended

-4.5

-4.0

70-74

-4.5

-4.0

-3.5

>75

-4.0

-4.0

-3.0

  • raloxifene is not recommended as a treatment option for the primary prevention of osteoporotic fragility fractures in postmenopausal women

Notes:

  • independent clinical risk factors for fracture are parental history of hip fracture, alcohol intake of 4 or more units per day, and rheumatoid arthritis
  • indicators of low BMD are low body mass index (defined as less than 22 kg/m2), medical conditions such as ankylosing spondylitis, Crohn's disease, conditions that result in prolonged immobility, and untreated premature menopause
  • intolerance of alendronate, risedronate or etidronate is defined as persistent upper gastrointestinal disturbance that is sufficiently severe to warrant discontinuation of treatment, and that occurs even though the instructions for administration have been followed correctly
  • primary prevention refers to opportunistic identification, during visits to a healthcare professional for any reason, of postmenopausal women who are at risk of osteoporotic fragility fractures and who could benefit from drug treatment. It does not imply a dedicated screening programme

Reference:


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