NICE guidance - bisphosphonates , strontium ranelate , raloxifene and teriparatide for the secondary prevention of fractures in osteoporotic postmenopausal women

Last reviewed 11/2021

Points from the NICE guidance are summarised below. For detailed guidance then consult the full NICE guideline (1):

• 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 secondary 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 secondary prevention of osteoporotic fragility fractures in the following groups:
    • recommended as a treatment option for the secondary prevention of osteoporotic fragility fractures in postmenopausal women who are confirmed to have osteoporosis (that is, a T-score of -2.5 SD or below)
    • in women aged 75 years or older, a DXA scan may not be required if the responsible clinician considers it to be clinically inappropriate or unfeasible
  • risedronate and etidronate are recommended as alternative treatment options for the secondary 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
      
      
      • T-scores (SD) at (or below) which risedronate or etidronate is recommended when alendronate 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
    50-54	Treatment with risedronate or etidronate is not recommended	-3.0	-2.5
    55-59	-3.0	-3.0	-2.5
    60-64	-3.0	-3.0	-2.5
    65-69	-3.0	-2.5	-2.5
    70 or older	-2.5	-2.5	-2.5

   

  • 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 and raloxifene
  • strontium ranelate and raloxifene are recommended as alternative treatment options for the secondary prevention of osteoporotic fragility fractures in postmenopausal women:
  • recommended as an alternative treatment option for the secondary 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
      
      
      • T-scores (SD) at (or below) which strontium ranelate and raloxifene 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
          50-54	Treatment strontium ranelate or raloxifene is not recommended	-3.5	-3.5
          55-59	-4.0	-3.5	-3.5
          60-64	-4.0	-3.5	-3.5
          65-69	-4.0	-3.5	-3.0
          70-74	-3.0	-3.0	-2.5
          75 or older	-3.0	-2.5	-2.5

      • if a woman aged 75 years or older who has one 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
      • for the purposes of this guidance, 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
      • in deciding between strontium ranelate and raloxifene, clinicians and patients need to balance the overall proven effectiveness profile of these drugs against their tolerability and other effects in individual patients
        
        
• teriparatide
  • recommended as an alternative treatment option for the secondary prevention of osteoporotic fragility fractures in postmenopausal women:
    • who are unable to take alendronate and either risedronate or etidronate, or have a contraindication to or are intolerant of alendronate and either risedronate or etidronate, or who have a contraindication to, or are intolerant of strontium ranelate, or who have had an unsatisfactory response to treatment with alendronate, risedronate or etidronate and
    • who are 65 years or older and have a T-score of -4.0 SD or below, or a T-score of -3.5 SD or below plus more than two fractures, or who are aged 55-64 years and have a T-score of -4 SD or below plus more than two fractures

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
• 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
• intolerance of strontium ranelate is defined as persistent nausea or diarrhoea, either of which warrants discontinuation of treatment
• an unsatisfactory response is defined as occurring when a woman has another fragility fracture despite adhering fully to treatment for 1 year and there is evidence of a decline in BMD below her pre-treatment baseline

Reference:

• 1. NICE (January 2011). Alendronate, etidronate, risedronate, raloxifene, strontium ranelate and teriparatide for the secondary prevention of osteoporotic fragility fractures in postmenopausal women