6.6.2 Bisphosphonates and other drugs affecting bone metabolism

NICE TA279 Vertebral fractures - vertebroplasty and kyphoplasty (April 2013)

Please refer to formulary guidance: Management of osteoporosis

Bisphosphonates

Alendronic acid
  • Tablets 10mg (£1.83)
  • Weekly tablets 70mg (£0.74 = 4 tablets)

Dose

  • 70mg once weekly or 10mg daily

Notes

  1. Alendronate is not recommended for patients with renal impairment - eGFR less than 35mL/minute/1.73m2
  2. NICE TA464: Bisphosphonates for treating osteoporosis. Alendronic acid is recommended as an option for treating osteoporosis in adults (August 2017)
Risedronate sodium
  • Tablets 5mg, 30mg (£18.85 = 5mg)
  • Weekly tablets 35mg (£0.85 = 4 tablets)

Dose

  • 35mg once weekly or 5mg daily

Notes

  1. The use of risedronate sodium is contraindicated in patients with severe renal impairment - avoid if eGFR less than 30 mL/minute/1.73 m2
  2. NICE TA464: Bisphosphonates for treating osteoporosis. Risedronate sodium is recommended as an option for treating osteoporosis in adults (August 2017)
Sodium clodronate
  • Capsules 400mg (£139.83 = 120)
  • Tablets 800mg (£146.43 = 60)
  • Tablets 520mg (£152.59 = 60)

Indications

  • Osteolytic lesions, hypercalcaemia and bone pain associated with skeletal metastases in patients with breast cancer or multiple myeloma

Notes

  1. Sodium clodronate is eliminated mainly via the kidneys. Please refer to the manufacturer's information for guidance regarding dose alterations.
Denosumab
  • Injection 60mg/ml (£183.00 = 1ml syringe)
  • Injection 70mg/ml (£309.86 = 1.7ml vial)

Indications

  • Prevention of postmenopausal osteoporotic fractures (60mg/ml)
  • Prevention of skeletal-related events in adults with bone metastases from solid tumours (70mg/ml)

Notes

  1. To avoid unnecessary out of pocket expenses, practices or pharmacies should order Prolia® direct from Movianto: www.prolia.co.uk/HCP/how_to_order_prolia.html
  2. See here for the NEW Devon CCG Specialised Medicines Service Guideline for Denosumab (Prolia®) for osteoporosis
  3. NICE TA204 - Osteoporotic fractures – denosumab (October 2010)
  4. NICE TA265 - Bone metastases from solid tumours - denosumab (October 2012)
  5. MHRA Drug Safety Update July 2015 and MHRA Drug Safety Update June 2017:
    • Before prescribing denosumab or intravenous bisphosphonates:
      1. give patients the patient reminder card for their medicine
      2. explain the risk of osteonecrosis of the jaw, and osteonecrosis of the external auditory canal, and advise patients on precautions to take
      3. do not prescribe denosumab 120mg (cancer indication) to patients with unhealed lesions from dental or oral surgery
      4. advise patients to report any problems with their mouth or teeth, any ear pain, discharge from the ear, or an ear infection during denosumab treatment
      5. please continue to report suspected side effects to denosumab, bisphosphonates or any other medicines on a Yellow Card.
Ibandronic acid
  • Tablets 150mg
  • Solution for injection 1mg/ml

Notes

  1. NICE TA464: Bisphosphonates for treating osteoporosis. Ibandronic acid is recommended as an option for treating osteoporosis in adults (August 2017)
Zoledronic acid
  • IV infusion 50 micrograms/ml
  • Conc for IV infusion 800 micrograms/ml
  • Solution for IV infusion 40 microgram/ml

Notes

  1. Bisphosphonate therapy is commissioned as part of routine care of patients with symptomatic multiple myeloma. Zoledronic acid may be used as the bisphosphonate at least until disease progression if it can be provided at a negotiated contract price consistent with the financial modelling used for this decision (see Commissioning Policy for more information).
  2. NICE TA464: Bisphosphonates for treating osteoporosis. Zoledronic acid is recommended as an option for treating osteoporosis in adults (August 2017)
Pamidronate disodium
  • Concentrate for intravenous infusion

Indications

  • Hypercalcaemia of malignancy
  • Osteolytic lesions and bone pain in bone metastases associated with breast cancer or multiple myeloma
  • Paget's disease

Raloxifene

Raloxifene
  • Tablets 60mg (£8.24)

Indications

  • Secondary prevention of osteoporotic fragility fractures in postmenopausal women

Notes

  1. Raloxifene does not reduce menopausal vasomotor symptoms.
  2. Women taking raloxifene are at increased risk of thromboembolism.
  3. Refer to NICE CG164 (June 2013) for guidance on the use of raloxifene in patients with breast cancer.
  4. NICE TA160: Raloxifene is not recommended as a treatment option for the primary prevention of osteoporotic fragility fractures in postmenopausal women (August 2017)
  5. NICE TA161: Raloxifene is recommended as an alternative treatment option for the secondary prevention of osteoporotic fragility fractures in postmenopausal women (August 2017)

Strontium ranelate

Strontium ranelate
  • Granules 2g sachet (£27.08 = 28 sachets)

Indications

  • See MHRA warning in notes below

Notes

  1. Strontium ranelate was discontinued at the end of August 2017, patients taking this medication require a review and a fracture risk assessment.
  2. Use of strontium ranelate is now restricted to treatment of severe osteoporosis: i) in postmenopausal women at high risk of fracture; ii) in men at increased risk of fracture (see MHRA warning below).
  3. MHRA Drug Safety Update (April 2013) Strontium ranelate (Protelos): risk of serious cardiac disorders—restricted indications, new contraindications, and warnings
    • Treatment should only be initiated by a physician with experience in the treatment of osteoporosis, and the decision to prescribe strontium ranelate should be based on an assessment of the individual patient's overall risks
    • Strontium ranelate should not be used in patients with: ischaemic heart disease, peripheral arterial disease; cerebrovascular disease; a history of these conditions; or in patients with uncontrolled hypertension
    • Prescribers are advised to assess the patient's risk of developing cardiovascular disease before starting treatment and thereafter at regular intervals
    • Patients with significant risk factors for cardiovascular events (e.g. hypertension, hyperlipidaemia, diabetes mellitus, smoking) should only be treated with strontium ranelate after careful consideration
    • Treatment should be stopped if the patient develops ischaemic heart disease, peripheral arterial disease, cerebrovascular disease, or if hypertension is uncontrolled
    • Healthcare professionals should review patients at a routine appointment and consider whether or not to continue treatment
  4. Strontium should be taken in-between meals, preferably at bedtime at least two hours after food, milk products or calcium supplements. Ensure patients can comply with this regimen.
  5. Strontium should not be used in patients with severe renal impairment (creatinine clearance less than 30mL/min).
  6. Laboratory measurements of serum calcium are unreliable for patients taking strontium.
  7. Reductions in vertebral and non-vertebral fractures have been demonstrated but reductions in hip fracture only apparent in those aged over 74 years with T score of -2.4SD.
  8. Strontium reduces the absorption of tetracyclines and quinolones: therapy should be suspended for the duration of the antibiotic course.
  9. Strontium should not be used during pregnancy or lactation.
  10. Severe hypersensitivity syndromes including drug rash with eosinophilia and systemic symptoms (DRESS) has been reported with strontium.
  11. NICE TA160: Strontium ranelate is recommended as an alternative treatment option for the primary prevention of osteoporotic fragility fractures in postmenopausal women (August 2017)
  12. NICE TA161: Strontium ranelate is recommended as an alternative treatment option for the secondary prevention of osteoporotic fragility fractures in postmenopausal women (August 2017)

 

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