6.6.2 Bisphosphonates

Prescribing Notes

• See NICE TA464 Bisphosphonates for treating osteoporosis.
• People receiving drug treatment for osteoporosis (unless confident that the patient is receiving an adequate dietary intake) should receive a vitamin D supplement (+/- calcium). Click here for formulary choices.
• Before starting treatment, calcium and renal function should be checked.
• Due to concerns about these potential side effects of long-term bisphosphonate therapy, patients should be assessed for benefit and on-going need after 5 years of oral bisphosphonate therapy:
  • Where a ‘drug holiday’ is deemed appropriate, note this is a pause not a stop, see Bisphosphonate Drug Holiday
    • For risedronate, place the patient on a 1-2 year bisphosphonate drug holiday
    • For alendronic acid place the patient on a 2-3 year bisphosphonate drug holiday
    • Once drug holiday period has elapsed, reassess fracture risk and restart treatment if appropriate
  • For those patients who are then deemed at continued high risk of fracture and who continue to receive treatment, local expert opinion is that no patient should receive continuous oral bisphosphonate therapy for more than 10 years without referral to a specialist.
  • Refer to Osteoporosis Medication Review Tool and NOGG guideline for further information.
• GI Side Effects
  • Bisphosphonates have complex administration instructions. GI side effects are minimised by following these instructions. Oral bisphosphonates should be avoided in anyone who is unable to follow the administration instructions e.g. unable to sit upright after swallowing the tablet.
  • Alendronate should not be given to patients with abnormalities of the oesophagus and/or other factors which delay oesophageal emptying such as stricture or achalasia. Risedronate should be used with caution in such patients. Refer to MHRA.
  • Alendronate and risedronate should be used with caution in patients with active or recent upper gastrointestinal problems. Risedronate may be preferable in those patients that have a history of (recent) upper GI problems or develop significant GI side effects on alendronate. See BNF for risedronate prescribing information.
  • PPIs are unlikely to be helpful as this is due to a local irritant effect.
• Long term adherence is poor and patients should be encouraged to continue taking their bisphosphonate.
• The intravenous bisphosphonates zoledronic acid and ibandronic acid are red list drugs for specialist use only.

Cautions

• Renal impairment:
  • Alendronate should be avoided if Creatinine Clearance <35mL/min
  • Risedronate should be avoided if Creatinine Clearance < 30mL/min
• Do not prescribe a bisphosphonate to people with hypocalcaemia or other disturbances of bone and mineral metabolism (such as parathyroid dysfunction and hypovitaminosis D) – these should be treated before starting alendronate or risedronate.
• Bisphosphonate therapy is associated with rare but serious adverse effects, notably atypical femoral fractures (AFF) and osteonecrosis of the jaw (ONJ).
  • The risk of ONJ is substantially greater for patients receiving IV bisphosphonates for cancer indications. History of poor dentition is a risk factor. See MHRA
  • AFF has been reported rarely with bisphosphonate treatment, mainly in patients receiving long-term treatment for osteoporosis. Patients should be advised to report any thigh, hip or groin pain. The need to continue bisphosphonate treatment for osteoporosis should be re-evaluated periodically based on the benefits and potential risks of bisphosphonate therapy for individual patients, particularly after 5 or more years of use and should not exceed 10 years. See MHRA.
  • Osteonecrosis of the external auditory canal has been reported very rarely with bisphosphonates. For full details see MHRA.