Bisphosphonates used in osteoporosis (Formulary)

• Counsel patients to swallow bisphosphonate tablets whole with a full glass of water on an empty stomach and to stand or sit upright for at least 30 minutes afterwards. After swallowing the tablet they should wait at least 30 minutes before eating breakfast.
• Avoid in patients with oesophageal abnormalities and other factors which delay transit or emptying (eg stricture or achalasia).
• Correct disturbances of calcium and mineral metabolism (eg vitamin D deficiency, hypocalcaemia) before starting.
• For information on the duration of bisphosphonate therapy and ‘bisphosphonate holidays’ refer to guidance.

Note: Bisphosphonates and denosumab

Osteonecrosis of the jaw (ONJ):
All bisphosphonates and denosumab are associated with ONJ:
• alendronic acid and risedronate are associated with a very small risk of ONJ (less than
1 case per 10 000). Advise patients to minimise the risk by maintaining good oral hygiene, attending routine dental check-ups and immediately reporting any oral symptoms such as dental mobility, pain or swelling to a doctor and dentist.
• denosumab and intravenous bisphosphonates; give patients the patient reminder card for their medicine, explain the risk of ONJ and advise on precations to take, see www.gov.uk/drug-safety-update.

Osteonecrosis of the external auditory canal: Denosumab has been reported to be associated with osteonecrosis of the external auditory canal. Consider the possibility of osteonecrosis of the external auditory canal in patients receiving denosumab who present with ear symptoms including chronic ear infections or in those with suspected cholesteatoma. Advise patients to report any ear pain, discharge from the ear, or an ear infection during denosumab treatment. For further information see www.gov.uk/drug-safety-update.

Atypical fracture:
Long-term treatment with bisphosphonates and denosumab is associated with a very small risk of atypical femoral fractures. The risk of fracture increases with duration of therapy and has been shown to decrease rapidly following drug cessation. Treatment may need to be discontinued while patients are being evaluated for suspected stress fracture. Stress fractures may often be bilateral and therefore the contralateral side should also be investigated. Advise patients to report new hip or thigh pain while on treatment (www.gov.uk/drug-safety-update).

 

Note: Inability to tolerate medication, lack of persistence or treatment failure
• Bisphosphonate treatment is only recommended in high-risk patients and therefore if patients stop taking treatment then alternatives must be sought. In general oral alendronic acid and risedronate sodium are the preferred therapies but if intolerant of bisphosphonates consider denosumab as the preferred next option (contact the Rheumatology Department if you wish to use denosumab).
• Potential treatment failure is defined as a fracture despite at least 1 year of persistence with therapy. Patients should then be re-referred to the rheumatology clinic for further investigations and selection of alternative medication.

ALENDRONIC ACID - (First line)

Important: Therapy notes

  • Calcium and vitamin D must be co-prescribed.
  • The effervescent tablets should only be used in patients who are unable to swallow tablets.
  • For NHS Highland Rheumatology Department GP and Patient information click here (NHSH intranet access required).

Important: Formulation and dosage details

Formulation:

Tablets 10mg, 70mg

Dosage:

Treatment of postmenopausal osteoporosis and osteoporosis in men, 10mg daily or (in postmenopausal osteoporosis) 70mg once weekly on the same day each week.

Prophylaxis of glucocorticoid-induced osteoporosis in postmenopausal women not receiving HRT, 10mg daily.

Important: Formulation and dosage details

Formulation:

Effervescent tablets 70mg (contain 602mg sodium per tablet)

Dosage:

Treatment of postmenopausal osteoporosis 70mg once weekly on the same day each week. 

RISEDRONATE SODIUM

Important: Therapy notes

  • Calcium and vitamin D must be co-prescribed.

Important: Formulation and dosage details

Formulation:

Tablets 5mg, 35mg

Dosage:

Treatment and prevention of osteoporosis, including corticosteroid-induced osteoporosis, in postmenopausal women, 5mg daily

Treatment of postmenopausal osteoporosis to reduce risk of vertebral or hip fractures, 35mg once weekly on the same day each week.

Treatment of osteoporosis in men, 35mg weekly dose.

Document Id: F184