Alendronic acid | Drugs | BNF content published by NICE (2024)

MHRA/CHM advice: Bisphosphonates: atypical femoral fractures (June 2011)

Atypical femoral fractures have been reported rarely with bisphosphonate treatment, mainly in patients receiving long-term treatment for osteoporosis.

The need to continue bisphosphonate treatment for osteoporosis should be re-evaluated periodically based on an assessment of the benefits and risks of treatment for individual patients, particularly after 5 or more years of use.

Patients should be advised to report any thigh, hip, or groin pain during treatment with a bisphosphonate.

Discontinuation of bisphosphonate treatment in patients suspected to have an atypical femoral fracture should be considered after an assessment of the benefits and risks of continued treatment.

MHRA/CHM advice: Bisphosphonates: osteonecrosis of the jaw (November 2009) and Intravenous bisphosphonates: osteonecrosis of the jaw—further measures to minimise risk (July 2015)

The risk of osteonecrosis of the jaw is substantially greater for patients receiving intravenous bisphosphonates in the treatment of cancer than for patients receiving oral bisphosphonates for osteoporosis or Paget’s disease.

Risk factors for developing osteonecrosis of the jaw that should be considered are: potency of bisphosphonate (highest for zoledronate), route of administration, cumulative dose, duration and type of malignant disease, concomitant treatment, smoking, comorbid conditions, and history of dental disease.

All patients with cancer and patients with poor dental status should have a dental check-up (and any necessary remedial work should be performed) before bisphosphonate treatment, or as soon as possible after starting treatment. Patients should also maintain good oral hygiene, receive routine dental check-ups, and report any oral symptoms such as dental mobility, pain, or swelling, non-healing sores or discharge to a doctor and dentist during treatment.

Before prescribing an intravenous bisphosphonate, patients should be given a patient reminder card and informed of the risk of osteonecrosis of the jaw. Advise patients to tell their doctor if they have any problems with their mouth or teeth before starting treatment, and if the patient wears dentures, they should make sure their dentures fit properly. Patients should tell their doctor and dentist that they are receiving an intravenous bisphosphonate if they need dental treatment or dental surgery.

Guidance for dentists in primary care is included in Oral Health Management of Patients at Risk of Medication-related Osteonecrosis of the Jaw: Dental Clinical Guidance, Scottish Dental Clinical Effectiveness Programme, March 2017 (available at https://www.sdcep.org.uk/published-guidance/medication-related-osteonecrosis-of-the-jaw/).

MHRA/CHM advice: Bisphosphonates: osteonecrosis of the external auditory canal (December 2015)

Benign idiopathic osteonecrosis of the external auditory canal has been reported very rarely with bisphosphonate treatment, mainly in patients receiving long-term therapy (2 years or longer).

The possibility of osteonecrosis of the external auditory canal should be considered in patients receiving bisphosphonates who present with ear symptoms, including chronic ear infections, or suspected cholesteatoma.

Risk factors for developing osteonecrosis of the external auditory canal include: steroid use, chemotherapy, infection, an ear operation, or cotton-bud use.

Patients should be advised to report any ear pain, discharge from the ear, or an ear infection during treatment with a bisphosphonate.