Drug action
Drug action For all bisphosphonates
Bisphosphonates are adsorbed onto hydroxyapatite crystals in bone, slowing both their rate of growth and dissolution, and therefore reducing the rate of bone turnover.
Indications and dose
For alendronic acid
Treatment of postmenopausal osteoporosis for alendronic acid
By mouth
- Adult (female)
- 10mg once daily, alternatively 70mg once weekly.
Treatment of osteoporosis in men for alendronic acid
By mouth
- Adult (male)
- 10mg once daily.
Prevention and treatment of corticosteroid-induced osteoporosis in postmenopausal women not receiving hormone replacement therapy for alendronic acid
By mouth
- Adult (female)
- 10mg once daily.
Important safety information
Important safety information For all bisphosphonates
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.
Contra-indications
Contra-indications For alendronic acid
Abnormalities of oesophagus; hypocalcaemia; other factors which delay emptying (e.g. stricture or achalasia)
Cautions
Cautions For all bisphosphonates
Cautions, further information
Elderly
With oral use:
Screening Tool of Older Persons' potentially inappropriate Prescriptions (STOPP) criteria to aid medication reviews (see Prescribing in the elderly for information): potentially inappropriate in patients with a current or recent history of upper gastro-intestinal disease or bleeding (risk of relapse/exacerbation of oesophagitis, oesophageal ulcer, or oesophageal stricture).
Cautions For alendronic acid
Active gastro-intestinal bleeding; atypical femoral fractures; duodenitis; dysphagia; exclude other causes of osteoporosis; gastritis; history (within 1 year) of ulcers; surgery of the upper gastro-intestinal tract; symptomatic oesophageal disease; ulcers; upper gastro-intestinal disorders
Interactions
View interactions for alendronate
Side-effects
Side-effects For all bisphosphonates
Common or very common
Alopecia; anaemia; appetite decreased; arthralgia; asthenia; chills; constipation; diarrhoea; dizziness; dysphagia; electrolyte imbalance; eye inflammation; fever; gastritis; gastrointestinal discomfort; headache; influenza like illness; malaise; myalgia; nausea; oesophageal ulcer (discontinue); oesophagitis (discontinue); pain; peripheral oedema; renal impairment; skin reactions; taste altered; vomiting
Uncommon
Anaphylactic reaction; angioedema; bronchospasm; oesophageal stenosis (discontinue); osteonecrosis
Rare or very rare
Atypical femur fracture; Stevens-Johnson syndrome
Side-effects For alendronic acid
Common or very common
Gastrointestinal disorders; joint swelling; vertigo
Uncommon
Haemorrhage
Rare or very rare
Femoral stress fracture; oropharyngeal ulceration; photosensitivity reaction; severe cutaneous adverse reactions (SCARs)
Side-effects, further information
Severe oesophageal reactions (oesophagitis, oesophageal ulcers, oesophageal stricture and oesophageal erosions) have been reported; patients should be advised to stop taking the tablets and to seek medical attention if they develop symptoms of oesophageal irritation such as dysphagia, new or worsening heartburn, pain on swallowing or retrosternal pain.
Pregnancy
Pregnancy For alendronic acid
Avoid.
Breast feeding
Breast feeding For alendronic acid
Manufacturer advises avoid—no information available.
Renal impairment
Renal impairment For alendronic acid
Avoid if creatinine clearance less than 35mL/minute. M See Prescribing in renal impairment.
Monitoring requirements
Monitoring requirements For alendronic acid
Monitoring of patient parameters For alendronic acid
Correct disturbances of calcium and mineral metabolism (e.g. vitamin-D deficiency, hypocalcaemia) before starting treatment. Monitor serum-calcium concentration during treatment.
Directions for administration
Directions for administration For alendronic acid
Manufacturer advises tablets should be swallowed whole and oral solution should be swallowed as a single 100mL dose. Doses should be taken with plenty of water while sitting or standing, on an empty stomach at least 30 minutes before breakfast (or another oral medicine); patient should stand or sit upright for at least 30 minutes after administration.
Patient and carer advice
Patient and carer advice For all bisphosphonates
Atypical femoral fractures
Patients should be advised to report any thigh, hip, or groin pain during treatment with a bisphosphonate.
Osteonecrosis of the jaw
During bisphosphonate treatment patients should maintain good oral hygiene, receive routine dental check-ups, and report any oral symptoms.
Osteonecrosis of the external auditory canal
Patients should be advised to report any ear pain, discharge from ear or an ear infection during treatment with a bisphosphonate.
Patient and carer advice For alendronic acid
Patients or their carers should be given advice on how to administer alendronic acid tablets and oral solution.
Oesophageal reactions
Patients (or their carers) should be advised to stop taking alendronic acid and to seek medical attention if they develop symptoms of oesophageal irritation such as dysphagia, new or worsening heartburn, pain on swallowing or retrosternal pain.
National funding/access decisions
National funding/access decisions For alendronic acid
For full details see funding body website.
NICE decisions For alendronic acid
NICE TA464
Bisphosphonates for treating osteoporosis (updated July 2019)
- Funding decision:
- Recommended with restrictions
Scottish Medicines Consortium (SMC) decisions For alendronic acid
Alendronic acid (Binosto®) for the treatment of postmenopausal osteoporosis (April 2016)
- Funding decision:
- Recommended with restrictions
Medicinal forms
There can be variation in the licensing of different medicines containing the same drug.
Forms available from special-order manufacturers include: oral solution.
View all medicinal forms and pricinginformation
Or jump straight to:
- Oral tablet
- Effervescent tablet
- Oral solution
- Osteoporosis
Other drugs in class
Other drugs in classBisphosphonates
- Alendronic acid with colecalciferol
- Ibandronic acid
- Pamidronate disodium
- Risedronate sodium
- Risedronate with calcium carbonate and colecalciferol
- Sodium clodronate
- Zoledronic acid