Drugs List

Therapeutic Indications

Uses

Prophylaxis and treatment of glucocorticoid induced osteoporosis
Treatment of osteoporosis in men to prevent fractures
Treatment of osteoporosis in postmenopausal women to prevent fractures

Contraindications

Children under 18 years
Inability to stand or sit upright for at least 30 minutes
Achalasia
Breastfeeding
Delayed oesophageal emptying
Galactosaemia
Hypocalcaemia
Oesophageal obstruction
Oesophageal strictures
Pregnancy
Renal impairment - glomerular filtration rate below 35ml/minute

Precautions and Warnings

Duodenitis
Dysphagia
Gastritis
Gastrointestinal haemorrhage
Glucose-galactose malabsorption syndrome
History of gastrointestinal ulceration
Hypoparathyroidism
Lactose intolerance
Oesophagitis
Peptic ulcer
Upper gastrointestinal surgery
Vitamin D deficiency

Calcium supplements may be required if risk of calcium/vitamin D deficiency
Consider a dental exam & appropriate preventive dentistry before treatment
Consider other causes of osteoporosis
Contains lactose
Patient must remain upright for at least 30 minutes after dose
Correct disturbances of calcium and mineral metabolism before initiation
Dental check-ups advisable during long-term treatment
Ensure patient's dietary intake of calcium and vitamin D is adequate
Evaluate benefit/risk in long term use ( > 5 years)
Monitor serum calcium levels
Advise patient to report any ear pain, discharge or infection
Advise patient to report any new thigh, hip or groin pain
Patients should seek medical attention upon signs of oesophageal irritation
Consider discontinuation if atypical femoral fracture occurs
Discontinue if symptoms of oesophageal irritation occur
Advise patients to avoid aspirin and NSAID use
Advise patient of need for high oral hygiene standards
Advise patient to follow dosage instructions closely
Advise patient to report any dental mobility, pain or swelling
Patient to inform dentist of bisphosphonate use: avoid invasive procedures

Severe oesophageal reactions (oesophagitis, oesophageal ulcers, oesophageal stricture and oesophageal erosions) have been reported. Physicians should be alert to the possibility of such reactions developing and patients should be advised to discontinue treatment and seek medical attention if they develop signs of oesophageal irritation such as dysphagia, pain on swallowing, retrosternal pain or new or worsening heartburn.

Atypical stress fractures of the proximal femoral shaft with poor healing have been reported in patients treated with alendronic acid, mainly in patients receiving long term treatment for osteoporosis.

Osteonecrosis of the jaw has been reported in cancer patients taking bisphosphonate regimens often with concurrent chemotherapy and corticosteroids. These cases have mainly been associated with dental procedures such as tooth extraction and many have shown signs of local infection including osteomyelitis. There is no data available to suggest discontinuation of bisphosphonate treatment prior to dentistry reduces the risk of osteonecrosis of the jaw.

Osteonecrosis of the external auditory canal has been reported very rarely with bisphosphonates, mainly in association with long term therapy (2 years or longer). Risk factors include steroid use and chemotherapy and/or local risk factors as infection or trauma. 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.

Patients should be re-evaluated periodically based on an assessment of the benefits and risks of the bisphosphonate treatment, especially after 5 years or more of treatment.

Pregnancy and Lactation

Pregnancy

Alendronic acid is contraindicated during pregnancy.

The manufacturer does not recommend using alendronic acid during pregnancy. Animal studies have shown reproduction toxicological effects and although the significance to humans is unknown, alendronic acid should not be used in human pregnancy. If treatment has been discontinued before pregnancy, the very long elimination half life from bone indicates that women treated with alendronic acid will have detectable concentrations of the drug for a prolonged interval (Briggs, 2015). Schaeffer (2015) states that accidental use of a single dose does not justify interruption of the pregnancy or additional diagnostic procedures.

Lactation

Alendronic acid is contraindicated during breastfeeding.

The manufacturer does not recommend breastfeeding whilst taking alendronic acid. It is not known whether alendronic acid passes to human milk. However, the extremely low oral bioavailability of bisphosphonates in the non-fasting state implies that systemic levels in the nursing infant should be negligible. A risk to the neonate cannot be excluded.

Side Effects

Abdominal distension
Abdominal pain
Acid regurgitation
Alopecia
Angioedema
Asthenia
Atypical femoral fracture
Bone pain
Constipation
Decrease in plasma calcium
Decrease in serum phosphate
Diarrhoea
Dizziness
Dysgeusia
Dyspepsia
Dysphagia
Episcleritis
Erythema
Fever
Flatulence
Gastritis
Gastro-intestinal perforation
Gastro-intestinal ulceration
Gastrointestinal bleeding
Headache
Hypersensitivity reactions
Hypocalcaemia (symptomatic)
Joint pain
Joint swelling
Malaise
Melaena
Musculoskeletal pain
Myalgia
Nausea
Oesophageal erosions
Oesophageal stricture
Oesophageal ulceration
Oesophagitis
Oropharyngeal ulceration
Osteonecrosis (primarily of the jaw)
Osteonecrosis of the external auditory canal
Peripheral oedema
Photosensitivity
Pruritus
Rash
Scleritis
Stevens-Johnson syndrome
Toxic epidermal necrolysis
Urticaria
Uveitis
Vertigo
Vomiting

Presentation

Oral formulation of low strength alendronic acid (10mg).

Drugs List

Therapeutic Indications

Uses

Prophylaxis and treatment of glucocorticoid induced osteoporosis
Treatment of osteoporosis in men to prevent fractures
Treatment of osteoporosis in postmenopausal women to prevent fractures

Dosage

Adults

Contraindications

Children under 18 years
Inability to stand or sit upright for at least 30 minutes
Achalasia
Breastfeeding
Delayed oesophageal emptying
Galactosaemia
Hypocalcaemia
Oesophageal obstruction
Oesophageal strictures
Pregnancy
Renal impairment - glomerular filtration rate below 35ml/minute

Precautions and Warnings

Duodenitis
Dysphagia
Gastritis
Gastrointestinal haemorrhage
Glucose-galactose malabsorption syndrome
History of gastrointestinal ulceration
Hypoparathyroidism
Lactose intolerance
Oesophagitis
Peptic ulcer
Upper gastrointestinal surgery
Vitamin D deficiency

Calcium supplements may be required if risk of calcium/vitamin D deficiency
Consider a dental exam & appropriate preventive dentistry before treatment
Consider other causes of osteoporosis
Contains lactose
Patient must remain upright for at least 30 minutes after dose
Correct disturbances of calcium and mineral metabolism before initiation
Dental check-ups advisable during long-term treatment
Ensure patient's dietary intake of calcium and vitamin D is adequate
Evaluate benefit/risk in long term use ( > 5 years)
Monitor serum calcium levels
Advise patient to report any ear pain, discharge or infection
Advise patient to report any new thigh, hip or groin pain
Patients should seek medical attention upon signs of oesophageal irritation
Consider discontinuation if atypical femoral fracture occurs
Discontinue if symptoms of oesophageal irritation occur
Advise patients to avoid aspirin and NSAID use
Advise patient of need for high oral hygiene standards
Advise patient to follow dosage instructions closely
Advise patient to report any dental mobility, pain or swelling
Patient to inform dentist of bisphosphonate use: avoid invasive procedures

Severe oesophageal reactions (oesophagitis, oesophageal ulcers, oesophageal stricture and oesophageal erosions) have been reported. Physicians should be alert to the possibility of such reactions developing and patients should be advised to discontinue treatment and seek medical attention if they develop signs of oesophageal irritation such as dysphagia, pain on swallowing, retrosternal pain or new or worsening heartburn.

Atypical stress fractures of the proximal femoral shaft with poor healing have been reported in patients treated with alendronic acid, mainly in patients receiving long term treatment for osteoporosis.

Osteonecrosis of the jaw has been reported in cancer patients taking bisphosphonate regimens often with concurrent chemotherapy and corticosteroids. These cases have mainly been associated with dental procedures such as tooth extraction and many have shown signs of local infection including osteomyelitis. There is no data available to suggest discontinuation of bisphosphonate treatment prior to dentistry reduces the risk of osteonecrosis of the jaw.

Osteonecrosis of the external auditory canal has been reported very rarely with bisphosphonates, mainly in association with long term therapy (2 years or longer). Risk factors include steroid use and chemotherapy and/or local risk factors as infection or trauma. 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.

Patients should be re-evaluated periodically based on an assessment of the benefits and risks of the bisphosphonate treatment, especially after 5 years or more of treatment.

Pregnancy and Lactation

Pregnancy

Alendronic acid is contraindicated during pregnancy.

The manufacturer does not recommend using alendronic acid during pregnancy. Animal studies have shown reproduction toxicological effects and although the significance to humans is unknown, alendronic acid should not be used in human pregnancy. If treatment has been discontinued before pregnancy, the very long elimination half life from bone indicates that women treated with alendronic acid will have detectable concentrations of the drug for a prolonged interval (Briggs, 2015). Schaeffer (2015) states that accidental use of a single dose does not justify interruption of the pregnancy or additional diagnostic procedures.

Lactation

Alendronic acid is contraindicated during breastfeeding.

The manufacturer does not recommend breastfeeding whilst taking alendronic acid. It is not known whether alendronic acid passes to human milk. However, the extremely low oral bioavailability of bisphosphonates in the non-fasting state implies that systemic levels in the nursing infant should be negligible. A risk to the neonate cannot be excluded.

Counselling

Advise patients that the tablet should be swallowed whole and not sucked or chewed.

Advise patients that the tablets should be taken 30 minutes before the first food, beverage or medication of the day, washed down with a full glass of plain (not mineral) water only.

Also advise patients that they should remain upright for at least 30 minutes after dose and until after first food of the day. They should not take the tablets at bedtime or before rising for the day.

Inform patients that failure to follow these instructions may increase their risk of oesophageal problems.

Patients should be counselled to discontinue treatment and seek medical attention if they develop signs of oesophageal irritation (dysphagia, new or worsening heartburn, pain on swallowing or retrosternal pain).

Advise patients to inform their dentist that they are taking bisphosphonates and should not undergo invasive dental procedures.

Advise patients to maintain adequate oral hygiene during and after treatment with bisphosphonates. Patients should report any oral symptoms such as dental mobility, pain or swelling.

Advise patients to report any new thigh, hip or groin pain during treatment with alendronic acid.

Advise patients not to self medicate with aspirin or ibuprofen.

Advise patient to report any ear pain, discharge or infection.

Side Effects

Abdominal distension
Abdominal pain
Acid regurgitation
Alopecia
Angioedema
Asthenia
Atypical femoral fracture
Bone pain
Constipation
Decrease in plasma calcium
Decrease in serum phosphate
Diarrhoea
Dizziness
Dysgeusia
Dyspepsia
Dysphagia
Episcleritis
Erythema
Fever
Flatulence
Gastritis
Gastro-intestinal perforation
Gastro-intestinal ulceration
Gastrointestinal bleeding
Headache
Hypersensitivity reactions
Hypocalcaemia (symptomatic)
Joint pain
Joint swelling
Malaise
Melaena
Musculoskeletal pain
Myalgia
Nausea
Oesophageal erosions
Oesophageal stricture
Oesophageal ulceration
Oesophagitis
Oropharyngeal ulceration
Osteonecrosis (primarily of the jaw)
Osteonecrosis of the external auditory canal
Peripheral oedema
Photosensitivity
Pruritus
Rash
Scleritis
Stevens-Johnson syndrome
Toxic epidermal necrolysis
Urticaria
Uveitis
Vertigo
Vomiting

Overdosage

It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

The following number will direct the caller to the relevant local centre (0844) 892 0111

Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Further Information

Last Full Review Date: November 2021

Reference Sources

Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 3rd edition (2015) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.

Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 10th edition (2015) ed. Briggs, G., Freeman, R. Wolters Kluwer Health, Philadelphia.

Summary of Product Characteristics: Alendronic Acid 10mg Tablets. Accord Healthcare Ltd. Revised March 2017.

MHRA Drug Safety Update November 2009
Available at: https://www.mhra.gov.uk
Last accessed: 17 November 2021

MHRA Drug Safety Update December 2011
Available at: https://www.mhra.gov.uk
Last accessed: 17 November 2021

MHRA Drug Safety Update December 2015
Available at: https://www.mhra.gov.uk
Last accessed: 17 November 2021

NICE - Evidence Services
Available at: www.nice.org.uk
Last accessed: 17 November 2021