Skip to content
ClinCalc Pro
Menu
Calculators Drugs Pathways AI Dx Donate Get the App
Bisphosphonate + vitamin D₃ Pregnancy: Must not be used in pregnancy or breast-feeding. §4.6, verbatim: 'FOSAVANCE is only intended for use in postmenopausal women and therefore it should not be used during pregnancy or in breast-feeding women... Studies in animals have shown reproductive toxicity. Alendronate given during pregnancy in rats caused dystocia related to hypocalcaemia. Studies in animals have shown hypercalcaemia and reproductive toxicity with high doses of vitamin D. FOSAVANCE should not be used during pregnancy.' Breast-feeding: 'It is unknown whether alendronate/metabolites are excreted in human milk. A risk to the newborns/infants cannot be excluded. Colecalciferol and some of its active metabolites pass into breast milk. FOSAVANCE should not be used during breast-feeding.' §4.6 also flags a residual consideration after stopping: 'there is a theoretical risk of foetal harm, predominantly skeletal, if a woman becomes pregnant after completing a course of bisphosphonate therapy.'

Alendronic acid with colecalciferol

Brand names: Fosavance

Used in: Osteoporosis Falls & Frailty

A fixed-dose oral combination of the bisphosphonate alendronic acid with colecalciferol (vitamin D3), used in the treatment of osteoporosis where vitamin D repletion is also required. This page covers the combination tablet and its administration constraints.

Adult dose

Dose: Osteoporosis in postmenopausal women — one tablet once weekly. §4.2, verbatim: 'The recommended dose is one tablet once weekly.' The SPC covers two strengths and doses both the same way: 'FOSAVANCE 70 mg/2,800 IU tablets' and 'FOSAVANCE 70 mg/5,600 IU tablets' — i.e. alendronic acid 70 mg with either 2,800 IU or 5,600 IU colecalciferol, one tablet of the prescribed strength once a week.
Route: Oral, on an empty stomach with plain water, upright. §4.2, verbatim: 'FOSAVANCE must be taken with water only (not mineral water) at least 30 minutes before the first food, beverage, or medicinal product (including antacids, calcium supplements and vitamins) of the day... FOSAVANCE should only be swallowed after getting up for the day with a full glass of water (not less than 200 ml). Patients should only swallow FOSAVANCE whole. Patients should not crush or chew the tablet or allow the tablet to dissolve in their mouths because of a potential for oropharyngeal ulceration. Patients should not lie down for at least 30 minutes after taking FOSAVANCE and until after the first food of the day. FOSAVANCE should not be taken at bedtime or before arising for the day.'
Frequency: Once weekly, on a chosen fixed day. Missed dose, §4.2 verbatim: 'Patients should be instructed that if they miss a dose of FOSAVANCE they should take one tablet on the morning after they remember. They should not take two tablets on the same day but should return to taking one tablet once a week, as originally scheduled on their chosen day.'
Max: One tablet (alendronic acid 70 mg with 2,800 IU or 5,600 IU colecalciferol) in any one week. The SPC states no higher dose and explicitly bars doubling up after a missed dose: 'They should not take two tablets on the same day but should return to taking one tablet once a week, as originally scheduled on their chosen day.'
CALCIUM AND VITAMIN D (§4.2, verbatim): 'Patients should receive supplemental calcium if intake from diet is inadequate (see section 4.4). Additional supplementation with vitamin D should be considered on an individual basis taking into account any vitamin D intake from vitamins and dietary supplements.' The SPC also cautions on equivalence for BOTH strengths: 'The equivalence of intake of 2,800 IU of vitamin D3 weekly in FOSAVANCE to daily dosing of vitamin D 400 IU has not been studied' and 'The equivalence of intake of 5,600 IU of vitamin D3 weekly in FOSAVANCE to daily dosing of vitamin D 800 IU has not been studied.' || DURATION AND REVIEW (§4.2, verbatim): 'Due to the nature of the disease process in osteoporosis, FOSAVANCE is intended for long-term use. The optimal duration of bisphosphonate treatment for osteoporosis has not been established. The need for continued treatment should be re-evaluated periodically based on the benefits and potential risks of FOSAVANCE on an individual patient basis, particularly after 5 or more years of use.' || SPECIAL POPULATIONS: Elderly — 'In clinical studies there was no age-related difference in the efficacy or safety profiles of alendronate. Therefore no dose adjustment is necessary for the elderly.' Renal — 'FOSAVANCE is not recommended for patients with renal impairment where creatinine clearance is less than 35 ml/min, due to lack of experience. No dose adjustment is necessary for patients with a creatinine clearance greater than 35 ml/min.' The SPC gives NO hepatic-impairment paragraph in §4.2. || PAEDIATRIC — NOT FOR UNDER-18s, so paedDose is null: 'The safety and efficacy of FOSAVANCE in children less than 18 years of age have not been established. This medicinal product should not be used in children less than 18 years of age because no data are available for the alendronic acid/colecalciferol combination.' || WHY THE ADMINISTRATION INSTRUCTIONS MATTER (§4.4): 'The risk of severe oesophageal adverse reactions appears to be greater in patients who fail to take alendronate properly and/or who continue to take alendronate after developing symptoms suggestive of oesophageal irritation. It is very important that the full dosing instructions are provided to, and are understood by the patient.' || This SPC covers TWO strengths; the sourced dose above therefore states the dose as one tablet weekly of whichever strength is prescribed.

Dose adjustments

Renal

§4.2, verbatim: 'FOSAVANCE is not recommended for patients with renal impairment where creatinine clearance is less than 35 ml/min, due to lack of experience. No dose adjustment is necessary for patients with a creatinine clearance greater than 35 ml/min.'

Hepatic

No hepatic-impairment paragraph appears in the §4.2 retrieved, and none has been supplied from elsewhere.

Dose independently re-sourced from UK Summary of Product Characteristics (SPC) via the eMC — clinician-reviewed. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

  • Hypersensitivity to the active substances or to any of the excipients listed in section 6.1 (§4.3)
  • Abnormalities of the oesophagus and other factors which delay oesophageal emptying such as stricture or achalasia (§4.3)
  • Inability to stand or sit upright for at least 30 minutes (§4.3)
  • Hypocalcaemia (§4.3)
  • Not recommended (§4.2, not a §4.3 contraindication) where creatinine clearance is less than 35 ml/min
  • Should not be used in children less than 18 years of age (§4.2)
  • Should not be used during pregnancy or in breast-feeding women — 'FOSAVANCE is only intended for use in postmenopausal women' (§4.6)

Side effects

  • Most common: upper gastrointestinal reactions including abdominal pain, dyspepsia, oesophageal ulcer, dysphagia, abdominal distension and acid regurgitation (> 1 %)
  • Very common: musculoskeletal (bone, muscle or joint) pain which is sometimes severe
  • Common: headache, dizziness, vertigo, abdominal pain, dyspepsia, constipation, diarrhoea, flatulence, oesophageal ulcer, dysphagia, abdominal distension, acid regurgitation, alopecia, pruritus, joint swelling, asthenia, peripheral oedema
  • Uncommon: nausea, vomiting, gastritis, oesophagitis, oesophageal erosions, melaena, dysgeusia, eye inflammation (uveitis, scleritis or episcleritis), rash, erythema, and 'transient symptoms as in an acute-phase response (myalgia, malaise and rarely, fever), typically in association with initiation of treatment'
  • Rare: symptomatic hypocalcaemia, hypersensitivity reactions including urticaria and angioedema, oesophageal stricture, oropharyngeal ulceration, upper gastrointestinal perforation/ulcers/bleeding, rash with photosensitivity, severe skin reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis, osteonecrosis of the jaw, atypical subtrochanteric and diaphyseal femoral fractures
  • Very rare: osteonecrosis of the external auditory canal (a bisphosphonate class adverse reaction). Not known: atypical fractures of other bones
  • §4.8 notes 'No additional adverse reactions have been identified for the combination of alendronate and colecalciferol' beyond those reported for alendronate
  • NOTE: §4.8 is cut off at the source-fetch limit inside the atypical-femoral-fracture paragraph, so the 'Description of selected adverse reactions' text is incomplete here

Monitoring

  • §4.4: 'Physicians should therefore be alert to any signs or symptoms signalling a possible oesophageal reaction and patients should be instructed to discontinue alendronate and seek medical attention if they develop symptoms of oesophageal irritation such as dysphagia, pain on swallowing or retrosternal pain or new or worsening heartburn.'
  • §4.4: caution with active upper gastrointestinal problems (dysphagia, oesophageal disease, gastritis, duodenitis, ulcers) or recent major GI disease within the previous year; in known Barrett's oesophagus, 'prescribers should consider the benefits and potential risks of alendronate on an individual patient basis'
  • §4.4: osteonecrosis of the jaw — the risk-factor list names cancer, chemotherapy, radiotherapy, corticosteroids, angiogenesis inhibitors, smoking, a history of dental disease, poor oral hygiene, periodontal disease and invasive dental procedures (the list is cut off at the source-fetch limit)
  • §4.2: re-evaluate the need for continued treatment periodically, 'particularly after 5 or more years of use'
  • §4.2: ensure adequate calcium intake and consider individual vitamin D supplementation on top of the tablet
  • §4.2: check creatinine clearance — not recommended below 35 ml/min
  • §4.3: correct hypocalcaemia before starting (hypocalcaemia is a contraindication)

Clinical monograph

How it works

Alendronic acid binds to bone and inhibits osteoclast-mediated bone resorption, reducing fracture risk, while colecalciferol supports calcium absorption and bone mineralisation.

Prescribing in practice

  • Strict administration is the critical safety point — take on an empty stomach with plain water while sitting or standing upright and remain so for the recommended period, to reduce the risk of oesophageal irritation and ulceration.
  • Correct hypocalcaemia and severe vitamin D deficiency before starting, and counsel patients on the risks of osteonecrosis of the jaw and atypical femoral fracture.
  • Avoid in significant renal impairment, oesophageal abnormalities, or where the patient cannot remain upright, and the colecalciferol content may be insufficient as a sole vitamin D source.

Monitoring

Monitor serum calcium and vitamin D status, renal function and for any oesophageal, dental or atypical bone symptoms.

Counselling the patient

  • Swallow whole with a full glass of plain water first thing, then stay upright and do not eat or take other medicines for the advised period.
  • Report difficulty or pain on swallowing, heartburn, or new thigh, hip or jaw pain.
  • Maintain adequate dietary calcium and attend dental check-ups.

Evidence & guidelines

Alendronic acid's anti-fracture efficacy is established in large randomised trials, with the colecalciferol component added to address common co-existing vitamin D deficiency.

Reference: NICE NG225; NOGG 2021; SmPC Fosavance; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Related

Curated clinical cross-links plus same-class fallbacks.

Calculators
Pathways