Skip to content
ClinCalc Pro
Menu
Bisphosphonate — Intravenous (Annual) Pregnancy: Contraindicated during pregnancy and during breast-feeding. Not recommended in women of childbearing potential. There are no adequate data on use in pregnant women; animal studies have shown reproductive toxicological effects including malformations and the potential risk for humans is unknown. It is unknown whether zoledronic acid is excreted into human milk.

Zoledronic Acid (Rheumatology — Osteoporosis)

Brand names: Aclasta, Zometa

Zoledronic acid is a potent intravenous bisphosphonate given as an annual infusion for the treatment and prevention of osteoporosis, including glucocorticoid-induced osteoporosis, to reduce fracture risk.

Auto-extracted from the source labelling — not yet independently clinician-verified. These values were distilled from the UK SPC (or the US label where noted) but have not had a clinician sign-off. Confirm against the current SmPC before prescribing.

Adult dose

Dose: 5 mg
Route: Intravenous infusion, via a vented infusion line, given slowly at a constant infusion rate; the infusion time must not be less than 15 minutes
Frequency: A single intravenous infusion once a year
Indication in the fetched UK SPC (Aclasta 5 mg solution for infusion, eMC product 210) for this dose: treatment of post-menopausal osteoporosis, osteoporosis in men, and osteoporosis associated with long-term systemic glucocorticoid therapy. Patients must be appropriately hydrated prior to administration — especially important for the elderly (65 years and over) and for patients receiving diuretic therapy. Adequate calcium and vitamin D intake are recommended in association with administration. The optimal duration of bisphosphonate treatment for osteoporosis has not been established; the need for continued treatment should be re-evaluated periodically on an individual patient basis, particularly after 5 or more years of use. In patients with a recent low-trauma hip fracture it is recommended to give the infusion at least two weeks after hip fracture repair, and a loading dose of 50 000 to 125 000 IU of vitamin D given orally or via the intramuscular route is recommended prior to the first infusion. Paget's disease (same product, prescribed only by physicians experienced in treating Paget's disease of the bone): a single intravenous infusion of 5 mg; adequate supplemental calcium corresponding to at least 500 mg elemental calcium twice daily is strongly advised for at least 10 days following administration; re-treatment consists of an additional intravenous infusion of 5 mg after an interval of one year or longer from initial treatment in patients who have relapsed (limited data). No dose adjustment is required for hepatic impairment or for the elderly (65 years and over). Patients should be given the package leaflet and the patient reminder card. Paediatric (no per-kg dose is stated, so paedDose is null): the SPC states Aclasta should not be used in children and adolescents below 18 years of age; there are no data available for children under 5 years of age. Verify any under-18 use against a children's formulary.

Dose adjustments

Renal

Contraindicated in patients with creatinine clearance less than 35 ml/min. No dose adjustment is necessary in patients with creatinine clearance of 35 ml/min or greater.

Dose auto-extracted from UK Summary of Product Characteristics (SPC) via the eMC; US FDA prescribing information (openFDA / DailyMed) — cross-check; US labelling may differ from UK — not yet clinician-verified. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

  • Hypersensitivity to the active substance, to any bisphosphonates or to any of the excipients
  • Patients with hypocalcaemia
  • Severe renal impairment with creatinine clearance less than 35 ml/min
  • Pregnancy and breast-feeding

Side effects

  • Pyrexia (17.1% after the first infusion), influenza-like illness and headache — part of the acute phase reaction
  • Myalgia (7.8%), arthralgia (4.8%), bone pain, back pain and pain in extremity
  • Hypocalcaemia (common); hypophosphataemia (rare)
  • Nausea, vomiting and diarrhoea
  • Atrial fibrillation (common); dizziness
  • Osteonecrosis of the jaw and atypical subtrochanteric and diaphyseal femoral fractures (bisphosphonate class effects); ocular inflammation including uveitis, episcleritis and iritis (rare)

Interactions

  • Aminoglycosides and calcitonin — may have an additive effect to lower serum calcium for prolonged periods; caution advised (US labelling §7.1)
  • Loop diuretics — increased risk of hypocalcaemia; exercise caution (US labelling §7.2)
  • Other potentially nephrotoxic drugs — use with caution (US labelling §7.3)
  • Thalidomide — no dose adjustment for zoledronic acid injection 4 mg is needed when coadministered (US labelling §7.4)

Clinical monograph

How it works

It inhibits osteoclast-mediated bone resorption by interfering with the mevalonate pathway, increasing bone mineral density.

Prescribing in practice

  • Correct hypocalcaemia and ensure adequate vitamin D and calcium before infusion, as the infusion can precipitate dangerous hypocalcaemia, and it is contraindicated in significant renal impairment.
  • Ensure good hydration and assess renal function before each dose, since rapid or repeated infusion can cause acute kidney injury.
  • Counsel on the rare risks of osteonecrosis of the jaw and atypical femoral fractures, and arrange a dental check before treatment where needed.

Monitoring

Monitor renal function and serum calcium before infusion, and review for acute-phase reactions, jaw symptoms, and atypical thigh or groin pain over time.

Counselling the patient

  • A flu-like reaction with fever and aches is common after the first infusion and usually settles within a few days.
  • Maintain good calcium and vitamin D intake and attend dental check-ups.
  • Report any new thigh, hip, or groin pain, or jaw pain, to your doctor.

Evidence & guidelines

Annual zoledronic acid infusion reduces vertebral and non-vertebral fractures in osteoporosis trials and is recommended in NICE guidance.

Reference: HORIZON Trial (NEJM 2007); MHRA DSU 2011 (ONJ/AFFs); NICE TA204 (Osteoporosis); SPC Aclasta; 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.