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Anti-Sclerostin Monoclonal Antibody — Anabolic Osteoporosis Treatment Pregnancy: Contraindicated

Romosozumab

Brand names: Evenity

Adult dose

Dose: 210 mg subcutaneous injection monthly (given as two 105 mg injections at two separate sites)
Route: Subcutaneous
Frequency: Once monthly (two simultaneous 105 mg injections)
Max: 210 mg/month; maximum 12 doses (12-month treatment course only)
Limited to 12 months total — then transition to antiresorptive therapy (bisphosphonate or denosumab) to maintain gains. Administer two 105 mg injections consecutively at separate injection sites (e.g., abdomen and thigh). MHRA: do not use in patients with MI or stroke in previous 12 months.

Paediatric dose

Route:
Not licensed for paediatric use

Dose adjustments

Renal

Use with caution in severe renal impairment (eGFR <30 mL/min) — limited data; hypocalcaemia risk increased

Hepatic

No dose adjustment required

Clinical pearls

  • MHRA 2019: Romosozumab associated with increased risk of MI and stroke — ARCH trial (vs alendronate) showed higher CV event rate in romosozumab arm. CONTRAINDICATED in patients with MI or stroke within previous 12 months; use with caution in high CV risk
  • ARCH trial (NEJM 2017): romosozumab 210 mg monthly for 12 months followed by alendronate reduced vertebral fracture risk by 48% and hip fracture risk by 38% compared to alendronate alone — remarkable efficacy
  • Dual mechanism — unique in osteoporosis pharmacology: romosozumab simultaneously INCREASES bone formation (via Wnt pathway activation) AND DECREASES bone resorption (via RANKL and OPG effects) — no other approved agent has both mechanisms
  • 12-month limit is mandatory: sclerostin inhibition effect diminishes and bone formation marker response wanes after 12 months — always plan transition therapy
  • Dental review before starting: ONJ risk is lower than with IV bisphosphonates but still present — complete invasive dental work first

Contraindications

  • MI or stroke in the previous 12 months — MHRA 2019 CRITICAL warning
  • Hypocalcaemia
  • Pregnancy

Side effects

  • Cardiovascular events — MI and stroke; higher rates than in alendronate comparator arm (ARCH trial)
  • Hypocalcaemia — ensure calcium and vitamin D supplementation
  • Injection site reactions
  • Osteonecrosis of the jaw (rare)
  • Atypical femoral fractures (rare — class effect with antiresorptive phase after romosozumab)

Interactions

  • No significant drug interactions identified — monoclonal antibody, not hepatically metabolised

Monitoring

  • Serum calcium before each injection
  • Vitamin D levels at baseline
  • CV risk assessment before initiation
  • DXA scan at baseline and 12 months
  • Dental review before starting

Reference: BNFc; BNF 90; ARCH Trial (NEJM 2017); FRAME Trial (NEJM 2017); MHRA DSU 2019 (Cardiovascular Risk); NICE TA791 (Romosozumab). Verify against your local formulary and the latest BNF before prescribing.

Related

Curated clinical cross-links plus same-class fallbacks.

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