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Antiresorptive and Anabolic Osteoporosis Treatment (RANK/Wnt modulator) Pregnancy: Contraindicated

Strontium Ranelate

Brand names: Protelos

Adult dose

Dose: 2 g once daily in water at bedtime
Route: Oral (granules dissolved in water)
Frequency: Once daily at bedtime
Max: 2 g/day
MHRA 2014: Use now RESTRICTED to severe osteoporosis in postmenopausal women with high fracture risk and no alternative — due to serious cardiovascular side effects. Take at least 2 hours after food, milk, calcium, or antacids. Dissolve in water and take immediately.

Paediatric dose

Route:
Not licensed in children

Dose adjustments

Renal

Avoid if eGFR <30 mL/min

Hepatic

No dose adjustment required

Clinical pearls

  • MHRA 2014: Benefit-risk review concluded cardiovascular risk (especially MI) restricts use to ONLY postmenopausal women with severe osteoporosis and high fracture risk where bisphosphonates, denosumab, and raloxifene are unsuitable — inform patients; annual cardiovascular risk reassessment required
  • DRESS syndrome: rare but life-threatening skin reaction (fever, rash, lymphadenopathy, eosinophilia, organ involvement) — usually weeks 3–8; stop immediately and refer to dermatologist
  • Mechanism: strontium ranelate both reduces bone resorption and stimulates bone formation (dual action) — strontium is incorporated into hydroxyapatite crystal, artificially elevating DXA bone mineral density readings (DXA overcounts strontium as calcium)
  • DXA interpretation: DXA readings during strontium treatment are NOT directly comparable to those without treatment — strontium raises apparent BMD beyond biological bone mineral gain
  • Largely superseded: romosozumab and teriparatide provide dual/anabolic effects with better safety profiles — strontium ranelate is rarely initiated in new patients

Contraindications

  • Established ischaemic heart disease, peripheral arterial disease, cerebrovascular disease, or uncontrolled hypertension — MHRA 2014
  • Current or past VTE
  • Temporary or permanent immobilisation
  • eGFR <30 mL/min

Side effects

  • Serious cardiovascular events — MI (2-fold increased risk in MHRA 2014 review); contraindicated in all CV disease
  • VTE — DVT and pulmonary embolism
  • DRESS syndrome (drug reaction with eosinophilia and systemic symptoms) — rare but potentially fatal skin reaction; usually in first 3–8 weeks
  • Diarrhoea (most common)
  • Nausea
  • Headache

Interactions

  • Calcium and antacids — reduce strontium absorption significantly; separate by 2 hours
  • Tetracyclines — strontium chelates and reduces antibiotic absorption; avoid combination or separate by several hours
  • Oral bisphosphonates — do not combine

Monitoring

  • Cardiovascular risk at baseline and annually — ECG if indicated
  • Skin for rash — especially weeks 3–8 (DRESS)
  • Renal function
  • DXA every 2 years (note interpretation caveat)

Reference: BNFc; BNF 90; MHRA DSU 2014 (Cardiovascular Risk); SOTI Trial (NEJM 2004); TROPOS Trial (J Clin Endocrinol Metab 2004); EMA Review 2014. Verify against your local formulary and the latest BNF before prescribing.

Related

Curated clinical cross-links plus same-class fallbacks.

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