What it's for (Indications)
- Treatment of severe postmenopausal osteoporosis to reduce the risk of vertebral and hip fractures.
- Note: Strontium ranelate has been largely withdrawn from markets globally due to safety concerns.
Dosage Information
| Type | Guideline |
|---|---|
| Standard | The recommended dose is 2 g once daily. It should be taken as an oral suspension, mixed in a glass of water, preferably at bedtime, at least two hours after food, milk, or calcium-containing products. Co-administration with food, calcium, or antacids can reduce absorption. Note: Given significant safety concerns, its use is severely restricted or it has been withdrawn in many regions. |
Safety & Warnings
Common Side Effects
- Common: Nausea, diarrhea, headache, dermatitis.
- Serious/Rare: Venous thromboembolism (VTE), myocardial infarction (MI), DRESS syndrome (Drug Reaction with Eosinophilia and Systemic Symptoms), other severe cutaneous adverse reactions (SCARs), seizures, elevated creatine phosphokinase.
Serious Warnings
- Black Box Warning: Although not carrying a US FDA Black Box Warning (as it was not FDA approved), strontium ranelate was voluntarily withdrawn from the market in many regions, including the European Union, due to concerns over serious cardiovascular events (myocardial infarction, venous thromboembolism), severe skin reactions (DRESS syndrome), and other severe adverse effects. Its use was highly restricted before withdrawal, indicating significant safety concerns that should be considered equivalent to a very strong warning.
- Strontium ranelate is associated with an increased risk of serious cardiovascular events, including myocardial infarction and venous thromboembolism (VTE).
- Patients should be carefully assessed for cardiovascular risk factors before and during treatment.
- There is an increased risk of DRESS syndrome and other severe skin reactions, which can be fatal.
- Renal function should be monitored, as severe renal impairment (CrCl < 30 mL/min) is a contraindication.
- Use with caution in patients with risk factors for VTE or in cases of temporary/permanent immobilization.
How it Works (Mechanism of Action)
Strontium ranelate has a dual mechanism of action; it stimulates bone formation by promoting osteoblast proliferation and increasing collagen synthesis, and inhibits bone resorption by decreasing osteoclast differentiation and activity. It incorporates into the bone mineral crystal structure.
Commercial Brands (Alternatives)
No other brands found for this formula.