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Published on: September 18, 2017
Cardiac concerns associated with strontium ranelate
1University of Liège, Department of Public Health, Epidemiology and Health Economics , CHU Sart-Tilman, 4020 Liège , Belgium +32 4270 3257 ; +32 4270 3253 ; jyreginster@ulg.ac.be.
Insights
Strontium ranelate effectively reduces osteoporosis fractures. However, randomized controlled trials show an increased myocardial infarction (MI) risk, which is mitigated by excluding patients with cardiovascular contraindications.
Area of Science:
- Osteoporosis treatment
- Cardiovascular safety of medications
Background:
- Strontium ranelate is effective in reducing vertebral and non-vertebral fractures in osteoporosis patients.
- Cardiac safety concerns have led to contraindications for strontium ranelate in patients with specific cardiovascular conditions.
Purpose of the Study:
- To evaluate the cardiac safety of strontium ranelate.
- To assess the risk of myocardial infarction (MI) associated with strontium ranelate treatment.
Main Methods:
- Literature search and data collection from the European Medicines Agency.
- Analysis of randomized controlled trial (RCT) data on MI incidence.
- Review of observational studies from real-life medical practice.
Main Results:
- RCTs showed a higher incidence of non-adjudicated MI with strontium ranelate versus placebo (1.7% vs 1.1%).
- No increase in cardiovascular mortality was observed.
- Excluding patients with cardiovascular contraindications mitigated the MI risk (OR: 0.99).
- Observational studies in real-life settings did not report a cardiac safety signal.
Conclusions:
- Increased cardiac event risk with strontium ranelate detected in RCTs, but not in real-world data.
- Excluding patients with cardiovascular contraindications effectively controls MI risk.
- Strontium ranelate remains a viable option for severe osteoporosis patients without cardiovascular contraindications who cannot tolerate other treatments.
Introduction:
Strontium ranelate is proven to reduce vertebral and non-vertebral fracture risk in osteoporosis. Concerns about cardiac safety have led to a new contraindication to strontium ranelate in patients with uncontrolled hypertension and/or current or past history of ischaemic heart disease, peripheral arterial disease and/or cerebrovascular disease.
Areas Covered:
A literature search was performed; data were also collected from the European Medicines Agency website. Randomised controlled trial (RCT) data indicate a higher incidence of non-adjudicated myocardial infarction (MI) with strontium ranelate versus placebo (1.7 vs 1.1%; odds ratio [OR]: 1.6; 95% CI: 1.07 - 2.38; p = 0.020) (Mantel-Haenzel estimate of the OR). There was no increase in cardiovascular mortality. MI risk was mitigated by excluding patients with cardiovascular contraindications (OR: 0.99; 95% CI: 0.48 - 2.04; p = 0.988). Three observational studies performed in the context of real-life medical practice in the UK and Denmark did not report a signal.
Expert Opinion:
The increased risk for cardiac events with strontium ranelate has been detected in RCTs but not in real life. Excluding patients with cardiovascular contraindications appears to be an effective measure for controlling the risk of MI. Strontium ranelate remains a useful therapeutic alternative in patients with severe osteoporosis without cardiovascular contraindications who are unable to take another osteoporosis treatment.
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