Strontium ranelate

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[edit] BRAND NAMES

[edit] STRUCTURE

Strontium ranelate.jpg

[edit] MECHANISM OF ACTION

Osteoporosis is defined as a spinal or hip bone mineral density (BMD) that is 2.5 standard deviations or more below the mean BMD for healthy, young women. A number of risk factors are associated with postmenopausal osteoporosis including low bone mass, low bone mineral density, early menopause, a history of smoking and a family history of osteoporosis. The clinical consequence of osteoporosis is fractures. The risk of fractures is increased with the number of risk factors

Strontium ranelate may have a dual effect

  • Anabolic effect: It increases osteoblastic differentiation and activity (Osteoblast are responsible for bone formation)
  • Anti-catabolic effect: It reduces bone resorption by decreasing osteoclast differentiation and resorbing activity. (osteoclast cells are involved in breaking down the bone tissue)

This results in a rebalance of bone turnover in favour of bone formation, thus reducing vertebral and hip fracture risk

[edit] INDICATIONS

Strontium ranelate was authorised in the EU in 2004 for the treatment of osteoporosis in women who have been through the menopause, to reduce the risk of fractures in the spine and the hip. In 2012, its authorisation was extended to include the treatment of osteoporosis in men at increased risk of fractures. In March 2012, following concerns over the risks of blood clots in the veins (VTE, venous thromboembolism) and severe allergic skin reactions, the EMA recommended that the medicine must not be used in patients with blood clots or a history of blood clots, as well as in patients who were temporarily or permanently immobilised.

In April 2013 The EMA has recommended a restriction in the use of Strontium ranelate, following an assessment of data showing an increased risk of heart attack compared to placebo: Strontium ranelate should only be used for the treatment of SEVERE osteoporosis in postmenopausal women at high risk for fracture and SEVERE osteoporosis in men at increased risk of fracture.

[edit] DOSAGE

The recommended daily dose is one 2g sachet once daily by oral administration. The absorption of strontium ranelate is reduced by food intake, and the drug should be administered, on an empty stomach. Ideally, it should be taken at bedtime, preferably at least 2 hours after eating.

[edit] CONTRAINDICATIONS

  • Known hypersensitivity to strontium ranelate or to any of the excipients
  • Severe renal impairment
  • Current or previous venous thromboembolic events (VTE), including deep vein thrombosis and pulmonary embolism.
  • Temporary or permanent immobilisation (e.g. post-surgical recovery or prolonged bed rest).
  • History of ischaemic heart disease (such as angina or a heart attack), peripheral arterial disease (obstruction of large blood vessels, often in the legs) or cerebrovascular disease (diseases affecting the blood vessels supplying the brain, such as stroke)
  • Patients with hypertension: Systolic blood pressure greater than or equal to 160 mmHg, or diastolic blood pressure greater than or equal to 90 mmHg.

[edit] WARNINGS AND PRECAUTIONS

  • The patient’s risk of developing cardiovascular disease should be evaluated before and at regular intervals during treatment (a significant increase in myocardial infarction has been observed in Strontium ranelate treated patients compared to placebo (1.7% versus 1.1 %))
  • Patients should receive vitamin D and calcium supplements if dietary intake is inadequate.
  • Strontium ranelate is associated with an increase in the incidence of venous thromboembolism (VTE)
  • Cases of life-threatening cutaneous reactions :Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) and drug rash with eosinophilia and systemic symptoms (e.g. adenopathy, hepatitis, interstitial nephropathy, interstitial lung disease) have been reported. Patients should be advised of the signs and symptoms and monitored closely for skin reactions. The highest risk for occurrence of SJS or TEN is within the first weeks of treatment and usually around 3-6 weeks.

[edit] INTERACTIONS

  • Food, milk and derivative products, and medicines containing calcium may reduce the bioavailability of strontium ranelate. Therefore, the drug should preferably be taken at least two hours after such products

[edit] PREGNANCY AND LACTATION

Strontium ranelate is intended for use in postmenopausal women.

[edit] SIDE EFFECTS

The most common adverse events are nausea and diarrhea which are generally reported at the beginning of treatment and usually disappear after the third month of treatment.

Serious adverse reactions are discussed in the Warnings and Precautions section

[edit] RELATED LINKS

How osteoporosis develops

[edit] BIBLIOGRAPHY

[edit] REFERENCES