Strontium Safety

Strontium is safe for most people, but there are certain individuals who should not take it. These include those with any of the following disorders:

- Decreased kidney function.

- History of blood clots in the veins (venous thromboembolism, e.g., deep vein thrombosis or pulmonary embolism).

- Blood disorders that increase the risk of blood clots in the veins, e.g. antiphospholipid syndrome, factor V Leiden.

There is some evidence that strontium could slightly increase the incidence of blood clots. The tests were performed on strontium ranelate.

Strontium should also not be taken by children nor by pregnant or lactating women.

A Dose-Response Study With Strontium Malonate

Osteologix, Inc. is conducting a Phase II clinical trial with strontium malonate in postmenopausal women. The study's primary objective is to compare dose-response effect of three levels of strontium malonate to placebo on bone resorption quantified by S-CTX-1 following 12 weeks of treatment. The four parallel groups in this trial will take 750 mg strontium malonate, 1000 mg strontium malonate, 2000 mg strontium malonate, 2 grams Protelos (strontium ranelate), and placebo. For more details, visit http://clinicaltrials.gov/ct2/show/NCT00409032

FDA Bisphosphonate Alert

Information on Bisphosphonates (marketed as Actonel, Actonel+Ca, Aredia, Boniva, Didronel, Fosamax, Fosamax+D, Reclast, Skelid, and Zometa)

FDA ALERT [1/7/2008] - FDA is highlighting the possibility of severe and sometimes incapacitating bone, joint, and/or muscle (musculoskeletal) pain in patients taking bisphosphonates. Although severe musculoskeletal pain is included in the prescribing information for all bisphosphonates, the association between bisphosphonates and severe musculoskeletal pain may be overlooked by healthcare professionals, delaying diagnosis, prolonging pain and/or impairment, and necessitating the use of analgesics.

The severe musculoskeletal pain may occur within days, months, or years after starting a bisphosphonate. Some patients have reported complete relief of symptoms after discontinuing the bisphosphonate, whereas others have reported slow or incomplete resolution. The risk factors for and incidence of severe musculoskeletal pain associated with bisphosphonates are unknown.

This severe musculoskeletal pain is in contrast to the acute phase response characterized by fever, chills, bone pain, myalgias, and arthralgias that sometimes accompanies initial administration of intravenous bisphosphonates and may occur with initial exposure to once-weekly or once-monthly doses of oral bisphosphonates. The symptoms related to the acute phase response tend to resolve within several days with continued drug use.

Healthcare professionals should consider whether bisphosphonate use might be responsible for severe musculoskeletal pain in patients who present with these symptoms and consider temporary or permanent discontinuation of the drug.
This information reflects FDA's current analysis of data available to FDA concerning this drug. FDA intends to update this when additional information or analyses become available.