Ibandronate and Strontium Ranelate Treatment

There have been numerous studies examining the effects of medical therapies for the treatment of osteoporosis to prevent radiographic fractures. The focus of this recommendation is not the use of medical therapies for treatment of osteoporosis (i.e. prevention of fragility fracture), but their use in patients with an existing fracture and the prevention of those patients experiencing symptomatic fractures (i.e. the critical outcome for this recommendation). Three studies of osteoporosis drugs exclusively enrolled symptomatic patients but none reported the critical outcome of a symptomatic fracture. Thirty-four additional studies were included that enrolled patients with symptomatic fractures or asymptomatic fractures (incident fracture determined by radiograph). Three of these studies reported the critical outcome of symptomatic fracture.

One Level II study³¹ investigated daily (2.5 mg) and intermittent (20 mg every other day for 12 doses every 3 months) administration of ibandronate for symptomatic vertebral fractures compared to placebo.  Daily and intermittent ibandronate treatment regimens reduced new symptomatic vertebral fractures in a statistically significant manner at 3 years. There were no statistically significant differences in adverse events between ibandronate and placebo groups including those in the upper gastrointestinal tract.

One Level II study³² investigated daily strontium ranelate (2g) for vertebral fractures compared to placebo. Strontium ranelate reduced new symptomatic vertebral fractures in a statistically significant manner at 1 and 3 years. The occurrence of adverse events was similar between patients assigned to placebo or strontium ranelate. The only statistically significant differences were diarrhea, which occurred more frequently in patients receiving strontium ranelate, and incidence of gastritis, which occurred more frequently in patients receiving placebo. Effective as of July 15, 2010, Strontium Ranelate is not approved for marketing or the treatment of any medical condition in the United States. The United States Food and Drug Administration’s (FDA) current policy regarding disclosure of marketing applications can be found in “Current Disclosure Policies for Marketing Applications” on the FDA website.

One Level II study³³ investigated daily oral pamidronate (150 mg) for vertebral fractures compared to placebo. Oral pamidronate did not reduce new symptomatic vertebral fractures in a statistically significant manner at 3 years and adverse events were similar between patients receiving placebo or oral pamidronate.

No recommendation is made for or against the use of any of the treatments considered not applicable to the reduction of future symptomatic vertebral fractures despite the large body of evidence for their use in osteoporosis.