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Treatment To Prevent Fractures in Men and Women With Low Bone Density or Osteoporosis: An Update

Slide: 28 of 40

Adverse Effects of Medications for Low Bone Density or Osteoporosis (1 of 3)

For bisphosphonates (as a class), a possible association with atypical subtrochanteric fractures of the femur has been of concern. The magnitude of the association is not known, but the risk for this type of fracture is low. Data are not consistent, but the FDA has issued a boxed warning about this possible adverse effect. The strength of evidence for this finding is low.

Alendronate is more often associated with mild upper gastrointestinal (GI) events. Mild upper GI events are conditions involving the upper gastrointestinal tract such as acid reflux, esophageal irritation, nausea, vomiting, and heartburn. The odds ratio for the risk of upper GI events is 1.08, with a statistically valid range for the likelihood, as defined by the 95 percent confidence interval, falling between 1.01 and 1.15. The strength of evidence for this finding is high. Hypocalcemia is associated with alendronate, but the risk has not been calculated as there are zero events in the placebo group. Data show 9 out of 301 alendronate-treated patients experienced hypocalcemia versus 0 of 207 in the placebo-treated group. The strength of evidence for this finding is moderate.

Zoledronic acid is associated with hypocalcemia, with a 7.22-fold likelihood compared with placebo and a statistically valid range for the association between 1.81- and 42.7-fold. The strength of evidence for this finding is moderate.

Patients treated with intravenous (IV) forms of zoledronic acid and ibandronate have been considered to have greater risk of osteonecrosis of the jaw. The evidence to date indicates less than 1 case per 100,000 person-years of exposure with these agents. Nearly all cases of osteonecrosis of the jaw are reported in people being treated for cancer. The strength of evidence for this finding is moderate.