In a nutshell
This study investigated the effects of the drug denosumab (Prolia) in postmenopausal patients with hormone-receptor positive breast cancer treated with aromatase inhibitors. The study concluded that denosumab reduces the risk of bone fracture in these patients.
Some background
Aromatase inhibitors are hormonal therapies. They are often used to treat postmenopausal women diagnosed with hormone-receptor positive breast cancer (cancer that grows in response to hormones such as estrogen or progesterone). A side effect of this treatment can be bone weakening over time. This increases the chances of bone fractures or breaks. Denosumab is a therapy that is being investigated as a possible treatment for bone weakening in women taking aromatase inhibitors.
Methods & findings
The study included 3,420 postmenopausal women. The women had been diagnosed with early-stage, hormone-receptor positive breast cancer. They were being treated with an aromatase inhibitor. Participants were randomly assigned to get either an injection of denosumab every 6 months or a placebo (a substance that looked like denosumab but had no effect) injection every 6 months.
The patients in the denosumab group had a significantly delayed time until the occurrence of a bone fracture. There were 92 fractures in the denosumab group compared to 176 in the placebo group. There was not a significant difference in adverse events (unfavorable symptoms associated with the use of a medical treatment) between the two groups. There were 521 serious adverse events in the denosumab group and 511 in the placebo group. These events included joint pain, and all were thought to be related to the aromatase inhibitors.
The bottom line
The current study concluded that denosumab reduced the risk of bone fracture in postmenopausal patients with hormone-receptor positive breast cancer receiving treatment with aromatase inhibitors.
The fine print
Amgen provided the funding for the study. Amgen is the manufacturer of denosumab.
Published By :
The Lancet
Date :
May 29, 2015