The Endocrine Society

The Endocrine Society

March 06, 2015
2 min read
Save

Prolia reverses cortical bone density loss in women with postmenopausal osteoporosis

You've successfully added to your alerts. You will receive an email when new content is published.

Click Here to Manage Email Alerts

We were unable to process your request. Please try again later. If you continue to have this issue please contact customerservice@slackinc.com.

SAN DIEGO — Treatment with Prolia helped stop and reverse cortical bone density loss at the wrist among women with postmenopausal osteoporosis, according to study findings presented here.

“The skeleton is 80% cortical bone and cortical bone loss contributes importantly to increased fracture risk,” the researchers wrote. “Denosumab has been shown to increase [bone mineral density] at sites of cortical bone, including the 1/3 radius, a skeletal site not responsive to most osteoporosis treatments.”

John P. Bilezikian, MD, of Columbia University, and colleagues evaluated data from 2,207 women from the FREEDOM Trial for 1/3 radius BMD changes and wrist fracture rates during 3 years of treatment with placebo who were then treated with 60 mg Prolia (denosumab, Amgen) for 6 years in the FREEDOM Extension Trial. All participants received daily calcium and vitamin D supplementation.

John P. Bilezikian

John P. Bilezikian

“The important point to make is that this study tracked the first 3 years of the placebo arm and the subsequent years when the placebo-treated subjects were treated with denosumab,” Bilezikian told Endocrine Today.

A substudy of 115 participants also received DXA measurements at baseline, FREEDOM (1-3 years) and FREEDOM Extension (years 1-3 and 5).

Compared with FREEDOM baseline, a progressive and significant loss of BMD at the 1/3 radius was found during the 3 years of the FREEDOM trial (–1.2%; P < .05). However, during FREEDOM Extension, denosumab resulted in a reversal and 1.5% BMD gain at the 1/3 radius by year 5 (P < .05).

Wrist fracture rate was 1.02 per 100 person-years during the FREEDOM trial; wrist fracture rate remained comparable during the first 3 years of the Extension Trial, whereas BMD was recovered with denosumab and returned to original baseline levels.

BMD increased over baseline during years 4 and 5 of the Extension Trial, and the rate of wrist fractures reduced significantly compared with FREEDOM (RR = 0.57; 95% CI, 0.34-0.95).

Similarly, through the end of the Extension Trial, the rate of wrist fractures remained lower than that during the FREEDOM Trial (RR = 0.61; 95% CI, 0.39-0.94).

“During the first 3 years of FREEDOM, the placebo arm lost distal radius density, but during the period when the placebo arm was treated with denosumab, bone density was reversed and was associated with a reduction in wrist fractures,” Bilezikian said. “The study is important because it associates an effect of denosumab to improve cortical bone density with a clinically significant endpoint, namely wrist fractures.” ­– by Amber Cox

Reference:

Bilezikian JP, et al. OR22-1. Presented at: The Endocrine Society Annual Meeting; March 5-8, 2015; San Diego.

Disclosure: Bilezikian reports various financial ties with Amgen, Asahi, Johnson and Johnson, Merck and NPS Pharma. The study was funded in part by Amgen. Please see the full study for a list of all other authors’ financial disclosures.