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Safety of denosumab reported out to 8 years in extension study
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ASBMR 2011
Results of a phase 2 extension study of denosumab showed continued increases in bone mineral density over 8 years of treatment, according to data presented at the meeting.
For postmenopausal women with low bone mass or osteoporosis who received up to 8 years of continued treatment with denosumab (Prolia, Amgen), BMD at the lumbar spine and total hip increased on average by 16.8% and 6.9%, respectively, as compared with baseline. The women also exhibited persistent reductions in markers of bone turnover.
The phase 2 study extension sought to determine the effects of up to 8 years of continued bone treatment with denosumab on BMD and bone turnover markers in women with low bone mass or osteoporosis. The original phase 2 dose-ranging trial enrolled 412 women with a BMD T-score between -1.8 and -4 at the lumbar spine and -1.8 and -3.5 at the total hip or femoral neck. Of the 262 women who completed the parent study, 200 enrolled in the extension study. All received denosumab 60 mg every 6 months.
The overall adverse event profile up to 8 years is consistent with events previously reported, according to information in a press release issued by Amgen. The most common adverse events associated with the drug include urinary tract infection, upper respiratory tract infection, sciatica, cataracts, constipation, rash and pain in extremities.
"We don't yet have a cure for osteoporosis, and many postmenopausal women with this condition who are at high risk for fractures require long-term therapy for this serious disease," researcher Michael McClung, MD, founding director of the Oregon Osteoporosis Center, said in a press release. "This study provides additional data that Prolia continues to increase BMD progressively over a treatment period of 8 years. This study supports the long-term clinical experience of Prolia for women with this chronic condition."
For more information:
- McClung M. Concurrent oral session 11. Abstract #1061. Presented at: the American Society for Bone and Mineral Research 2011 Annual Meeting; Sept. 16-20, 2011; San Diego.
Disclosure: This study was conducted by Amgen. Dr. McClung has received research grants from Amgen, Merck and Warner Chilcott; consulting fees or other remuneratoin from Amgen, Lilly, Merck, Novartis and Warner Chilcott; and is on the speaker's bureau for Amgen, Lilly, Novartis and Warner Chilcott.
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