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Romosozumab increased BMD, bone formation in postmenopausal women
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Romosozumab was associated with increased bone mineral density and bone formation and with decreased bone resorption in postmenopausal women with low bone mass, according to results from a 1-year phase 2 study.
All dosages of romosozumab (AMG 785/CDP7851, Amgen/UCB Pharma) were associated with significant increases in BMD at the lumbar spine, according to Michael R. McClung, MD, of the Oregon Osteoporosis Center in Portland, Ore., and colleagues.
“The effects of romosozumab on bone turnover reflect a rapid, marked, and transitory increase in bone formation and a moderate but more sustained decrease in bone resorption,” the researchers wrote.
Michael R. McClung
They randomly assigned 367 postmenopausal women to one of five dosing categories of the subcutaneous drug: 70 mg, 140 mg, 210 mg once monthly; 140 mg or 210 mg every 3 months; or to one of two open-label comparators — 70 mg or oral alendronate weekly or 20 mcg of subcutaneous teriparatide (Forteo, Eli Lilly and Company) daily.
Specifically, there was an 11.3% increase with the 210-mg monthly dose vs. a decrease of 0.1% with placebo and increases of 4.1% with alendronate and 7.1% with teriparatide, according to data.
The agent also was tied to greater increases in BMD at the total hip and femoral neck. In addition, the use of romosozumab yielded transitory increases in bone-formation markers and sustained decreases in a bone-resorption marker, according to data.
In an accompanying editorial, Carol B. Becker, MD, of Brigham and Women’s Hospital in Boston, wrote that the data reported by McClung and colleagues were impressive.
“The pattern of brief anabolic stimulation coupled with chronic suppression of bone resorption seen with romosozumab is unprecedented among current therapies for osteoporosis,” Becker wrote.
For more information:
Becker CB. N Engl J Med. 2014;doi:10.1056/NEJMe1315500.
McClung MR. N Engl J Med. 2014;doi:10.1056/NEJMoa1305224.
Disclosure: Becker reports no relevant financial disclosures. McClung reports financial relationships with Amgen, Lilly, Merck, Novartis and Warner-Chilcott. See the study for a full list of all other researchers’ disclosures.