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FREEDOM, ADAMO: Denosumab improved BMD in women and men
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CHICAGO — In two studies presented at the joint meeting of the International Congress of Endocrinology and the Endocrine Society, researchers showed that denosumab succeeded in increasing bone mineral density in both men and women with osteoporosis.
“Denosumab treatment for up to 8 years was associated with persistent reduction in bone turnover, continued increases in BMD, low incidence of new vertebral, [and] non-vertebral hip fractures and the benefit/risk profile for denosumab remains favorable,” E. Michael Lewiecki, MD, of New Mexico Clinical Research and Osteoporosis Center, said during his presentation. “Whether this persists for years 9 and 10 is yet to be seen.”
FREEDOM trial
Lewiecki presented the fifth year of the FREEDOM open-label extension trial, which showed up to 8 years of continuous treatment with denosumab, 3 years of which the women were randomized to the drug or placebo and 5 years of which all participants received denosumab every 6 months in conjunction with daily calcium and vitamin D.
The data presented showed a maintenance of the reductions in serum C-terminal telopeptide of type 1 collagen and procollagen type 1 N-terminal propeptide seen in the original cohort treated with denosumab, and similar reductions in the crossover group.
Additionally, bone mineral density (BMD) continued to show an increase in the long-term group, gaining a total of 18.4% in the lumbar spine and 8.3% at the total hip from baseline (both P<.0001) to 8 years. In the crossover group, BMD increased from baseline drug delivery: 13.7% at the lumbar spine and 4.9% at the total hip (both P<.0001).
At year 8, incidence for both new vertebral and non-vertebral fractures remained low at 0.7% in the long-term group and 1.4% in the crossover group, according to Lewiecki. Incidence of hip fracture was 0.2% in the long-term group and 0.1% in the crossover group.
ADAMO study
Denosumab also showed success in men treated with the drug for 2 years, according to Bente L. Langdahl, MD, PhD, DMSc, from Aarhus University Hospital, Aarhus, Denmark, who presented data from the ADAMO study.
“In men with low BMD treated with [denosumab] for 2 years, BMD increased further at all skeletal sites assessed, bone resorption remained reduced, and therapy was well tolerated,” she said.
This phase 3 trial included men with low BMD defined as T-score ≤–2.0 and ≥–3.5 at the lumbar spine or femoral neck, or T-score ≤–1.0 and ≥–3.5 with a previous major osteoporotic fracture who had received 60 mg of denosumab every 6 months. Like the trial in women, the 2-year trial was blinded in the first year, but open-label in its second 12 months when all men (n=219) received the medication.
At the end of 24 months, those treated with denosumab for the entire study period showed the following increases in BMD from baseline: 8% at the lumbar spine, 3.4% total hip; and 3.4% at the femoral neck (all P<.01). Those in the crossover group had similar results after the delivery of denosumab: 6% in lumbar spine; 2% in total hip: and 1.8% at femoral neck (all P≤.02), according to Langdahl, who pointed out that many of these measurements mirrored those in the postmenopausal women presented by Lewiecki.
“We suggest that long-term [denosumab] may be considered in men with low BMD,” she concluded.
For More Information: Leweicki EM. Abstract OR22-1. Langdahl BL. Abstract OR22-2. Both presented at: the joint meeting of the International Congress of Endocrinology and the Endocrine Society; June 21-24, 2014; Chicago.
Disclosures: Lewiecki reports financial relationships with Agnovos, Amgen, GlaxoSmithKline, Lilly, Merck, Radius Health, Roche, Axsome, Novartis. Langdehl reports financial relationships with Amgen, Axellus, Eli Lilly & Company, Merck and Sharp & Dohme.