The results of the Houston-III ADAMO trial suggest that treatment of denosumab (denosumab) for men with low bone mineral density (BMD) for 1 year resulted in significantly increased BMD in the lumbar spine and all other skeletal sites tested.
Dr. Ugis Gruntmanis, MD, of the Veterans Affairs Medical Center in Dallas, and Ugis Gruntmanis of the Southwestern Medical Center at Texas State University, pointed out that in men, osteoporosis and fractures are still common and inadequately treated and undertreated. It is estimated that 2 million men in the United States have osteoporosis. Globally, 39% of all osteoporotic fractures occur in men over 50 years of age.
ADAMO is a multicenter, double-blind, randomized, phase III trial in which 242 patients with low-BMD were enrolled. Patients were randomized to receive denosumab 60 mg every 6 months or placebo administered subcutaneously for a total of 1 year. The primary end point was the change in lumbar BMD from baseline to 12 months of treatment. From 12 months, all patients continued to receive open-label denosumab for 1 year; the secondary endpoint of 24 months had not yet reached the results. The study required participants to have a BMD T score of -2.0 to -3.5 on the lumbar or femoral neck; or prior to a large osteoporotic fracture, with a BMD T score of -1.0 to -3.5 at the lumbar or femoral neck. The average age of the patients was 65 years old, of which 94% were white, and 1/4 had a history of major osteoporotic fractures. All subjects received daily calcium and vitamin D supplementation.
The results showed that lumbar spine BMD increased by 4.3% and 0.9%, respectively, from baseline in denosumab and control groups at 6 months. At 1 year, the denosumab group had a mean increase of 5.7% from baseline, while the placebo group remained at a 0.9% increase. At 12 months, total hip BMD in the denosumab and control groups increased by 2.4% and 0.3%, respectively, from baseline, and BMD at the distal third of the tibia increased by 0.6% and decreased by 0.3%, respectively, from baseline. These differences in favor of denosumab are statistically significant. In addition, denosumab induces increased BMD at the femoral neck and the trochanter. Subgroup analysis showed that denosumab had similar effects on BMD regardless of patient age, baseline testosterone levels, initial bone density, and estimated 10-year risk of osteoporotic fracture. In men with baseline serum testosterone below 250 250 ng/dl (15%), lumbar spine BMD increased by 4.4% in patients receiving denosumab compared with placebo; in subjects with ng/dl of testosterone The lumbar spine BMD increased similarly in both groups, both with a net increase of 4.8%.
Among men with a large-scale osteoporotic fracture risk in the lowest quartile within 10 years (<6.4%) based on the baseline FRAX score, the degenerative BMD in the denosumab group had an absolute 5.1% increase over the placebo group; at a risk of 6.4 Among men with %11.2%, there was a net increase in BMD of the lumbar spine in the denosumab group by 5.3%; in men with a risk of >11.2%, the lumbar spine BMD was increased by 4.0% compared with the placebo group. In these 3 fracture risk groups, the degree of increase in BMD driven by denosumab was similar from a statistical point of view.
One of the secondary endpoints of the ADAMO trial was the change from baseline to day 15 in bone resorption biomarker CTX-1. Results On the 15th day, the CTX-1 level in the denosumab group was reduced by 81%, and 60% was suppressed at the 12th month. Also, there was no difference in the spectrum of adverse events between the denosumab group and the placebo group.
Dr. Gruntmanis disclosed that he has received research funding from Amgen, Novartis, GlaxoSmithKline, and Procter & Gamble.
Dr. Ugis Gruntmanis, MD, of the Veterans Affairs Medical Center in Dallas, and Ugis Gruntmanis of the Southwestern Medical Center at Texas State University, pointed out that in men, osteoporosis and fractures are still common and inadequately treated and undertreated. It is estimated that 2 million men in the United States have osteoporosis. Globally, 39% of all osteoporotic fractures occur in men over 50 years of age.
ADAMO is a multicenter, double-blind, randomized, phase III trial in which 242 patients with low-BMD were enrolled. Patients were randomized to receive denosumab 60 mg every 6 months or placebo administered subcutaneously for a total of 1 year. The primary end point was the change in lumbar BMD from baseline to 12 months of treatment. From 12 months, all patients continued to receive open-label denosumab for 1 year; the secondary endpoint of 24 months had not yet reached the results. The study required participants to have a BMD T score of -2.0 to -3.5 on the lumbar or femoral neck; or prior to a large osteoporotic fracture, with a BMD T score of -1.0 to -3.5 at the lumbar or femoral neck. The average age of the patients was 65 years old, of which 94% were white, and 1/4 had a history of major osteoporotic fractures. All subjects received daily calcium and vitamin D supplementation.
The results showed that lumbar spine BMD increased by 4.3% and 0.9%, respectively, from baseline in denosumab and control groups at 6 months. At 1 year, the denosumab group had a mean increase of 5.7% from baseline, while the placebo group remained at a 0.9% increase. At 12 months, total hip BMD in the denosumab and control groups increased by 2.4% and 0.3%, respectively, from baseline, and BMD at the distal third of the tibia increased by 0.6% and decreased by 0.3%, respectively, from baseline. These differences in favor of denosumab are statistically significant. In addition, denosumab induces increased BMD at the femoral neck and the trochanter. Subgroup analysis showed that denosumab had similar effects on BMD regardless of patient age, baseline testosterone levels, initial bone density, and estimated 10-year risk of osteoporotic fracture. In men with baseline serum testosterone below 250 250 ng/dl (15%), lumbar spine BMD increased by 4.4% in patients receiving denosumab compared with placebo; in subjects with ng/dl of testosterone The lumbar spine BMD increased similarly in both groups, both with a net increase of 4.8%.
Among men with a large-scale osteoporotic fracture risk in the lowest quartile within 10 years (<6.4%) based on the baseline FRAX score, the degenerative BMD in the denosumab group had an absolute 5.1% increase over the placebo group; at a risk of 6.4 Among men with %11.2%, there was a net increase in BMD of the lumbar spine in the denosumab group by 5.3%; in men with a risk of >11.2%, the lumbar spine BMD was increased by 4.0% compared with the placebo group. In these 3 fracture risk groups, the degree of increase in BMD driven by denosumab was similar from a statistical point of view.
One of the secondary endpoints of the ADAMO trial was the change from baseline to day 15 in bone resorption biomarker CTX-1. Results On the 15th day, the CTX-1 level in the denosumab group was reduced by 81%, and 60% was suppressed at the 12th month. Also, there was no difference in the spectrum of adverse events between the denosumab group and the placebo group.
Dr. Gruntmanis disclosed that he has received research funding from Amgen, Novartis, GlaxoSmithKline, and Procter & Gamble.
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