TY - JOUR
T1 - The Efficacy and Safety of Abaloparatide-SC in Men With Osteoporosis
T2 - A Randomized Clinical Trial
AU - Czerwinski, Edward
AU - Cardona, Jose
AU - Plebanski, Rafal
AU - Recknor, Chris
AU - Vokes, Tamara
AU - Saag, Kenneth G.
AU - Binkley, Neil
AU - Lewiecki, E. Michael
AU - Adachi, Jonathan
AU - Knychas, Dorota
AU - Kendler, David
AU - Orwoll, Eric
AU - Chen, Yinzhong
AU - Pearman, Leny
AU - Li, Y. Heather
AU - Mitlak, Bruce
N1 - Funding Information:
Funding for this study (NCT03512262 available from www.clinicaltrials.gov ) was provided by Radius Health, Inc. Radius provided the drugs tested in the study, as well as overall support. All listed authors meet the criteria for authorship set forth by the International Committee for Medical Journal Editors. Editorial support was provided by Allyson Lehrman, DPM (assembling tables and figures, collating author comments, copyediting, fact checking, and referencing) and graphic services were provided by AOIC, LLC, and were funded by Radius.
Funding Information:
EC reports travel support from Amgen and institutional funding from Radius Health, Inc., to conduct this study. JC and RP received institutional funding from Radius to conduct this study. CR has received research support and grants from Amgen, CytoDyn, Eli Lilly, Genentech, Integra, Novartis, Radius, Roche, and Senhwa and institutional funding from Radius to conduct this study. TV reports consulting fees and study funding from Takeda, study funding from Ascendis, and consulting and speaker fees from Radius outside of this work, and institutional funding from Radius to conduct this study. KGS has received research support from Horizon, Sobi, and Shanton and consulting fees from Arthrosi, Atom Bioscience, Horizon, Inflazome, L.G. Pharma, Mallinckrodt, Takeda, and Sobi pharmaceuticals and institutional funding from Radius to conduct this study. NCB reports consulting fees from Amgen and institutional funding from Radius to conduct this study. EML reports consulting fees and study funding from Amgen and Radius outside of this work and institutional funding from Radius to conduct this study. JA has provided consultancy to Amgen, Gilead, and Paladin Pharma; received research funding from Amgen and Radius; is an advisory board member of Amgen and Gilead; and participated in speaker bureaus for Amgen and Gilead. DKn received institutional funding from Radius to conduct this study. DKe reports speaker and consulting fees from Amgen, consulting fees from Paladin Pharma and Biosynt, and institutional funding from Radius to conduct this study. EO reports research support from Mereo, consulting fees from Amgen, Sanofi, Biogen, Bayer, NextCure, and Ultragenyx, and consulting fees from Radius in relation to this study. YC is a former employee of and holds equity in Radius. LP, YHL, and BM are employees of and hold equity in Radius.
Publisher Copyright:
© 2022 Radius Health Inc and The Authors. Journal of Bone and Mineral Research published by Wiley Periodicals LLC on behalf of American Society for Bone and Mineral Research (ASBMR).
PY - 2022/12
Y1 - 2022/12
N2 - Abaloparatide significantly increased bone mineral density (BMD) in women with postmenopausal osteoporosis and decreased risk of vertebral, nonvertebral, and clinical fractures compared with placebo. The Abaloparatide for the Treatment of Men with Osteoporosis (ATOM; NCT03512262) study evaluated the efficacy and safety of abaloparatide compared with placebo in men. Eligible men aged 40 to 85 years with osteoporosis were randomized 2:1 to daily subcutaneous injections of abaloparatide 80 μg or placebo for 12 months. The primary endpoint was change from baseline in lumbar spine BMD. Key secondary endpoints included BMD change from baseline at the total hip and femoral neck. A total of 228 men were randomized (abaloparatide, n = 149; placebo, n = 79). Baseline characteristics were similar across treatment groups (mean age, 68.3 years; mean lumbar spine BMD T-score, −2.1). At 12 months, BMD gains were greater with abaloparatide compared with placebo at the lumbar spine (least squares mean percentage change [standard error]: 8.48 [0.54] versus 1.17 [0.72]), total hip (2.14 [0.27] versus 0.01 [0.35]), and femoral neck (2.98 [0.34] versus 0.15 [0.45]) (all p < 0.0001). The most common (≥5%) treatment-emergent adverse events were injection site reaction, dizziness, nasopharyngitis, arthralgia, bronchitis, hypertension, and headache. During 12 months of abaloparatide treatment, men with osteoporosis exhibited rapid and significant improvements in BMD with a safety profile consistent with previous studies. These results suggest abaloparatide can be considered as an effective anabolic treatment option for men with osteoporosis.
AB - Abaloparatide significantly increased bone mineral density (BMD) in women with postmenopausal osteoporosis and decreased risk of vertebral, nonvertebral, and clinical fractures compared with placebo. The Abaloparatide for the Treatment of Men with Osteoporosis (ATOM; NCT03512262) study evaluated the efficacy and safety of abaloparatide compared with placebo in men. Eligible men aged 40 to 85 years with osteoporosis were randomized 2:1 to daily subcutaneous injections of abaloparatide 80 μg or placebo for 12 months. The primary endpoint was change from baseline in lumbar spine BMD. Key secondary endpoints included BMD change from baseline at the total hip and femoral neck. A total of 228 men were randomized (abaloparatide, n = 149; placebo, n = 79). Baseline characteristics were similar across treatment groups (mean age, 68.3 years; mean lumbar spine BMD T-score, −2.1). At 12 months, BMD gains were greater with abaloparatide compared with placebo at the lumbar spine (least squares mean percentage change [standard error]: 8.48 [0.54] versus 1.17 [0.72]), total hip (2.14 [0.27] versus 0.01 [0.35]), and femoral neck (2.98 [0.34] versus 0.15 [0.45]) (all p < 0.0001). The most common (≥5%) treatment-emergent adverse events were injection site reaction, dizziness, nasopharyngitis, arthralgia, bronchitis, hypertension, and headache. During 12 months of abaloparatide treatment, men with osteoporosis exhibited rapid and significant improvements in BMD with a safety profile consistent with previous studies. These results suggest abaloparatide can be considered as an effective anabolic treatment option for men with osteoporosis.
KW - ABALOPARATIDE
KW - BONE MINERAL DENSITY
KW - FRACTURE
KW - MEN
KW - OSTEOPOROSIS
UR - http://www.scopus.com/inward/record.url?scp=85140049071&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85140049071&partnerID=8YFLogxK
U2 - 10.1002/jbmr.4719
DO - 10.1002/jbmr.4719
M3 - Article
C2 - 36190391
AN - SCOPUS:85140049071
SN - 0884-0431
VL - 37
SP - 2435
EP - 2442
JO - Journal of Bone and Mineral Research
JF - Journal of Bone and Mineral Research
IS - 12
ER -