The Efficacy and Safety of Abaloparatide-SC in Men With Osteoporosis: A Randomized Clinical Trial.

Czerwinski E, Cardona J, Plebanski R, Recknor C, Vokes T, Saag KG, Binkley N, Lewiecki EM, Adachi J, Knychas D, Kendler D, Orwoll E and 4 more

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Chen Y, Pearman L, Li YH, Mitlak B

Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research18 Oct 2022Cited by 34 (Europe PMC)

PMID36190391PMCIDPMC10091818DOI10.1002/jbmr.4719PepBankPUB-36190391

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Summary

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. © 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).

CC BYText from Europe PMC. Highlighted sentences are the source of results.

Results from this study4

4 results from studies that gave the peptide. 4 results from people.

01HumanRandomized controlled trialEfficacy outcome
In men with osteoporosis, abaloparatide increased lumbar spine BMD more than placebo.
In plain wordsIn men with osteoporosis, abaloparatide increased lower spine bone density more than placebo.
Peptide
Abaloparatide (Tymlos)
Outcome
IncreaseLumbar spine BMD
Study
n = 228
Comparator
Placebo
Analysis
Primary
Outcome group
Bone and joint · Musculoskeletal
Studied dose
80 μg daily · subcutaneous · 12 monthsAs given in this study (human).
Measurements
BMD percentage change
8.48%
abaloparatide
BMD percentage change
1.17%
placebo
Source sentences
Summary
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).
1 context sentence(design, population, supporting numbers)
Summary · context
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.
Show in the study text Report a problemFND-3619039101
02HumanRandomized controlled trialEfficacy outcome
In men with osteoporosis, abaloparatide increased total hip BMD more than placebo.
In plain wordsIn men with osteoporosis, abaloparatide increased total hip bone density more than placebo.
Peptide
Abaloparatide (Tymlos)
Outcome
IncreaseTotal hip BMD
Study
n = 228
Comparator
Placebo
Analysis
Secondary
Outcome group
Bone and joint · Musculoskeletal
Studied dose
80 μg daily · subcutaneous · 12 monthsAs given in this study (human).
Measurements
BMD percentage change
2.14%
abaloparatide
BMD percentage change
0.01%
placebo
Source sentences
Summary
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).
1 context sentence(design, population, supporting numbers)
Summary · context
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.
Show in the study text Report a problemFND-3619039102
03HumanRandomized controlled trialEfficacy outcome
In men with osteoporosis, abaloparatide increased femoral neck BMD more than placebo.
In plain wordsIn men with osteoporosis, abaloparatide increased femoral neck bone density more than placebo.
Peptide
Abaloparatide (Tymlos)
Outcome
IncreaseFemoral neck BMD
Study
n = 228
Comparator
Placebo
Analysis
Secondary
Outcome group
Bone and joint · Musculoskeletal
Studied dose
80 μg daily · subcutaneous · 12 monthsAs given in this study (human).
Measurements
BMD percentage change
2.98%
abaloparatide
BMD percentage change
0.15%
placebo
Source sentences
Summary
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).
1 context sentence(design, population, supporting numbers)
Summary · context
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.
Show in the study text Report a problemFND-3619039103
04HumanRandomized controlled trialSafety outcome
In men with osteoporosis, the most common (at least 5%) treatment-emergent adverse events in the abaloparatide trial were injection site reaction, dizziness, nasopharyngitis, arthralgia, bronchitis, hypertension and headache.
In plain wordsIn men with osteoporosis, common side effects in the abaloparatide trial included injection site reaction, dizziness, nasopharyngitis, joint pain, bronchitis, high blood pressure and headache.
Peptide
Abaloparatide (Tymlos)
Outcome
Direction not reportedMost common (>=5%) treatment-emergent adverse events
Study
n: not reported in source
Outcome group
Adverse events · Whole body
Studied dose
80 μg daily · subcutaneous · 12 monthsAs given in this study (human).
Source sentences
Summary
The most common (≥5%) treatment-emergent adverse events were injection site reaction, dizziness, nasopharyngitis, arthralgia, bronchitis, hypertension, and headache.
1 context sentence(design, population, supporting numbers)
Summary · context
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.
Show in the study text Report a problemFND-3619039104

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Version 2Current
22 Oct 2026, 02:25 UTC
Study results updated
Version 1
21 Oct 2026, 18:59 UTC
First added · source update from Europe PMC

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