Bone health · Phase 3
ATOM: bone density in men
What was tested?
Abaloparatide versus placebo in men with osteoporosis. ↗
Registered primary question: Percentage change in lumbar-spine bone mineral density at month 12. ↗
What the reviewed report found
Journal year 2022 · Article summary reviewed 2026-09-14
Reported lumbar-spine bone-density gains were 8.48% with abaloparatide versus 1.17% with placebo. Common reported adverse events included injection-site reactions and dizziness.↗
Keep in context: The primary outcome was bone density. The selected report does not establish a reduction in fractures in this population. ↗↗
What a closer reading adds
Selected full-text sections checked 2026-09-20. These notes add context to the earlier article summary; they are not a complete risk-of-bias assessment.
What the study could measure
The sample-size calculation targeted a difference in bone density. Only one clinical fracture in the abaloparatide group and three in the placebo group were reported; the authors say those few events do not permit a meaningful fracture-incidence comparison. Full text ↗ · Indexed abstract ↗
Sections: Statistical analysis; Fracture incidence; Discussion.
Participants, design, limitations and sources
Registry snapshot
- Registry enrollment
- 228 · reported actual
- Registry status
- Completed
- Allocation and masking
- Randomized · Quadruple
- Design
- Parallel
- Eligible ages
- 40 Years to 85 Years
- Registry results
- Posted in this snapshot
Registry source ↗ · Updated 2023-04-07; retrieved 2026-09-20. Registry enrollment is not necessarily the analyzed sample in a publication. Posted registry results and published article results are separate.
ATOM: bone-density outcomes in men
- Design in the report
- A 12-month randomized placebo-controlled trial used change in lumbar-spine bone mineral density as its primary endpoint.↗
- Participants in the report
- A total of 228 men with osteoporosis were randomized: 149 to abaloparatide and 79 to placebo.↗
- Limitations
- Bone density was the primary endpoint; the reported gains should not be presented as demonstrated fracture reduction. The sample and duration limit conclusions about uncommon or longer-term harms.↗
This reading covers the article abstract and record metadata. Read its preserved Human Evidence Review →
How the study identity and sources were checked
Study context checked 2026-09-20. Existing article summaries keep their original review dates. This is a selected study reading, not a complete literature or full-text appraisal.
Registry
Safety and Efficacy of Abaloparatide-SC in Men With Osteoporosis (ATOM) ↗
Protocol identifier: BA058-05-019. Sponsor: Radius Health, Inc..
Retrieved 2026-09-20; SHA-256 87a3c49f62227506d0aaaa3aa5544e79ab386e54ce534b7d0756d4c497e865c3.
PMID 36190391
The Efficacy and Safety of Abaloparatide-SC in Men With Osteoporosis: A Randomized Clinical Trial ↗
Exact trial identity is declared in the article abstract indexed in PubMed. No matching reference is declared in this registry snapshot. These source labels do not establish that every result in a paper applies to this trial.
Identity metadata retrieved 2026-09-20. EFetch batch XML; locate MedlineCitation/PMID 36190391. SHA-256 f2177628b98083064df17512c3dd229b760887c00cc64c4cfa4fc4e49523b12a.
Scientific summary uses the original 2026-09-14 source snapshot: SHA-256 505bd0197b0a42beff4ed79f51ab0a025b1ebdbd3d2dbf8fcdb7b354e1d0e75b.
Selected full text: PMC10091818
The Efficacy and Safety of Abaloparatide‐SC in Men With Osteoporosis: A Randomized Clinical Trial ↗
Retrieved 2026-09-20; SHA-256 7e13c964871e3a13603c3b5add661d412019f247a8c703963f3645554c7d12fa. Section identifiers and hashes are included in the cited study data.