Abaloparatide official-source update · version 1
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Official-source update
Reviewed 2026-09-19 · Preserved version 1
ATOM’s primary result concerns bone density in men
NCT03512262 enrolled 228 men and measured lumbar-spine bone mineral density at 12 months. The posted modeled mean changes are 8.4820% with abaloparatide and 1.1654% with placebo; this endpoint is distinct from a direct fracture-reduction estimate. NCT03512262 ↗
More findings and the sources behind them
Selected sponsor-submitted ClinicalTrials.gov records retrieved September 19, 2026, with design, population, endpoint and result-availability checks. This does not complete a registry search or replace primary-publication appraisal.
Randomized and analyzed counts differ
ATOM randomized 149 participants to abaloparatide and 79 to placebo, while its primary outcome table lists 119 and 66 evaluable participants. The total randomized sample should not be presented as the number with an observed 12-month measurement. NCT03512262 ↗
The extension studies sequential treatment
NCT01657162 enrolled eligible completers from the earlier abaloparatide-versus-placebo trial and then used alendronate in both groups. It evaluates treatment sequences; it is not a new randomized comparison of continued abaloparatide against placebo. NCT01657162 ↗
The fracture window starts before the extension
The extension’s primary vertebral-fracture endpoint runs from the parent trial’s baseline to extension month six. Its counts therefore should not be described as new fractures arising only during the extension, or compared with another trial without matching the time window. NCT01657162 ↗
What remains to be checked
- Reconcile ATOM missing-data methods and fracture outcomes with the primary report and regulatory supplement.
- Appraise sequential-treatment follow-up without counting parent and extension participants twice.
Source dates and review coverage
PDF citations use file page numbers. Named webpage sections and registry fields identify the portions read. These are selected readings, not complete source coverage.
Twenty-Four Month Extension Study of BA058-05-003 (Abaloparatide) in Participants With Osteoporosis ↗
Source dated 2020-12-11; retrieved 2026-09-19.
- protocolSection.identificationModule, designModule and armsInterventionsModule
- resultsSection.participantFlowModule
- resultsSection.outcomeMeasuresModule
SHA-256:
b9968ba5bde74d8fb94ad28094be33dc0895fa2ef32e0ae543e8be75157428b2Safety and Efficacy of Abaloparatide-SC in Men With Osteoporosis (ATOM) ↗
Source dated 2023-04-07; retrieved 2026-09-19.
- protocolSection.identificationModule, designModule and armsInterventionsModule
- resultsSection.participantFlowModule
- resultsSection.outcomeMeasuresModule
SHA-256:
87a3c49f62227506d0aaaa3aa5544e79ab386e54ce534b7d0756d4c497e865c3