Three selected primary reports in osteoporosis: ACTIVE, its ACTIVExtend follow-up, and ATOM. The extension follows participants from ACTIVE rather than providing an independent replication.123
Bottom line from this bounded source set
ACTIVE reported fewer new vertebral and nonvertebral fractures with abaloparatide than placebo in postmenopausal women. Its extension studied subsequent alendronate in both groups. ATOM reported greater bone-density gains in men; that endpoint does not by itself establish fracture reduction in men.123
Reviewed study record
ACTIVE: fracture outcomes in postmenopausal women
Design
An 18-month randomized Phase 3 trial compared blinded abaloparatide and placebo groups, with an additional open-label teriparatide group.1
Population
The trial enrolled 2,463 postmenopausal women with osteoporosis; 1,901 completed the study.1
Outcomes reported
The authors reported fewer new vertebral and nonvertebral fractures and greater bone-density gains with abaloparatide than placebo. Reported hypercalcemia occurred in 3.4% with abaloparatide and 6.4% with teriparatide.1
Limitations
Follow-up was limited to 18 months and the teriparatide comparison was open-label. These results do not establish outcomes in men or all osteoporosis populations. PubMed links a 2017 erratum to this report.1
Reviewed study record
ACTIVExtend: follow-up of ACTIVE participants
Design
An extension followed eligible ACTIVE completers, with both groups subsequently receiving alendronate. It did not randomly assign a new independent cohort.2
Population
The extension enrolled 558 women from the former abaloparatide group and 581 from the former placebo group.2
Outcomes reported
Across the integrated 43-month period, the authors reported new radiographic vertebral fractures in 0.9% of evaluable women in the abaloparatide/alendronate group versus 5.6% in the placebo/alendronate group.2
Limitations
The findings describe a treatment sequence among participants who entered the extension. They cannot isolate ongoing abaloparatide effects or establish outcomes after stopping all treatment.2
Reviewed study record
ATOM: bone-density outcomes in men
Design
A 12-month randomized placebo-controlled trial used change in lumbar-spine bone mineral density as its primary endpoint.3
Population
A total of 228 men with osteoporosis were randomized: 149 to abaloparatide and 79 to placebo.3
Outcomes reported
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.3
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.3
No registered Crossref update in the reviewed snapshotChecked September 14, 2026 for DOI 10.1001/jama.2016.11136. This bounded result is not proof that the publication has never been corrected or retracted. Open the pinned Crossref work endpoint ↗
No registered Crossref update in the reviewed snapshotChecked September 14, 2026 for DOI 10.1210/jc.2018-00163. This bounded result is not proof that the publication has never been corrected or retracted. Open the pinned Crossref work endpoint ↗
No registered Crossref update in the reviewed snapshotChecked September 14, 2026 for DOI 10.1002/jbmr.4719. This bounded result is not proof that the publication has never been corrected or retracted. Open the pinned Crossref work endpoint ↗