Bone health · Phase 3
ACTIVExtend: outcomes after ACTIVE
NCT01657162 ↗ · Extension or follow-up
What was tested?
Alendronate after prior abaloparatide or placebo treatment in eligible ACTIVE completers. ↗
Registered primary question: New vertebral fractures measured from the parent-study baseline through the first six extension months. ↗
What the reviewed report found
Journal year 2018 · Article summary reviewed 2026-09-14
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.↗
Keep in context: The registry primary window ends at cumulative month 25; this later report follows the treatment sequence through month 43. Both extension groups received alendronate. ↗↗
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.
Who entered the extension
Extension eligibility required completion and adherence in the parent trial. People who stopped treatment, withdrew, or had a treatment-related serious adverse event in ACTIVE were excluded. The extension therefore describes selected completers. Full text ↗ · Indexed abstract ↗
Sections: ACTIVExtend inclusion and exclusion criteria.
Which follow-up is being counted
The published primary fracture analysis compares the original ACTIVE baseline with cumulative month 43. Separate extension-only analyses begin at the later extension baseline. Those are different observation windows, not independent replications. Full text ↗ · Indexed abstract ↗
Sections: Primary efficacy endpoint; Statistical analysis.
Participants, design, limitations and sources
Registry snapshot
- Registry enrollment
- 1,139 · reported actual
- Registry status
- Completed
- Allocation and masking
- Na · Open label
- Design
- Single group
- Eligible ages
- 50 Years to 85 Years
- Registry results
- Posted in this snapshot
Registry source ↗ · Updated 2020-12-11; retrieved 2026-09-20. Registry enrollment is not necessarily the analyzed sample in a publication. Posted registry results and published article results are separate.
ACTIVExtend: follow-up of ACTIVE participants
- Design in the report
- An extension followed eligible ACTIVE completers, with both groups subsequently receiving alendronate. It did not randomly assign a new independent cohort.↗
- Participants in the report
- The extension enrolled 558 women from the former abaloparatide group and 581 from the former placebo group.↗
- 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.↗
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
Twenty-Four Month Extension Study of BA058-05-003 (Abaloparatide) in Participants With Osteoporosis ↗
Protocol identifier: BA058-05-005. Sponsor: Radius Health, Inc..
Retrieved 2026-09-20; SHA-256 b9968ba5bde74d8fb94ad28094be33dc0895fa2ef32e0ae543e8be75157428b2.
PMID 29800372
Exact trial identity is declared in PubMed’s ClinicalTrials.gov databank field. The registry independently labels this reference RESULT. 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 29800372. SHA-256 0e6795be99af1c93f3a3e2726fc8a17152661ca29e8dead110bff36feb856127.
Scientific summary uses the original 2026-09-14 source snapshot: SHA-256 b734d5e42a384c3774541918b8e649c1ab725359b2d6aafc379a26cce8c15821.
Selected full text: PMC6097601
Retrieved 2026-09-20; SHA-256 51fc75294fea4226f28c808cc56c3c080dd2f93566024ac54781a310f76855d7. Section identifiers and hashes are included in the cited study data.