Phase 3
Completed N=1,139
Twenty-Four Month Extension Study of BA058-05-003 (Abaloparatide) in Participants With Osteoporosis
Source: ClinicalTrials.gov NCT01657162 ↗Enrolled (actual)
1,139
Serious AEs
10.9%
Results posted
Dec 2020
Primary outcomePrimary: Number of Participants With ≥1 New Vertebral Fracture Since Study BA058-05-003 Baseline — 3; 25 Participants
◆ Published Evidence
Highly cited
201citations · ~25 / year
ACTIVExtend: 24 Months of Alendronate After 18 Months of Abaloparatide or Placebo for Postmenopausal Osteoporosis.
Summary
The purpose of this study is to provide 24 months of standard of care data on participants previously enrolled in Study BA058-05-003 (NCT02653417).
Linked Publications (5)
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ACTIVExtend: 24 Months of Alendronate After 18 Months of Abaloparatide or Placebo for Postmenopausal Osteoporosis.
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Eighteen Months of Treatment With Subcutaneous Abaloparatide Followed by 6 Months of Treatment With Alendronate in Postmenopausal Women With Osteoporosis: Results of the ACTIVExtend Trial.
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Effect of Abaloparatide on Bone Microarchitecture Assessed by Trabecular Bone Score in Women With Osteoporosis: Post Hoc Analysis of ACTIVE and ACTIVExtend.
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Abaloparatide followed by alendronate in women ≥80 years with osteoporosis: post hoc analysis of ACTIVExtend.
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Forearm bone mineral density and fracture incidence in postmenopausal women with osteoporosis: results from the ACTIVExtend phase 3 trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With ≥1 New Vertebral Fracture Since Study BA058-05-003 Baseline |
3; 25 | — |
| SECONDARY Number of Participants With a Nonvertebral Fracture Since Study BA058-05-003 Baseline (Data From Studies BA058-05-005 and BA058-05-003 Combined) |
15; 32 | — |
| SECONDARY Percent Change From Study BA058-05-003 Baseline in Total Hip BMD at Study BA058-05-005 Month 6 (Study BA058-05-003 Month 25) |
5.4737; 1.3698 | — |
| SECONDARY Percent Change From Study BA058-05-003 Baseline in Femoral Neck BMD at Study BA058-05-005 Month 6 (Study BA058-05-003 Month 25) |
4.5113; 0.4649 | — |
| SECONDARY Percent Change From Study BA058-05-003 Baseline in Lumbar Spine BMD at Study BA058-05-005 Month 6 (Study BA058-05-003 Month 25) |
12.7921; 3.5133 | — |
| SECONDARY Kaplan-Meier Estimated Event Rate of the First Incident of Nonvertebral Fracture Since Study BA058-05-003 Baseline (Data From Studies BA058-05-005 and BA058-05-003 Combined) |
2.7; 5.6 | — |
| SECONDARY Number of Participants With Treatment Emergent Adverse Events (TEAEs) (Data From Study BA058-05-005 Only) |
452; 466; 85; 80; 38; 40 | — |
| SECONDARY Number of Participants With a Clinically Notable Serum Chemistry Laboratory Value (Data From Study BA058-05-005 Only) |
1; 0; 75; 73; 2; 1 | — |
| SECONDARY Number of Participants With a Clinically Notable Hematology Laboratory Value (Data From Study BA058-05-005 Only) |
15; 11; 15; 11; 0; 2 | — |
| SECONDARY Number of Participants With a Clinically Notable Coagulation Laboratory Value (Data From Study BA058-05-005 Only) |
9; 4 | — |
| SECONDARY Number of Participants With a Clinically Notable Urine Laboratory Value (Data From Study BA058-05-005 Only) |
4; 3; 6; 6; 77; 50 | — |
Eligibility Criteria
Inclusion Criteria
- The participant was enrolled, randomized to either the abaloparatide-SC (BA058) or placebo arm, and successfully completed Study BA058-05-003 (NCT02653417).
- The participant was no more than 40 days from End-of-Treatment (Month 18) in Study BA058-05-003 (NCT02653417).
Exclusion Criteria
- Participants who were withdrawn from Study BA058-05-003 (NCT02653417) for any reason.
- Participants who experienced a treatment-related serious adverse event (SAE) during Study BA058-05-003 (NCT02653417).
Data sourced from ClinicalTrials.gov (NCT01657162) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.