Phase 3
Completed N=2,463
Study to Evaluate the Safety and Efficacy of BA058 (Abaloparatide) for Prevention of Fracture in Postmenopausal Women
Source: ClinicalTrials.gov NCT01343004 ↗Enrolled (actual)
2,463
Serious AEs
10.2%
Results posted
Mar 2017
Primary outcomePrimary: Number of Participants With New Vertebral Fractures at 18 Months — 30; 4; 6 participants — p=<0.0001
◆ Published Evidence
Established
47citations · ~8 / year
Cardiovascular Safety of Abaloparatide in Postmenopausal Women With Osteoporosis: Analysis From the ACTIVE Phase 3 Trial.
Summary
The purpose of this study is to determine whether BA058 (abaloparatide), a parathyroid hormone-related peptide, is effective in preventing fractures in postmenopausal women with severe osteoporosis who are at risk of fractures.
Linked Publications (5)
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Cardiovascular Safety of Abaloparatide in Postmenopausal Women With Osteoporosis: Analysis From the ACTIVE Phase 3 Trial.
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Pharmacological interventions versus placebo, no treatment or usual care for osteoporosis in people with chronic kidney disease stages 3-5D.
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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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Effect of abaloparatide on fracture incidence and bone mineral density in postmenopausal women with osteoporosis at highest risk for fracture.
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Abaloparatide effects on BMD in acetabular regions corresponding to DeLee and Charnley zones in women with postmenopausal osteoporosis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With New Vertebral Fractures at 18 Months |
30; 4; 6 | <0.0001 sig |
| SECONDARY Percent Change in Bone Mineral Density (BMD) of Lumbar Spine From Baseline to 18 Months |
0.48; 9.20; 9.12 | <0.0001 sig |
| SECONDARY Percent Change in Bone Mineral Density (BMD) of Total Hip From Baseline to Month 18 |
-0.08; 3.44; 2.81 | <0.0001 sig |
| SECONDARY Percent Change in Bone Mineral Density (BMD) of Femoral Neck From Baseline to Month 18 |
-0.44; 2.90; 2.26 | <0.0001 sig |
| SECONDARY Number of Participants With Non-vertebral Fractures at 18 Months |
33; 18; 24 | 0.0318 sig |
| SECONDARY Number of Treatment-Emergent Adverse Events Associated With Hypercalcemia at 18 Months |
5; 15; 34 | — |
Eligibility Criteria
Inclusion Criteria
- Healthy ambulatory postmenopausal (≥ 5 years) women from 50 to 85 years of age (inclusive) with a diagnosis of osteoporosis
- The women are to have a bone mineral density (BMD) T score ≤ -2.5 and > -5.0 at the lumbar spine or hip (femoral neck) by dual energy x-ray absorptiometry (DXA) and radiological evidence of 2 or more mild or one or more moderate lumbar or thoracic vertebral fractures, or history of low trauma forearm, humerus, sacral, pelvic, hip, femoral, or tibial fracture within the past 5 years. Postmenopausal women older than 65 who meet the above fracture criteria but have a T score ≤ -2.0 and > -5.0 may be enrolled. Women older than 65 who do not meet the fracture criteria may also be enrolled if their T score is ≤ -3.0 and > -5.0
- Normal physical exam, vital signs, electrocardiogram (ECG) and medical history
- Laboratory tests within the normal range including serum calcium, PTH(1-84), serum phosphorus and alkaline phosphatase
Exclusion Criteria
- History of more than 4 mild or moderate spine fractures or any severe fracture
- Abnormality of the spine or hip that would prohibit assessment of bone mineral density (BMD)
- Unexplained elevation of serum alkaline phosphatase, history of bone disorders (such as Paget's disease) or a diagnosis of cancer within the last 5 years (with the exception of basal cell or squamous cancer of the skin)
- History of thyroid, parathyroid, or adrenal disorders, or malabsorptive syndromes or any chronic or recurrent diseases or disturbances that would interfere with the interpretation of study data or compromise the safety of the patient
- Prior treatment with parathyroid hormone (PTH) or parathyroid hormone-related peptid (PTHrP)
- Prior treatment with bisphosphonates, fluoride, or strontium within the past five years or treatment with androgens, anabolic steroids, corticosteroids or selective estrogen receptor modulators within the past 12 months (except hormone replacement therapy)
- Prior treatment with an investigational drug within the past 12 months
- History of nephrolithiasis or urolithiasis within the past five years, or history of osteosarcoma at any time
Data sourced from ClinicalTrials.gov (NCT01343004) 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.