Study to Evaluate the Safety and Efficacy of BA058 (Abaloparatide) for Prevention of Fracture in Postmenopausal Women

Study Overview
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Brief Summary
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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.

Detailed Description
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This is a randomized, double-blind, placebo-controlled, comparative Phase 3, multicenter international study to evaluate the efficacy and safety of BA058 (abaloparatide) 80 µg in the prevention of fracture in otherwise healthy ambulatory postmenopausal women with severe osteoporosis.

Official Title
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A Randomized, Double-blind, Placebo-Controlled, Comparative Multicenter Phase 3 Study to Evaluate the Safety and Efficacy of BA058 (Abaloparatide) for Injection for Prevention of Fracture in Ambulatory Postmenopausal Women With Severe Osteoporosis and at Risk of Fracture

Conditions
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Osteoporosis, Postmenopausal Osteoporosis

Intervention / Treatment
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* Drug: Placebo
* Drug: BA058 80 mcg
* Drug: teriparatide


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Placebo identical in appearance to BA058 study drug | Drug: Placebo<br>* Placebo 0 mcg subcutaneous daily<br>|
| Experimental: BA058 80 mcg (abaloparatide)<br> | Drug: BA058 80 mcg<br>* BA058 80 mcg subcutaneous daily<br>* Other names: abaloparatide, Abaloparatide-SC;|
| Active Comparator: teriparatide<br>Blinded until after randomization, then open-label | Drug: teriparatide<br>* teriparatide 20 mcg subcutaneous daily<br>* Other names: Forsteo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With New Vertebral Fractures at 18 Months |  | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change in Bone Mineral Density (BMD) of Lumbar Spine From Baseline to 18 Months |  | Basline and 18 months | 
| Percent Change in Bone Mineral Density (BMD) of Total Hip From Baseline to Month 18 |  | Baseline and 18 months | 
| Percent Change in Bone Mineral Density (BMD) of Femoral Neck From Baseline to Month 18 |  | Baseline and 18 months | 
| Number of Participants With Non-vertebral Fractures at 18 Months |  | 18 months | 
| Number of Treatment-Emergent Adverse Events Associated With Hypercalcemia at 18 Months |  | 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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BA058, abaloparatide, Abaloparatide-SC, osteoporosis, postmenopausal, bone loss, ACTIVE, fracture