Phase 2 Dose-finding Study to Evaluate the Effects of BA058 in the Treatment of Postmenopausal Women With Osteoporosis

Study Overview
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Brief Summary
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The purpose of this study is to determine whether BA058 is effective in building bone in postmenopausal women with osteoporosis.

Detailed Description
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This is a randomized, parallel-group, multi-center, dose-finding study to evaluate the effects of BA058 in the treatment of otherwise healthy postmenopausal women with osteoporosis.

Official Title
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A Randomized, Parallel-Group, Phase 2 Dose-finding Study to Evaluate the Effects of BA058 in the Treatment of Postmenopausal Women With Osteoporosis

Conditions
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Osteoporosis

Intervention / Treatment
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* Drug: teriparatide
* Drug: Placebo
* Drug: BA058 20 µg
* Drug: BA058 40 µg
* Drug: BA058 80 µg


Participation Criteria
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Eligibility Criteria
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Primary Inclusion Criteria: The patient has a bone mineral density T-score ≤ 2.5 at the lumbar spine or hip (femoral neck) by dual energy x-ray absorptiometry (DXA). Women with a bone mineral density T-score of 2.0 or lower and a prior low-trauma forearm, humerus, vertebral, sacral, pelvic, hip, femoral, or tibial fracture within the past 5 years, or who have an additional risk factor such as age 65 or greater or a strong maternal history of osteoporosis defined as a fracture related to osteoporosis or osteoporosis itself as determined by BMD criteria, are also study candidates. The patient is in good general health as determined by medical history and physical examination and is without evidence of clinically significant abnormality in the opinion of the Investigator. Primary Exclusion Criteria: History of bone disorders (e.g., Paget's disease) other than postmenopausal osteoporosis. Prior treatment with approved or as yet unapproved bone-acting investigational agents. History of carcinoma, nephrolithiasis or urolithiasis within the past five years or osteosarcoma at any time. History of radiotherapy (radiation therapy).

Ages Eligible for Study
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Minimum Age: 55 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Placebo subcutaneous daily<br>|
| Experimental: BA058 20 µg<br> | Drug: BA058 20 µg<br>* BA058 20 µg subcutaneous daily<br>|
| Experimental: BA058 40 µg<br> | Drug: BA058 40 µg<br>* BA058 40 µg subcutaneous daily<br>|
| Experimental: BA058 80 µg<br> | Drug: BA058 80 µg<br>* BA058 80 µg subcutaneous daily<br>|
| Active Comparator: teriparatide<br> | Drug: teriparatide<br>* teriparatide 20 µg subcutaneous daily<br>* Other names: PTH;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Marker of Bone Metabolism, PINP | PINP, N-terminal propeptide of type I procollagen, is a marker of anabolic bone growth. | 6 months | 
| Change in Bone Mineral Density, Total Spine. | Total analyzable spine bone mineral density (BMD) was analyzed by DXA at Week 24. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Bone Mineral Density, Femoral Neck. | Femoral neck bone mineral density (BMD) was analyzed by DXA at Week 24. | 6 months | 
| Change in Bone Mineral Density, Total Hip. | Total analyzable hip bone mineral density (BMD) was analyzed by DXA at Week 24. | 6 months | 
| Change in Bone Mineral Density, Total Spine. | Total analyzable spine bone mineral density (BMD) was analyzed by DXA at Week 48. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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osteoporosis, postmenopausal, bone loss