Title
Phase 2 Dose-finding Study to Evaluate the Effects of BA058 in the Treatment of Postmenopausal Women With Osteoporosis
A Randomized, Parallel-Group, Phase 2 Dose-finding Study to Evaluate the Effects of BA058 in the Treatment of Postmenopausal Women With Osteoporosis
Phase
Phase 2Lead Sponsor
Radius HealthStudy Type
InterventionalStatus
Completed Results PostedIndication/Condition
OsteoporosisIntervention/Treatment
abaloparatide teriparatide ...Study Participants
222The purpose of this study is to determine whether BA058 is effective in building bone in postmenopausal women with osteoporosis.
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.
BA058 80 µg subcutaneous daily
teriparatide 20 µg subcutaneous daily
Placebo subcutaneous daily
BA058 20 µg subcutaneous daily
BA058 40 µg subcutaneous daily
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).
| Event Type | Organ System | Event Term | Placebo | BA058 20 µg | BA058 40 µg | BA058 80 µg | Teriparatide |
|---|
PINP, N-terminal propeptide of type I procollagen, is a marker of anabolic bone growth.
Total analyzable spine bone mineral density (BMD) was analyzed by DXA at Week 24.
Femoral neck bone mineral density (BMD) was analyzed by DXA at Week 24.
Total analyzable hip bone mineral density (BMD) was analyzed by DXA at Week 24.
Total analyzable spine bone mineral density (BMD) was analyzed by DXA at Week 48.
