DRUG
teriparatide
teriparatide 20 µg subcutaneous daily
Status
Completed
Phase
Phase 2
Enrollment
222
Locations
1
Results
Posted
Publications
1
Study summary
The 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.
Interventions
DRUG
teriparatide 20 µg subcutaneous daily
DRUG
Placebo subcutaneous daily
DRUG
BA058 20 µg subcutaneous daily
DRUG
BA058 40 µg subcutaneous daily
DRUG
BA058 80 µg subcutaneous daily
Timeline
First posted
Oct 11, 2007
Study start
Apr 2007
Primary completion
Jun 2009
Study completion
Jun 2009
Results posted
Jul 29, 2010
Registry updated
Oct 30, 2017
Outcomes
Change in Marker of Bone Metabolism, PINP
Time frame · 6 months
PINP, N-terminal propeptide of type I procollagen, is a marker of anabolic bone growth.
Change in Bone Mineral Density, Total Spine.
Time frame · 6 months
Total analyzable spine bone mineral density (BMD) was analyzed by DXA at Week 24.
Change in Bone Mineral Density, Femoral Neck.
Time frame · 6 months
Femoral neck bone mineral density (BMD) was analyzed by DXA at Week 24.
Change in Bone Mineral Density, Total Hip.
Time frame · 6 months
Total analyzable hip bone mineral density (BMD) was analyzed by DXA at Week 24.
Change in Bone Mineral Density, Total Spine.
Time frame · 12 months
Total analyzable spine bone mineral density (BMD) was analyzed by DXA at Week 48.
Eligibility
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).
Study locations
United States. Showing up to 24 locations stored in the fast local snapshot.
Radius Health, Inc.
Cambridge, Massachusetts, United States
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