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
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
- 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).