Clinical trial NCT00542425 (phase 2, status: completed)
Conditions: osteoporosis
ICD codes: M81.6, Z82.62, Z13.820, M81.8, Z87.310, M81.0, M80.80XS
Drugs: teriparatide, placebo, ba058 20 µg, ba058 40 µg, ba058 80 µg
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Eligibility criteria:

        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).