STUDY ASSESSMENTS. Physical examinations, ▇▇▇▇▇ ▇▇▇▇▇, ECGs, clinical labs (hematology, chemistry, urinalysis), serum total and ionized calcium, phosphorus, thyroid hormones, adverse events, and local tolerability. · Pharmacokinetics: serial PK samples taken on a subgroup of patients. · Pharmacodynamics (i.e., biochemical markers of bone metabolism and resorption): procollagen 1 carboxy terminal propeptide (PICP) bone specific alkaline phosphatase (BSAP), osteocalcin, cathepsin K, urine N telopeptide (NTX) urinary free deoxypyridinoline, nephrogenic cAMP level, urinary calcium excretion, creatinine clearance, vitamin D, intact PTH (1-84). · Efficacy: measure a reduction in the proportion of patients with new vertebral fractures following treatment. Other assessments changes in BMD (lumbar spine, hip, forearm). · Anti-BA058 antibody.
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Sources: License Agreement (Radius Health, Inc.), License Agreement (Radius Health, Inc.), License Agreement (Radius Health, Inc.)