STUDY ASSESSMENTS. Subjects randomized to BA058 Injection 80 µg/Placebo in Study BA058-05-003 will receive alendronate at a dose of 70 mg once per week for a total of 24 months. The assessments performed at each study visit are displayed in the Schedule of Visits and Procedures in Appendix 14.1. Appendix 14.2 provides a more detailed schedule of the study procedures by study visit with a suggested order of procedure conduct. Exact procedures for centrifuging, storage, and shipping of laboratory samples will be detailed in a separate document. The actual time of each blood collection will be recorded on the appropriate source documents and in the eCRF. Study-specific assessments are to be conducted only after the subject has provided written informed consent to participate in this study. The study assessments are described in more detail in Section 7.1 below.
STUDY ASSESSMENTS. Physical examinations, xxxxx xxxxx, 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.
STUDY ASSESSMENTS. All images taken from the study will be saved and shared to the Sponsor via a data-protected platform.
STUDY ASSESSMENTS. Physical examinations, xxxxx xxxxx, 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): [*]. · 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.
STUDY ASSESSMENTS. This is a noninterventional study. Standard of care at many institutions include the following assessments.
STUDY ASSESSMENTS. The research component of the Community Pediatric Acceptability Study (CPAS) study included the following data collection instruments for parents (Appendix II):
STUDY ASSESSMENTS. 11.4.1 Data control measures In order to assure adequate control and provide study data that are consistent and of the highest quality, the following measures are employed:
STUDY ASSESSMENTS. All clinical laboratory assessments will be conducted locally at the clinical site facilities.
STUDY ASSESSMENTS
