STUDY ASSESSMENTS. Subjects randomized to Abaloparatide-SC/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. 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. At each visit, the following examinations will be performed in both eyes in the following order: - OSDI questionnaire - XXXXX - Xxxxxxxx test - TBUT - Corneal staining evaluation (Oxford scale) All above mentioned examinations and all evaluations required by the study are part of the normal clinical practice.
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:
1. Each clinical procedure (i.e. physical examination) for a particular patient is conducted by the same person if possible throughout the patient's study participation.
2. Each clinical laboratory procedure is conducted by the same laboratory throughout the study.
3. Data generated automatically is reviewed by the appropriate specialist, i.e. computer generated EKG interpretation is reviewed and signed off by a cardiologist.
STUDY ASSESSMENTS. All clinical laboratory assessments will be conducted locally at the clinical site facilities.
STUDY ASSESSMENTS. Before performing any study procedures, all potential subjects will sign an ICF as outlined in Section 10.2.2.3. Subjects will undergo study procedures at the time points specified in the SOE (Section 3). The total amount of blood collected from each subject over the duration of the study, including any extra assessments that may be required, will not exceed 500 mL.
7.1 PHARMACOKINETIC ASSESSMENTS
STUDY ASSESSMENTS. For study assessments not included in sections below (e.g., vital signs, performance status, ECHO, bone monitoring), refer to Table 11 for details.
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. This is a noninterventional study. Standard of care at many institutions include the following assessments.
