Laboratory Assessments. At each study visit, all subjects had venous blood samples collected by a clinical scientist (SE) following a 10 hour overnight fast. Thirty millilitres of whole blood was collected in serum separation tubes (SST’s) for measurement of lipid and bone profiles. The prospective study group had also had routine haematology and clinical chemistry tests performed at screening to exclude any secondary causes of OP. These included a full blood count (FBC), erythrocyte sedimentation rate (ESR), protein electrophoresis, parathyroid hormone (PTH), vitamin D and a full lipid, bone, renal and thyroid profile. Six millilitres of whole blood was sent to St Xxxxxx Hospital Department of Clinical Chemistry for the measurement of total cholesterol, triglycerides, HDL and LDL-cholesterol levels in addition to calcium, albumin corrected calcium, albumin, phosphate and sodium, magnesium and chloride using standard laboratory methods on the Roche Modular analysers (Roche Diagnostics Limited, West Sussex, UK). The remaining 24mls of whole blood was centrifuged and serum was separated into 10 aliquots which were then frozen at -70o for the analysis of systemic and local factors involved in bone remodelling and atherosclerosis. These included PTH, PINP, CTX, vitamin D, sclerostin and Dkk1. Parathyroid hormone and vitamin D was analysed by consultant chemical pathologist Xx Xxxxx Xxxxxxx in the Department of Clinical Chemistry at St Xxxxxx’ Hospital. PINP, CTX, sclerostin and Dkk1 were analysed by the commercial bone marker laboratory at the University of Sheffield. During the prospective study a further blood sample was collected at 6, 12 and 24-months for the measurement of circulating endothelial progenitor cells (EPCs). These samples were processed immediately after collection and analysed using flow-cytometry to enable identification and characterisation of EPCs. Analysis was performed by Xx Xxxxxx Xxxxxx in the flow-cytometry department of the Clinical Trials Unit at Guy’s Hospital.
Laboratory Assessments. Local laboratories will be used for the analysis of scheduled hematology, biochemistry, coagulation and other tests collected as part of safety monitoring. Screening labs (Table 21) will be performed within 14 days of first dose. Repeat testing on Cycle 1, Day 1 is not required if tests were obtained within 4 days of dosing and are within acceptable ranges. Repeat testing will be performed as outlined in the Schedule of Assessments (Table 2, Table 3, and Table 4) and as clinically indicated. Note that before each administration of study drug, laboratory results must be reviewed to evaluate for potential toxicity.
Laboratory Assessments. Complete blood counts (CBC), CMP, PT/PTT, CA19-9 will be performed as part of this study. Additional laboratory assessments will also be performed at the time points indicated in the Schedule of Events (Table 1).
Laboratory Assessments. All samples should be collected and shipped as directed in the Laboratory Procedures Manual. Routine clinical laboratory testing will be performed for all subjects at the time points indicated in Table 3, or as applicable. Samples may be stored up to 20 years. If the investigator believes that access to laboratory data is medically indicated and that a delay in access to central laboratory safety results would pose a potential safety risk to the subject, the sample will be split; a portion will be sent to the local laboratory for appropriate laboratory tests, and the other portion will be sent to the central laboratory for routinely scheduled testing. Samples will be collected and stored for testing for additional safety or PK testing as necessary.
Laboratory Assessments. Blood and urine samples will be collected for hematology, serum chemistry, coagulation, select hormone parameters, and urinalysis. Where consent is given, an optional blood sample for hormone and exploratory biochemistry testing and optional genetic sample for biomarker testing will be collected at the Screening visit, Day 8 and Day 15. Serum and urine samples for pregnancy tests will also be collected. These assessments should be performed as outlined below. All samples will be analyzed at the central laboratory. Subjects may be considered eligible for the study based on local laboratory results; however, screening samples must also be sent to the central laboratory. Both local and central screening labs must adhere to the visit window provided in the Schedule of Events. All clinical laboratory test results outside the reference range will be interpreted by the Investigator as abnormal, not clinically significant (NCS) or abnormal, clinically significant (CS). Screening results considered abnormal, CS recorded at the Screening visit may make the subject ineligible for the study pending review by the Medical Monitor. Clinical laboratory results that are abnormal, CS during the study but within normal range at baseline and/or indicate a worsening from baseline will be considered adverse events, assessed according to Section 13.2.1, and recorded in the eCRF.
Laboratory Assessments. All laboratory data will be summarised at each scheduled time point and by dose group using descriptive statistics. Change from baseline on continuous data will be summarised using descriptive statistics at each scheduled time point by dose group. For categorical data, shift from baseline will be summarised using frequency and proportion at each scheduled time point by dose group. For all laboratory variables, which are included in the CTCAE version 4.0, the CTCAE grade will be calculated and summarised using frequency counts and percentages in the form of shifts from baseline to maximum grade post baseline. For urinalysis, shift table comparing baseline to maximum value by treatment will be presented (i.e. using number of patients with results of negative, trace or positive).
Laboratory Assessments. Std Plate Count Less than 10,000 per gram Yeast and Mold Less than 100 per gram Coliforms Less than 100 per gram
