Suggested Schedule of Events and Procedures by Study Visit. The purpose of this guide is to provide more detailed instructions for the study procedures listed in Appendix 14.1. This guide presents the procedures in a suggested sequence of performance at each study visit. Further information may be found within the protocol and in other study reference manuals (e.g., ECG, clinical lab sample processing). Of note: · During the Treatment Period, on the days of clinic visits, study medication must be injected at the clinic to accommodate pre-injection and post-injection procedures; study personnel may administer the study medication on those days. · Pre-injection procedures include assessments of the patient, xxxxx xxxxx, ECG, and pre-injection blood/urinalysis collections. · Pre-injection blood and urinalysis samples are to be obtained under fasting conditions (N.P.O. for 8 hours; water is acceptable) in the morning of each scheduled study visit; post-injection blood samples do not require fasting. · BMD Scans: Always use the same study-validated machine; preferably the same technician. · The 24-hour urine collection will be started at home the day before the clinic visit where the collection is required. Patients will be instructed to discard the first morning void and begin the collection at least 24 hours before their clinic visit the following day. They will collect all urine for 24 hours with a final void before coming to the clinic. Routine urinalyses are to be performed using samples freshly voided during the clinic visit. · Pen devices and needles for administration of study medications will be provided. BA058 80 µg and Placebo will be supplied in cartridges, each containing enough study medication to deliver the required daily dose for 30 days. Patients are to be instructed to change to a new cartridge after 30 days, regardless of how much medication is left in the cartridge. At each clinic visit, the used BA058 80 µg or Placebo cartridges, but not pen, are to be returned and a sufficient number of new cartridges to last until the next clinic visit are to be provided. Teriparatide will be supplied as pre-filled pens, each with enough medication for 28 days. At each clinic visit, the used teriparatide pens should be returned and a sufficient number of new pens provided to last until the next clinic visit. · Patients will be instructed to take the Calcium and Vitamin D supplements daily (in the evening with or without food or as otherwise instructed by the Investigator) until they are discharged from the study....
Suggested Schedule of Events and Procedures by Study Visit. The purpose of this guide is to provide more detailed instructions for the study procedures listed in Appendix 14.1. This guide presents the procedures in a suggested sequence of performance at each study visit. Further information may be found within the protocol and in other study reference manuals (e.g., ECG, clinical laboratory sample processing). Of note: · Blood and urinalysis samples are to be obtained under fasting conditions (NPO. for 8 hours; water is acceptable) in the morning of Day 1 and Months 6, 12, 18, and 24. · DXA Scans: Always use the same study-validated machine; preferably the same technician. · The 24-hour urine collection will be started at home the day before the clinic visit where the collection is required. Subjects will be instructed to discard the first morning void and begin the collection at least 24 hours before their clinic visit the following day. They will collect all urine for 24 hours with a final void before coming to the clinic. Routine urinalyses are to be performed using samples freshly voided during the clinic visit. Subjects should receive a reminder to initiate their 24-hour urine 2 days before their scheduled visit. · Alendronate for Europe, Hong Kong and the US will be sourced centrally; alendronate for South America will be sourced locally by the medical center and reimbursed by the Sponsor. · Subjects will be instructed to take the calcium and vitamin D supplements daily (in the evening with or without food or as otherwise instructed by the Investigator) until discharge from the study. This is required until the end of Month 24.
Suggested Schedule of Events and Procedures by Study Visit. The purpose of this guide is to provide more detailed instructions for the study procedures listed in Appendix 14.1. This guide presents the procedures in a suggested sequence of performance at each study visit. Further information may be found within the protocol and in other study reference manuals (e.g., ECG, clinical laboratory sample processing). Of note: · Blood and urinalysis samples are to be obtained under fasting conditions (NPO. for 8 hours; water is acceptable) in the morning of Day 1 and Months 6, 12, 18, and 24. · DXA Scans: Always use the same study-validated machine; preferably the same technician. · The 24-hour urine collection will be started at home the day before the clinic visit where the collection is required. Subjects will be instructed to discard the first morning void and begin the collection at least 24 hours before their clinic visit the following day. They will collect all urine for 24 hours with a final void before coming to the clinic. Routine urinalyses are to be performed using samples freshly voided during the clinic visit. Subjects should receive a reminder to initiate their 24-hour urine 2 days before their scheduled visit. · Alendronate for Europe, Hong Kong and the US will be sourced centrally; alendronate for South America will be sourced locally by the medical center and reimbursed by the Sponsor. · Subjects will be instructed to take the calcium and vitamin D supplements daily (in the evening with or without food or as otherwise instructed by the Investigator) until discharge from the study. This is required until the end of Month 24. Protocol BA058-05-005 Amendment 4, Version 1 (24 August 2015) Radius Health, Inc. Confidential Definitions of Common Procedures: The terms used in the by-visit schedule that follows are further defined below. Recent health status (document any changes from last visit) · Question subject regarding any new health issues · Question subject regarding any new adverse events · Question subject regarding any new concomitant medications · Question subject regarding any new issues related to ability to continue with study Pulse, respiration and temperature: · Pulse rate (beats/minute) taken after approximately five minutes in the supine position. · Respiration rate (breaths/minute). · Body temperature (°C). Weight and height measurements: · Weight (kg). · Height (cm) standing measurements are to be performed using the same medical stadiometer and standardized procedures each time. Orthostatic b...
