Pretreatment Period Sample Clauses

Pretreatment Period. During the Pretreatment Period, one visit (Visit 2) is scheduled. Patients will have baseline evaluations performed as outlined in the Schedule of Visits and Procedures (Appendix 14.1). Patients will undergo baseline efficacy labs. This study visit is to be scheduled within 7 days prior to the anticipated first day of treatment to allow confirmation of clinical laboratory test results and continued eligibility. Patients who have experienced a serious adverse event during the Pretreatment Period will be terminated from the study. Patients will undergo training on self-injection with the BA058 pen injector device in anticipation of treatment assignment. Teriparatide is a marketed treatment; therefore, if the patient is subsequently randomized to teriparatide, training will be done with the teriparatide pen after randomization but before the first injection on Day 1 (Visit 3). In addition, patients will be provided with daily Calcium (500—1000 mg) and Vitamin D (400—800 IU) supplementation, or a dose to be determined by Investigator and agreed upon by the Sponsor Medical Monitor, according to the patient’s need, which will be continued until the end of the Treatment Period; it will be recommended to patients that they continue these supplements through the Follow-up Period. Patients will be instructed to take the supplements during the evening with or without food or as otherwise instructed by the Investigator. Only the daily doses of Calcium and Vitamin D identified in the study protocol and determined by the Investigator may be taken during the study. Any patient unable to take the preparation of Calcium and Vitamin D supplied may be recommended a different preparation of Calcium and Vitamin D by the Investigator as long as the same daily dose of both Calcium and Vitamin D is administered. On completion of the Pretreatment period, eligible patients will enter the Treatment Period.