INVESTIGATIONAL PLAN. 3.1 Overall Design and Study Plan This study is an open-label extension of Study BA058-05-003. Subjects and Investigators who participate in Study BA058-05-005 will remain blinded to prior treatment assignment as part of BA058-05-003. At the End-of-Treatment visit (Visit 9) for Study BA058-05-003, the possibility of participating in the Extension Study will be discussed with subjects randomized to BA058 80 µg/Placebo. The Extension Study will be comprised of an initial six months of treatment with alendronate. In the month between Visit 9 and Visit 10, the Investigator will review the results of the assessments performed at Visit 9, including a local interpretation of BMD, and determine if alendronate is appropriate for the subject. All subjects will continue to receive vitamin D and calcium supplementation as they did in Study BA058-05-003. The study design is presented in Figure 2, below. Figure 2: Protocol BA058-05-005 Study Design Participation for both the initial and observational phases of the will be approximately 24 months. There are a total of six clinic visits during the course of the study. A brief summary of the study is provided below. For a summary of the study assessments to be performed, refer to Section 7.0 (Study Assessments) and to the Schedule of Visits and Procedures (Appendix 14.1). A more detailed description of the study procedures on a by-visit basis is provided in Appendix 14.2 (Suggested Schedule of Events and Procedures by Study Visit). A suggested order of procedures is also provided in this schedule.
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Samples: Clinical Trial Services Agreement (Radius Health, Inc.), Clinical Study Protocol (Radius Health, Inc.)
INVESTIGATIONAL PLAN. 3.1 Overall Design and Study Plan This study is an open-label extension of Study BA058-05-003. Subjects and Investigators who participate in Study BA058-05-005 will remain blinded to prior treatment assignment as part of BA058-05-003. At the End-of-Treatment visit (Visit 9) for Study BA058-05-003, the possibility of participating in the Extension Study will be discussed with subjects randomized to BA058 80 µgAbaloparatide-SC/Placebo. The Extension Study will be comprised of an initial six months of treatment with alendronate. In the month between Visit 9 and Visit 10, the Investigator will review the results of the assessments performed at Visit 9, including a local interpretation of BMD, and determine if alendronate is appropriate for the subject. All subjects will continue to receive vitamin D and calcium supplementation as they did in Study BA058-05-003. The study design is presented in Figure 2, below. Figure 2: Protocol BA058-05-005 Study Design Participation for both the initial and observational phases of the will be approximately 24 months. There are a total of six clinic visits during the course of the study. A brief summary of the study is provided below. For a summary of the study assessments to be performed, refer to Section 7.0 (Study Assessments) and to the Schedule of Visits and Procedures (Appendix 14.1). A more detailed description of the study procedures on a by-visit basis is provided in Appendix 14.2 (Suggested Schedule of Events and Procedures by Study Visit). A suggested order of procedures is also provided in this schedule.
Appears in 1 contract
INVESTIGATIONAL PLAN. 3.1 Overall Design and Study Plan This study is an open-label extension of Study BA058-05-003. Subjects and Investigators who participate in Study BA058-05-005 will remain blinded to prior treatment assignment as part of BA058-05-003. At the End-of-Treatment visit (Visit 9) for Study BA058-05-003, the possibility of participating in the Extension Study will be discussed with subjects randomized to BA058 80 µgAbaloparatide-SC/Placebo. The Extension Study will be comprised of an initial six months of treatment with alendronate. In the month between Visit 9 and Visit 10, the Investigator will review the results of the assessments performed at Visit 9, including a local interpretation of BMD, and determine if alendronate is appropriate for the subject. All subjects will continue to receive vitamin D and calcium supplementation as they did in Study BA058-05-003. The study design is presented in Figure 2, below. Radius Health, Inc. Confidential Figure 2: Protocol BA058-05-005 Study Design Participation for both the initial and observational phases of the will be approximately 24 months. There are a total of six clinic visits during the course of the study. A brief summary of the study is provided below. For a summary of the study assessments to be performed, refer to Section 7.0 (Study Assessments) and to the Schedule of Visits and Procedures (Appendix 14.1). A more detailed description of the study procedures on a by-visit basis is provided in Appendix 14.2 (Suggested Schedule of Events and Procedures by Study Visit). A suggested order of procedures is also provided in this schedule.
Appears in 1 contract