Common use of Treatment Period Clause in Contracts

Treatment Period. Subjects will enter into Study BA058-05-005 on Day 1, and Day 1 will also serve as Visit 10 (the Follow-up Visit) for Study BA058-05-003. The Informed Consent must be signed prior to undergoing any BA058-05-005 study related procedures, and may be signed at either Visit 9 or Visit 10 of Study BA058-05-003. Subjects who received Abaloparatide-SC/Placebo in Study BA058-05-003 will receive six months of open-label oral alendronate treatment as part of this study (BA058-05-005). Following the initial six months of treatment in this study, subjects will then enter the long-term observational phase of this study during which the subjects will continue to receive alendronate care for an additional 18 months. If determined by the Investigator to be appropriate, treatment will be by oral administration of alendronate at a total dose of 70 mg once per week. Subjects will be given a weekly diary card to record missed doses of medication including calcium and vitamin D. A total of six clinic visits are scheduled during the study (Day 1, Month 3, Month 6, Month 12, Month 18 and Month 24). Subjects will be instructed to take their first dose of study drug for Study BA058-05-005 in the morning, within a week of their Day 1 visit (Day 2 of this study). Study subjects will continue calcium and vitamin D supplementation during this study as was administered during BA058-05-003 (Section 6.1). At Month 3, subjects will return to the clinic for medication resupply, subject diary review and questioning as to their use of concomitant medications and the occurrence of adverse events. At the Month 6 visit ECG, and safety labs will be performed. Vertebral fractures will be determined clinically and via protocol directed x-ray evaluation; non-vertebral fractures will be determined clinically. In addition, subjects will undergo a DXA of the hip and spine (and wrist, if the subject was enrolled in the wrist DXA sub-study in Study BA058-05-003), and have samples drawn for bone markers and anti-abaloparatide antibodies. Procedures are to be performed as described in Section 7.0, Appendix 14.1 and Appendix 14.2. At Months 12 and 18, subjects will return to the clinic for safety labs, DXA of the hip and spine (and wrist, if the subject was enrolled in the wrist DXA sub-study in Study BA058-05-003), medication resupply, subject diary review and questioning as to their use of concomitant medications and occurrence of adverse events. Serum samples for bone markers will also be drawn. At Month 24, subjects will return to the clinic for safety labs, and will undergo clinical and radiologic fracture assessments and have DXA of the hip and spine (and wrist, if the subject was enrolled in the wrist DXA sub-study in Study BA058-05-003). Serum samples for bone markers will also be drawn. Any adverse event or clinical laboratory abnormality recorded at the Month 24 Visit will be monitored until it has resolved, become chronic or stable.

Treatment Period. Subjects will enter into Study BA058-05-005 on Day 1, and Day 1 will also serve as Visit 10 (the Follow-up Visit) for Study BA058-05-003. The Informed Consent must be signed prior to undergoing any BA058-05-005 study related procedures, and may be signed at either Visit 9 or Visit 10 of Study BA058-05-003. Subjects who received Abaloparatide-SCBA058 Injection 80 µg/Placebo in Study BA058-05-003 will receive six months of open-label oral alendronate treatment as part of this study (BA058-05-005). Following the initial six months of treatment in this study, subjects will then enter the long-term observational phase of this study during which the subjects will continue to receive alendronate osteoporosis care for an additional 18 months. If determined by the Investigator to be appropriate, treatment will be by oral administration of alendronate at a total dose of 70 mg once per week. Subjects will be given a weekly diary card to record missed doses of medication including calcium and vitamin D. A total of six clinic visits are scheduled during the study (Day 1, Month 3, Month 6, Month 12, Month 18 and Month 24). Subjects will be instructed to take their first dose of study drug for Study BA058-05-005 in the morning, within a week of morning on the day following their Day 1 visit (Day 2 of this study). Study subjects will continue calcium and vitamin D supplementation during this study as was administered during BA058-05-003 (Section 6.1). At Month 3, subjects will return to the clinic for medication resupply, subject diary review and questioning as to their use of concomitant medications and the occurrence of adverse events. At the Month 6 visit ECG, and safety labs will be performed. Vertebral fractures will be determined clinically and via protocol directed x-ray evaluation; non-vertebral fractures will be determined clinically. In addition, subjects will undergo a DXA of the hip and spine (and wrist, if the subject was enrolled in the wrist DXA sub-study in Study BA058-05-003), and have samples drawn for bone markers and anti-abaloparatide BA058 antibodies. Procedures are to be performed as described in Section 7.0, Appendix 14.1 and Appendix 14.2. At Months 12 and 18, subjects will return to the clinic for safety labs, DXA of the hip and spine (and wrist, if the subject was enrolled in the wrist DXA sub-study in Study BA058-05-003), medication resupply, subject diary review and questioning as to their use of concomitant medications and occurrence of adverse events. Serum samples for bone markers will also be drawn. At Month 24, subjects will return to the clinic for safety labs, and will undergo clinical and radiologic fracture assessments and have DXA of the hip and spine (and wrist, if the subject was enrolled in the wrist DXA sub-study in Study BA058-05-003). Serum samples for bone markers will also be drawn. Any adverse event or clinical laboratory abnormality recorded at the Month 24 6 Visit will be monitored until it has resolved, become chronic or stable.