Common use of Study Visits Clause in Contracts

Study Visits. 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. This Extension Study will be comprised of standard-of-care osteoporosis management, including 24 months of treatment with alendronate. In the month between Visit 9 and Visit 10 (between months 18 and 19 of Study BA058-05-003), the Investigator will consider the results of the assessments performed at Visit 9, including a local review of BMD, and determine if alendronate is appropriate for the subject, as part of this Extension Study. At the Follow-up (Visit 10 for Protocol BA058-05-003, Day 1 for Protocol BA058-05-005) subjects; who were randomized to BA058 Injection 80 µg/Placebo, who fulfill the inclusion/exclusion criteria (Section 4.1 and Section 4.2), and who have agreed to participate in the Extension Study; will sign the Informed Consent Form and be enrolled in the study. Alendronate is the recommended osteoporosis treatment for this Extension Study. Subjects who have been determined by the Investigator to be candidates for alendronate therapy will receive open-label oral alendronate treatment at a total dose of 70 mg once per week for 24 months. Subjects will be instructed to take their first dose of alendronate for Study BA058-05-005 in the morning, on the day following their Day 1 visit. Following the initial six months of treatment in this study, subjects will enter the long-term observational phase of this study, during which subjects will continue to receive alendronate treatment for an additional 18 months. All subjects will have clinic visits for study related procedures at Day 1, Month 3, Month 6, Month 12, Month 18 and Month 24. For the purpose of this study one month is equal to 30 days. Exploratory statistical analyses will assess longer term safety, fracture incidence (including vertebral and non-vertebral fracture), and BMD change following treatment with alendronate for six months after the completion of a subject’s participation of 18 months in study BA058-05-003. The analyses performed at six months will be used as a follow-up to the 18 month fracture endpoint for Study BA058-05-003. At this time-point, subjects will be analyzed based on the randomization assignment in the BA058-05-003 study. Other analyses performed on the data in this study will be descriptive in nature.