Study Visits. Upon signing of the informed consent, patients will enter a 1-4 week period of screening and prestudy training. Patients will be trained on self-administration of study drug and on recording of medication usage and local tolerance. After eligibility is assessed during the Screening period, a one week Pretreatment period is used to collect baseline data. Once enrolled, patients will return to their study center for safety and efficacy assessments at baseline (Day 1) and 1, 3, 6, 9, 12, and 18 months, and at any other time as warranted by safety, efficacy or compliance concerns. A final study visit is planned one month after the last dose of study drug. The study periods and number of clinic visits are summarized below: Study Period Duration of Study Period Scheduled Visits (#)
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. Statistical Considerations: 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.
Study Visits. Usually for short periods of from one to three weeks, with the aim of visiting a number of laboratories in the host country for discussions and liaison, or for study visits.
Study Visits. The sending Party will pay the international return air fares of its visitors to the airport nearest to the first host institution in the programme, while the host Party will provide for the local costs of the visit (board, lodging and transport connected with the objects of the visit) in accordance with the Financial Annex to this agreement.
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 Abaloparatide-SC/Placebo. This Extension Study will be comprised of 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 Abaloparatide-SC/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. 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, within a week of 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.
Study Visits. For patients who completed Study RP103-03, study visits consist of: Screening Visit: The RP103-04 Screening visit occurs simultaneously with the RP103-03 Period 2 Day 7 (End of Study) visit. These patients will continue RP103 Q12H treatment at the last dose level prescribed during their participation in Study RP103-03. Monthly Study Visits are only for patients who completed Study RP103-03 and will begin within 1 month (± 7 days) after study entry. Each patient will complete a minimum of 6 consecutive Monthly visits. Quarterly Study Visits will commence for each patient ≥ 1 month and < 4 months after the patient has completed at least 6 consecutive Monthly visits. Each Quarterly visit will take place by the middle of the first month (± 7 days) of each calendar quarter (i.e., January 15, April 15, July 15 and October 15). End of Study (EOS) Visit will be conducted within 7 (± 2 days) from the last completed study visit or from the date of decision to terminate. For patients who did not complete Study RP103-03, study visits consist of: Screening Visit which may occur up to 28 days prior to Day 1. Dose Confirmation Period (Days 1-5) which includes 3 study visits over 5 days. o Day 1 includes a morning study visit while the patient is fasted, with pre-dose blood samples collected for trough cysteamine and peak WBC cystine determination while the subject is still taking Cystagon®. RP103 treatment regimen begins at the clinic on the morning of Day 1, administered Q12H at a starting total daily RP103 dose equal to 70% of the Screening total daily Cystagon® dose. Patients will leave the clinic for Days 2-3 and take RP103 as instructed. o Days 4 and 5 each include a morning study visit; RP103 Q12H treatment regimen continues. Quarterly Study Visits will commence for each patient by the middle of the first month (± 7 days) of each calendar quarter (i.e., January 15, April 15, July 15 and October 15). End of Study (EOS) Visit will be conducted within 7 (± 2 days) from the last completed study visit or from the date of decision to terminate.
Study Visits. 1. The aim of the study visits is to establish or enhance cooperation between researchers of both Parties in order to prepare and submit joint project proposals to national or international funding bodies.
Study Visits. The study consists of a Screening Period, a Pretreatment Period, a Treatment Period and a Follow-up Period. The study periods are summarized in Error! Reference source not found., below. Table 2
Study Visits. Screening/Baseline Visit (Study Day 1) The following procedures should be completed prior to initiating study treatment:
Study Visits. 3. Joint seminars on issues of mutual interest.
