Selection of Dose Sample Clauses
The 'Selection of Dose' clause defines how the appropriate dosage of a drug or treatment will be determined within the context of a clinical trial or research study. Typically, this clause outlines the criteria, procedures, and responsible parties for choosing the initial and subsequent doses, which may involve factors such as patient safety, prior study results, or regulatory guidance. Its core practical function is to ensure that dosing decisions are made systematically and transparently, thereby minimizing risks to participants and supporting the scientific integrity of the study.
Selection of Dose. The dose of alendronate (70 mg per week, oral) selected for this study is based upon the recommended daily dose in the product’s prescribing information. All enrolled subjects will also continue to receive calcium (500-1000 mg) and vitamin D (400-800 IU) supplementation.
Selection of Dose. The BA058 dose to be studied in this Phase 3 trial has been previously studied in the Phase 1 and Phase 2 clinical trials. The dose chosen for this study is based on the safety and pharmacodynamic information derived in study BA058-05-002 according to predetermined criteria provided in the protocol. The 80 µg dose was the maximum efficacy dose in the BA058 Phase 2 clinical program, was well tolerated (refer to Section 0) and demonstrated a significant increase in mean lumbar spine and mean femoral neck BMD when compared to Placebo. This beneficial effect was achieved safely and with substantially less hypercalcemia than teriparatide. Doses of up to 120 µg have been studied in the Phase 1 program and 100 µg has been determined to be the maximum tolerated dose, due to patients experiencing an increase in nausea and one discontinuation due to vomiting at the 120 µg dose. BA058 80 µg per day will be dosed by SC self-administered injection. In addition, a matching Placebo comparator will be employed in one treatment arm and teriparatide will be employed as a reference drug and comparator for secondary efficacy and safety outcomes. All enrolled patients will also receive Calcium (500-1000 mg) and Vitamin D (400-800 IU) supplementation, or a dose to be determined by the Investigator and agreed by the Sponsor Medical Monitor, according to the patient’s need, from the Pretreatment Period until the end of the Treatment Period; it will be recommended to patients that they continue these supplements through the Follow-up Period. The treatment regimens are summarized in the table in Section 0. The primary objective of this study is to determine the safety and efficacy of BA058 80 µg when compared to Placebo for prevention of vertebral fracture in otherwise healthy ambulatory postmenopausal women at risk of fracture from severe osteoporosis. The secondary objectives of this study are to determine the safety and efficacy of BA058 80 µg when compared to Placebo for prevention of non-vertebral fractures and for additional secondary efficacy outcomes (bone mineral density of spine, hip and femoral neck) and safety (hypercalcemia) when compared to teriparatide (▇▇▇ ▇▇▇▇▇ and Co.) in otherwise healthy ambulatory postmenopausal women at risk of fracture from severe osteoporosis. The specific objectives of this study are to: · Determine the comparative efficacy of 18 months of treatment with BA058 80 µg on reduction of vertebral fracture incidence in otherwise healthy ambulator...