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Oral rsCT in Healthy Postmenopausal Women
NCT00803686Phase 2
Key facts
- Status
- Completed
- Start
- Dec 2008
- Primary completion
- Jan 2009
- Countries
- 1
- Sponsor
- Tarsa Therapeutics, Inc.
- Modality
- Recombinant Proteins and Enzymes
- Drugs
- calcitonin salmon
- Conditions
- postmenopausal osteoporosis
01
Overview
Phase 2, randomised, double-blind trial of calcitonin salmon in postmenopausal osteoporosis (4 arms), sponsored by Tarsa Therapeutics, Inc. Primary endpoint: Pharmacodynamic Effect of Oral Calcitonin at 12 hours. Started Dec 2008; status: completed.
02
Design
4 arms- Study design
- RandomizedDouble-blind
Part 1 Double Blind Oral rsCT Tablet
Oral rsCT tablet given once 4 hours after evening meal.
Part 1, Double-blind Oral Placebo Tablet
Oral placebo tablet matching the oral rsCT tablet.
Part 2 Open label, Oral rsCT tablet
Oral rsCT tablet given once 2 hours after evening meal.
Part 2, Open Label Fortical Nasal Spray
Fortical (rsCT) nasal spray given once 2 hours after evening meal.
03
Who it enrols
Healthy postmenopausal women (at least 5 years since last menses) with plasma CTx-1 >= 0.25 ng/ml.
04
Endpoints
Primary
Pharmacodynamic Effect of Oral Calcitonin
Secondary
AUCInhibition=Hours*%P
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