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A Randomized, Double-Blind, Multi-Center, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oral Salmon Calcitonin in the Treatment of Osteoporosis in Postmenopausal Women Taking Calcium and Vitamin D
The purpose of this Phase III study is to evaluate the efficacy and safety of oral salmon calcitonin in the treatment of patients with osteoporosis
Details
| Lead sponsor | Nordic Bioscience A/S |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 4665 |
| Start date | 2007-03 |
| Completion | 2011-11 |
Conditions
- Osteoporosis
Interventions
- SMC021 Oral calcitonin
- SMC021 Placebo
Primary outcomes
- Number of Patients With New Vertebral Fractures — From baseline to month 36
The primary variable was the occurrence or not of a new vertebral fracture during the 3 year observation period. New vertebral fractures were identified from an assessment of x-ray of the lateral spine through time (at baseline and at yearly intervals thereafter). The outcome is the number of new vertebral fractures from baseline to 36 months.
Countries
United States, Brazil, China, Czechia, Denmark, Estonia, France, Hong Kong, Italy, Lithuania, Poland, Romania