NCT00525798

A Study to Evaluate Oral Salmon Calcitonin in the Treatment of Osteoporosis in Postmenopausal Women Taking Calcium and Vitamin D

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 4,665 (actual)
• Sponsor: Nordic Bioscience A/S · Industry
• Sex: Female
• Age: 55 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Osteoporosis

Interventions

Type	Name	Description
DRUG	SMC021 Oral calcitonin	0.8mg SMC021 - oral calcitonin, once daily
DRUG	SMC021 Placebo	SMC021 - Placebo, once daily

Timeline

• Start date: 2007-03-01
• Primary completion: 2011-08-01
• Completion: 2011-11-01
• First posted: 2007-09-06
• Last updated: 2012-10-29
• Results posted: 2012-10-18

Locations

16 sites across 12 countries: United States, Brazil, China, Czechia, Denmark, Estonia, France, Hong Kong, Italy, Lithuania, Poland, Romania