At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 4,665 enrolled
Drug / intervention
SMC021 Oral calcitonin +1 moredrug
Likely dose
SMC021 Oral calcitonin 0.8mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating SMC021 Oral calcitonin and SMC021 Placebo for Osteoporosis. Completed, enrolled 4,665 participants across 16 sites in 12 countries.
Detailed 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
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOsteoporosis
CountriesBrazil, China, Czechia, Denmark, Estonia, France, Hong Kong, Italy, Lithuania, Poland, Romania, United States
CollaboratorsNovartis
Timeline
Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartMar 2007
First PostedSep 2007
Primary CompletionAug 2011
Study CompletionNov 2011
TodayJul 2026
First PostedSep 6, 2007
Enrollment StartMar 1, 2007
Primary CompletionAug 1, 2011
Study CompletionNov 1, 2011
TodayJul 2, 2026
Enrollment to primary: 4.4 yearsPosted 18.8 years ago
Interventions
SMC021 Oral calcitonindrug
0.8mg SMC021 - oral calcitonin, once daily
SMC021 Placebodrug
SMC021 - Placebo, once daily