CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 565 enrolled
Drug / intervention
Oral Calcitonin Tablets +2 moredrug
Likely dose
Not stated in 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.

Search/NCT00959764
NCT00959764Phase 3Completed

A Randomized, Double-Blind, Multiple Dose, Placebo-Controlled, Parallel Group, 48-Week, Study of Oral Recombinant Salmon Calcitonin (rsCT) Compared to Salmon Calcitonin (sCT) Nasal Spray in Postmenopausal Osteoporotic Women

Tarsa Therapeutics, Inc.·interventional·Posted Aug 17, 2009·Updated Nov 19, 2013

In Brief

A Phase 3 clinical trial evaluating Oral Calcitonin Tablets, Intranasal Calcitonin, and 1 other intervention for Osteoporosis, Postmenopausal. Completed, enrolled 565 participants across 20 sites in 6 countries.

Detailed Summary

The purpose of this study is to compare the effectiveness and tolerability of two medications, calcitonin nasal spray and a tablet containing calcitonin, in postmenopausal women with osteoporosis. Osteoporosis is the term used to describe a large group of diseases, which are characterized by loss of bone density, which makes the bones weaker. Osteoporosis often occurs in postmenopausal women. Calcitonin is a hormone found in the human body. Together with other substances, it regulates the concentration of calcium in the blood and inhibits the natural resorption of bone. Both medications in this study contain salmon calcitonin (sCT), because this form of calcitonin is more active than human calcitonin when used as a medicine. The calcitonin Nasal Spray used in this study is registered and available to doctors in United States for the treatment of osteoporosis. The medication being tested in this study is an oral tablet form of salmon calcitonin.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBulgaria, Hungary, Poland, South Africa, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedAug 17, 2009
Enrollment StartJun 1, 2009
Primary CompletionFeb 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 16.9 years ago

Interventions

Oral Calcitonin Tabletsdrug

Oral Calcitonin tablets along with matching placebo intranasal spray

Intranasal Calcitonindrug

Intranasal Calcitonin Spray

Placebo tablets and placebo intranasal spraydrug

Oral Placebo Tablets/Intranasal placebo spray