CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 129 enrolled
Drug / intervention
Oral calcitonin at dinnertime +3 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/NCT01292187
NCT01292187Phase 2Completed
CompareCT.gov

A Randomized, Double-blind, Placebo-controlled Clinical Trial Evaluating the Safety and Efficacy of Oral Recombinant Salmon Calcitonin (rsCT) in the Prevention of Postmenopausal Osteoporosis in Women at Increased Risk of Fracture

Tarsa Therapeutics, Inc.·interventional·Posted Feb 9, 2011·Updated Sep 12, 2014

In Brief

A Phase 2 clinical trial evaluating Oral calcitonin at dinnertime, Oral placebo at dinnertime, and 2 other interventions for Osteopenia. Completed, enrolled 129 participants across 10 sites.

Detailed Summary

The primary purpose of this study was to evaluate the efficacy of oral calcitonin (rsCT)tablets in the prevention of bone loss in postmenopausal women with lower bone mineral density at increased risk of fracture. The secondary purpose of this study was to determine if there is any food effect by comparing the efficacy and safety of oral calcitonin tablets administered at dinner or at bedtime.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOsteopenia
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 9, 2011
Enrollment StartJan 1, 2011
Primary CompletionMay 1, 2012
Study CompletionJul 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 15.4 years ago

Interventions

Oral calcitonin at dinnertimedrug

Oral calcitonin at dinnertime.

Oral placebo at dinnertimedrug

Oral placebo at dinnertime.

Oral calcitonin at bedtimedrug

Oral calcitonin at bedtime

Oral placebo at bedtimedrug

Oral placebo at bedtime