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A Study of Oral Recombinant Salmon Calcitonin (rsCT) to Prevent Postmenopausal Osteoporosis

NCT01292187 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 129

Last updated 2014-09-12

Study results available
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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.

Conditions

  • Osteopenia

Interventions

DRUG

Oral calcitonin at dinnertime

Oral calcitonin at dinnertime.

DRUG

Oral placebo at dinnertime

Oral placebo at dinnertime.

DRUG

Oral calcitonin at bedtime

Oral calcitonin at bedtime

DRUG

Oral placebo at bedtime

Oral placebo at bedtime

Sponsors & Collaborators

  • Tarsa Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • David S. Krause, MD · Chief Medical Officer - Tarsa Therapeutics, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2012-05-31
Completion
2012-07-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01292187 on ClinicalTrials.gov