MedTrace Logo

A Study Comparing Oral Calcitonin to Nasal Spray Calcitonin in Postmenopausal Osteoporotic Women

NCT00959764 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 565

Last updated 2013-11-19

Study results available
· View outcomes & findings →

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.

Conditions

  • Osteoporosis, Postmenopausal

Interventions

DRUG

Oral Calcitonin Tablets

Oral Calcitonin tablets along with matching placebo intranasal spray

DRUG

Intranasal Calcitonin

Intranasal Calcitonin Spray

DRUG

Placebo tablets and placebo intranasal spray

Oral Placebo Tablets/Intranasal placebo spray

Sponsors & Collaborators

  • Tarsa Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • David Krause, M.D. · Tarsa Therapeutics, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-06-30
Primary Completion
2011-02-28
Completion
2011-02-28

Countries

  • United States
  • Bulgaria
  • Hungary
  • Poland
  • South Africa
  • United Kingdom

Study Locations

More Related Trials

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 NCT00959764 on ClinicalTrials.gov