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A Study to Evaluate Oral Salmon Calcitonin in the Treatment of Osteoporosis in Postmenopausal Women Taking Calcium and Vitamin D

NCT00525798 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 4665

Last updated 2012-10-29

Study results available
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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

Conditions

Interventions

DRUG

SMC021 Oral calcitonin

0.8mg SMC021 - oral calcitonin, once daily

DRUG

SMC021 Placebo

SMC021 - Placebo, once daily

Sponsors & Collaborators

  • Novartis

    collaborator INDUSTRY

  • Nordic Bioscience A/S

    lead INDUSTRY

Principal Investigators

  • Bente J Riis, M.D. · Nordic Bioscience A/S

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
55 Years
Max Age
85 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-03-31
Primary Completion
2011-08-31
Completion
2011-11-30

Countries

  • United States
  • Brazil
  • China
  • Czechia
  • Denmark
  • Estonia
  • France
  • Hong Kong
  • Italy
  • Lithuania
  • Poland
  • Romania

Study Locations

More Related Trials

Entities

Diseases
Companies

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 NCT00525798 on ClinicalTrials.gov