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

October 22, 2012 updated by: Nordic Bioscience A/S

A Randomized, Double-Blind, Multi-Center, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oral Salmon Calcitonin in the Treatment of Osteoporosis in Postmenopausal Women Taking Calcium and Vitamin D

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

4665

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Rio de Janeiro, Brazil, 22271-100
        • CCBR Brazil
  • China
      • Beijing, China, 102206
        • CCBR China
  • Czech Republic
      • Pardubice, Czech Republic, 53002
        • CCBR Czech
  • Denmark
      • Aalborg, Denmark, 9000
        • CCBR Aalborg
      • Ballerup, Denmark, 2750
        • CCBR Ballerup
      • Vejle, Denmark, 7100
        • CCBR Vejle
  • Estonia
      • Tallinn, Estonia, 10128
        • CCBR Estonia
  • France
      • Lyon, France, 69437
        • Hôpital Edouard Herriot
  • Hong Kong
      • Hong Kong, Hong Kong
        • CCBR Hong Kong
  • Italy
      • Florence, Italy
        • Department of Internal Medicine, University of Florence
  • Lithuania
      • Vilnius, Lithuania, 10323
        • CCBR Lithuania
  • Poland
      • Warsaw, Poland, 04703
        • CCBR Poland
  • Romania
      • Bucharest, Romania, 030463
        • CCBR Romania
  • United States
    • Georgia
      • Gainesville, Georgia, United States, 30501
        • United Osteporosis Centers
    • Michigan
      • Detroit, Michigan, United States, 48236
        • Michigan Bone & Mineral Clinic PC,
    • Oregon
      • Portland, Oregon, United States, 97213
        • Oregon Osteoporosis Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Postmenopausal women with osteoporosis, ambulatory, in general good health, not receiving medication that affects bone metabolism, and free from any underlying condition, other than osteoporosis, that may result in abnormal bone metabolism.

Exclusion Criteria:

  • BMD T-score below -4.0 (based on absolute values g/cm2 as given in the protocol) at one or more of the measured sites
  • More than 2 prevalent vertebral fractures (Genant et al, 15).
  • If BMD is lower than -2.5 T-score at one or more of the measured sites, the participants will be excluded from the study, if they have a severe vertebral fracture (Genant et al, 15).
  • Evidence of any clinical osteoporotic fracture and/or if they have a history of a clinical osteoporotic fracture (excluding wrist fractures)
  • BMD T-score > -1.5 in all of the following regions: Lumbar spine, femoral neck or total hip.

Other protocol defined inclusion/exclusion criteria may apply

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
SMC021 - Oral Calcitonin
Drug: SMC021 Oral calcitonin
0.8mg SMC021 - oral calcitonin, once daily
Placebo Comparator: SMC021- Placebo
SMC021 - placebo
Drug: SMC021 Placebo
SMC021 - Placebo, once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Patients With New Vertebral Fractures
Time Frame: From baseline to month 36

The primary variable was the occurrence or not of a new vertebral fracture during the 3 year observation period. New vertebral fractures were identified from an assessment of x-ray of the lateral spine through time (at baseline and at yearly intervals thereafter).

The outcome is the number of new vertebral fractures from baseline to 36 months.
From baseline to month 36

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Patients With Non-vertebral Fractures
Time Frame: From baseline to month 36

The secondary outcome was the occurrence or not of a non-vertebral fracture during the 3 year observation period. Non-vertebral fractures of interest were: hip fractures, forearm fractures, humurus fractures, rib fractures and clavicular fractures.

Any new non-vertebral fractures while on-study were recorded. A copy of radiographs confirming the fracture, as well as a copy of the radiologist's report was to be obtained. A copy of the emergency room discharge letter or a hospital discharge letter was also obtained.
From baseline to month 36

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nordic Bioscience A/S

Collaborators

Novartis

Investigators

  • Study Chair: Bente J Riis, M.D., Nordic Bioscience A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2007

Primary Completion (Actual)

August 1, 2011

Study Completion (Actual)

November 1, 2011

Study Registration Dates

First Submitted

September 5, 2007

First Submitted That Met QC Criteria

September 5, 2007

First Posted (Estimate)

September 6, 2007

Study Record Updates

Last Update Posted (Estimate)

October 29, 2012

Last Update Submitted That Met QC Criteria

October 22, 2012

Last Verified

October 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SMC021A2303

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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