Comparison of Bone Effects With Copaxone and Interferon in Multiple Sclerosis

January 17, 2014 updated by: Nancy Hammond, MD

Comparison of Bone Effects With Copaxone and Interferon in Multiple Sclerosis: A Pilot Study

The purpose of this study is to determine if certain drugs commonly used to treat multiple sclerosis have an effect on bone health.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

There will be 60 female patients with MS at University of Kansas Medical Center (KUMC). They will be split into two groups: a Copaxone group and an Interferon (Avonex, Rebif, or Betaseron) group. Each group will be composed of 30 women matched for menopausal status. Each subject will be given a questionnaire assessing risk factors for low bone density. All patients will have a determination of an Expanded Disability Status Scale (EDSS), height and weight, medical history, and fracture history. All patients will undergo hip and spine dual x-ray absorptiometry (DEXA) and will have labs drawn to determine serum 25 hydroxyvitamin D, parathyroid hormone, ionized calcium, estradiol, bone-specific acetyl phosphatase, osteocalcin, and C-peptides.

Study Type

Observational

Enrollment (Actual)

60

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

  • United States
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Medical Center
      • Kansas City, Kansas, United States, 66160
        • General Clinical Research 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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

The participants must be female with clinical diagnosis of multiple sclerosis and have been using either Copaxone or interferon injections for the past 1 or more years.

Description

Inclusion Criteria:

  • Female, age > 18
  • Able to understand and give informed consent
  • Relapsing remitting multiple sclerosis (RRMS)
  • Treatment with interferons or Copaxone for at least one year prior to study entry

Exclusion Criteria:

  • Known osteoporosis
  • History of hypercalcemia
  • Currently pregnant
  • History of primary hyperparathyroidism, hyperthyroidism, or hypothyroidism
  • Unstable medical condition
  • Ongoing use of bisphosphonates

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

  • Observational Models: Cohort

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
1
Patients receive Copaxone
Drug: Copaxone
20 mg, subcutaneous injections, taken daily
Other Names:
  • Glatiramer acetate
2
Patients receive interferons
Drug: Interferon-beta 1a
30 mcg injected intramuscularly, once weekly
Other Names:
  • Avonex
Drug: Interferon-beta 1b
.25 mg/day, taken every other day, subcutaneous injections
Other Names:
  • Betaseron

Collaborators and Investigators

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

Sponsor

Nancy Hammond, MD

Collaborators

Kansas City Area Life Sciences Institute, Inc.

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

June 1, 2007

Primary Completion (Actual)

February 1, 2009

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

June 21, 2007

First Submitted That Met QC Criteria

June 22, 2007

First Posted (Estimate)

June 25, 2007

Study Record Updates

Last Update Posted (Estimate)

January 22, 2014

Last Update Submitted That Met QC Criteria

January 17, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KCALSI-06-01

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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