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Comparison of Bone Effects With Copaxone and Interferon in Multiple Sclerosis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00490906
First Posted: June 25, 2007
Last Update Posted: January 22, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Kansas City Area Life Sciences Institute, Inc.
Information provided by (Responsible Party):
Nancy Hammond, MD, University of Kansas Medical Center Research Institute
  Purpose
The purpose of this study is to determine if certain drugs commonly used to treat multiple sclerosis have an effect on bone health.

Condition Intervention
Multiple Sclerosis Low Bone Density Drug: Copaxone Drug: Interferon-beta 1a Drug: Interferon-beta 1b

Study Type: Observational
Study Design: Observational Model: Cohort
Official Title: Comparison of Bone Effects With Copaxone and Interferon in Multiple Sclerosis: A Pilot Study

Resource links provided by NLM:


Further study details as provided by Nancy Hammond, MD, University of Kansas Medical Center Research Institute:

Enrollment: 60
Study Start Date: June 2007
Study Completion Date: December 2012
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
Patients receive Copaxone
Drug: Copaxone
20 mg, subcutaneous injections, taken daily
Other Name: Glatiramer acetate
2
Patients receive interferons
Drug: Interferon-beta 1a
30 mcg injected intramuscularly, once weekly
Other Name: Avonex
Drug: Interferon-beta 1b
.25 mg/day, taken every other day, subcutaneous injections
Other Name: Betaseron

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00490906


Locations
United States, Kansas
General Clinical Research Center
Kansas City, Kansas, United States, 66160
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Sponsors and Collaborators
Nancy Hammond, MD
Kansas City Area Life Sciences Institute, Inc.
Investigators
Principal Investigator: Nancy Hammond, MD University of Kansas Medical Center
  More Information

Responsible Party: Nancy Hammond, MD, Assistant Professor, Director Comprehensive Epilepsy Center, University of Kansas Medical Center Research Institute
ClinicalTrials.gov Identifier: NCT00490906     History of Changes
Other Study ID Numbers: KCALSI-06-01
First Submitted: June 21, 2007
First Posted: June 25, 2007
Last Update Posted: January 22, 2014
Last Verified: January 2014

Keywords provided by Nancy Hammond, MD, University of Kansas Medical Center Research Institute:
MS (Multiple Sclerosis)

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Interferons
Interferon-beta
Interferon beta-1a
Glatiramer Acetate
Interferon beta-1b
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic
Immunosuppressive Agents
Antirheumatic Agents