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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
June 21, 2007
June 25, 2007
January 22, 2014
June 2007
February 2009   (Final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT00490906 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Not Provided
 
Comparison of Bone Effects With Copaxone and Interferon in Multiple Sclerosis
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.
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.
Observational
Observational Model: Cohort
Not Provided
Not Provided
Non-Probability Sample
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.
  • Multiple Sclerosis
  • Low Bone Density
  • Drug: Copaxone
    20 mg, subcutaneous injections, taken daily
    Other Name: Glatiramer acetate
  • 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
  • 1
    Patients receive Copaxone
    Intervention: Drug: Copaxone
  • 2
    Patients receive interferons
    Interventions:
    • Drug: Interferon-beta 1a
    • Drug: Interferon-beta 1b
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
December 2012
February 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00490906
KCALSI-06-01
Yes
Not Provided
Not Provided
Nancy Hammond, MD, University of Kansas Medical Center Research Institute
Nancy Hammond, MD
Kansas City Area Life Sciences Institute, Inc.
Principal Investigator: Nancy Hammond, MD University of Kansas Medical Center
University of Kansas Medical Center
January 2014