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Comparison of Bone Effects With Copaxone and Interferon in Multiple Sclerosis

This study has been completed.
Sponsor:
Collaborator:
Kansas City Area Life Sciences Institute, Inc.
Information provided by (Responsible Party):
Nancy Hammond, MD, University of Kansas Medical Center Research Institute
ClinicalTrials.gov Identifier:
NCT00490906
First received: June 21, 2007
Last updated: January 17, 2014
Last verified: January 2014

June 21, 2007
January 17, 2014
June 2007
February 2009   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00490906 on ClinicalTrials.gov Archive Site
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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
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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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00490906
KCALSI-06-01
Yes
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
University of Kansas
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP