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Comparison of Bone Effects With Copaxone and Interferon in Multiple Sclerosis

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

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
Patients receive Copaxone
Drug: Copaxone
20 mg, subcutaneous injections, taken daily
Other Name: Glatiramer acetate
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.

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.

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
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Please refer to this study by its identifier: NCT00490906

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.
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 Identifier: NCT00490906     History of Changes
Other Study ID Numbers: KCALSI-06-01
Study First Received: June 21, 2007
Last Updated: January 17, 2014

Keywords provided by University of Kansas Medical Center:
MS (Multiple Sclerosis)

Additional relevant MeSH terms:
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Interferon beta-1a
Interferon beta-1b
Glatiramer Acetate
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Immunosuppressive Agents
Antirheumatic Agents processed this record on May 24, 2017