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Comparison of Bone Effects With Copaxone and Interferon in Multiple Sclerosis

This study is ongoing, but not recruiting participants.
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: September 24, 2012
Last verified: September 2012
History of Changes
  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:

U.S. FDA Resources

Further study details as provided by University of Kansas:

Estimated Enrollment: 60
Study Start Date: June 2007
Estimated Study Completion Date: January 2013
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

Ages Eligible for Study:   18 Years and older
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00490906

Locations
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
General Clinical Research 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
  More Information

No publications provided

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
Study First Received: June 21, 2007
Last Updated: September 24, 2012
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on May 23, 2013