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| Sponsors and Collaborators: |
University of Kansas Kansas City Area Life Sciences Institute, Inc. |
|---|---|
| Information provided by: | University of Kansas |
| ClinicalTrials.gov Identifier: | NCT00490906 |
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: | Cohort |
| Official Title: | Comparison of Bone Effects With Copaxone and Interferon in Multiple Sclerosis: A Pilot Study |
| Estimated Enrollment: | 60 |
| Study Start Date: | June 2007 |
| Estimated Study Completion Date: | February 2009 |
| Estimated 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
|
|
2
Patients receive interferons
|
Drug: Interferon-beta 1a
30 mcg injected intramuscularly, once weekly
Drug: Interferon-beta 1b
.25 mg/day, taken every other day, subcutaneous injections
|
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 |
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:
Exclusion Criteria:
Contacts and 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 | |
| Principal Investigator: | Nancy Hammond, MD | University of Kansas |
More Information
| Responsible Party: | University of Kansas Medical Center ( Nancy Hammond, MD ) |
| Study ID Numbers: | KCALSI-06-01 |
| Study First Received: | June 21, 2007 |
| Last Updated: | November 5, 2008 |
| ClinicalTrials.gov Identifier: | NCT00490906 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
MS (Multiple Sclerosis) |
|
Interferon Type I, Recombinant Autoimmune Diseases Immunologic Factors Demyelinating Diseases Interferons Adjuvants, Immunologic Interferon-beta Sclerosis Immunosuppressive Agents |
Angiogenesis Inhibitors Antiviral Agents Copolymer 1 Multiple Sclerosis Interferon beta 1a Interferon beta-1b Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System |
|
Anti-Infective Agents Interferon Type I, Recombinant Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Pathologic Processes Multiple Sclerosis Therapeutic Uses Interferon beta 1a Growth Inhibitors Angiogenesis Modulating Agents Autoimmune Diseases of the Nervous System Autoimmune Diseases Immune System Diseases |
Demyelinating Diseases Growth Substances Interferons Nervous System Diseases Adjuvants, Immunologic Interferon-beta Sclerosis Immunosuppressive Agents Antiviral Agents Angiogenesis Inhibitors Pharmacologic Actions Copolymer 1 Interferon beta-1b Demyelinating Autoimmune Diseases, CNS |
