Comparison of Bone Effects With Copaxone and Interferon in Multiple Sclerosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-06-30

Study Completion Date

2012-12-31

Brief Summary

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The purpose of this study is to determine if certain drugs commonly used to treat multiple sclerosis have an effect on bone health.

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Detailed Description

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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.

Conditions

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Multiple Sclerosis Low Bone Density

Study Design

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Observational Model Type

COHORT

Study Groups

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1

Patients receive Copaxone

Copaxone

Intervention Type DRUG

20 mg, subcutaneous injections, taken daily

2

Patients receive interferons

Interferon-beta 1a

Intervention Type DRUG

30 mcg injected intramuscularly, once weekly

Interferon-beta 1b

Intervention Type DRUG

.25 mg/day, taken every other day, subcutaneous injections

Interventions

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Copaxone

20 mg, subcutaneous injections, taken daily

Intervention Type DRUG

Interferon-beta 1a

30 mcg injected intramuscularly, once weekly

Intervention Type DRUG

Interferon-beta 1b

.25 mg/day, taken every other day, subcutaneous injections

Intervention Type DRUG

Other Intervention Names

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Glatiramer acetate Avonex Betaseron

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No