Comparison of Bone Effects With Copaxone and Interferon in Multiple Sclerosis

Nancy Hammond, MD

Status

Completed

Conditions

Low Bone Density

Multiple Sclerosis

Treatments

Drug: Interferon-beta 1b

Drug: Interferon-beta 1a

Drug: Copaxone

Study type

Observational

Funder types

Other

Identifiers

NCT00490906

KCALSI-06-01

Details and patient eligibility

About

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

Full 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.

Enrollment

60 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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