Multiple Sclerosis, Low Bone Density
Conditions
Keywords
MS (Multiple Sclerosis)
Brief summary
The purpose of this study is to determine if certain drugs commonly used to treat multiple sclerosis have an effect on bone health.
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.
Interventions
DRUGCopaxone
20 mg, subcutaneous injections, taken daily
30 mcg injected intramuscularly, once weekly
DRUGInterferon-beta 1b
.25 mg/day, taken every other day, subcutaneous injections
Sponsors
Kansas City Area Life Sciences Institute, Inc.
Nancy Hammond, MD
Study design
Observational model
COHORT
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Countries
United States
Outcome results
None listed