NCT00490906

Comparison of Bone Effects With Copaxone and Interferon in Multiple Sclerosis

Comparison of Bone Effects With Copaxone and Interferon in Multiple Sclerosis: A Pilot Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 60 (actual)
• Sponsor: Nancy Hammond, MD · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Multiple Sclerosis
• Low Bone Density

Interventions

Type	Name	Description
DRUG	Copaxone	20 mg, subcutaneous injections, taken daily
DRUG	Interferon-beta 1a	30 mcg injected intramuscularly, once weekly
DRUG	Interferon-beta 1b	.25 mg/day, taken every other day, subcutaneous injections

Timeline

• Start date: 2007-06-01
• Primary completion: 2009-02-01
• Completion: 2012-12-01
• First posted: 2007-06-25
• Last updated: 2014-01-22

Locations

2 sites across 1 country: United States