Comparison of Bone Effects With Copaxone and Interferon in Multiple Sclerosis

Completed

• Conditions: Multiple Sclerosis; Low Bone Density
• Interventions: Drug: Interferon-beta 1a; Drug: Copaxone; Drug: Interferon-beta 1b

• Registration Number: NCT00490906
• Lead Sponsor: Nancy Hammond, MD

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.

Study Timeline

• Study Start: 2007-06
• Study First Submitted: 2007-06-21
• Study First Submitted QC: 2007-06-22
• Study First Posted: 2007-06-25
• Primary Completion: 2009-02
• Study Completion: 2012-12
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-17
• Last Update Posted: 2014-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
2	Interferon-beta 1a	Patients receive interferons
2	Interferon-beta 1b	Patients receive interferons
1	Copaxone	Patients receive Copaxone

Trial Locations

Locations (2)

General Clinical Research Center; 🇺🇸 Kansas City, Kansas, United States

University of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States