Comparison of Bone Effects With Copaxone and Interferon in Multiple Sclerosis

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00490906
• Other study ID #: KCALSI-06-01
• Status: Completed
• Phase: N/A
• First received: June 21, 2007
• Last updated: January 17, 2014
• Start date: June 2007
• Est. completion date: December 2012

Study information

• Verified date: January 2014
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2012
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort

Related Conditions & MeSH terms

• Low Bone Density
• Multiple Sclerosis
• Sclerosis

Intervention

Drug:
• Copaxone
20 mg, subcutaneous injections, taken daily
• Interferon-beta 1a
30 mcg injected intramuscularly, once weekly
• Interferon-beta 1b
.25 mg/day, taken every other day, subcutaneous injections

Locations

Country	Name	City	State
United States	General Clinical Research Center	Kansas City	Kansas
United States	University of Kansas Medical Center	Kansas City	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
Nancy Hammond, MD	Kansas City Area Life Sciences Institute, Inc.

Country where clinical trial is conducted

United States,