Comparison of Bone Effects With Copaxone and Interferon in Multiple Sclerosis

NCT00490906 | Completed DMC

• 1 other identifier: KCALSI-06-01
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 2

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.

Conditions

Multiple Sclerosis; Low Bone Density

Keywords

MS (Multiple Sclerosis)

Study Arms (2)

1

Patients receive Copaxone

Drug: Copaxone

2

Patients receive interferons

Drug: Interferon-beta 1a; Drug: Interferon-beta 1b

Interventions

Copaxone DRUG

20 mg, subcutaneous injections, taken daily

Also known as: Glatiramer acetate

1

Interferon-beta 1a DRUG

30 mcg injected intramuscularly, once weekly

Also known as: Avonex

2

Interferon-beta 1b DRUG

.25 mg/day, taken every other day, subcutaneous injections

Also known as: Betaseron

2

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The participants must be female with clinical diagnosis of multiple sclerosis and have been using either Copaxone or interferon injections for the past 1 or more years.

You may qualify if:

• 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

You may not qualify if:

• Known osteoporosis
• History of hypercalcemia
• Currently pregnant
• History of primary hyperparathyroidism, hyperthyroidism, or hypothyroidism
• Unstable medical condition
• Ongoing use of bisphosphonates

Sponsors & Collaborators

• Nancy Hammond, MD: lead
• Kansas City Area Life Sciences Institute, Inc.: collaborator

Study Sites (2)

General Clinical Research Center

Kansas City, Kansas, 66160, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis; Bone Diseases, Metabolic

Interventions

Glatiramer Acetate; Interferon beta-1a; Interferon beta-1b

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Peptides; Amino Acids, Peptides, and Proteins; Interferon-beta; Interferon Type I; Interferons; Cytokines; Intercellular Signaling Peptides and Proteins; Proteins; Biological Factors

Study Officials

• Nancy Hammond, MD

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor, Director Comprehensive Epilepsy Center

Study Record Dates

• First Submitted: June 21, 2007
• First Posted: June 25, 2007
• Study Start: June 1, 2007
• Primary Completion: February 1, 2009
• Study Completion: December 1, 2012
• Last Updated: January 22, 2014

Record last verified: 2014-01

Locations

US (2)