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Completed

NCT Number: NCT00490906

Comparison of Bone Effects With Copaxone and Interferon in Multiple Sclerosis

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

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Bone Diseases Bone Diseases, Metabolic Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Low Bone Density Metabolic Diseases Musculoskeletal Diseases Nervous System Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

General Clinical Research Center, Kansas City, Kansas, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Copaxone

Drug

20 mg, subcutaneous injections, taken daily

Other names: Glatiramer acetate

Interferon-beta 1a

Drug

30 mcg injected intramuscularly, once weekly

Other names: Avonex

Interferon-beta 1b

Drug

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

Other names: Betaseron

Sponsors and collaborators

Lead sponsor

Nancy Hammond, MD

Other

Collaborators

  • Kansas City Area Life Sciences Institute, Inc.

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2009
Study completion
2012
First posted
Jun 25, 2007
Registry last updated
Jan 22, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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