Multiple SclerosisNCT00490906
Comparison of Bone Effects With Copaxone and Interferon in Multiple Sclerosis
An observational study of Multiple Sclerosis and Low Bone Density, run by Nancy Hammond, MD at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Multiple Sclerosis, Low Bone Density
- What is being tested?
- Copaxone, Interferon-beta 1a and Interferon-beta 1b
- Type of treatment
- Injection or infusion
- How many people
- 60 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2007to Dec 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Known osteoporosis
- History of hypercalcemia
- Currently pregnant
- History of primary hyperparathyroidism, hyperthyroidism, or hypothyroidism
- Unstable medical condition
- Ongoing use of bisphosphonates
Trial locations and contacts
2 sites in 1 country.
United States2 sites
General Clinical Research Center
Kansas City, Kansas, 66160
University of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
Official title: Comparison of Bone Effects With Copaxone and Interferon in Multiple Sclerosis: A Pilot Study
The purpose of this study is to determine if certain drugs commonly used to treat multiple sclerosis have an effect on bone health.
Read the 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
- Being tested
- Copaxone, Interferon-beta 1a, Interferon-beta 1b
- Keywords
- MS (Multiple Sclerosis)
- Medical subject headings
- Multiple Sclerosis, Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CopaxoneDrug
Also called Glatiramer acetate
20 mg, subcutaneous injections, taken daily
Interferon-beta 1aDrug
Also called Avonex
30 mcg injected intramuscularly, once weekly
Interferon-beta 1bDrug
Also called Betaseron
.25 mg/day, taken every other day, subcutaneous injections
| Study group | Role | What they receive |
|---|---|---|
| 1 | Patients receive Copaxone Receives: Drug: Copaxone | |
| 2 | Patients receive interferons Receives: Drug: Interferon-beta 1a; Drug: Interferon-beta 1b |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2007 (estimated)
- Study startJun 2007
- Primary completionFeb 2009
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nancy Hammond, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Kansas City Area Life Sciences Institute, Inc.
- Responsible party
- Sponsor-investigator, Nancy Hammond, MD, University of Kansas Medical Center
- Investigators
- Nancy Hammond, MD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00490906
- Sponsor's protocol ID
- KCALSI-06-01
- Status last verified
- Jan 2014
- First submitted
- 21 Jun 2007
- Last updated
- 22 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Bone Effects With Copaxone and Interferon in Multiple Sclerosis: A Pilot Study
- ClinicalTrials.gov ID
- NCT00490906
- Acronym / sponsor ID
- KCALSI-06-01
- Conditions
- Multiple Sclerosis, Low Bone Density
- Keywords
- MS (Multiple Sclerosis)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Nancy Hammond, MDUniversity, hospital or other
- Collaborators
- Kansas City Area Life Sciences Institute, Inc.
- Study start
- Jun 2007
- Primary completion
- Feb 2009 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 25 Jun 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Drug: CopaxonePatients receive Copaxone |
| 2 | – | Drug: Interferon-beta 1a, Drug: Interferon-beta 1bPatients receive interferons |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- Known osteoporosis
- History of hypercalcemia
- Currently pregnant
- History of primary hyperparathyroidism, hyperthyroidism, or hypothyroidism
- Unstable medical condition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CopaxoneAlso: Glatiramer acetate20 mg, subcutaneous injections, taken daily | Drug | 1 |
| Interferon-beta 1aAlso: Avonex30 mcg injected intramuscularly, once weekly | Drug | 2 |
| Interferon-beta 1bAlso: Betaseron.25 mg/day, taken every other day, subcutaneous injections | Drug | 2 |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nancy Hammond, MD principal investigator
University of Kansas Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis and Low Bone Density, run by Nancy Hammond, MD at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2014.