Multiple SclerosisMS-BMDNCT01811290
A Pilot Study Assessing the Impact of Gilenya Therapy on Bone Density Change in Relapsing Forms of Multiple Sclerosis
An observational study of Multiple Sclerosis, run by Simnad, Virginia, M.D. at 1 site in United States.
Trial summary
The purpose of this study is to assess whether Multiple Sclerosis patients treated with Gilenya show a beneficial change over time in bone mass density and bone turnover markers as compared to matched controls treated with alternative FDA approved therapy or no therapy. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Multiple Sclerosis
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to Dec 2018
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Men and women aged 21 or older diagnosed with a relapsing form of Multiple Sclerosis. Minimum age was defined due to the limitations of site's current DXA bone scan software in scanning any person under 21 years of age. A total of 36 subjects will be recruited, with estimated 20% screen failure/early termination to allow for 30 subjects enrolled to complete the study. Racial composition of the regional population (Puget Sound of the Pacific Northwest, USA) from which study candidates will be recruited over-represents Caucasian individuals, and thus this pilot study may not be balanced for race.
Who may be able to join
- • Male and female subjects, 21 years of age or older.
- Subjects must be able to give consent by signing and dating an informed consent form (written in English) prior to any study assessments being performed.
- Ambulatory with an Expanded Disability Status Scale(EDSS) between 2.5 - 6.5 inclusive.
- Must meet McDonald criteria for a relapsing form (relapsing remitting and secondary progressive) of Multiple Sclerosis.
- Gilenya therapy group subjects must have been treated with Gilenya a minimum of 3 months uninterrupted prior to screening visit, and approved by the principal investigator to continue on this agent.
- Control therapy group subjects must have been consistently on an FDA approved disease modifying therapy other than Gilenya or off such therapy a minimum of 6 months prior to screening visit.
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- Subjects must be neurologically stable and have not received any form of steroid therapy for 4 weeks prior to screening visit.
- Subjects must abide by safety surveillance monitoring studies appropriate to their disease modifying therapy and considered standard of care. Such monitoring will be considered outside the scope of this study.
- Subjects must be willing and able to comply with the protocol requirements for the duration of the study.
Who cannot join
- • Subjects must not have been treated with Fingolimod, Gilenya or other experimental Sphingosine 1-phosphate receptor agonist therapy in a clinical trial prior to enrollment in this study.
- Subjects on an FDA approved disease modifying therapy other than Gilenya, or on no therapy, must not have received Gilenya therapy within 12 months of screening visit.
- Current or previous use of bisphosphonate therapy, estrogen replacement, calcitonin, Depo-Provera, dehydroepiandrosterone, or methotrexate within 12 months of screening visit.
- Medical contraindication to daily calcium intake of at least 1000 mg daily, and vitamin D3 supplementation of 800 IU daily.
- Vitamin D insufficiency (25-hydroxy vitamin D level <=30 ng/ml) at the time of baseline visit.
- Meeting National Osteoporosis Foundation criteria for osteoporosis requiring treatment with study prohibited therapies:
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- History of osteoporosis with baseline Dexa bone scan T score <-1.5 but >-2.0 with one or more risk factors for fracture (age >50 years, current smoking, low Body Mass Index (i.e. < 18.5), previous fragility fracture, parental history of osteoporosis or of fragility fracture of hip, femur, or vertebrae , alcohol consumption greater than 3 units per day, daily glucocorticoid usage).
- Dexa bone scan T score < -2.0 with or without additional risk factors.
- Subjects with Body Mass Index >=40 kg/m2 due to artifacts in Body mass density measurement with Dexa unit used.
- Subjects with anatomical deformities or vertebral fractures that would potentially distort Body mass density measurements.
- Current diagnosis of parathyroid disorder, untreated hyperthyroidism or hypothyroidism, renal insufficiency (Glomerular filtration rate- (GFR) <= 55), history of renal calculi or stones, uncontrolled mood disorder, drug or alcohol abuse.
- Current use of "first generation" anticonvulsant medication (barbiturate, phenytoin, carbamazepine, valproate), or of "second generation" anticonvulsant levetiracetam (implicated recently in accelerated bone density loss). Stable use of "second generation" anticonvulsant medication (gabapentin, pregabalin, lamotrigine, topiramate, lacosamide, zonisamide, oxcarbazepine) for symptoms management will be acceptable. Stable use of dopamine reuptake inhibitor class, Serotonin Norepinephrine Reuptake Inhibitors, Selective serotonin re-uptake inhibitor antidepressant therapies will be allowed.
- Continuous or "pulsed" treatment with a corticosteroid for any medical condition. Brief therapy with intravenous methylprednisolone 1 gram for 3-5 days with no oral taper, for a confirmed neurological relapse will be allowed.
- Subjects must not have any unstable medical or psychiatric condition per the judgment of the principal investigator which would risk safety or completion of the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
MS Center at Evergreen Health
Kirkland, Washington, 98034
About this study
Official title: A Single Center Prospective, Open Label, Pilot Study to Assess Change in Bone Mass Density and Select Bone Turnover Biomarkers in Gilenya Treated Versus Non-Gilenya Treated Ambulatory Subjects With a Relapsing Form of Multiple Sclerosis
The purpose of this study is to assess whether Multiple Sclerosis patients treated with Gilenya show a beneficial change over time in bone mass density and bone turnover markers as compared to matched controls treated with alternative FDA approved therapy or no therapy.
Read the detailed description
To assess the effect of Gilenya on the rate of decline in bone mass density and expression of selected bone turnover biomarkers in ambulatory subject with a relapsing form of Multiple Sclerosis compared to control subjects matched for age, race, gender, duration of disease, and disability on an alternative FDA approved disease modifying therapy or no therapy at 24 months compared to baseline.
- Conditions
- Multiple Sclerosis
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Gilenya Subjects | Gilenya therapy group subjects must have been treated with Gilenya a minimum of 3 months uninterrupted prior to screening visit, and approved by the principal investigator to continue on this agent. | |
| Controlled Therapy Group | Control therapy group subjects must have been consistently on an FDA approved disease modifying therapy other than Gilenya or off such therapy a minimum of 6 months prior to screening visit. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess change in bone mass density in subjects taking Gilenya versus subjects taking alternative disease modifying therapy or no therapy.
The primary objective of this pilot study will be to assess the effect of Gilenya (fingolimod) on the rate of decline in bone mass density and expression of selected bone turnover biomarkers over 2 years in ambulatory subjects with a relapsing form of Multiple Sclerosis compared to control subjects matched for age, gender, race, duration of disease, and disability on an alternative FDA approved disease modifying therapy or no therapy.
Measured: baseline and 22 months (96 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2013 (estimated)
- Study startJan 2013
- Primary completionJul 2018 (estimated)
- Study completionDec 2018 (estimated)
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
- Other
- Time perspective
- Prospective
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Simnad, Virginia, M.D.
- Collaborators
- Novartis
- Responsible party
- Principal investigator, Virginia I. Simnad, MD, Simnad, Virginia, M.D.
- Investigators
- Virginia I Simnad, MD, Principal investigator, Evergreen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01811290
- Sponsor's protocol ID
- MS-BMD
- Acronym
- MS-BMD
- Status last verified
- Jan 2018
- First submitted
- 8 Mar 2013
- Last updated
- 1 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Center Prospective, Open Label, Pilot Study to Assess Change in Bone Mass Density and Select Bone Turnover Biomarkers in Gilenya Treated Versus Non-Gilenya Treated Ambulatory Subjects With a Relapsing Form of Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT01811290
- Acronym / sponsor ID
- MS-BMD / MS-BMD
- Conditions
- Multiple Sclerosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Simnad, Virginia, M.D.
- Collaborators
- Novartis
- Study start
- Jan 2013
- Primary completion
- Jul 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 14 Mar 2013 (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 assess whether Multiple Sclerosis patients treated with Gilenya show a beneficial change over time in bone mass density and bone turnover markers as compared to matched controls treated with alternative FDA approved therapy or no therapy.
Detailed description
To assess the effect of Gilenya on the rate of decline in bone mass density and expression of selected bone turnover biomarkers in ambulatory subject with a relapsing form of Multiple Sclerosis compared to control subjects matched for age, race, gender, duration of disease, and disability on an alternative FDA approved disease modifying therapy or no therapy at 24 months compared to baseline.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gilenya Subjects | – | –Gilenya therapy group subjects must have been treated with Gilenya a minimum of 3 months uninterrupted prior to screening visit, and approved by the principal investigator to continue on this agent. |
| Controlled Therapy Group | – | –Control therapy group subjects must have been consistently on an FDA approved disease modifying therapy other than Gilenya or off such therapy a minimum of 6 months prior to screening visit. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Men and women aged 21 or older diagnosed with a relapsing form of Multiple Sclerosis. Minimum age was defined due to the limitations of site's current DXA bone scan software in scanning any person under 21 years of age. A total of 36 subjects will be recruited, with estimated 20% screen failure/early termination to allow for 30 subjects enrolled to complete the study. Racial composition of the regional population (Puget Sound of the Pacific Northwest, USA) from which study candidates will be recruited over-represents Caucasian individuals, and thus this pilot study may not be balanced for race.
Key inclusion criteria (9 listed)
- • Male and female subjects, 21 years of age or older.
Key exclusion criteria (14 listed)
- • Subjects must not have been treated with Fingolimod, Gilenya or other experimental Sphingosine 1-phosphate receptor agonist therapy in a clinical trial prior to enrollment in this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Assess change in bone mass density in subjects taking Gilenya versus subjects taking alternative disease modifying therapy or no therapy.
Time frame: baseline and 22 months (96 weeks)
The primary objective of this pilot study will be to assess the effect of Gilenya (fingolimod) on the rate of decline in bone mass density and expression of selected bone turnover biomarkers over 2 years in ambulatory subjects with a relapsing form of Multiple Sclerosis compared to control subjects matched for age, gender, race, duration of disease, and disability on an alternative FDA approved disease modifying therapy or no therapy.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2018.
- Individual participant dataSharing planned: No
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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.
Virginia I Simnad, MD principal investigator
Evergreen Hospital
1 site 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, run by Simnad, Virginia, M.D. at 1 site 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 9 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 1 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
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.
What does the primary outcome measure?
Assess change in bone mass density in subjects taking Gilenya versus subjects taking alternative disease modifying therapy or no therapy. (time frame: baseline and 22 months (96 weeks)). It is what the study was designed to measure, not a finding.
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 1 Feb 2018.