Avascular NecrosisPhase 2NCT00412841
Atorvastatin to Prevent Avascular Necrosis of Bone in Steroid Treated Exacerbated Systemic Lupus Erythematosus
A Phase 2 study testing Atorvastatin and MRI, Venipuncture in people with Avascular Necrosis, run by NYU Langone Health at 1 site in United States.
Trial summary
This study uses the cholesterol lowering drug atorvastatin, also known as lipitor, to show reduction of avascular necrosis in steroid treated lupus patients. Avascular necrosis is a disease resulting from the loss of blood supply to the bones which can cause the bone to collapse. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Avascular Necrosis
- What is being tested?
- Atorvastatin and MRI, Venipuncture
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2002to Jan 2008
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All individuals must fulfill 4 of the revised criteria of the American College of Rheumatology for SLE
- Patient started on corticosteroids at a dose of at least .5mg/kg for an interval greater than two weeks
- To be able to come for all follow-up visits for nine months
- No contraindications to undergoing MRI
- Age 18-75 years
Who cannot join
- Evidence of liver disease, not secondary to active lupus, or liver enzyme greater than 2x normal
- Elevated CPK at baseline
- Pregnancy or Lactating
- Allergy to a statin
- Current or recent use of a statin within 3 months
Trial locations and contacts
1 site in 1 country.
United States1 site
The New York University Hospital For Joint Diseases
New York, New York, 10003
About this study
Official title: AVN Prevention With Lipitor in Lupus Erythematosus APLLE Trial
This study uses the cholesterol lowering drug atorvastatin, also known as lipitor, to show reduction of avascular necrosis in steroid treated lupus patients. Avascular necrosis is a disease resulting from the loss of blood supply to the bones which can cause the bone to collapse. The collapse of bone may require a surgical replacement of the joint and can be disabling for life. Avascular necrosis is presently not preventable but research has shown that lipid lowering drugs such as lipitor can reduce or prevent avascular necrosis in animals. We therefore hypothesize that lipitor will reduce the incidence of avascular necrosis in lupus patients taking high dose steroids.
Read the detailed description
If you have started on prednisone 30mg or greater and expect to be on it for greater than two weeks you may be a candidate for the study. Also, you would need to be enrolled in the study within three days of starting prednisone. If you are eligible you will receive lipitor 40mg per day or pills which look exactly like lipitor but do not contain any medication (called placebo). During the time of the study, you will not know if you are taking lipitor or the placebo. The period of time that you will receive lipitor or placebo is 9 months and you must be willing to return for 5 follow up visits during this time which include blood tests, physical exams and 3 MRI studies of the hips, knees and ankles.
- Conditions
- Avascular Necrosis
- Being tested
- Atorvastatin, MRI, Venipuncture, Placebo
- Keywords
- Avascular Necrosis, Lipitor, SLE
- Medical subject headings
- Osteonecrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtorvastatinDrug
Also called Atorvasatatin 40mg vs Placebo
Atorvastatin 40mg vs placebo 40mg daily
MRI, VenipunctureProcedure or surgery
Also called MRI at baseline, 4 months and 9 months
MRIs done baseline, four and nine months
PlaceboDrug
Tablets identical to atorvastatin 40mg
| Study group | Role | What they receive |
|---|---|---|
| Atorvastatin | Experimental | Atorvastatin 40mg Receives: Drug: Atorvastatin; Procedure: MRI, Venipuncture |
| Placebo | Placebo comparator | Tablets identical to atorvastatin 40mg Receives: Procedure: MRI, Venipuncture; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With AVN After 9 Months
Measured: 9 months
Secondary outcomes (3)
Number of Participants With AVN After 4 Months
Measured: 4 months
To Determine if Atorvastatin is Effective in Lowering Serum Lipid Levels Chol, TG, HDL, & LDL in SLE Patients
Measured: 6 years
To Determine if Atorvastatin Has an Anti-inflammatory Effect in Active SLE That Reduces Biological Markers of the Inflammatory Process (ESR, Hs-CRP) and Reduces Disease Activity Assessed by Serology (C3, C4, Anti-dsDNA) or Clinical Instrument (SLEDAI)
Measured: 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2006 (estimated)
- Study startNov 2002
- Primary completionJan 2008
- Study completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Avascular NecrosisStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Howard M Belmont, M.D., Principal investigator, The New York University Hospital for Joint Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00412841
- Sponsor's protocol ID
- H-8795
- Status last verified
- Oct 2018
- First submitted
- 18 Dec 2006
- Last updated
- 23 Nov 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Belmont HM, Lydon E. Avascular necrosis prevention with lipitor in lupus erythematosus. Lupus. 2005;14(10):869-70. doi: 10.1191/0961203305lu2189xx. No abstract available.
PubMed 16302686
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AVN Prevention With Lipitor in Lupus Erythematosus APLLE Trial
- ClinicalTrials.gov ID
- NCT00412841
- Acronym / sponsor ID
- H-8795
- Conditions
- Avascular Necrosis
- Keywords
- Avascular Necrosis, Lipitor, SLE
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 43 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- Nov 2002
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 19 Dec 2006 (estimated)
- Results
- Posted 3 Mar 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study uses the cholesterol lowering drug atorvastatin, also known as lipitor, to show reduction of avascular necrosis in steroid treated lupus patients. Avascular necrosis is a disease resulting from the loss of blood supply to the bones which can cause the bone to collapse. The collapse of bone may require a surgical replacement of the joint and can be disabling for life. Avascular necrosis is presently not preventable but research has shown that lipid lowering drugs such as lipitor can reduce or prevent avascular necrosis in animals. We therefore hypothesize that lipitor will reduce the incidence of avascular necrosis in lupus patients taking high dose steroids.
Detailed description
If you have started on prednisone 30mg or greater and expect to be on it for greater than two weeks you may be a candidate for the study. Also, you would need to be enrolled in the study within three days of starting prednisone. If you are eligible you will receive lipitor 40mg per day or pills which look exactly like lipitor but do not contain any medication (called placebo). During the time of the study, you will not know if you are taking lipitor or the placebo. The period of time that you will receive lipitor or placebo is 9 months and you must be willing to return for 5 follow up visits during this time which include blood tests, physical exams and 3 MRI studies of the hips, knees and ankles.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Atorvastatin | Experimental | Drug: Atorvastatin, Procedure: MRI, VenipunctureAtorvastatin 40mg |
| Placebo | Placebo comparator | Procedure: MRI, Venipuncture, Drug: PlaceboTablets identical to atorvastatin 40mg |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- All individuals must fulfill 4 of the revised criteria of the American College of Rheumatology for SLE
- Patient started on corticosteroids at a dose of at least .5mg/kg for an interval greater than two weeks
- To be able to come for all follow-up visits for nine months
- No contraindications to undergoing MRI
- Age 18-75 years
Key exclusion criteria (5 listed)
- Evidence of liver disease, not secondary to active lupus, or liver enzyme greater than 2x normal
- Elevated CPK at baseline
- Pregnancy or Lactating
- Allergy to a statin
- Current or recent use of a statin within 3 months
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 |
|---|---|---|
| AtorvastatinAlso: Atorvasatatin 40mg vs PlaceboAtorvastatin 40mg vs placebo 40mg daily | Drug | Atorvastatin |
| MRI, VenipunctureAlso: MRI at baseline, 4 months and 9 monthsMRIs done baseline, four and nine months | Procedure or surgery | Atorvastatin, Placebo |
| PlaceboTablets identical to atorvastatin 40mg | Drug | Placebo |
Primary outcome
Number of Participants With AVN After 9 Months
Time frame: 9 months
3 secondary outcomes
Number of Participants With AVN After 4 Months
Time frame: 4 months
To Determine if Atorvastatin is Effective in Lowering Serum Lipid Levels Chol, TG, HDL, & LDL in SLE Patients
Time frame: 6 years
To Determine if Atorvastatin Has an Anti-inflammatory Effect in Active SLE That Reduces Biological Markers of the Inflammatory Process (ESR, Hs-CRP) and Reduces Disease Activity Assessed by Serology (C3, C4, Anti-dsDNA) or Clinical Instrument (SLEDAI)
Time frame: 6 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 16302686Belmont HM, Lydon E. Avascular necrosis prevention with lipitor in lupus erythematosus. Lupus. 2005;14(10):869-70. doi: 10.1191/0961203305lu2189xx. No abstract available.
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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.
Howard M Belmont, M.D. principal investigator
The New York University Hospital for Joint Diseases
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Atorvastatin and MRI, Venipuncture in people with Avascular Necrosis, run by NYU Langone Health 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 5 inclusion and 5 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: stopped early, as of the sponsor's last update on 23 Nov 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Mar 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With AVN After 9 Months (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00412841, which also lists 1 linked publication.
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 23 Nov 2018.