Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00085995
Status:
COMPLETED
Last Update Posted:
2024-07-15
First Post:
2004-06-18
Brief Title:
Progression of Spinal Fusion in Ankylosing Spondylitis
Sponsor:
National Institute of Arthritis and Musculoskeletal and Skin Diseases NIAMS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Progression of Spinal Fusion in Ankylosing Spondylitis
Status:
COMPLETED
Status Verified Date:
2024-08-29
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will evaluate 1 whether computed tomography CT scanning is better than regular x-rays for measuring changes in the stiffness or fusion of the spine in patients with ankylosing spondylitis and 2 if CT can be used to determine how fast extra bone forms in the spine of these patients Better ways to measure spinal fusion are needed to be able to evaluate the effectiveness of medicines in slowing or stopping its progression CT uses x-rays to provide detailed pictures of the inside of the body and are valuable for detecting spinal abnormalities because of the precision with which it can show these structures For the procedure the patient lies on a table that moves into a large donut-shaped scanner that can move around the body to take pictures at different angles which are viewed on a computer monitor
Patients 18 years of age and older with ankylosing spondylitis who are not currently taking or planning to receive treatment with anti-TNF alpha medications etanercept infliximab adalimumab for 1 year may be eligible for this study Participants have eight clinic visits scheduled at study entry and at 4 8 12 16 20 24 and 48 months at the NIH Clinical Center for the following procedures
Clinical assessment all visits - includes medical history and physical examination measurement of spine flexibility with a tape measure and protractor symptoms questionnaire
Blood tests for measures of inflammation including red blood cell sedimentation rate and C-reactive protein level all visits
Urine pregnancy test in women of child-bearing age visits 1 4 7 8
X-rays of the pelvis low back and neck visits 1 4 7
X-ray of the low back visit 8
CT scan of the low back visits 1 4 7
Magnetic resonance imaging MRI of the low back visits 1 4 - MRI combines a powerful magnet with an advanced computer system and radio waves to produce accurate detailed pictures of organs and tissues The patient lies on a table in a narrow cylinder containing a magnetic field wearing earplugs to muffle loud noises that occur with electrical switching of the magnetic fields He or she can speak with a staff member via an intercom system at all times during the procedure During the scan a contrast dye gadolinium is injected into the bloodstream through a catheter plastic tube inserted in a vein to brighten the images
In addition participants will complete a symptoms questionnaire by mail every 4 months for 2 years between visits 7 and 8
Patients 18 years of age and older with ankylosing spondylitis who are not currently taking or planning to receive treatment with anti-TNF alpha medications etanercept infliximab adalimumab for 1 year may be eligible for this study Participants have eight clinic visits scheduled at study entry and at 4 8 12 16 20 24 and 48 months at the NIH Clinical Center for the following procedures
Clinical assessment all visits - includes medical history and physical examination measurement of spine flexibility with a tape measure and protractor symptoms questionnaire
Blood tests for measures of inflammation including red blood cell sedimentation rate and C-reactive protein level all visits
Urine pregnancy test in women of child-bearing age visits 1 4 7 8
X-rays of the pelvis low back and neck visits 1 4 7
X-ray of the low back visit 8
CT scan of the low back visits 1 4 7
Magnetic resonance imaging MRI of the low back visits 1 4 - MRI combines a powerful magnet with an advanced computer system and radio waves to produce accurate detailed pictures of organs and tissues The patient lies on a table in a narrow cylinder containing a magnetic field wearing earplugs to muffle loud noises that occur with electrical switching of the magnetic fields He or she can speak with a staff member via an intercom system at all times during the procedure During the scan a contrast dye gadolinium is injected into the bloodstream through a catheter plastic tube inserted in a vein to brighten the images
In addition participants will complete a symptoms questionnaire by mail every 4 months for 2 years between visits 7 and 8
Detailed Description:
Spinal fusion is the clinical radiological and pathological hallmark of ankylosing spondylitis AS However spinal fusion occurs slowly in AS Serial radiographs rarely show changes over 2 years and often 5 or more years are needed to demonstrate progression of spinal fusion Methods that are more sensitive to changes in the extent of spinal fusion than plain radiographs are needed to test if any treatments can slow or halt spinal fusion in AS The need for an improved measure of spinal fusion is heightened now that several new medications are available that have the potential to markedly decrease spinal inflammation in AS
The goal of this pilot study is to test whether measurement of bone mineral density bone volume or bone mass at the annulus fibrosis of lumbar disc spaces by computed tomography CT can provide a reliable valid and sensitive measure of spinal fusion in patients with AS Fifty-five participants will have lumbar spine CT scans at baseline 12 months and 24 months lumbar spine magnetic resonance imaging at baseline and 12 months and spinal radiographs at baseline 12 months 24 months and 48 months In addition clinical assessments will be done every 4 months during the first 24 months An option to perform only the baseline studies is also possible No treatment is provided in the protocol Reliability of image processing will be tested on repeated measurements of baseline scans Reliability will also be assessed with repeat CT scans on up to 10 participants Construct validity will be tested by correlation of CT measures with scores of plain radiographs lumbar magnetic resonance imaging and spinal range of motion The sensitivity to change of the CT measures over 12 months and 24 months will be compared to those of two scoring systems based on plain radiographs
The goal of this pilot study is to test whether measurement of bone mineral density bone volume or bone mass at the annulus fibrosis of lumbar disc spaces by computed tomography CT can provide a reliable valid and sensitive measure of spinal fusion in patients with AS Fifty-five participants will have lumbar spine CT scans at baseline 12 months and 24 months lumbar spine magnetic resonance imaging at baseline and 12 months and spinal radiographs at baseline 12 months 24 months and 48 months In addition clinical assessments will be done every 4 months during the first 24 months An option to perform only the baseline studies is also possible No treatment is provided in the protocol Reliability of image processing will be tested on repeated measurements of baseline scans Reliability will also be assessed with repeat CT scans on up to 10 participants Construct validity will be tested by correlation of CT measures with scores of plain radiographs lumbar magnetic resonance imaging and spinal range of motion The sensitivity to change of the CT measures over 12 months and 24 months will be compared to those of two scoring systems based on plain radiographs
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 04-AR-0205 | None | None | None |