Progression of Spinal Fusion in Ankylosing Spondylitis

This study is currently recruiting participants.
Verified October 2013 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00085995
First received: June 18, 2004
Last updated: March 14, 2014
Last verified: October 2013
  Purpose

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.


Condition
Spondylitis, Ankylosing

Study Type: Observational
Official Title: Progression of Spinal Fusion in Ankylosing Spondylitis

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 65
Study Start Date: June 2004
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. 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • A. LONGITUDINAL STUDY PROTOCOL:

Fifty-five patients will be studied.

INCLUSION CRITERIA:

  1. Age 18 years or older
  2. Diagnosis of AS by the modified New York criteria
  3. Lumbar spine BASRI score of 0, 1, 2, or 3

We will aim to recruit at least 6 patients in each of the following BASRI lumbar spine categories:

  • 0 or 1 (normal or suspicious changes)
  • 2 (erosions, sclerosis or squaring with or without syndesmophytes or 2 or fewer vertebrae)
  • 3 (syndesmophytes on 3 or more vertebrae with fusion of at most 2 vertebrae)

EXCLUSION CRITERIA:

  1. Inability to provide informed consent.
  2. BASRI lumbar spine score of 4 (complete fusion; 12)
  3. Contraindication to MRI scanning based on the NMR Center MRI Safety Screening Questionnaire or size or weight limitations of the scanner.
  4. History of allergic reactions to gadolinium-DPTA contrast used for MRI
  5. Anticipated unavailability for follow-up over 2 years
  6. Pregnancy
  7. Onset of AS at age 16 or younger
  8. Spondyloarthropathy other than AS

B. CROSS-SECTIONAL (RELIABILITY) STUDY PROTOCOL

Up to 10 patients will be studied.

INCLUSION CRITERIA:

  1. Age 18 years or older
  2. Diagnosis of AS by the modified New York criteria (5)
  3. Lumbar spine BASRI score of 2, or 3 (i.e. presence of at least one syndesmophyte)(12)

EXCLUSION CRITERIA:

  1. Inability to provide informed consent
  2. BASRI lumbar spine score of 0, 1, or 4 (complete fusion)< TAB>
  3. Pregnancy
  4. Onset of AS at age 16 or younger
  5. Spondyloarthropathy other than AS
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00085995

Contacts
Contact: Eileen D Lange, R.N. (301) 435-8434 langeeil@mail.nih.gov
Contact: Michael M Ward, M.D. (301) 496-7263 wardm1@mail.nih.gov

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL)    800-411-1222 ext TTY8664111010    prpl@mail.cc.nih.gov   
Sponsors and Collaborators
Investigators
Principal Investigator: Michael M Ward, M.D. National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00085995     History of Changes
Other Study ID Numbers: 040205, 04-AR-0205
Study First Received: June 18, 2004
Last Updated: March 14, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Computerized Tomography
Magnetic Resonance Imaging
Health Outcomes
Ankylosing Spondylitis
AS
Spondyloarthropathy
Spondyloarthritis

Additional relevant MeSH terms:
Spondylitis
Spondylitis, Ankylosing
Bone Diseases, Infectious
Infection
Bone Diseases
Musculoskeletal Diseases
Spinal Diseases
Spondylarthropathies
Spondylarthritis
Ankylosis
Joint Diseases
Arthritis

ClinicalTrials.gov processed this record on April 22, 2014