Progression of Spinal Fusion in Ankylosing Spondylitis

NCT00085995 | Completed

• 2 other identifiers: 04020504-AR-0205
• Study Type: observational
• Target: 63
• Locations: 1 country
• Sites: 1

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.

Conditions

Ankylosing Spondylitis

Keywords

Syndesmophyte; Natural History; Ankylosing Spondylitis; AS; Spondyloarthropathy; Spondyloarthritis

Outcome Measures

Primary Outcomes (1)

• Syndesmophyte growth

  syndesmophyte growth by CT

  1 and 2 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

clinical sample

You may qualify if:

• Age 18 years or older
• Diagnosis of AS by the modified New York criteria
• 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:
• or 1 (normal or suspicious changes)
• (erosions, sclerosis or squaring with or without syndesmophytes or 2 or fewer vertebrae)
• (syndesmophytes on 3 or more vertebrae with fusion of at most 2 vertebrae)

You may not qualify if:

• Inability to provide informed consent.
• BASRI lumbar spine score of 4 (complete fusion; 12)
• Contraindication to MRI scanning based on the NMR Center MRI Safety Screening Questionnaire or size or weight limitations of the scanner.
• History of allergic reactions to gadolinium-DPTA contrast used for MRI
• Anticipated unavailability for follow-up over 2 years
• Pregnancy
• Onset of AS at age 16 or younger
• Spondyloarthropathy other than AS
• Severe scoliosis or other spinal malalignment that would complicate scan interpretation
• B. CROSS-SECTIONAL (RELIABILITY) STUDY PROTOCOL
• Up to 35 patients will be studied.
• Age 18 years or older
• Diagnosis of AS by the modified New York criteria (5)
• Inability to provide informed consent
• BASRI lumbar spine score of 4 (complete fusion)\<TAB\>

Sponsors & Collaborators

• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• Keaveny TM. Biomechanical computed tomography-noninvasive bone strength analysis using clinical computed tomography scans. Ann N Y Acad Sci. 2010 Mar;1192:57-65. doi: 10.1111/j.1749-6632.2009.05348.x.

  PMID: 20392218 BACKGROUND

• Simkin PA, Downey DJ, Kilcoyne RF. Apophyseal arthritis limits lumbar motion in patients with ankylosing spondylitis. Arthritis Rheum. 1988 Jun;31(6):798-802. doi: 10.1002/art.1780310617.

  PMID: 3382452 BACKGROUND

• Cann CE, Genant HK, Kolb FO, Ettinger B. Quantitative computed tomography for prediction of vertebral fracture risk. Bone. 1985;6(1):1-7. doi: 10.1016/8756-3282(85)90399-0.

  PMID: 3994856 BACKGROUND

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Spondylitis, Ankylosing; Spondylarthropathies; Spondylarthritis

Condition Hierarchy (Ancestors)

Axial Spondyloarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Ankylosis; Joint Diseases; Arthritis

Study Officials

• Robert A Colbert, M.D.

  National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2004
• First Posted: June 21, 2004
• Study Start: December 3, 2004
• Primary Completion: October 18, 2019
• Study Completion: February 13, 2021
• Last Updated: April 16, 2026

Record last verified: 2026-04

Locations

US (1)