Progression of Spinal Fusion in Ankylosing Spondylitis

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.

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Key information

Conditions

Ankylosing Spondylitis Ankylosis Arthritis Axial Spondyloarthritis Bone Diseases Joint Diseases Musculoskeletal Diseases Spinal Diseases Spondylarthritis Spondylarthropathies Spondylitis Spondylitis, Ankylosing

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

A. LONGITUDINAL STUDY PROTOCOL:

Fifty-five patients will be studied.

Inclusion criteria

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:

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

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.

Inclusion criteria

Age 18 years or older
Diagnosis of AS by the modified New York criteria (5)

Exclusion criteria

Inability to provide informed consent
BASRI lumbar spine score of 4 (complete fusion)<TAB>
Pregnancy
Onset of AS at age 16 or younger
Spondyloarthropathy other than AS
Severe scoliosis or other spinal malalignment that would complicate scan interpretation

Treatment and study plan

Primary outcomes

Syndesmophyte growth

Time frame: 1 and 2 years

syndesmophyte growth by CT

Sponsors and collaborators

Lead sponsor

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

Nih

Registry information

Important dates

Study start: 2004
Primary completion: 2019
Study completion: 2021
First posted: Jun 21, 2004
Registry last updated: Apr 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed