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| Sponsored by: |
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) |
| Information provided by: | National Institutes of Health Clinical Center (CC) |
| ClinicalTrials.gov Identifier: | NCT00085995 |
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:
In addition, participants will complete a symptoms questionnaire by mail every 4 m...
| Condition |
|
Spondylitis, Ankylosing |
| Genetics Home Reference related topics: | ankylosing spondylitis |
| MedlinePlus related topics: | Ankylosing Spondylitis CT Scans MRI Scans X-Rays |
| Study Type: | Observational |
| Official Title: | Progression of Spinal Fusion in Ankylosing Spondylitis |
| Estimated Enrollment: | 30 |
| Study Start Date: | June 2004 |
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. Twenty-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. Treatment with anti-tumor necrosis factor medications is not permitted during the first study year, but there are no other restrictions on the treatments participants may receive.
Reliability of image processing will be tested on repeated measurements of baseline scans. 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 |
Twenty-five patients will be studied. Inclusion criteria are:
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 vetebrae)
EXCLUSION CRITERIA:
Contacts and Locations| Contact: Patient Recruitment and Public Liaison Office | (800) 411-1222 | prpl@mail.cc.nih.gov |
| Contact: TTY | 1-866-411-1010 |
| United States, Maryland | |||||
| Johns Hopkins University | Recruiting | ||||
| Baltimore, Maryland, United States, 21205 | |||||
More Information
NIH Clinical Center Detailed Web Page 
  |
| Study ID Numbers: | 040205, 04-AR-0205 |
| First Received: | June 18, 2004 |
| Last Updated: | July 18, 2008 |
| ClinicalTrials.gov Identifier: | NCT00085995 |
| Health Authority: | United States: Federal Government |
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