Completed

Progression of Spinal Fusion in Ankylosing Spondylitis

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What is being collected

Data Collection

Collected from today forward - Prospective
Who is being recruted

Axial Spondyloarthritis+8

+ Ankylosis

+ Arthritis

Over 18 Years
+14 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Case-Only

Examining characteristics of individuals with a disease in order to identify genetic or environmental factors contributing to the condition.
Observational
Study Start: December 2004
See protocol details

Summary

Principal SponsorNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Last updated: December 25, 2025
Sourced from a government-validated database.Claim as a partner

Study start date: December 3, 2004

Actual date on which the first participant was enrolled.

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.

Official TitleProgression of Spinal Fusion in Ankylosing Spondylitis 
NCT00085995
Principal SponsorNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Last updated: December 25, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

63 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Case-only

These studies focus only on individuals who have a specific disease. Researchers examine patterns—often genetic or environmental—to uncover what might be linked to the condition.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Axial SpondyloarthritisAnkylosisArthritisBone DiseasesJoint DiseasesMusculoskeletal DiseasesSpinal DiseasesSpondylitisSpondylitis, AnkylosingSpondylarthritisSpondylarthropathies

Criteria

4 inclusion criteria required to participate
Lumbar spine BASRI score of 0, 1, 2, or 3

Age 18 years or older

Diagnosis of AS by the modified New York criteria

Diagnosis of AS by the modified New York criteria (5)

10 exclusion criteria prevent from participating
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

Inability to provide informed consent.

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

National Institutes of Health Clinical Center

Bethesda, United StatesSee the location
CompletedOne Study Center