Effect of Biological Disease Modifying Anti Rheumatic Drug (bDMARD) Treatment on Spinal Fracture Incidence in Patients With Ankylosing Spondylitis (AS)

Ankylosing spondylitis (AS) is a rheumatoid disease affecting all segments of the axial skeleton, leading to the complete fusion of all spinal segments - the bamboo-spine. During the last decade biological disease modifying anti-rheumatic drugs (bDMARD) have been successfully introduced to reduce the disease activity. It is unclear whether bDMARD treatment had an effect on spinal fracture risk related to AS. This national registry study will investigate the effect of bDMARD treatment on spinal fracture risk in a national cohort of patients with AS.

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Key information

Conditions

Ankylosing Spondylitis Ankylosis Arthritis Axial Spondyloarthritis Back Injuries Bone Diseases Fractures, Bone Joint Diseases Musculoskeletal Diseases Spinal Diseases Spinal Fractures Spinal Injuries Spondylarthritis Spondylarthropathies Spondylitis Spondylitis, Ankylosing Wounds and Injuries

Age range

30 year–60 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

age 30-60 years
registered diagnosis of ankylosing spondylitis

Exclusion criteria

age <30 or >60 years

Treatment and study plan

bDMARD treatment

Drug

Treatment with bDMARD includes registered ATC-codes: L04AA and L04AB.

Other names: Biological Disease Modifying Drug treatment

Primary outcomes

Spinal fracture

Time frame: 10 years

Censored data with occurrence of spinal fracture within 10 years observation

Sponsors and collaborators

Lead sponsor

Uppsala University

Other

Registry information

Important dates

Study start: 2005
Primary completion: 2015
Study completion: 2017
First posted: Jul 21, 2016
Registry last updated: Oct 30, 2017

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.

Published trials that share one or more normalized conditions with this study.

Completed