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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02840695

Enrollment

9858

Registered

2016-07-21

Start date

2005-01-31

Completion date

2017-10-24

Last updated

2017-10-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ankylosing Spondylitis, Spinal Fractures

Brief summary

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.

Interventions

DRUGbDMARD treatment

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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

30 Years to 60 Years

Healthy volunteers

Inclusion criteria

* age 30-60 years * registered diagnosis of ankylosing spondylitis

Exclusion criteria

* age \<30 or \>60 years

Design outcomes

Primary

Measure	Time frame	Description
Spinal fracture	10 years	Censored data with occurrence of spinal fracture within 10 years observation

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 25, 2026