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

Completed

• Conditions: Ankylosing Spondylitis; Spinal Fractures
• Interventions: Drug: bDMARD treatment

• Registration Number: NCT02840695
• Lead Sponsor: Uppsala University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-01
• Primary Completion: 2015-12
• Study First Submitted: 2016-07-18
• Study First Submitted QC: 2016-07-18
• Study First Posted: 2016-07-21
• Status Verified: 2017-10
• Study Completion: 2017-10-24
• Last Update Submitted: 2017-10-27
• Last Update Posted: 2017-10-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9858

Inclusion Criteria

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

Exclusion Criteria

• age <30 or >60 years

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
AS patients	bDMARD treatment	Patients registered in the Swedish Patient Registry with active AS treated with or without biological DMARD according to the Swedish Prescribed Drugs Registry, with or without spinal fractures

Primary Outcome Measures

Name	Time	Method
Spinal fracture	10 years	Censored data with occurrence of spinal fracture within 10 years observation