NCT00858819

Brief Summary

This is an observational study aiming to study the prevalence and risk factors for osteoporosis and vertebral fractures in patients with ankylosing spondylitis attending three Rheumatology clinics in Western Sweden.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2009

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

March 9, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 10, 2009

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
2.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

May 29, 2015

Status Verified

May 1, 2015

Enrollment Period

3.2 years

First QC Date

March 9, 2009

Last Update Submit

May 28, 2015

Conditions

Ankylosing Spondylitis

Keywords

OsteoporosisFracturesBone Mineral DensityQuantitative Computed Tomography

Outcome Measures

Primary Outcomes (1)

  • The prevalence of osteoporosis and osteoporosis related fractures in patients with AS in Western Sweden.

    October 2009

Secondary Outcomes (1)

  • To investigate which method is the most reliable for measuring bone mineral density in ankylosing spondylitis

    May 2010

Study Arms (1)

AS

Patients with AS attending three different rheumatology clinics in Western Sweden have been invited to participate.

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with definitive ankylosing spondylitis attending three rheumatology clinics in Western Sweden.

You may qualify if:

  • Definitive Ankylosing spondylitis according to the New York criteria
  • At least 18 years old

You may not qualify if:

  • Pregnant
  • Dementia
  • Not able to understand, speak or read Swedish

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Rheumatology and Inflammation Research

Gothenburg, S-41346, Sweden

Location

Related Publications (5)

  • Klingberg E, Magnusson MK, Strid H, Deminger A, Stahl A, Sundin J, Simren M, Carlsten H, Ohman L, Forsblad-d'Elia H. A distinct gut microbiota composition in patients with ankylosing spondylitis is associated with increased levels of fecal calprotectin. Arthritis Res Ther. 2019 Nov 27;21(1):248. doi: 10.1186/s13075-019-2018-4.

    PMID: 31771630DERIVED

  • Law L, Beckman Rehnman J, Deminger A, Klingberg E, Jacobsson LTH, Forsblad-d'Elia H. Factors related to health-related quality of life in ankylosing spondylitis, overall and stratified by sex. Arthritis Res Ther. 2018 Dec 27;20(1):284. doi: 10.1186/s13075-018-1784-8.

    PMID: 30587228DERIVED

  • Torres L, Klingberg E, Nurkkala M, Carlsten H, Forsblad-d'Elia H. Hepatocyte growth factor is a potential biomarker for osteoproliferation and osteoporosis in ankylosing spondylitis. Osteoporos Int. 2019 Feb;30(2):441-449. doi: 10.1007/s00198-018-4721-4. Epub 2018 Oct 10.

    PMID: 30306221DERIVED

  • Deminger A, Klingberg E, Geijer M, Gothlin J, Hedberg M, Rehnberg E, Carlsten H, Jacobsson LT, Forsblad-d'Elia H. A five-year prospective study of spinal radiographic progression and its predictors in men and women with ankylosing spondylitis. Arthritis Res Ther. 2018 Aug 3;20(1):162. doi: 10.1186/s13075-018-1665-1.

    PMID: 30075808DERIVED

  • Klingberg E, Strid H, Stahl A, Deminger A, Carlsten H, Ohman L, Forsblad-d'Elia H. A longitudinal study of fecal calprotectin and the development of inflammatory bowel disease in ankylosing spondylitis. Arthritis Res Ther. 2017 Feb 2;19(1):21. doi: 10.1186/s13075-017-1223-2.

    PMID: 28148281DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum

MeSH Terms

Conditions

Spondylitis, AnkylosingOsteoporosisFractures, Bone

Condition Hierarchy (Ancestors)

Axial SpondyloarthritisSpondylarthropathiesSpondylarthritisSpondylitisSpinal DiseasesBone DiseasesMusculoskeletal DiseasesAnkylosisJoint DiseasesArthritisBone Diseases, MetabolicMetabolic DiseasesNutritional and Metabolic DiseasesWounds and Injuries

Study Officials

  • Helena Forsblad d'Elia, Md, PhD

    Department of Rheumatology and Inflammation Research

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 9, 2009

First Posted

March 10, 2009

Study Start

March 1, 2009

Primary Completion

May 1, 2012

Study Completion

December 1, 2014

Last Updated

May 29, 2015

Record last verified: 2015-05

Locations

SE(1)