NCT01104987

Brief Summary

This prospective study will assess the effects of treatment with alendronate in osteoporotic patients with ankylosing spondylitis. Primary objectives:

  • To investigate if alendronate effect bone mineral density (BMD) assessed by dual energy x-ray absorptiometry (DXA) in lumbar spine, hip and distal forearm and assessed by quantitative computed tomography (QCT) in lumbar spine and by Xtreme CT in radius and tibia. Secondary objectives:
  • To investigate if alendronate effects markers of bone remodeling
  • To investigate if alendronate influences disease activity (BASDAI), spinal function (BASFI), spinal movement (BASMI) and health related quality of life (SF-36).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 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

October 1, 2009

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 13, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 16, 2010

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

August 9, 2016

Status Verified

August 1, 2016

Enrollment Period

6.8 years

First QC Date

April 13, 2010

Last Update Submit

August 8, 2016

Conditions

Ankylosing SpondylitisOsteoporosis

Keywords

Ankylosing spondylitisspondarthritisOsteoporosisBone mineral densityDual energy x-ray absorptiometryQuantitative computed tomography

Outcome Measures

Primary Outcomes (1)

  • Bone mineral density

    The effect on bone mineral density (BMD) assessed by dual energy x-ray absorptiometry (DXA) in lumbar spine, hip and distal forearm and assessed by quantitative computed tomography (QCT) in lumbar spine and by Xtreme CT in radius and tibia by treatment with alendronate.

    2 years

Secondary Outcomes (5)

  • Markers of bone remodeling

    2 years

  • Disease activity

    2 years

  • Spinal function

    2 years

  • Spinal movement

    2 years

  • Health related quality of life

    2 years

Study Arms (1)

alendronate

A cross sectional study assessing the prevalence of osteoporosis and vertebral fractures in AS has been conducted during the spring in 2009. Patients with osteoporosis that fulfilled the inclusion criteria and did not have any exclusion criteria for the present trial were asked to join this study.

Drug: alendronate

Interventions

alendronateDRUG

One tablet of alendronate à 70 mg once a week during two years.

alendronate

Eligibility Criteria

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

Patients with AS and osteoporosis.

You may qualify if:

  • Fulfill diagnostic criteria of ankylosing spondylitis, 1984 New York
  • Patients should previously have been included in the observational trial, "Clinical study of osteoporosis in ankylosing spondylitis".
  • Patients should not have changed treatment with any biologics the past 4 months.
  • Patients on glucocorticosteroids should not have changed the dose the last 4 months.
  • BMD with a T-score ≤ -2,5 SD assessed by DXA in lumbar spine and/or hip (total hip and/or neck).
  • BMD with a T-score ≤ -2,0 SD assessed by DXA in lumbar spine and/or hip (total hip and/or neck) and presence of any vertebral fracture, hip fracture or peripheral fragility fracture.
  • BMD with a T-score ≤ - 1,0 SD assessed by DXA in lumbar spine and/or hip (total hip and/or neck) in patients on oral glucocorticosteroids

You may not qualify if:

  • Ongoing treatment with any bisphosphonate.
  • Ongoing treatment with any sex-hormone.
  • Renal insufficiency, creatinine clearance \< 35 ml/min
  • Difficulties in swallowing and/or acute illness in the upper gastro-intestinal canal.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Rheumatology, Sahlgrenska University Hospital

Gothenburg, S-413 45, Sweden

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum and plasma

MeSH Terms

Conditions

Spondylitis, AnkylosingOsteoporosisSpondylarthritis

Interventions

Alendronate

Condition Hierarchy (Ancestors)

Axial SpondyloarthritisSpondylarthropathiesSpondylitisSpinal DiseasesBone DiseasesMusculoskeletal DiseasesAnkylosisJoint DiseasesArthritisBone Diseases, MetabolicMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

DiphosphonatesOrganophosphonatesOrganophosphorus CompoundsOrganic Chemicals

Study Officials

  • Helena Forsblad d'Elia, MD, PhD

    Sahlgrenska Academy at University of Gothenburg, Department of Rheumatology and Inflammation Research

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 13, 2010

First Posted

April 16, 2010

Study Start

October 1, 2009

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

August 9, 2016

Record last verified: 2016-08

Locations

SE(1)