Treatment With Alendronate in Patients With Ankylosing Spondylitis (AS)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Göteborg University
ClinicalTrials.gov Identifier:
NCT01104987
First received: April 13, 2010
Last updated: September 20, 2013
Last verified: September 2013
  Purpose

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).

Condition Intervention Phase
Ankylosing Spondylitis
Osteoporosis
Drug: alendronate
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Treatment With Alendronate in Patients With Ankylosing Spondylitis (AS), an Open Label Prospective Trial

Resource links provided by NLM:


Further study details as provided by Göteborg University:

Primary Outcome Measures:
  • Bone mineral density [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Markers of bone remodeling [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    To investigate the effects on serum markers of bone remodeling by treatment with alendronate.

  • Disease activity [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    To investigate if alendronate influences disease activity measured by the validated instrument BASDAI.

  • Spinal function [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    To investigate if alendronate influences spinal function measured by the validated instrument BASFI.

  • Spinal movement [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    To investigate if alendronate influences spinal movement measured by the validated instrument BASMI.

  • Health related quality of life [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    To investigate if alendronate influences health related quality of life measured by the validated instrument SF-36.


Enrollment: 16
Study Start Date: October 2009
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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 interventional study.
Drug: alendronate
One tablet of alendronate à 70 mg once a week during two years.

Detailed Description:

Ankylosing spondylitis (AS) is a common inflammatory rheumatic disease with a prevalence of 0.5-1.0%. Men are more commonly affected by the disease as compared to women, ratio 2.6-4:1. Pain in the back is a frequent symptom of debut. This pain is often associated with sacroilitis. In later stages also the lumbar, thoracic and cervical spine are hit by the disease. Peripheral joints, eyes, heart, lungs and urinary tract may also be influenced.

The risk of osteoporosis is increased in AS. However, this field has not yet been significantly studied probably due to several reasons such as the predominance of men with the disease and men are more seldom investigated for osteoporosis compared to women. When AS progresses syndesmophytes of the spine are developed which makes it difficult to assess bone mineral density (BMD) correctly with the conventional method, dual energy x-ray absorptiometry (DXA). Fractures in the spine are easy to foreseen since the pain of the patient might be misjudged to be related to increased disease activity. Fractures are also overlooked in radiographs in AS. AS is associated with both increased bone formation and increased bone resorption. The bone remodeling process in the spine renders the spine less flexible and stiffer and as a consequence also a quite small trauma may result in a fracture. These fractures are often instable risking injuring the spinal cord and nerves.

Treatment with bisphosphonates in AS have indicated an anti-inflammatory effect. The effects of treatment with bisphosphonate on BMD assessed by DXA, QCT and Xtreme CT in AS has not yet been fully investigated.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Fulfill diagnostic criteria of ankylosing spondylitis, 1984 New York
  2. Patients should previously have been included in the observational trial, "Clinical study of osteoporosis in ankylosing spondylitis".
  3. Patients should not have changed treatment with any biologics the past 4 months.
  4. Patients on glucocorticosteroids should not have changed the dose the last 4 months.
  5. BMD with a T-score ≤ -2,5 SD assessed by DXA in lumbar spine and/or hip (total hip and/or neck).
  6. 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.
  7. 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

Exclusion criteria:

  1. Ongoing treatment with any bisphosphonate.
  2. Ongoing treatment with any sex-hormone.
  3. Renal insufficiency, creatinine clearance < 35 ml/min
  4. Difficulties in swallowing and/or acute illness in the upper gastro-intestinal canal.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01104987

Locations
Sweden
Department of Rheumatology, Sahlgrenska University Hospital
Gothenburg, Sweden, S-413 45
Sponsors and Collaborators
Göteborg University
Investigators
Principal Investigator: Helena Forsblad d'Elia, MD, PhD Sahlgrenska Academy at University of Gothenburg, Department of Rheumatology and Inflammation Research
  More Information

No publications provided

Responsible Party: Göteborg University
ClinicalTrials.gov Identifier: NCT01104987     History of Changes
Other Study ID Numbers: 20090618
Study First Received: April 13, 2010
Last Updated: September 20, 2013
Health Authority: Sweden: Medical Products Agency
Sweden: Swedish National Council on Medical Ethics

Keywords provided by Göteborg University:
Ankylosing spondylitis
spondarthritis
Osteoporosis
Bone mineral density
Dual energy x-ray absorptiometry
Quantitative computed tomography

Additional relevant MeSH terms:
Osteoporosis
Spondylitis
Spondylitis, Ankylosing
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Bone Diseases, Infectious
Infection
Spinal Diseases
Spondylarthropathies
Spondylarthritis
Ankylosis
Joint Diseases
Arthritis
Alendronate
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 16, 2014