Treatment With Alendronate in Patients With Ankylosing Spondylitis (AS)

Treatment With Alendronate in Patients With Ankylosing Spondylitis (AS), an Open Label Prospective Trial

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).

Study Overview

• Status: Completed
• Conditions: Osteoporosis; Ankylosing Spondylitis
• Intervention / Treatment: Drug: alendronate

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.

• Study Type: Observational
• Enrollment (Actual): 16

Contacts and Locations

Study Locations

• Sweden
  • Gothenburg, Sweden, S-413 45
    • Department of Rheumatology, Sahlgrenska University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with AS and osteoporosis.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; One tablet of alendronate à 70 mg once a week during two years.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Markers of bone remodeling	To investigate the effects on serum markers of bone remodeling by treatment with alendronate.	2 years
Disease activity	To investigate if alendronate influences disease activity measured by the validated instrument BASDAI.	2 years
Spinal function	To investigate if alendronate influences spinal function measured by the validated instrument BASFI.	2 years
Spinal movement	To investigate if alendronate influences spinal movement measured by the validated instrument BASMI.	2 years
Health related quality of life	To investigate if alendronate influences health related quality of life measured by the validated instrument SF-36.	2 years

Collaborators and Investigators

• Sponsor: Göteborg University
• Investigators: Principal Investigator: Helena Forsblad d'Elia, MD, PhD, Sahlgrenska Academy at University of Gothenburg, Department of Rheumatology and Inflammation Research

Study record dates

Study Major Dates

• Study Start: October 1, 2009
• Primary Completion (Actual): July 1, 2016
• Study Completion (Actual): July 1, 2016

Study Registration Dates

• First Submitted: April 13, 2010
• First Submitted That Met QC Criteria: April 15, 2010
• First Posted (Estimate): April 16, 2010

Study Record Updates

• Last Update Posted (Estimate): August 9, 2016
• Last Update Submitted That Met QC Criteria: August 8, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Keywords: Osteoporosis; Ankylosing spondylitis; Bone mineral density; Dual energy x-ray absorptiometry; spondarthritis; Quantitative computed tomography
• Additional Relevant MeSH Terms: Metabolic Diseases; Infections; Joint Diseases; Musculoskeletal Diseases; Arthritis; Spinal Diseases; Bone Diseases; Spondylarthropathies; Bone Diseases, Metabolic; Bone Diseases, Infectious; Ankylosis; Osteoporosis; Spondylitis; Spondylarthritis; Spondylitis, Ankylosing; Physiological Effects of Drugs; Bone Density Conservation Agents; Alendronate
• Other Study ID Numbers: 20090618