Study of Bone Mineral Density and Trabecular Bone Score in Patients With Ankylosing Spondylitis

AS Clinical Trial

Official title:

Performance of Bone Mineral Density and Trabecular Bone Score in Assessment of Bone Quality in Egyptian Male Patients With Ankylosing Spondylitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04392596
• Other study ID #: IRB 20201
• Status: Completed
• Phase: N/A
• Start date: January 2, 2019
• Est. completion date: January 15, 2020

Study information

• Verified date: May 2020
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Osteoporosis is a common complication of AS even in the early stages of disease. Yet, AS is also characterized by new bone growth that leads to syndesmophytes formation and subsequent vertebral ankyloses.

Description:

Accordingly, previously-published studies have demonstrated large discrepancies in the reported incidence of osteoporosis, based on measurement of bone mineral density (BMD), in patients with AS ranging from 18.7% to 62%. Measurement of trabecular bone score (TBS) is a novel tool used to evaluate bone microarchitecture. Aim of the work: to compare bone quality using TBS between AS patients and healthy controls and to evaluate factors associated with TBS in patients with AS. Patients and methods: A total of 40 male AS patients recruited from Outpatient Clinic of Rheumatology, Mansoura University Hospital. 40 age-matched healthy males as matched control. TBS was analyzed using DXA images over exactly the same region as the lumbar BMD assessment (L1-L4). Lumbar spine DXA images were reanalyzed using TBS iNight software version 2.1 (Med-I maps, Merignac, France). Patients were divided in 3 TBS groups according to guidelines for fracture risk: any TBS >1.31 was considered as normal; TBS values between 1.23 and 1.31 were consistent as partially degraded structure; and any TBS <1.23 was considered as degraded structure

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 15, 2020
• Est. primary completion date: January 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 22 Years to 64 Years

Eligibility

Inclusion Criteria:

• A total of 40 consecutive male AS patients were invited to participate in this study. Patients were recruited from Outpatient Clinic of Rheumatology, Mansoura University Hospital, between January and September 2019. AS was diagnosed according to modified New York criteria. During the same period, 40 age-matched healthy males were invited to participate in the study as a control group.

Exclusion Criteria:

• patients or controls with thyroid or parathyroid disorders, presence of chronic renal or liver disease, and use of any medication that could potentially interfere with bone metabolism including bisphosphonates, teriparatide, anticonvulsants, anticoagulants, calcium and corticosteroids. None of the participants was using vitamin D supplements.

Related Conditions & MeSH terms

• AS
• Spondylitis
• Spondylitis, Ankylosing

Intervention

Device:
• Bone Mineral Density and Trabecular Bone score
structural damage in the cervical and lumbar spine was scored according to the modified Stoke AS Spinal Score (mSASSS) which yielded a final summation score ranging from zero to 72. BMD was measured using DXA (Lunar Prodigy densitometer, GE Healthcare, Madison, WI, USA). BMD was measured at the lumbar spine (L1-L4) and the left hip (femoral neck and total proximal femur). TBS was analyzed using DXA images over exactly the same region as the lumbar BMD assessment (L1-L4). Lumbar spine DXA images were reanalyzed using TBS iNight software version 2.1 (Med-I maps, Merignac, France). Patients were divided in 3 TBS groups according to guidelines for fracture risk [22]: any TBS >1.31 was considered as normal; TBS values between 1.23 and 1.31 were consistent as partially degraded structure; and any TBS <1.23 was considered as degraded structure.

Locations

Country	Name	City	State
Egypt	Mansoura University Hospital	Mansoura	Ad Daqahliyah

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	to compare bone quality using TBS between AS patients and healthy controls and to evaluate factors associated with TBS in patients with AS	TBS was analyzed using DXA images over exactly the same region as the lumbar BMD assessment (L1-L4). Lumbar spine DXA images were reanalyzed using TBS iNight software version 2.1 (Med-I maps, Merignac, France). Patients were divided in 3 TBS groups according to guidelines for fracture risk: any TBS >1.31 was considered as normal; TBS values between 1.23 and 1.31 were consistent as partially degraded structure; and any TBS <1.23 was considered as degraded structure	1 year