Skip to main content
OpenTrials
Completed

NCT Number: NCT04392596

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

AS

Age range

22 year–64 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Mansoura University Hospital

Al Mansurah, Dakahlia Governorate, 35516, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Bone Mineral Density and Trabecular Bone score

Device

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.

Primary outcomes

  1. to compare bone quality using TBS between AS patients and healthy controls and to evaluate factors associated with TBS in patients with AS

    Time frame: 1 year

    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

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
May 19, 2020
Registry last updated
May 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.