NCT04392596

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Mansoura University · Academic / Other
• Sex: Male
• Age: 22 Years – 64 Years
• Healthy volunteers: Accepted

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.

Detailed 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

Conditions

• AS

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-01-02
• Primary completion: 2020-01-01
• Completion: 2020-01-15
• First posted: 2020-05-19
• Last updated: 2020-05-19

Locations

1 site across 1 country: Egypt

Regulatory

• FDA-regulated device study