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

NCT04392596 | Completed DMC FDA Device

• 1 other identifier: IRB 20201
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

AS

Outcome Measures

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

  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

Study Arms (1)

patients

EXPERIMENTAL

40

Device: Bone Mineral Density and Trabecular Bone score

Interventions

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.

patients

Eligibility Criteria

• Age: 22 Years - 64 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura University Hospital

Al Mansurah, Dakahlia Governorate, 35516, Egypt

Location

Study Officials

• Yasmin AD Hussein, MD

  Mansoura University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2020
• First Posted: May 19, 2020
• Study Start: January 2, 2019
• Primary Completion: January 1, 2020
• Study Completion: January 15, 2020
• Last Updated: May 19, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)