Long-term Effect of Steroid on Metabolic Diseases in Asthmatics

Recruiting

• Conditions: Asthma; Osteoporosis, Osteopenia; Osteoporotic Fractures; Osteoporosis Risk

• Registration Number: NCT06279078
• Lead Sponsor: Ajou University School of Medicine

Brief Summary

The goal of this retrospective/observational study is to compare the clinical outcomes between the high-cumulative-dose group and the low- cumulative-dose group of oral/inhaled corticosteroid in the long-term management of asthma patients. The main hypothesis are:

i. High cumulative dose of corticosteroid is related to the prevalence of osteoporosis/osteoporosis in the long-term management of adult asthma.

ii. High cumulative dose of corticosteroid can affect populations that have a high-risk of osteoporosis (females over 50 years of age).

iii. High cumulative dose of corticosteroid is related to the prevalence of diabetes mellitus, hypertension, and hyperlipidemia in the long-term management of adult asthma.

iv. High cumulative dose of corticosteroid affects bone metabolism-related diagnostic tests and laboratory values and the prescription rate of bone metabolism-related medications.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-12-30
• Study First Submitted: 2024-01-10
• Status Verified: 2024-02
• Study First Submitted QC: 2024-02-23
• Last Update Submitted: 2024-02-23
• Study First Posted: 2024-02-26
• Last Update Posted: 2024-02-26
• Primary Completion: 2024-12-30
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20000

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prevalence of osteoporosis/osteopenia	5 years	Prevalence of osteoporosis/osteopenia according to cumulative dose of steroid will be compared with incidence, incidence rate, and hazard ratio

Secondary Outcome Measures

Name	Time	Method
Serum albumin	5 years	Change of bone metabolism-related tests (known to be reduced in osteoporosis patients)
prevalence of steroid related comorbidities(Diabetes Mellitus, Hypertension, Hyperlipidemia, etc.)	5 years	Compare the prevalence of steroid related comorbidities(Diabetes Mellitus, Hypertension, Hyperlipidemia, etc.) according to cumulative dose of steroid with incidence, incidence rate, and hazard ratio
Bone mineral density (BMD) score	5 years	Change of BMD score (T-score), especially for L1-L4 and femur neck. (Z-score will also be evaluated for premenopausal women and men under 50 years of age)
Corrected calcium	5 years	Change of bone metabolism-related tests
Total alkaline phosphatase	5 years	Change of bone metabolism-related tests
Serum phosphate	5 years	Change of bone metabolism-related tests

Trial Locations

Locations (1)

Ajou University Medical Center; 🇰🇷 Suwon, Gyeonggi, Korea, Republic of