Long-term Effect of Steroid on Metabolic Diseases in Asthmatics

NCT06279078 | Completed

• 1 other identifier: AJOUIRB-DB-2023-446
• Study Type: observational
• Target: 19,968
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma; Osteoporosis, Osteopenia; Osteoporosis Risk; Osteoporotic Fractures

Keywords

asthma; osteoporosis; corticosteroid; inhaled corticosteroid; fractures

Outcome Measures

Primary Outcomes (1)

• Prevalence of osteoporosis/osteopenia

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

  5 years

Secondary Outcomes (6)

• Bone mineral density (BMD) score

  5 years

• Total alkaline phosphatase

  5 years

• Corrected calcium

  5 years

• Serum phosphate

  5 years

• Serum albumin

  5 years

Interventions

Corticosteroid DRUG

oral/inhaled corticosteroid

Also known as: inhaled corticosteroid

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult asthma patients that visited AUMC (Ajou University Medical Center) from 1994 to 2023

You may qualify if:

• ii. At least 1 asthma diagnosis within 1 year before the first corticosteroid exposure date by asthma specialists at Ajou University Medical Center (AUMC, Suwon, South Korea) with informed consent.
• iii. A high cumulative dose is defined as the dose of corticosteroids above the mean cumulative dose of corticosteroids prescribed during 1 year.
• iv. The equivalent dose will use for calculating the mean cumulative dose of each inhaled corticosteroid inhaler or systemic corticosteroid prescribed.
• v. Prescriptions within 365 days from the first prescription will be assumed to be continuous, and the cohort end date will be defined as the end of the continuous drug exposure.

Sponsors & Collaborators

• Ajou University School of Medicine: lead
• AstraZeneca: collaborator

Study Sites (1)

Ajou University Medical Center

Suwon, Gyeonggi-do, 16499, South Korea

Location

MeSH Terms

Conditions

Asthma; Osteoporosis; Bone Diseases, Metabolic; Osteoporotic Fractures; Fractures, Bone

Interventions

Adrenal Cortex Hormones

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical fellow, dept. of Allergy and Clinical Immunology

Study Record Dates

• First Submitted: January 10, 2024
• First Posted: February 26, 2024
• Study Start: December 30, 2023
• Primary Completion: December 30, 2024
• Study Completion: June 30, 2025
• Last Updated: November 17, 2025

Record last verified: 2025-11

Locations

KR (1)