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Completed

NCT Number: NCT06279078

Long-term Effect of Steroid on Metabolic Diseases in Asthmatics

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.

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Key information

Who can participate

Healthy volunteers accepted: No

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

A. Inclusion criteria i. Adult asthmatics (over 18 years) who have maintained inhaled corticosteroid with or without systemic corticosteroid for more than 12 months before the index date in our Medical Center.

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.

B. Exclusion criteria i. Patients younger than 18 years ii. Patients younger than 50 years and males in high-risk population cohorts iii. Patients with osteoporosis or osteoporosis-related major fracture outcomes (pathological fracture due to osteoporosis, closed fracture of the femur, pelvis, and vertebral column) before the index date iv. Patients with corticosteroid-related outcomes (diabetes mellitus, hypertension, hyperlipidemia) before the index date (for secondary endpoint).

Treatment and study plan

Corticosteroid

Drug

oral/inhaled corticosteroid

Other names: inhaled corticosteroid

Primary outcomes

  1. Prevalence of osteoporosis/osteopenia

    Time frame: 5 years

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

Secondary outcomes

  1. Bone mineral density (BMD) score

    Time frame: 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)

  2. Total alkaline phosphatase

    Time frame: 5 years

    Change of bone metabolism-related tests

  3. Corrected calcium

    Time frame: 5 years

    Change of bone metabolism-related tests

  4. Serum phosphate

    Time frame: 5 years

    Change of bone metabolism-related tests

  5. Serum albumin

    Time frame: 5 years

    Change of bone metabolism-related tests (known to be reduced in osteoporosis patients)

  6. prevalence of steroid related comorbidities(Diabetes Mellitus, Hypertension, Hyperlipidemia, etc.)

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Ajou University School of Medicine

Other

Collaborators

  • AstraZeneca

Registry information

Official study title

Long-term Comparative Effectiveness for Osteoporosis/Osteoporosis and Metabolic Disease in Adult Asthmatic Patients Maintaining Inhaled/Systemic Corticosteroid: a Real-world Evidence

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Feb 26, 2024
Registry last updated
Nov 17, 2025

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.

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