Asthma, Osteoporosis, Osteopenia, Osteoporosis Risk, Osteoporotic Fractures
Conditions
Keywords
asthma, osteoporosis, corticosteroid, inhaled corticosteroid, fractures
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.
Interventions
DRUGCorticosteroid
oral/inhaled corticosteroid
Sponsors
AstraZeneca
Ajou University School of Medicine
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Total alkaline phosphatase | 5 years | Change of bone metabolism-related tests |
| Corrected calcium | 5 years | Change of bone metabolism-related tests |
| 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) |
| 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 |
| Serum phosphate | 5 years | Change of bone metabolism-related tests |
Countries
South Korea
Outcome results
None listed