Effects of Steroid Replacement Therapy on Metabolic, Cardiovascular and Bone Outcomes in Adrenal Insufficiency
Conventional Glucocorticoids vs. Dual-release Hydrocortisone Effects on Metabolic, Cardiovascular, and Bone Outcomes in Treatment-naïve Patients With Adrenal Insufficiency: a 10-year Prospective Randomised Study
1 other identifier
interventional
88
0 countries
N/A
Brief Summary
The current study is a randomized, open study aimed to compare the effects of conventional glucocorticoid replacement treatment and dual-release hydrocortisone on anthropometric, metabolic, cardiovascular and bone outcomes in treatment-naïve patients with primary adrenal insufficiency and secondary adrenal insufficiency in a 10 year-observation period.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Jan 2012
Longer than P75 for phase_3
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2023
CompletedFirst Submitted
Initial submission to the registry
January 24, 2024
CompletedFirst Posted
Study publicly available on registry
February 15, 2024
CompletedFebruary 15, 2024
February 1, 2024
10.8 years
January 24, 2024
February 13, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Change of body weight
Single outcome measurement of body weight (kg).
0, 5 years, 10 years
Secondary Outcomes (7)
Change of anthropometric parameters
0, 5 years and 10 years
Change of metabolic parameters
0, 5 years and 10 years
Change of insulin sensitivity parameters
0, 5 years and 10 years
Change of cardiovascular parameters
0, 5 years and 10 years
Change of bone metabolic parameters
0, 5 years and 10 years
- +2 more secondary outcomes
Study Arms (2)
Conventional steroid treatment
EXPERIMENTALCortisone acetate and hydorocortisone will be administered in two daily doses
Dual-release hydrocortisone
EXPERIMENTALDual-release hydrocortisone will be administered once daily
Interventions
Oral tablets 20-25-30-40 mg/day
Oral tablets 10-15-20-25-37,5-50-62,5 mg/day
Eligibility Criteria
You may qualify if:
- Adrenal insufficiency
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Guarnotta V, Di Stefano C, Tomasello L, Maniscalco L, Pizzolanti G, Arnaldi G, Giordano C. Conventional steroids vs. dual-release hydrocortisone on metabolic, cardiovascular, and bone outcomes in adrenal insufficiency: a 10-year study. Eur J Endocrinol. 2024 Aug 30;191(3):300-311. doi: 10.1093/ejendo/lvae107.
PMID: 39171906DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- professor
Study Record Dates
First Submitted
January 24, 2024
First Posted
February 15, 2024
Study Start
January 1, 2012
Primary Completion
September 30, 2022
Study Completion
December 30, 2023
Last Updated
February 15, 2024
Record last verified: 2024-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- 2 years
- Access Criteria
- Send an email to carla.giordano@unipa.it
Study protocol could be available on request