Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000514404
Ethics application status
Approved
Date submitted
5/02/2025
Date registered
23/05/2025
Date last updated
23/05/2025
Date data sharing statement initially provided
23/05/2025
Type of registration
Retrospectively registered

Titles & IDs
Public title
A Registry on comparing the older and and newer treatment methods for Hypoparathyroidism in Greece
Scientific title
The Greek National Registry of HypOPArathyroidism (The OPA study): Burden of Disease, Care Gaps and Treatment Efficacy DIfferences Between Older and Newer Treatments.
Secondary ID [1] 313879 0
NONE
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypoparathyroidism 336548 0
Condition category
Condition code
Metabolic and Endocrine 333065 333065 0 0
Other endocrine disorders

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
5
Target follow-up type
Years
Description of intervention(s) / exposure
Prospective registry of patients affected by hypoparathyroidism of any etiology, followed at the Endocrinology, Diabetes and Metabolism clinics of the Hellenic Endocrine Network. In this study the data recorded will consist of clinical information regarding patients' gender, age at diagnosis of hypoparathyroidism, the disease cause, severity, treatments used in the past, the complications observed along with the recentmost treatments and their outcomes. These data will consist of all available information from the date off diagnosis of hypoparathyroidism to the date of study enrollment, with a minimum period of 18 months required for study participation. Additionally, prospective data on disease related complications, quality of life, treatment success or failure and care gaps will be collected over 5 years, including use of usual or newer agents. The main outcomes are the maintenance of eucalcemia (normal serum calcium corrected to albumin: 8.5-10.0mg/dl), the maintenance of normal urine calcium as measured by 24 hours urine collection (<300mg/dl/24hrs), the incidence of nephrolithiasis, nephrocalcinosis, ectopic calcifications, chronic kidney disease (eGFR<60ml/min/1.73m2), need for renal replacement therapy, cardiovascular disease events (myocardial infarctions, cerebrovascular events, peripheral arterial disesase events, significant vascular stenoses, need for percutaneous vascular interventions), arrhythmias (atrial fibrillation, other), congestive heart failure, osteoporosis, osteoporotic and non-osteoporotic fractures, patients' quality of life.
The treatment that the patients involved in the Registry receive, will not be affected by their participation in the Registry, since this is not an interventional study. Each participating center will decide on the treatment strategy to follow in each case, based on clinical information and current national and international clinical practice guidelines.
Intervention code [1] 330468 0
Diagnosis / Prognosis
Comparator / control treatment
Patients will be compared with regard to the efficacy of older treatments for hypoparathyroidism (Conventional therapies, i.e. vitamin D analogs, calcium, magnesium and calcium-sparing diuretics) vs. newer treatments (i.e. parathyroid hormone analogs). The comparison will be both in the self-control format and between groups that never received newer treatments and those that did. The retrospective data will date back to the date of original diagnosis, with no time limit. No data spanning less than 1 year will be included.
Control group
Active

Outcomes
Primary outcome [1] 340600 0
Composite of renal calcinosis complications of hypoparathyroidism, including nephrolithiasis, nephrocalcinosis and microlithiasis.
Timepoint [1] 340600 0
Baseline assessment and at least once more within 5 years post enrollment in the study.
Primary outcome [2] 340601 0
Composite of cardiovascular disease events, including myocardial infarctions, cerebrovascular events, peripheral arterial disease events, need for percutaneous vascular catheterizations.
Timepoint [2] 340601 0
Yearly for 5 years post-enrollment.
Primary outcome [3] 340604 0
Renal function change
Timepoint [3] 340604 0
After 5 years of follow up.
Secondary outcome [1] 444575 0
Ectopic calcifications
Timepoint [1] 444575 0
Once within 5 years follow up post treatment based on clinical discretion
Secondary outcome [2] 444576 0
Osteoporosis occurrence
Timepoint [2] 444576 0
Once within 5 years follow up post treatment based on clinical discretion
Secondary outcome [3] 444577 0
Osteoporotic fractures
Timepoint [3] 444577 0
Once within 5 years follow up post treatment based on clinical discretion
Secondary outcome [4] 444578 0
Cataracts
Timepoint [4] 444578 0
Once within 5 years follow up post treatment based on clinical discretion
Secondary outcome [5] 444579 0
Urine calcium excretion
Timepoint [5] 444579 0
Yearly for all 5 years of follow up

Eligibility
Key inclusion criteria
Permanent hypoparathyroidism, defined as a serum calcium corrected for albumin persistently < 8.5mg/dl for at least 12 consecutive months.
Minimum age
12 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Transient hypoparathyroidism, defined as a serum calcium corrected for albumin persistently < 8.5mg/dl for at less than 12 consecutive months.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Both
Statistical methods / analysis
Comparison of the effects of newer vs. older treatments used for the disease's treatment.
Categorical variables will be compared with Fisher’s exact test or chi sqaured test. Continuous variables will be assessed for normality with Kolmogorov-Smirnov test. When normality is not present, the data will be log transformed and normality will be re-assessed. If the data do not follow the normal distribution either way, the non-parametric Kruskal Wallis and Mann-Whitney tests will be used, while t-test and 1-way ANOVA will be used for data following the normal distribution. P values < 0.05 will be deemed significant.
The analysis will be performed using GraphPad Prism v5.0 and SPSS 30.0.0.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
3/03/2025
Date of last participant enrolment
Anticipated
21/01/2030
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
500
Accrual to date
165
Final
Recruitment outside Australia
Country [1] 26862 0
Greece
State/province [1] 26862 0

Funding & Sponsors
Funding source category [1] 318347 0
Commercial sector/Industry
Name [1] 318347 0
Ascendis Pharma
Country [1] 318347 0
United States of America
Funding source category [2] 318704 0
Charities/Societies/Foundations
Name [2] 318704 0
Hellenic Endocrine Network
Country [2] 318704 0
Greece
Primary sponsor type
Individual
Name
Rodis D Paparodis - Hellenic Endocrine Network
Address
Country
Greece
Secondary sponsor category [1] 320750 0
None
Name [1] 320750 0
Address [1] 320750 0
Country [1] 320750 0
Other collaborator category [1] 283409 0
Charities/Societies/Foundations
Name [1] 283409 0
Hellenic Endocrine Network
Address [1] 283409 0
Country [1] 283409 0
Greece

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316981 0
Hellenic Endocrine Network IRB
Ethics committee address [1] 316981 0
Ethics committee country [1] 316981 0
Greece
Date submitted for ethics approval [1] 316981 0
04/02/2025
Approval date [1] 316981 0
01/03/2025
Ethics approval number [1] 316981 0
N2025/0121319

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 139642 0
Dr Rodis D Paparodis - Hellenic Endocrine Network
Address 139642 0
24, Gerokostopoulou St, Patras, 26221
Country 139642 0
Greece
Phone 139642 0
+302610222176
Fax 139642 0
Email 139642 0
[email protected]
Contact person for public queries
Name 139643 0
Rodis D Paparodis - Hellenic Endocrine Network
Address 139643 0
24, Gerokostopoulou St, Patras, 26221
Country 139643 0
Greece
Phone 139643 0
+302610222176
Fax 139643 0
Email 139643 0
[email protected]
Contact person for scientific queries
Name 139644 0
Rodis D Paparodis - Hellenic Endocrine Network
Address 139644 0
24, Gerokostopoulou St, Patras, 26221
Country 139644 0
Greece
Phone 139644 0
+302610222176
Fax 139644 0
Email 139644 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Any scientific body upon reasonable request for a scientifically sound research proposal, upon aproval by the Principal Investigator.

Conditions for requesting access:
• -

What individual participant data might be shared?
• All participants data can be shared upon reasonable request with the aproval of the Principal Investigator of ths study.

What types of analyses could be done with individual participant data?
• Any scientific analysis, upon aproval by the Principal Investigator.

When can requests for individual participant data be made (start and end dates)?
From:
At the end of the study
To:
A finite period of: 1 years
Where can requests to access individual participant data be made, or data be obtained directly?
• The data will become available to interested parties for scientific purposes only, upon aproval by the Principal Investigator.

Are there extra considerations when requesting access to individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.