ANZCTR - Registration

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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]

NONE

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Hypoparathyroidism

Condition category

Condition code

Metabolic and Endocrine

Other endocrine disorders

Intervention/exposure

Study type

Observational

Patient registry

True

Target follow-up duration

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]

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]

Composite of renal calcinosis complications of hypoparathyroidism, including nephrolithiasis, nephrocalcinosis and microlithiasis.

Timepoint [1]

Baseline assessment and at least once more within 5 years post enrollment in the study.

Primary outcome [2]

Composite of cardiovascular disease events, including myocardial infarctions, cerebrovascular events, peripheral arterial disease events, need for percutaneous vascular catheterizations.

Timepoint [2]

Yearly for 5 years post-enrollment.

Primary outcome [3]

Renal function change

Timepoint [3]

After 5 years of follow up.

Secondary outcome [1]

Ectopic calcifications

Timepoint [1]

Once within 5 years follow up post treatment based on clinical discretion

Secondary outcome [2]

Osteoporosis occurrence

Timepoint [2]

Once within 5 years follow up post treatment based on clinical discretion

Secondary outcome [3]

Osteoporotic fractures

Timepoint [3]

Once within 5 years follow up post treatment based on clinical discretion

Secondary outcome [4]

Cataracts

Timepoint [4]

Once within 5 years follow up post treatment based on clinical discretion

Secondary outcome [5]

Urine calcium excretion

Timepoint [5]

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?

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]

Greece

State/province [1]

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

Ascendis Pharma

Address [1]

Country [1]

United States of America

Funding source category [2]

Charities/Societies/Foundations

Name [2]

Hellenic Endocrine Network

Address [2]

Country [2]

Greece

Primary sponsor type

Individual

Name

Rodis D Paparodis - Hellenic Endocrine Network

Address

Country

Greece

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Other collaborator category [1]

Charities/Societies/Foundations

Name [1]

Hellenic Endocrine Network

Address [1]

Country [1]

Greece

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Hellenic Endocrine Network IRB

Ethics committee address [1]

irb@hen.gr

Ethics committee country [1]

Greece

Date submitted for ethics approval [1]

04/02/2025

Approval date [1]

01/03/2025

Ethics approval number [1]

N2025/0121319

Summary

Brief summary

The present study aims to characterize the treatment methods, outcomes and care gaps of the treatment strategies used in Greece to treat permanent hypoparathyroidism. Registering multiple patients with this uncommon condition, we will be able to identify flaw or care gaps in the treatment and follow up of this vulnerable patient population, Furthermore, the comparison of older (conventional) treatments' effects with newer agents introduced in the last decade could reveal unknown positive or negative effects of both and help define the populations more likely to benefit from each one of these strategies.

Trial website

N/A

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Rodis D Paparodis - Hellenic Endocrine Network

Address

24, Gerokostopoulou St, Patras, 26221

Country

Greece

Phone

+302610222176

Fax

[email protected]

Contact person for public queries

Name

Rodis D Paparodis - Hellenic Endocrine Network

Address

24, Gerokostopoulou St, Patras, 26221

Country

Greece

Phone

+302610222176

Fax

[email protected]

Contact person for scientific queries

Name

Rodis D Paparodis - Hellenic Endocrine Network

Address

24, Gerokostopoulou St, Patras, 26221

Country

Greece

Phone

+302610222176

Fax

[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?

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.

Trial Review

Documents added manually

Documents added automatically