PostmenopausAL heaLth And DIseAse (PALLADIA) Study (PALLADIA)

April 5, 2022 updated by: Irene Lambrinoudaki, National and Kapodistrian University of Athens

PostmenopausAL heaLth And DIseAse (PALLADIA) Study: Prospective Study of the Incidence and Risk Factors of Chronic Diseases Associated With Menopause

This is a prospective study of the incidence and risk factors of chronic diseases that are associated with menopause.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

4000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Greece
    • Attica
      • Athens, Attica, Greece, 11528
        • Recruiting
        • Menopause Clinic, Aretaieio Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 85 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

The study will include 4.000 postmenopausal women

Description

Inclusion Criteria:

Postmenopausal women

Exclusion Criteria:

Men Women of reproductive age

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cardiovascular death
Time Frame: up to 2025
up to 2025
Coronary heart disease
Time Frame: up to 2025
up to 2025
Stroke
Time Frame: up to 2025
up to 2025

Secondary Outcome Measures

Outcome Measure
Time Frame
Diabetes mellitus
Time Frame: up to 2025
up to 2025
Osteoporotic fractures
Time Frame: up to 2025
up to 2025
Breast cancer
Time Frame: up to 2025
up to 2025
Any cancer
Time Frame: up to 2025
up to 2025

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National and Kapodistrian University of Athens

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2021

Primary Completion (Anticipated)

October 1, 2025

Study Completion (Anticipated)

December 31, 2025

Study Registration Dates

First Submitted

July 23, 2021

First Submitted That Met QC Criteria

July 31, 2021

First Posted (Actual)

August 6, 2021

Study Record Updates

Last Update Posted (Actual)

April 6, 2022

Last Update Submitted That Met QC Criteria

April 5, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 8259

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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