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ADH1 and ADH2 Disease Monitoring Study (DMS) | Clinical Trials | Clareo Health

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ADH1 and ADH2 Disease Monitoring Study (DMS)

Autosomal Dominant Hypocalcemia Types 1 And 2 (ADH1/2) Disease Monitoring Study (DMS)

NCT05227287•Calcilytix Therapeutics, Inc., a BridgeBio company

Summary

A global, multi-center, Disease Monitoring Study (DMS) in participants with Autosomal Dominant Hypocalcemia Type 1 (ADH1) or Autosomal Dominant Hypocalcemia Type 2 (ADH2) designed to characterize ADH1 and ADH2 disease presentation and progression through retrospective (past) and longitudinal prospective (over time into the future) data collection.

Detailed Description

The ADH1 and ADH2 DMS is designed to better understand the disease burden of ADH1 and ADH2, how participants with ADH1 or ADH2 are managed with standard of care practices in a real-world setting, and how standard of care treatment impacts ADH1 and ADH2 symptoms. The study will include adult and pediatric participants with a confirmed clinical diagnosis of ADH1 or ADH2. Each participant's data will be collected over a period of up to 5 years. In addition, retrospective (or past) data will be collected.

Eligibility

Age

0 - 90 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Have a documented activating variant or variant of uncertain significance of the CASR gene causative of ADH1 or documented activating variant or variant of uncertain significance of the GNA11 gene causative of ADH2 associated with a clinical syndrome of hypoparathyroidism prior to enrollment
•Note: Acceptable documentation includes CASR or GNA11 genetic analysis report. If no prior documented CASR or GNA11 gene variant or variant of uncertain significance, potential participants can undergo CASR and GNA11 gene variant analysis at Screening.
•Be willing and able to provide informed consent or assent after the nature of the study and its details have been explained, and prior to any research-related procedures
•Be willing and able to provide access to prior medical records including imaging, biochemical, and diagnostic and medical history data, if available
•Be willing and able to comply with the study visit schedule and study procedures

Exclusion Criteria

•Have serious medical or psychiatric comorbidity that, in the opinion of the Investigator, would present a concern for participant safety or compromise the ability to provide consent or assent, or comply with the study visit schedule and study procedures
•Enrollment in an interventional clinical study at the time of DMS Screening visit

Locations (27)

University of California, San Francisco (UCSF) - Benioff Children's Hospital - Oakland

Oakland, California, United States

Children's Hospital Colorado

Aurora, Colorado, United States

Nemours Children's Clinic

Jacksonville, Florida, United States

Indiana University (IU) School of Medicine - University Hospital

Indianapolis, Indiana, United States

Boston Children's Hospital

Boston, Massachusetts, United States

Mayo Clinic

Rochester, Minnesota, United States

Physician's East Endocrinology

Greenville, North Carolina, United States

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Ohio State University Medical Center (OSUMC)

Columbus, Ohio, United States

Royal North Shore Hospital

Saint Leonards, New South Wales, Australia

Key Dates

Start Date

January 20, 2022

Primary Completion Date

November 1, 2028

Completion Date

December 1, 2028

Last Updated

April 4, 2025

Enrollment

ACTUAL participants

Conditions

Autosomal Dominant Hypocalcemia

Efficacy and Safety of Encaleret Compared to Standard of Care in Participants With ADH1

NCT05680818

Autosomal Dominant Hypocalcemia (ADH)

View study

COMPLETEDPHASE2

Comparing Pump With Subcutaneous Injection Delivery of PTH 1-34 in the Management of Chronic Hypoparathyroidism

NCT00743782

HypoparathyroidismHypocalcemia+2 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 4, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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ADH1 and ADH2 Disease Monitoring Study (DMS)

Inclusion Criteria

Exclusion Criteria

Efficacy and Safety of Encaleret Compared to Standard of Care in Participants With ADH1

Comparing Pump With Subcutaneous Injection Delivery of PTH 1-34 in the Management of Chronic Hypoparathyroidism

Safety, Tolerability, and Efficacy of Encaleret in Participants With Autosomal Dominant Hypocalcemia (ADH) Type 1

Recombinant Human rhPTH(1-34) VS Association Alfacalcidol/Hydrochlorothiazide in Severe Primary Hypoparathyroidism