A Registry for Patients With Chronic Hypoparathyroidism

Overview

About this study

This is a prospective, observational disease and drug registry designed to evaluate the safety and effectiveness profile of rhPTH(1-84) under conditions of routine clinical practice and to observe the clinical course of chronic hypoparathyrodism. No treatment is provided as a result of participating in this registry and all decisions on the participant's treatment are determined by his or her physician.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

- Participants diagnosed with chronic hypoparathyroidism, that is, hypoparathyroidism
with a duration of longer than 6 months, including:

1. Adult participants (greater than or equal to [>=] 18 years of age) who are
receiving for chronic hypoparathyroidism any of the following options: standard
therapy, standard therapy plus rhPTH(1-84), or rhPTH(1-84) therapy alone.

2. Pediatric participants (less than [<] 18 years of age) who are receiving for
chronic hypoparathyroidism any of the following options: standard therapy,
standard therapy plus rhPTH(1-84), or rhPTH(1-84) therapy alone.

Exclusion Criteria:

- Participants or legally acceptable representatives unable to provide informed consent.

- Participants using rhPTH(1-34) or who used rhPTH(1-34) for more than 2 years are
excluded. Participants who had been treated with rhPTH(1-34) within 3 months of
enrollment are also excluded as are participants currently using rhPTH(1-34).

FOR US SITES ONLY: Participants treated with rhPTH(1-84) prior to the US recall may use
rhPTH(1-34) only while rhPTH(1-84) is unavailable due to the recall.

- Participants currently enrolled in an interventional clinical study (whether or not
the study is related to hypoparathyroidism); note that this does not include
participants enrolled in other observational registries.

- History of hypoparathyroidism resulting from impaired responsiveness to PTH
(pseudohypoparathyroidism).

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 9/30/22. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Bart Clarke, M.D.

Closed for enrollment

Contact information:

Tamera Roberson

(507) 255-8621

Roberson.Tamera@mayo.edu

More information

Publications

Publications are currently not available