A Registry for Participants With Chronic Hypoparathyroidism

Completed

Conditions studied: Hypoparathyroidism

In brief

The main aim of this study is to find out the long-term safety and effectiveness profile of recombinant human parathyroid hormone (1-84) (rhPTH\[1-84\]) treatment in participants with chronic hypoparathyroidism under conditions of routine clinical practice. Participants will be treated according to their clinic's standard practice determined by the treating doctors. Each participant will fill out a study questionnaire during a routine doctor visit.

Key facts

Study ID

NCT01922440

Run by

Takeda

People needed

1339

Starts

2013-07-30

Expected to finish

2026-06-30

Last updated by the study team

2026-07-14

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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).

Where it is running

• Thyroid & Endocrine Center of Florida — Sarasota, Florida, United States
• East-West Medical Research Institute — Honolulu, Hawaii, United States
• Suburban Endocrinology & Diabetes — Arlington Heights, Illinois, United States
• University of Chicago Medical Center — Chicago, Illinois, United States
• Northshore University Health System — Evanston, Illinois, United States
• Loyola University Medical Center — Maywood, Illinois, United States
• Indiana University Hospital — Indianapolis, Indiana, United States
• Tilak Mallik, MD F.A.C.E., LCC — Marrero, Louisiana, United States
• Model Clinical Research — Baltimore, Maryland, United States
• Medstar Union Memorial Hospital — Baltimore, Maryland, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Brigham and Women's Hospital — Boston, Massachusetts, United States
• Harvard Medical School — Boston, Massachusetts, United States
• Boston Medical Center — Boston, Massachusetts, United States
• University of Minnesota — Minneapolis, Minnesota, United States
• Mayo Clinic - Rochester — Rochester, Minnesota, United States
• University of Missouri — Columbia, Missouri, United States
• Diabetes & Endocrine Associates, Methodist Physicians Clinic Diabetes and Endocrine Specialists — Omaha, Nebraska, United States
• Palm Research Center, Inc. — Las Vegas, Nevada, United States
• Northern Nevada Endocrinology — Reno, Nevada, United States
• Rutgers Robert Wood Johnson Medical School — New Brunswick, New Jersey, United States
• Rutgers-Robert Wood Johnson Medical School — New Brunswick, New Jersey, United States
• Albany Med Endocrine Specialists — Albany, New York, United States
• Brokhin Medical PC — Brooklyn, New York, United States
• Hanson Clinical Research Center — Port Charlotte, Florida, United States

Full record on ClinicalTrials.gov

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