A Registry for Participants With Chronic Hypoparathyroidism

N/AActive Not RecruitingNCT01922440

Takeda1,339 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

1,339

Conditions

Hypoparathyroidism

Interventions

No interventionOTHER

This is a non-interventional study.

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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).

Locations (100)

Outcomes

Primary Outcomes

Change from Baseline in 24-Hour Urine Calcium

Change from baseline in 24-hour urine calcium will be evaluated.

Time frame: Baseline up to 10 years (follow-up)

Change from Baseline in Serum Calcium

Change from baseline in serum calcium will be evaluated.

Time frame: Baseline up to 10 years (follow-up)

Change from Baseline in Serum Albumin

Change from baseline in serum albumin will be evaluated.

Time frame: Baseline up to 10 years (follow-up)

Change from Baseline in Albumin-Corrected Total Calcium

Change from baseline in albumin-corrected total calcium will be evaluated.

Time frame: Baseline up to 10 years (follow-up)

Change from Baseline in Serum Ionized Calcium

Change from baseline in serum ionized calcium will be evaluated.

Time frame: Baseline up to 10 years (follow-up)

Change from Baseline in Serum Magnesium

Change from baseline in serum magnesium will be evaluated.

Time frame: Baseline up to 10 years (follow-up)

Change from Baseline in Serum Phosphate

Change from baseline in serum phosphate will be evaluated

Time frame: Baseline up to 10 years (follow-up)

Change from Baseline in 25-Hydroxy (25-OH) Vitamin D results

Change from baseline in 25-OH vitamin D will be evaluated.

Time frame: Baseline up to 10 years (follow-up)

Data from ClinicalTrials.gov

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University of Alabama at Birmingham

Birmingham, Alabama, United States

University of Arizona Medical Center

Tucson, Arizona, United States

Children's Hospital Los Angeles

Los Angeles, California, United States

Cedars-Sinai Medical Center

Los Angeles, California, United States

Dr. Joselito Cabaccan

San Jose, California, United States

University of Colorado Hospital

Aurora, Colorado, United States

Yale University

New Haven, Connecticut, United States

Hanson Clinical Research Center

Port Charlotte, Florida, United States

Thyroid & Endocrine Center of Florida

Sarasota, Florida, United States

East-West Medical Research Institute

Honolulu, Hawaii, United States

...and 90 more locations

Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

An AE is any untoward medical occurrence in a participant administered a medicinal product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, a new disease or worsening in severity or frequency of a concomitant disease, temporally associated with the use of a medicinal product, whether or not the event is considered causally related to the use of the product. An SAE is any untoward medical occurrence (whether considered to be related to study product or not) that at any dose results in death, life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital abnormality or birth defect, an important medical event.

Time frame: Baseline up to 10 years (follow-up)

Secondary Outcomes

Health-related Quality of Life (HRQoL)

Health-Related Quality of Life (HRQoL), as measured by the short-form-10 (SF-10) for pediatrics, short-form-36 (SF-36) for adults will be examined longitudinally using methods for continuous data.

Time frame: Baseline up to 10 years (follow-up)

Disease-specific Patient-reported Outcome Measures

Chronic hypoparathyroidism patient-reported outcome will be recorded as measured by the hypoparathyroidism multi-symptom diary (HPT-SD).

Time frame: Baseline up to 10 years (follow-up)

Rate of Hospitalization/Emergency Room (ER) Visits

The rate of hospitalizations and ER visits during follow-up will be summarized.

Time frame: Baseline up to 10 years (follow-up)