A Registry for Participants With Chronic Hypoparathyroidism
- Conditions
- Hypoparathyroidism
- Registration Number
- NCT01922440
- Lead Sponsor
- Takeda
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 1339
-
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.
- 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).
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change from Baseline in Serum Magnesium Baseline up to 10 years (follow-up) Change from baseline in serum magnesium will be evaluated.
Change from Baseline in 25-Hydroxy (25-OH) Vitamin D results Baseline up to 10 years (follow-up) Change from baseline in 25-OH vitamin D will be evaluated.
Change from Baseline in Serum Creatinine Baseline up to 10 years (follow-up) Change from baseline in serum creatinine will be evaluated.
Incidence Rate of the Renal Events Baseline up to 10 years (follow-up) Incidence rate of the renal events will be recorded for nephrolithiasis, nephrocalcinosis, hospitalization/emergency room visits for renal events.
Change from Baseline in 24-Hour Urine Calcium Baseline up to 10 years (follow-up) Change from baseline in 24-hour urine calcium will be evaluated.
Change from Baseline in Serum Albumin Baseline up to 10 years (follow-up) Change from baseline in serum albumin will be evaluated.
Change from Baseline in Serum Phosphate Baseline up to 10 years (follow-up) Change from baseline in serum phosphate will be evaluated
Change from Baseline in Estimated Glomerular Filtration Rate (eGFR; calculated) Baseline up to 10 years (follow-up) Change from baseline in eGFR; calculated will be evaluated.
Incidence Rate of the Bone Fractures (site) Baseline up to 10 years (follow-up) Incidence rate of the bone fractures (site) will be recorded.
Change from Baseline in Serum Calcium Baseline up to 10 years (follow-up) Change from baseline in serum calcium will be evaluated.
Change from Baseline in Serum Ionized Calcium Baseline up to 10 years (follow-up) Change from baseline in serum ionized calcium will be evaluated.
Change from Baseline in 24-Hour Urine Protein Baseline up to 10 years (follow-up) Change from Baseline in 24-hour urine protein will be evaluated.
Change from Baseline in Albumin-Corrected Total Calcium Baseline up to 10 years (follow-up) Change from baseline in albumin-corrected total calcium will be evaluated.
Incidence Rate of the Soft Tissue Calcifications (site) Baseline up to 10 years (follow-up) Incidence rate of the soft tissue calcifications (site) will be recorded.
Incidence Rate of the Cardiovascular Events Baseline up to 10 years (follow-up) Incidence rate of the cardiovascular events will be calculated for this clinical outcome. Cardiovascular events include myocardial infarction, stroke, arrhythmia.
Incidence Rate of the Cataract Baseline up to 10 years (follow-up) Incidence rate of the cataract will be recorded by questionnaire (present/not present).
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Baseline up to 10 years (follow-up) 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.
- Secondary Outcome Measures
Name Time Method Health-related Quality of Life (HRQoL) Baseline up to 10 years (follow-up) 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.
Rate of Hospitalization/Emergency Room (ER) Visits Baseline up to 10 years (follow-up) The rate of hospitalizations and ER visits during follow-up will be summarized.
Disease-specific Patient-reported Outcome Measures Baseline up to 10 years (follow-up) Chronic hypoparathyroidism patient-reported outcome will be recorded as measured by the hypoparathyroidism multi-symptom diary (HPT-SD).
Trial Locations
- Locations (100)
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
Scroll for more (90 remaining)University of Alabama at Birmingham🇺🇸Birmingham, Alabama, United States