Active — Not RecruitingNot Applicable

A Registry for Participants With Chronic Hypoparathyroidism

United States1,339 participantsStarted 2013-07-30

Plain-language 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.

Who can participate

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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.

What they're measuring

Change from Baseline in 24-Hour Urine Calcium

Timeframe: Baseline up to 10 years (follow-up)

Change from Baseline in Serum Calcium

Timeframe: Baseline up to 10 years (follow-up)

Change from Baseline in Serum Albumin

Timeframe: Baseline up to 10 years (follow-up)

Change from Baseline in Albumin-Corrected Total Calcium

Timeframe: Baseline up to 10 years (follow-up)

Change from Baseline in Serum Ionized Calcium

Timeframe: Baseline up to 10 years (follow-up)

Change from Baseline in Serum Magnesium

Timeframe: Baseline up to 10 years (follow-up)

Change from Baseline in Serum Phosphate

Timeframe: Baseline up to 10 years (follow-up)

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

Timeframe: Baseline up to 10 years (follow-up)

Trial details

NCT IDNCT01922440

SponsorTakeda

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2034-11-30

View on ClinicalTrials.gov More Hypoparathyroidism trials

Plain-language summary

Who can participate

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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.

What they're measuring

Change from Baseline in 24-Hour Urine Calcium

Timeframe: Baseline up to 10 years (follow-up)

Change from Baseline in Serum Calcium

Timeframe: Baseline up to 10 years (follow-up)

Change from Baseline in Serum Albumin

Timeframe: Baseline up to 10 years (follow-up)

Change from Baseline in Albumin-Corrected Total Calcium

Timeframe: Baseline up to 10 years (follow-up)

Change from Baseline in Serum Ionized Calcium

Timeframe: Baseline up to 10 years (follow-up)

Change from Baseline in Serum Magnesium

Timeframe: Baseline up to 10 years (follow-up)

Change from Baseline in Serum Phosphate

Timeframe: Baseline up to 10 years (follow-up)

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

Timeframe: Baseline up to 10 years (follow-up)