A Registry for Participants With Chronic Hypoparathyroidism

• Register: ClinicalTrials.gov
• Last refreshed on: 21 October 2024
• Main ID: NCT01922440
• Date of registration: 01/08/2013
• Prospective Registration: No
• Primary sponsor: Takeda
• Public title: A Registry for Participants With Chronic Hypoparathyroidism PARADIGHM
• Scientific title: PARADIGHM (Physicians Advancing Disease Knowledge in Hypoparathyroidism): A Registry for Patients With Chronic Hypoparathyroidism
• Date of first enrolment: July 30, 2013
• Target sample size: 1339
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT01922440
• Study type: Observational [Patient Registry]

Countries of recruitment

Austria, Canada, Denmark, Germany, Greece, Italy, Norway, Spain, Sweden, United Kingdom, United States

Contacts

• Name: Study Director
• Affiliation: Takeda

Key inclusion & exclusion criteria

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).


Age minimum: N/A
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Hypoparathyroidism

Intervention(s)

Other: No intervention

Primary Outcome(s)

Incidence Rate of the Cataract [Time Frame: Baseline up to 10 years (follow-up)]

Incidence Rate of the Soft Tissue Calcifications (site) [Time Frame: Baseline up to 10 years (follow-up)]

Change from Baseline in 24-Hour Urine Protein [Time Frame: Baseline up to 10 years (follow-up)]

Change from Baseline in 25-Hydroxy (25-OH) Vitamin D results [Time Frame: Baseline up to 10 years (follow-up)]

Change from Baseline in Estimated Glomerular Filtration Rate (eGFR; calculated) [Time Frame: Baseline up to 10 years (follow-up)]

Change from Baseline in Serum Magnesium [Time Frame: Baseline up to 10 years (follow-up)]

Incidence Rate of the Bone Fractures (site) [Time Frame: Baseline up to 10 years (follow-up)]

Change from Baseline in Serum Albumin [Time Frame: Baseline up to 10 years (follow-up)]

Change from Baseline in Serum Creatinine [Time Frame: Baseline up to 10 years (follow-up)]

Change from Baseline in Serum Phosphate [Time Frame: Baseline up to 10 years (follow-up)]

Incidence Rate of the Renal Events [Time Frame: Baseline up to 10 years (follow-up)]

Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [Time Frame: Baseline up to 10 years (follow-up)]

Change from Baseline in 24-Hour Urine Calcium [Time Frame: Baseline up to 10 years (follow-up)]

Change from Baseline in Albumin-Corrected Total Calcium [Time Frame: Baseline up to 10 years (follow-up)]

Change from Baseline in Serum Calcium [Time Frame: Baseline up to 10 years (follow-up)]

Change from Baseline in Serum Ionized Calcium [Time Frame: Baseline up to 10 years (follow-up)]

Incidence Rate of the Cardiovascular Events [Time Frame: Baseline up to 10 years (follow-up)]

Secondary Outcome(s)

Health-related Quality of Life (HRQoL) [Time Frame: Baseline up to 10 years (follow-up)]

Disease-specific Patient-reported Outcome Measures [Time Frame: Baseline up to 10 years (follow-up)]

Rate of Hospitalization/Emergency Room (ER) Visits [Time Frame: Baseline up to 10 years (follow-up)]

Secondary ID(s)

EUPAS16927

PAR-R13-001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Takeda Development Center Americas, Inc.