A Registry for Participants With Chronic Hypoparathyroidism (PARADIGHM)

Takeda

Status: Active, not recruiting

Conditions: Hypoparathyroidism

Treatments: Other: No intervention

Study type: Observational

Funder types: Industry

Identifiers

NCT01922440

PAR-R13-001

EUPAS16927 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 1,339 patients

Sex: All

Volunteers: No Healthy Volunteers

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).

Trial design

1,339 participants in 2 patient groups

Natpar(a)

Description:

Participants receiving parathyroid hormone (rhPTH(1-84) (Natpar\[a\]) for treatment of chronic hypoparathyroidism as per standard clinical practice will be enrolled and evaluated during the study period.

Treatment:

Other: No intervention

Conventional Therapy

Description:

Participants receiving conventional therapy/standard of care (including calcium supplements, active vitamin D, vitamin D) for treatment of chronic hypoparathyroidism as per standard clinical practice will be enrolled and evaluated during the study period.

Treatment:

Other: No intervention