PARADIGHM
Research type
Research Study
Full title
PARADIGHM (Physicians Advancing Disease Knowledge in Hypoparathyroidism)-A Registry for Patients with Chronic Hypoparathyroidism
IRAS ID
267095
Contact name
William D Fraser
Contact email
Sponsor organisation
Shire Human Genetic Therapies, Inc. (Shire), part of Takeda Group
Clinicaltrials.gov Identifier
EUPAS16927, EU PAS Register
Duration of Study in the UK
16 years, 0 months, days
Research summary
This study is designed to collect information on the long term safety and effectiveness of recombinant human parathyroid hormone (rhPTH (1-84)) in patients with chronic hypoparathyroidism.
This is an observational study, which will collect information from the normal clinical treatment of patients. Patients will not be provided with any treatment as a result of participating in this study.
Selected data obtained during the treatment of patients with hypoparathyroidism during standard clinical practice will be collected and entered into the registry database. The study will be open to patients receiving treatment with standard therapy, rhPTH (1-84), or both. Participants will also be asked to complete some questionnaires regarding their health status, quality of life and use of healthcare resources.
The study results are intended to provide greater of the variability, progression and clinical course of the disease and therefore assist health care providers in optimizing their clinical decision making.
Patient Enrollment will be at least 900 globally (US / Canada / Europe)with minimum of 300 patients receiving treatment with rhPTH(1-84)and minimum of 10 years of follow-up per patient.
REC name
East of England - Cambridgeshire and Hertfordshire Research Ethics Committee
REC reference
19/EE/0253
Date of REC Opinion
16 Sep 2019
REC opinion
Further Information Favourable Opinion