Clinical Trial: PARADIGHM A Natural History Registry for Patients With Chronic Hypoparathyroidism
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational [Patient Registry]
Official Title: PARADIGHM (Physicians Advancing Disease Knowledge in Hypoparathyroidism): A Natural History Registry for Patients With Chronic Hypoparathyroidism
Brief Summary: This is a prospective, observational, natural history registry, designed to collect data on patients with chronic hypoparathyroidism. No study-defined procedures will be required, and if available, a select set of data will be collected at baseline and at least annually.
Detailed Summary:
Sponsor: Shire
Current Primary Outcome:
- Descriptive epidemiology of chronic hypoparathyroidism from baseline up to 17 years of follow-up [ Time Frame: From baseline up to 17 years of follow-up ]
- Change in chronic hypoparathyroidism clinical features from baseline up to 17 years of follow-up [ Time Frame: From baseline up to 17 years of follow-up ]
- Change in chronic hypoparathyroidism treatment from baseline up to 17 years of follow-up [ Time Frame: From baseline up to 17 years of follow-up ]
- Change in chronic hypoparathyroidism patients' health care resource use from baseline up to 17 years of follow-up [ Time Frame: From baseline up to 17 years of follow-up ]
- Change in chronic hypoparathyroidism patients' SF-36 health survey from baseline up to 17 years of follow-up [ Time Frame: From baseline up to 17 years of follow-up ]
- Change in chronic hypoparathyroidism patients' work productivity and activity impairment from baseline up to 17 years of follow-up [ Time Frame: From baseline up to 17 years of follow-up ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Shire
Dates:
Date Received: August 1, 2013
Date Started: July 2013
Date Completion: June 2032
Last Updated: April 3, 2017
Last Verified: April 2017
