Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:22 PM
Ignite Modification Date:
2025-12-24 @ 10:22 PM
NCT ID:
NCT00209235
Eligibility Criteria:
Inclusion Criteria for GH study:
* Diagnosis of pseudohypoparathyroidism type 1A with mutation confirmation
* For the portion of the study in which growth hormone is used for participants who are not growth hormone deficient (ie., growth hormone sufficient), the participant must be over 3 years of age (ie., after 3rd birthday) AND also be pre-pubertal at the time of GH initiation.
* As of now, the growth hormone sufficient participants must meet the FDA-approved criteria for idiopathic short stature or the SGA indication.
Therefore, for all participants enrolling in the growth hormone portion of this study as of now, the growth hormone is used according to FDA-approved indications, and growth hormone use is according to standard of care clinical guidelines.
Exclusion:
* Absence of above diagnosis and failure to meet above criteria
Inclusion Criteria for cognitive/behavioral studies:
* Confirmed diagnosis of Pseudohypoparathyroidism type 1A and Pseudopseudohypoparathyroidism with mutation confirmation
* Ages 4 - 65 yrs
Exclusion:
* Absence of above
Inclusion Criteria for Natural History Study:
* Confirmed diagnosis of Pseudohypoparathyroidism type 1A or Pseudopseudohypoparathyroidism with mutation confirmation
* Ages 0.2 yrs - 89 yrs
Exclusion:
* Absence of above
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
2 Months
Maximum Age:
89 Years
Study:
NCT00209235
Study Brief:
Protocol Section:
NCT00209235