Status:
RECRUITING
Albright Hereditary Osteodystrophy: Natural History, Growth, and Cognitive/Behavioral Assessments
Lead Sponsor:
Connecticut Children's Medical Center
Collaborating Sponsors:
Johns Hopkins University
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Conditions:
Pseudohypoparathyroidism Type 1A
Albright Hereditary Osteodystrophy
Eligibility:
All Genders
2-89 years
Phase:
NA
Brief Summary
We, the researchers, are following the natural history of Albright hereditary osteodystrophy. We have found that growth hormone deficiency is very common in patients with pseudohypoparathyroidism type...
Detailed Description
Pseudohypoparathyroidism type 1A (PHP1A) is a disorder that causes many endocrine and developmental problems. To date, medical treatment has focused primarily on maintenance of normal serum levels of ...
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
Key Trial Info
Start Date :
January 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2030
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT00209235
Start Date
January 1 2003
End Date
December 1 2030
Last Update
May 28 2025
Active Locations (1)
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1
Connecticut Children's Medical Center
Hartford, Connecticut, United States, 06103