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Growth Hormone Therapy for Pseudohypoparathyroidism

N/A
Recruiting
Led By Emily L Germain-Lee, MD
Research Sponsored by Connecticut Children's Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
For cognitive/behavioral studies: Ages 4 - 65 yrs
For cognitive/behavioral studies: Confirmed diagnosis of Pseudohypoparathyroidism type 1A and Pseudopseudohypoparathyroidism
Must not have
For GH study: Absence of diagnosis of pseudohypoparathyroidism type 1A
For cognitive/behavioral studies: Absence of confirmed diagnosis of Pseudohypoparathyroidism type 1A and Pseudopseudohypoparathyroidism
Timeline
Screening 3 weeks
Treatment Varies
Follow Up until achieve final height (approximately 12-15 years)
Awards & highlights
No Placebo-Only Group

Summary

This trial is observing the effects of growth hormone on patients with Albright hereditary osteodystrophy, specifically those with pseudohypoparathyroidism type 1a. This form of the condition typically leads to patients being short and obese. The trial is also observing the neurocognitive and psychosocial effects of the condition in order to better understand how to manage it.

Who is the study for?
This trial is for individuals aged 0.2 to 89 years with conditions like pseudohypoparathyroidism type 1A or pseudopseudohypoparathyroidism. Growth hormone treatment participants must be over 3, pre-pubertal, and meet criteria for idiopathic short stature or SGA if they are not growth hormone deficient.
What is being tested?
The study observes the natural progression of Albright hereditary osteodystrophy and tests the effects of growth hormone in certain patients. It also assesses cognitive and psychosocial functioning to identify common impairments and management strategies.
What are the potential side effects?
Since this trial focuses on observation and neurocognitive testing rather than medication, it does not list specific side effects related to drug interventions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 4 and 65 years old.
Select...
I have been diagnosed with Pseudohypoparathyroidism type 1A or Pseudopseudohypoparathyroidism.
Select...
I have been diagnosed with Pseudohypoparathyroidism type 1A or Pseudopseudohypoparathyroidism.
Select...
I have been diagnosed with pseudohypoparathyroidism type 1A.
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I am over 3 years old and have not started puberty yet.
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I am diagnosed with idiopathic short stature or was born small for gestational age.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I do not have pseudohypoparathyroidism type 1A.
Select...
I do not have a diagnosis of Pseudohypoparathyroidism type 1A or Pseudopseudohypoparathyroidism.
Select...
I do not have a confirmed diagnosis of Pseudohypoparathyroidism type 1A or Pseudopseudohypoparathyroidism.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~until achieve final height (approximately 12-15 years)
This trial's timeline: 3 weeks for screening, Varies for treatment, and until achieve final height (approximately 12-15 years) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Cognitive and behavioral function in Albright hereditary osteodystrophy
Lipids

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: AHO:neurocognitive and pyschosocialExperimental Treatment1 Intervention
Neurocognitive and psychosocial testing

Find a Location

Who is running the clinical trial?

Hugo W. Moser Research Institute at Kennedy Krieger, Inc.OTHER
90 Previous Clinical Trials
24,260 Total Patients Enrolled
UConn HealthOTHER
215 Previous Clinical Trials
60,121 Total Patients Enrolled
Johns Hopkins UniversityOTHER
2,339 Previous Clinical Trials
14,881,073 Total Patients Enrolled
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
2,068 Previous Clinical Trials
2,746,944 Total Patients Enrolled
Connecticut Children's Medical CenterLead Sponsor
73 Previous Clinical Trials
25,993 Total Patients Enrolled
Emily L Germain-Lee, MDPrincipal InvestigatorConnecticut Children's Medical Ctr. and Univ. of Connecticut School of Medicine

Media Library

Pseudopseudohypoparathyroidism Research Study Groups: AHO:neurocognitive and pyschosocial
Pseudopseudohypoparathyroidism Clinical Trial 2023: Neurocognitive and psychosocial testing Highlights & Side Effects. Trial Name: NCT00209235 — N/A
Neurocognitive and psychosocial testing 2023 Treatment Timeline for Medical Study. Trial Name: NCT00209235 — N/A
~124 spots leftby Oct 2030
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