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MinorTrial status: Recruiting to Active, Not RecruitingEligibility criteria expanded, about 21 words · Site details revised · Study description shortened, about 1 wordv36Show all 4 changesShow less
NotablePrimary completion date: Oct 2026 to Oct 2030Primary endpoints revised (2) · Completion date: Dec 2027 to Dec 2030 · Eligibility criteria expanded, about 25 words · 2 morev32Show all 6 changesShow less
NotablePhase: Phase 2/3 to Not applicableLead sponsor: Hugo W. Moser Research Institute at Kennedy Krieger, Inc. to Connecticut Children's Medical Center · Enrollment target: 300 to 600 · Interventions: Growth Hormone (Drug), Growth hormone (Drug) to neurocognitive and psychosocial testing (Behavioral) · 4 morev26Show all 8 changesShow less
Lead sponsor: Hugo W. Moser Research Institute at Kennedy Krieger, Inc. to Connecticut Children's Medical Center
Enrollment target: 300 to 600
Interventions: Growth Hormone (Drug), Growth hormone (Drug) to neurocognitive and psychosocial testing (Behavioral)
MinorEligibility criteria expanded, about 19 wordsStudy description expanded, about 27 words · Collaborators: 1 to 2 · Publications: details revised at 2 of 17 entriesv25Show all 4 changesShow less
NotableEnrollment target: 200 to 300Primary endpoints: 1 to 2 · Eligibility criteria expanded, about 24 words · Study description expanded, about 28 words · 2 morev22Show all 6 changesShow less
NotablePrimary endpoint revisedEligibility criteria shortened, about 42 words · Study description shortened, about 39 wordsv18Show all 3 changesShow less
NotablePhase: Not applicable to Phase 2/3Primary completion date: Oct 2012 to Oct 2017 · Completion date: Dec 2020 to Dec 2025 · Interventions: Growth Hormone (Drug), Growth hormone treatment (Drug) to Growth Hormone (Drug), Growth hormone (Drug) · 2 morev17Show all 6 changesShow less
NotableEnrollment target: 100 to 200Primary endpoint revised · Study description expanded, about 33 words · Publications: 11 to 12 · 1 morev13Show all 5 changesShow less
Minor2 versionsRe-verified since Jun 21, 2010, no change to tracked fieldsv11-v12
MinorCompletion date: Dec 2020Interventions: Growth hormone treatment (Drug) to Growth Hormone (Drug), Growth hormone treatment (Drug) · Site contact updated · Study title shortened, about 7 words · 1 morev10Show all 5 changesShow less
NotableLead sponsor: Johns Hopkins University to Hugo W. Moser Research Institute at Kennedy Krieger, Inc.Study site revised · Collaborators: 1 to 2 · Publications: 10 to 11v9Show all 4 changesShow less
NotableLead sponsor: Food and Drug Administration (FDA) to FDA Office of Orphan Products DevelopmentEnrollment target: 75 to 100 · Primary completion date: Oct 2011 · Collaborators: 3 to 1 · 2 morev7Show all 6 changesShow less
Stopped: an ongoing trial was terminated, suspended or withdrawn.
Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 1A, which falls under the broader condition termed Albright hereditary osteodystrophy. Patients with pseudohypoparathyroidism type 1A typically are short and obese. Some of these patients are not short during childhood, but due to a combination of factors, they end up short as adults. We are currently evaluating our data on the effect of growth hormone treatment in those patients with pseudohypoparathyroidism type 1A who were found to be growth hormone deficient (under R01 FD002568, IND 67148, which ended); those who were growth hormone sufficient and were found to have a positive clinical response to growth hormone in a prior clinical trial (under R01 FD00FD003409, IND 67148, which ended); or those who meet the criteria of idiopathic short stature or SGA.
We are also evaluating our data on neurocognitive and psychosocial functioning in participants with AHO in order to determine the specific impairments that are most common in the condition and to determine the best approach toward management.
Funding source -- Growth hormone study: FDA OOPD \[R01 FD003409 (which has ended) and R01 FD002568 (which has ended)\] Cognitive/behavior: NICHD R21 HD078864 (which has ended)
Trial Details
NCT Number
NCT00209235
Lead Sponsor
Connecticut Children's Medical Center Collaborators: Johns Hopkins University, Hugo W. Moser Research Institute at Kennedy Krieger, Inc., UConn Health, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions
Pseudohypoparathyroidism Type 1A, Albright Hereditary Osteodystrophy, Pseudopseudohypoparathyroidism