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Albright Hereditary Osteodystrophy: Natural History, Growth, and Cognitive/Behavioral Assessments

StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Trial status: Recruiting to Active, Not Recruiting
    • Eligibility criteria expanded, about 21 words
    • Site details revised
    • Study description shortened, about 1 word
    v36
  2. Re-verified, no change to tracked fieldsv35
  3. Eligibility criteria expanded, about 53 words
    • Site contact updated
    v34
  4. Publications: 22 to 23v33
  5. Primary completion date: Oct 2026 to Oct 2030v32 Show 5 more changesShow less
    • Primary endpoints revised (2)
    • Study completion date: Dec 2027 to Dec 2030
    • Eligibility criteria expanded, about 25 words
    • Study description expanded, about 11 words
    • Publications: 20 to 22
Show 30 earlier versionsHide 30 earlier versions
  1. Re-verified, no change to tracked fieldsv31
  2. Collaborators reorderedv30
  3. Primary completion date: Oct 2019 to Oct 2026
    • Study completion date: Dec 2025 to Dec 2027
    • Publications: 19 to 20
    v29
  4. Interventions: neurocognitive and psychosocial testing (Behavioral) to Neurocognitive and psychosocial testing (Behavioral)v28
  5. Publications: 17 to 19v27
  6. Phase: Phase 2/3 to Not applicablev26 Show 7 more 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)
    • Study description expanded, about 7 words
    • Study site revised
    • Collaborators: 2 to 4
    • Study title revised
  7. Eligibility criteria expanded, about 19 words
    • Study description expanded, about 27 words
    • Collaborators: 1 to 2
    • Publications: details revised at 2 of 17 entries
    v25
  8. Re-verified, no change to tracked fieldsv24
  9. Eligibility criteria revised
    • Study description revised
    v23
  10. Enrollment target: 200 to 300v22 Show 5 more changesShow less
    • Primary endpoints: 1 to 2
    • Eligibility criteria expanded, about 24 words
    • Study description expanded, about 28 words
    • Publications: 16 to 17
    • Study title expanded, about 2 words
  11. Re-verified, no change to tracked fieldsv21
  12. Publications: 15 to 16v20
  13. Primary completion date: Oct 2017 to Oct 2019
    • Study description shortened, about 7 words
    • Collaborators: 2 to 1
    v19
  14. Primary endpoint revised
    • Eligibility criteria shortened, about 42 words
    • Study description shortened, about 39 words
    v18
  15. Phase: Not applicable to Phase 2/3v17 Show 5 more changesShow less
    • Primary completion date: Oct 2012 to Oct 2017
    • Study completion date: Dec 2020 to Dec 2025
    • Interventions: Growth Hormone (Drug), Growth hormone treatment (Drug) to Growth Hormone (Drug), Growth hormone (Drug)
    • Eligibility criteria expanded, about 19 words
    • Study description expanded, about 10 words
  16. Eligibility criteria expanded, about 58 words
    • Study description shortened, about 16 words
    v16
  17. Primary completion date: Oct 2011 to Oct 2012
    • Publications: 12 to 15
    v15
  18. Re-verified, no change to tracked fieldsv14
  19. Enrollment target: 100 to 200v13 Show 4 more changesShow less
    • Primary endpoint revised
    • Study description expanded, about 33 words
    • Publications: 11 to 12
    • Study title revised
  20. 2 versions Re-verified since Jun 21, 2010, no change to tracked fieldsv11-v12
  21. Study completion date: Dec 2020v10 Show 4 more changesShow less
    • Interventions: Growth hormone treatment (Drug) to Growth Hormone (Drug), Growth hormone treatment (Drug)
    • Site contact updated
    • Study title shortened, about 7 words
    • Study arms: 0 to 1
  22. Lead sponsor: Johns Hopkins University to Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
    • Study site revised
    • Collaborators: 1 to 2
    • Publications: 10 to 11
    v9
  23. Lead sponsor: FDA Office of Orphan Products Development to Johns Hopkins University
    • Collaborator revised
    v8
  24. Lead sponsor: Food and Drug Administration (FDA) to FDA Office of Orphan Products Developmentv7 Show 5 more changesShow less
    • Enrollment target: 75 to 100
    • Primary completion date: Oct 2011
    • Collaborators: 3 to 1
    • Publications: 9 to 10
    • Study title expanded, about 3 words
  25. Study description expanded, about 14 words
    • Publications: 6 to 9
    v6
  26. Publications: 1 to 6v5
  27. Secondary endpoints shortened, about 2 wordsv4
  28. Re-verified, no change to tracked fieldsv3
  29. Start date: Dec 2000 to Jan 2003
    • Collaborators: 2 to 3
    v2
  1. Study First Submitted
  • 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
(from sponsor)		 Pseudohypoparathyroidism Type 1A, Albright Hereditary Osteodystrophy, Pseudopseudohypoparathyroidism
Related terms Behavior, Dwarfism, Pituitary, Pseudohypoparathyroidism, Pseudopseudohypoparathyroidism
Enrollment 600 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov