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Study 111-903 will generate baseline growth data in children with ISS by collecting growth measurements and other variables of interest.
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| Measure | Description | Time Frame |
|---|---|---|
| Change in annualized growth velocity (AGV) | Every 6 months through end of study, up to 15 years | |
| Change in Height Z-score | Every 6 months through end of study, up to 15 years | |
| Change in Standing Height | Every 6 months through end of study, up to 15 years | |
| Change in BMI | Every 6 months through end of study, up to 15 years | |
| Change in BMI Z-score | Every 6 months through end of study, up to 15 years |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of event rates of medical events of interest | Every 6 months through end of study, up to 15 years | |
| Frequency of Serious Medical Events | Every 6 months through end of study, up to 15 years |
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Inclusion Criteria:
Exclusion Criteria:
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The study population will include up to 600 pediatric individuals with Idiopathic Short Stature.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Trial Specialist | Contact | 18009834587 | Medinfo@bmrn.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Phoenix Children's Hospital - Thomas Campus (Main) | Withdrawn | Phoenix | Arizona | 85016 | United States | |
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| Association between specific variants and growth velocity | Every 6 months through end of study, up to 15 years |
| Association between other health outcomes directly related to short stature | Every 6 months through end of study, up to 15 years |
| Children's Hospital Los Angeles |
| Not yet recruiting |
| Los Angeles |
| California |
| 90027 |
| United States |
|
| Harbor-UCLA Medical Center - The Lundquist Institute (Los Angeles Biomedical Research Institute (LA BioMed) | Recruiting | Los Angeles | California | 90502 | United States |
|
| Children's Hospital of Orange County Main Campus - Orange | Not yet recruiting | Orange | California | 92868 | United States |
|
| Center Of Excellence in Diabetes and Endocrinology | Recruiting | Sacramento | California | 95821 | United States |
|
| Rady Children's Hospital - San Diego | Not yet recruiting | San Diego | California | 92123 | United States |
|
| University of California San Francisco (UCSF) | Recruiting | San Francisco | California | 94143 | United States |
|
| Connecticut Children's Medical Center | Recruiting | Hartford | Connecticut | 06106-3322 | United States |
|
| Yale School of Medicine | Withdrawn | New Haven | Connecticut | 06511 | United States |
| Children's National Health System | Recruiting | Washington D.C. | District of Columbia | 20010 | United States |
|
| Nemours Children's Clinic | Recruiting | Jacksonville | Florida | 32207 | United States |
|
| Nicklaus Children's Hospital | Recruiting | Miami | Florida | 33155 | United States |
|
| Nemours Children's Health System - Corporate Headquarters | Recruiting | Pensacola | Florida | 32514 | United States |
|
| Centricity Research | Recruiting | Columbus | Georgia | 31904 | United States |
|
| St. Luke's Children's Endocrinology | Recruiting | Boise | Idaho | 83712 | United States |
|
| Rocky Mountain Clinical Research - Idaho Falls | Recruiting | Idaho Falls | Idaho | 83404 | United States |
|
| University of Louisville School Of Medicine - Norton Children's Hospital | Recruiting | Louisville | Kentucky | 40202 | United States |
|
| Ochsner Health Center for Children - New Orleans | Withdrawn | New Orleans | Louisiana | 70121 | United States |
| University of Michigan | Recruiting | Ann Arbor | Michigan | 48109-4000 | United States |
|
| University of Minnesota Medical School - Masonic Children's Hospital - Pediatric Specialty Care Explorer Clinic | Withdrawn | Minneapolis | Minnesota | 55454 | United States |
| Dartmouth-Hitchcock Medical Center | Recruiting | Lebanon | New Hampshire | 03756 | United States |
|
| University of Iowa Stead Family Children's Hospital | Recruiting | Princeton | New Jersey | 08540 | United States |
|
| UBMD Pediatrics | Recruiting | Buffalo | New York | 14203 | United States |
|
| ACGC Research, NYU Ambulatory Care Garden City | Recruiting | Garden City | New York | 11530 | United States |
|
| New York University Grossman School of Medicine | Not yet recruiting | New York | New York | 10016 | United States |
|
| Icahn School of Medicine at Mount Sinai (ISMMS) - The Mount Sinai Hospital (MSH) - Pediatric Associates | Not yet recruiting | New York | New York | 10029 | United States |
|
| Montefiore Medical Center (MMC) - The Children's Hospital at Montefiore (CHAM) | Recruiting | The Bronx | New York | 10467 | United States |
|
| WakeMed Children's - Pediatric Endocrinology - North Raleigh | Withdrawn | Raleigh | North Carolina | 27615 | United States |
| Cincinnati Children's Hospital Medical Center Burnet Campus | Recruiting | Cincinnati | Ohio | 45229 | United States |
|
| Nationwide Children's Hospital | Not yet recruiting | Columbus | Ohio | 43205 | United States |
|
| Prisma Health Children's Hospital - Midlands | Recruiting | Columbia | South Carolina | 29203 | United States |
|
| Vanderbilt University Medical Center | Recruiting | Nashville | Tennessee | 37232-2578 | United States |
|
| University of Texas Southwestern Medical Center | Withdrawn | Dallas | Texas | 75390 | United States |
| Cook Children's Endocrinology | Withdrawn | Fort Worth | Texas | 76104 | United States |
| Baylor College of Medicine | Not yet recruiting | Houston | Texas | 77030 | United States |
|
| Seattle Children's Hospital | Not yet recruiting | Seattle | Washington | 98105 | United States |
|
| Charleston Area Medical Center (CAMC) Health System | Withdrawn | Charleston | West Virginia | 25304 | United States |
| Medical College of Wisconsin, Children's Hospital | Not yet recruiting | Milwaukee | Wisconsin | 53226 | United States |
|