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| Find a Clinical Trial |
| Principal Investigator: | Rosalind Brown |
| Trial Description: | The purpose of this study is to to learn whether daily dosing with a combination of Increlex (rhIGF-1) and Growth Hormone (rhGH) will help children with primary IGF-1 deficiency grow taller more quickly than children treated with Growth Hormone (rhGH alone). Study procedures will include a medical history review, a complete physical examination, fasting before some study visits, and finger sticks of blood. Blood will be drawn (approximately 1 to 2 ½ tablespoons at a time). Urine samples will be taken. An x-ray of your child’s hand will be taken to determine bone age. Parental heights will be measured for each biological parent. If participants have not had a Growth Hormone Stimulation test, it will be scheduled prior to the second study visit. Participants are randomized to either treatment with rhGH alone or rhGH in combination with various doses of rhIGF-1. Participants will receive the first dose of medicine at Children’s Hospital Boston. Children and parents will be taught how to prepare and administer the injections at home and will be given a supply of the study drug(s). A daily dosing diary will be provided and needs to be completed. The study lasts for 3 years.
Study participants will receive $25.00 per visit ($350 total) as compensation for time committed.
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| Recruitment Info: | Patients with Idiopathic Short Stature (ISS) (short for no identifiable reason) who have already had an evaluation in the Endocrine Clinic, or have one scheduled, and meet the following criteria, may be eligible:
Low IGF-1 level (level must be 1 standard deviation below normal)
Short stature (height must be 2 standard deviations below normal)
Age 5 or older
Bone age less than or equal to 11 years in boys and greater than or equal to 9 years in girls
Have not entered puberty
Have an adequate nutritional status (this will be measured by body mass index
No Previous treatment with growth hormone or other growth promoting substances
No treatment with chronic steroids or ADHD drugs
No primary IGF-1 deficiency, defined as IGF-1 SDS of < 3 and height SDS of < 3
Growth problems may not be associated with any other cause
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| Recruitment Contact Name: | Andrea Hale, RN |
| Recruitment Contact Phone: | 617-919-2867 |
| Recruitment Contact Email: | andrea.hale@childrens.harvard.edu |
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