Research Summary

Pediatric Endocrine Associates, P.C. is committed to providing our patients with access to the latest scientific advances and treatment options in the field of pediatric endocrinology. Much of what is common medical knowledge today is based upon information obtained from the research studies and clinical trials of the past. Even current therapies are constantly being adapted to better serve a wider range of patients through clinical research and long-term observational studies. We are proud to be an active part of advancing treatment options within the field of pediatric endocrinology while also contributing to the breadth of knowledge which may one day allow us to prevent certain disease processes from occurring.

Our practice currently participates in the following research studies:

Growth Related Projects:

Diabetes Related Projects:

* Studies conducted through the Medical College of Georgia

The Norditropin ANSWER Program Registry

The ANSWER Program registry is a post-marketing observational research study available to patients currently using Novo Nordisk Inc. Norditropin® for growth hormone replacement therapy. Participation in the registry has no effect on treatment. All participants will continue with their physician prescribed treatment regimen and follow-up office visit plan. All study data is collected from office visit notes and lab work drawn as a part of their routine growth hormone treatment.

The purpose of the ANSWER program registry is to study the real world treatment effects of Norditropin® – and help doctors who prescribe Norditropin® use it as safely and efficiently as possible. ANSWER will help scientists and physicians better understand the relationship between growth hormone dosing and IGF-I levels and successful treatment outcomes – which will serve to optimize growth hormone treatment for various diagnosis both now and in the future. ANSWER will also examine possible relationships between growth hormone levels obtained during stimulation testing and outcomes of growth hormone treatment, which may lead to the future development of models which will be able to predict patient success with growth hormone treatment before they even begin injections.

Please see the following patient consent forms for more information and/or contact the research department if you are interested in having your child participate.

The Lilly GeNeSIS Study

The Genetics and Neuroendocrinology of Short Stature International Study (GeNeSIS) is being conducted by Eli Lilly & Company to gain a deeper understanding of growth related issues and the effectiveness of treatment with Humatrope® synthetic growth hormone. GeNeSIS is an established international observational study which simply collects information related to the standard treatment of growth related conditions, to allow prescribing physicians to better understand growth, growth problems, and their response to growth hormone drug therapy. All patients currently receiving Humatrope® treatment are eligible to participate. Participation in the registry has no effect on treatment. All participants will continue with their physician prescribed treatment regimen and follow-up office visit plan. All study data is collected from office visit notes and lab work drawn as a part of their routine growth hormone treatment.

Please see the following patient consent forms for more information and/or contact the research department if you are interested in having your child participate.

The Ipsen/Tercica IGFD Registry

The IGFD Registry is an observational study designed to monitor the long term safety and efficacy of patients being treated with Increlex™ (mecasermin [rDNA origin] injection.) Increlex™ is used to treat children with growth failure due to Primary IGF-I deficiency. Children with this condition typically have normal growth hormone levels and may pass a growth hormone stimulation test, but have very low levels of IGF-I. IGF-I is normally stimulated by growth hormone to allow for proper bone growth and development, but in Primary IGF-I deficiency some portion of this process does not occur.

Increlex™ was approved by the FDA in 2005 based on data showing that it was a safe and effective treatment for Primary IGF-I deficiency in children. The goal of the registry is to continue collecting data about the dose related effectiveness and safety of growth therapy with Increlex™. All patients currently taking Increlex™ are eligible to participate.

Please see the following patient consent forms for more information and/or contact the research department if you are interested in having your child participate.

The Pfizer KIGS Registry

The purpose of the Pfizer International Growth Study (KIGS) is to evaluate the long-term safety and effectiveness of treatment with Genotropin®. During the study research staff will collect information from patient office visit notes and lab work drawn as a part of their routine growth hormone treatment. Since this is a completely observational study it will require no extra office visits or lab work, and will have absolutely no effect on a patient’s treatment plan. The goal of KIGS is to help scientists and physicians better understand conditions in children whose growth is not normal, and also gain insight into what happens to these children and their growth when treated with the growth hormone therapy Genotropin®.

Please see the following patient consent forms for more information and/or contact the research department if you are interested in having your child participate.