Safety Profile of IGF-I Administration in Adolescents - Full Text View

Safety Profile of IGF-I Administration in Adolescents

This study is currently recruiting participants.
Verified by Massachusetts General Hospital, August 2007

Sponsors and Collaborators:	Massachusetts General Hospital Tercica
Information provided by:	Massachusetts General Hospital
ClinicalTrials.gov Identifier:	NCT00516386

Purpose

The purpose of this study is to determine whether giving IGF-I to adolescent low weight girls is safe and whether this increases levels of bone formation markers.

Condition	Intervention	Phase
Anorexia Nervosa	Drug: IGF-I	Phase I Phase II

ChemIDplus related topics:

Insulin-like growth factor I Mecasermin rinfabate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Other, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:

Safety profile of IGF-I administration in low weight adolescents [ Time Frame: One month ]

Secondary Outcome Measures:

Effect of IGF-I on bone formation markers [ Time Frame: 1 month ]

Eligibility

Ages Eligible for Study:	12 Years to 18 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Adolescent girls with anorexia nervosa 12-18 years old

Exclusion Criteria:

Pregnancy or nursing
Hematocrit < 30%, K < 3 mmol/L
Any illness (other than anorexia nervosa) known to affect bone and mineral metabolism such as diabetes, alcoholism, untreated hypo- or hyperthyroidism, or hyperparathyroidism
History of use of any medicine, such as corticosteroids, known to affect bone density. Subjects who are on estrogen will still be eligible to participate in the study.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00516386

Contacts


Contact: Madhu Misra	617 726 3870	mmisra@partners.org

Locations


United States, Massachusetts
	Massachusetts General Hospital	Recruiting
	Boston, Massachusetts, United States, 02114
	Contact: Madhu Misra mmisra@partners.org
	Sub-Investigator: Anne Klibanski

Sponsors and Collaborators

Massachusetts General Hospital

Tercica

Investigators


Principal Investigator:	Madhu Misra	Massachusetts General Hospital

More Information

Study ID Numbers:	2006P-000737
First Received:	August 13, 2007
Last Updated:	August 14, 2007
ClinicalTrials.gov Identifier:	NCT00516386
Health Authority:	United States: Food and Drug Administration

Keywords provided by Massachusetts General Hospital:

Adolescents

Anorexia nervosa

Bone formation markers

IGf-I

Study placed in the following topic categories:

Signs and Symptoms

Signs and Symptoms, Digestive

Mental Disorders

Anorexia

Anorexia Nervosa

Eating Disorders

ClinicalTrials.gov processed this record on October 07, 2008