Growth Hormone Administration and Its Effects on Cardiovascular Risk Factors in Growth Hormone Deficient Women - Full Text View

Sponsor:	Massachusetts General Hospital
Information provided by:	Massachusetts General Hospital
ClinicalTrials.gov Identifier:	NCT00136032

Sponsor:

Massachusetts General Hospital

Information provided by:

Massachusetts General Hospital

ClinicalTrials.gov Identifier:

NCT00136032

Purpose

The purpose of the study is to evaluate the effects of growth hormone replacement on women with growth hormone deficiency. Growth hormone deficiency means the body no longer produces growth hormone due to a tumor or some kind of disease of the brain in an area called the pituitary/hypothalamic region. This is the area of the brain where growth hormone is normally produced. We, the researchers at Massachusetts General Hospital, will establish the effects of growth hormone replacement on cardiovascular parameters (laboratory tests, the flexibility of the arteries, changes in heart rate) in women with growth hormone deficiency. Our goal is to see if this therapy:

has effects on women's cardiovascular risk markers (special blood tests which indicate how healthy the heart and arteries are)
has effects on women's types and levels of various substances circulating in their blood
in women affects the stiffness of their arteries and heart rate variability in parallel with changes in cardiovascular risk markers
has different effects depending on whether women are pre or post menopausal.

Participation in this study is expected to last approximately 12 months.

Condition	Intervention
Growth Hormone Deficiency	Drug: Somatropin Drug: Placebo

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	Gender-Specific Effects of Physiologic GH Administration on Cardiovascular Risk Factors in Women With Growth Hormone Deficiency

Resource links provided by NLM:

Genetics Home Reference related topics: combined pituitary hormone deficiency pseudoachondroplasia

MedlinePlus related topics: Pituitary Disorders

Drug Information available for: Somatropin Somatotropin

U.S. FDA Resources

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:

Gender specific effects on cardiovascular risk markers [ Time Frame: baseline, 1, 3, 6, 7, 9, and 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Heart Rate Variability [ Time Frame: baseline, 3, 6, 9, and 12 months ] [ Designated as safety issue: Yes ]
Quality of Life [ Time Frame: baseline, 1, 3, 6, 7, 9, and 12 months ] [ Designated as safety issue: No ]

Enrollment:	63
Study Start Date:	January 2002
Study Completion Date:	November 2006
Primary Completion Date:	November 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1	Drug: Somatropin Stratified based on age and estrogen status from 3 to 6 mcg/kg/day Other Name: Genotropin
Placebo Comparator: 2	Drug: Placebo Dosage based on age and estrogen status ranging from 3 to 6 mcg/kg/day

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

GH deficiency due to pituitary or hypothalamic tumors or disease affecting this area. Subjects will have been treated with medication, surgery, radiation, or a combination of these. GH deficiency will be defined as a peak plasma GH of less than 5 ng/ml in response to insulin tolerance testing or growth hormone releasing hormone (GHRH) plus arginine stimulation test. In subjects with suspected hypothalamic dysfunction the arginine plus L-dopa stimulation test may be used, with a cutoff of 1.7 ng/ml for diagnosis of GH deficiency. Partial GH deficiency will be defined as a GH peak of 5 to 9 ng/ml (inclusive) during insulin tolerance testing or GHRH plus arginine testing.
GH deficiency will also be diagnosed if insulin-like growth factor-I (IGF-I) levels are below 2 standard deviations for the age-sex normal range in a patient with at least two documented hormone deficiencies.
Subjects must have evidence of a stable pituitary mass (for at least 12 months) if there is a history of a tumor except in the case of ACTH-producing microadenomas, where no follow-up imaging is required after cure.
Subjects age 40 and over must have a screening mammogram if they have not already had one within one year prior to their baseline visit

Exclusion Criteria:

Active Cushing's disease within 1 year
History of acromegaly
Untreated thyroid or adrenal insufficiency. Subjects on replacement therapy must be stable for at least 3 months prior to entry into the study.
History of malignancy except for skin cancer and except for childhood solid malignancy with documented cure for > 10 years prior to starting the study
Hemoglobin <10.0 gm/dl
Hepatic or renal disease (SGPT/SGOT > 3x upper limit of normal (ULN) or creatinine levels >2.5 mg/dl)
Congestive heart failure (CHF) (New York Heart Association's classification system Class II-IV CHF will be excluded)
History of unstable cardiovascular disease (coronary artery or cerebrovascular disease) or symptoms within one year prior to entry into the study
Diabetes mellitus
Pregnancy or nursing
Active carpal tunnel syndrome

Responsible Party:	Anne Klibanski, MD, Massachusetts General Hospital / Harvard Medical School
ClinicalTrials.gov Identifier:	NCT00136032 History of Changes
Other Study ID Numbers:	2001p-001761
Study First Received:	August 24, 2005
Last Updated:	February 12, 2008
Health Authority:	United States: Institutional Review Board

United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114