Status:
COMPLETED
Growth Hormone Administration and Its Effects on Cardiovascular Risk Factors in Growth Hormone Deficient Women
Lead Sponsor:
Massachusetts General Hospital
Conditions:
Growth Hormone Deficiency
Eligibility:
FEMALE
18-65 years
Phase:
NA
Brief Summary
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 du...
Detailed Description
The aim of the study is to evaluate the gender specific effects of physiologic Growth Hormone (GH) replacement in women with GH deficiency on the basis of pituitary/hypothalamic region tumors, radiati...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2006
Estimated Enrollment :
63 Patients enrolled
Trial Details
Trial ID
NCT00136032
Start Date
January 1 2002
End Date
November 1 2006
Last Update
February 18 2008
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114