Growth Hormone Administration and Its Effects on Cardiovascular Risk Factors in Growth Hormone Deficient Women

NCT00136032 | Completed DMC

• 1 other identifier: 2001p-001761
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Growth Hormone Deficiency

Keywords

Growth Hormone; Cardiovascular risk; Pituitary; Hypothalamic; GH Deficiency; Pituitary Tumor; Pituitary Disease

Outcome Measures

Primary Outcomes (1)

• Gender specific effects on cardiovascular risk markers

  baseline, 1, 3, 6, 7, 9, and 12 months

Secondary Outcomes (2)

• Heart Rate Variability

  baseline, 3, 6, 9, and 12 months

• Quality of Life

  baseline, 1, 3, 6, 7, 9, and 12 months

Study Arms (2)

1

ACTIVE COMPARATOR

Drug: Somatropin

2

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Somatropin DRUG

Stratified based on age and estrogen status from 3 to 6 mcg/kg/day

Also known as: Genotropin

1

Placebo DRUG

Dosage based on age and estrogen status ranging from 3 to 6 mcg/kg/day

2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

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MeSH Terms

Conditions

Dwarfism, Pituitary; Pituitary Diseases; Pituitary Neoplasms

Interventions

Human Growth Hormone

Condition Hierarchy (Ancestors)

Dwarfism; Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Bone Diseases, Endocrine; Hypopituitarism; Hypothalamic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Hypothalamic Neoplasms; Supratentorial Neoplasms; Brain Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms

Intervention Hierarchy (Ancestors)

Growth Hormone; Pituitary Hormones, Anterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Anne Klibanski, M.D

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 24, 2005
• First Posted: August 26, 2005
• Study Start: January 1, 2002
• Primary Completion: November 1, 2006
• Study Completion: November 1, 2006
• Last Updated: February 18, 2008

Record last verified: 2008-02

Locations

US (1)