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Acromegaly
 
005: A Study to Evaluate Treatment with a Combination of Pegvisomant Plus Sandostatin LAR, Pegvisomant (alone) and Sandostatin (alone) in Patients with Acromegaly
Two classes of medications are currently approved for the medical treatment of acromegaly: somatostatin analogues (Sandostatin LAR) and growth hormone antagonist (Pegvisomant). The aim of this 40-week study is to evaluate treatment with Sandostatin LAR plus pegvisomant and pegvisomant alone in those patients who have not responded to Sandostatin LAR alone. All adult patients who have undergone surgery and/or radiation therapy for the acromegaly and have been taking Sandostatin LAR for at least six months may be eligible for this study. Eligible subjects who are not controlled on their current dose of Sandostatin LAR will be randomly assigned to two groups: (1) will continue on the current dose of Sandostatin LAR in addition to Pegvisomant, or (2) will be asked to stop the Sandostatin LAR and be started on Pegvisomant alone. There are 12 visits occurring approximately once a month. Medication is provided at no cost during study participation. Travel expenses are reimbursed.
 
This study is currently closed to further enrollment.
 

SOM 230: A Study to Compare the Safety, Efficacy and PK/PD Relationship of Multiple Doses of SOM 230 in Patients with Acromegaly

This study is a short-term study designed to investigate the effects of an investigational medication (not approved by the Food and Drug Administration), SOM 230, in patients with active acromegaly. All patients who have active acromegaly and are not controlled on their current therapy and have not received radiation therapy to the pituitary gland in the last two years may be eligible for participation. There are approximately 9 visits over 16 weeks, with visits occurring approximately every two weeks. Eligible subjects will receive three different doses of SOM 230. Patients will receive a total of $900.00 for completing the study and SOM 230 at no charge. Those patients who receive benefit from this medication will be offered enrollment in an extension study where SOM 230 will be offered at no charge until it is approved by the Food and Drug Administration.

 
For more information, please contact Karen J. P. Liebert, RN at 617-726-7473 or kpulaski@partners.org.
 

Surgery vs. Sandostatin LAR: Does Surgical Debulking of Pituitary Adenomas Improve Responsiveness to Octreotide LAR in the Treatment of Acromegaly?

This 15-week study is designed to determine whether surgery (for removal of a pituitary tumor) improves the effectiveness of Sandostatin LAR post-surgery in achieving normal IGF-I and growth hormone levels. Subjects diagnosed with acromegaly who are anticipating surgery to remove the pituitary tumor may be eligible for this study. Subjects cannot have received any prior surgery, radiation therapy or medical therapy to treat the acromegaly. Eligible subjects will be randomized to one of two groups: (1) to receive 3 months of Sandostatin LAR prior to surgery, or (2) have surgery first, and if not cured, then patients will receive 3 months of Sandostatin LAR. There are approximately 3-6 visits over the course of the study and a total of $400-650 is available for travel expenses, depending upon which group patients are randomized into. Medication is provided free of charge while in the study.
 
For more information, please contact Karen J. P. Liebert, RN at 617-726-7473 or kpulaski@partners.org.
 

Effects of Growth Hormone Administration on Cardiovascular Risk Markers in Men and Women with Cured Acromegaly

This 12-month research study will evaluate the relationship between growth hormone (GH) levels and heart disease in subjects cured of acromegaly. GH is a hormone that the pituitary gland normally produces, and GH deficiency is associated with an increased risk for heart disease. This study investigates whether physiologic GH replacement therapy will reduce cardiovascular risk in men and women ages 18 to 75 with GH deficiency following cure of acromegaly. Eligible subjects may undergo 8 to 10 outpatient hospital visits which will include measurements of metabolism, body fat and muscle, as well blood tests reflecting the health of blood vessels. Subjects will be remunerated up to $300 for their participation.

We will also enroll subjects cured from acromegaly who are GH sufficient or who are GH deficient but have a contraindication to receiving GH for a cross-sectional study involving body composition and cardiovascular risk marker measurements.

 

For more information, please contact Amber Schaub at (617) 724-1579
or aschaub@partners.org


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