Effects of Sandostatin LAR® in Acromegaly
Effects of Sandostatin LAR® in Acromegaly
This study aims primarily to determine the effect Insulin-like Growth Factor 1 (IGF1)
 normalization into current IGF1 normal ranges with Sandostatin LAR® therapy on biochemical
 metabolic, cardiovascular and body composition parameters in patients with active acromegaly.
-Study Purpose: The purpose of this study is to assess the effect of IGFI normalization with
 Sandostatin LAR® therapy on metabolic abnormalities, cardiovascular risk profile and body
 composition in patients with active acromegaly.

 -Study Design: This is an open label,single center, prospective study. Patients with active
 acromegaly who have not received prior somatostatin analog therapy will receive sandostatin
 LAR® for 9 months. Assessments will include laboratory testing, intravenous glucose tolerance
 tests, signs and symptoms questions, cardiac echocardiography (ECHO) and Dual-emission X-ray
 absorptiometry (DEXA) body composition before and at the end of the 9 months of therapy.

 The primary endpoints of the analysis are change in insulin sensitivity, change in
 cardiovascular risk marker, change in biochemical markers of the Growth Hormone (GH)/IGF1
 axis, change in ECHO determined cardiac parameters and change in body composition such as
 increase in total body fat or decrease in lean body mass.

 -  Study Subjects A total of 20 subjects total at this site will be enrolled. Subjects will
 be recruited based on the inclusion and exclusion criteria from the protocol out of the
 patients who are seen at our Neuroendocrine unit for evaluation of acromegaly.

 -  Recruitment Method Subjects will be recruited from those presenting to the
 Neuroendocrine Unit for evaluation of acromegaly. Subjects will be recruited by the PI
 after they have been approached by their physician and expressed an interest in study
 participation.

 -  Study Procedures Subjects will come to the Neuroendocrine Unit for visits monthly during
 the study period and administration of study drug. Patients will have their doses
 titrated based on IGF1 level as per the study protocol. Patients will undergo laboratory
 testing, physical examinations, ECHO, DEXA and other noninvasive questionnaires and
 monitoring as specified by the protocol over the course of the study.

 -  Issues Small risks include possible pain and bruising at the site of the needle
 insertion for blood drawing. Sandostatin LAR® is associated with gastrointestinal side
 effects such as bloating and diarrhea which usually subside. About 15% of patients
 treated with this medication develop gallstones. These usually remain asymptomatic.
 Pituitary tumors may also change in size during these medical therapies.
Inclusion Criteria:

 1. Adults (age > 18 years) with diagnosis of Acromegaly ( previously confirmed by an
 elevated IGF-1 level)

 2. IGF-1 concentrations> 10% above the upper limit of normal at screening

 3. If the patient have undergone surgical resection of a pituitary adenoma, A minimum of
 two months must have elapsed post surgery prior to enrollment

 4. May have a history of radiotherapy

 5. Stable pituitary hormone supplements(x months) prior to baseline visit

 6. if female , ( □ not applicable)

 1. not pregnant (as evidence by negative serum pregnancy test) or lactating; and

 2. If childbearing potential, agree to use a medically acceptable form of
 contraception (such as oral, implantable, or barrier contraception) from the
 screening, for the duration of the study, and for at least on month after study
 discontinuation or completion. Childbearing potential is defined as women who are
 not surgically sterile or not at least one year postmenopausal.

 7. Sign and date an consent form document indicating that the subject (or legally
 acceptable representative) has been informed of and agrees to all pertinent aspects of
 trial

 Exclusion Criteria:

 1. Have other conditions that may result in abnormal GH and/or IGF-1 concentrations
 (e.g., severe hepatic disease, severe renal disease Malnutrition, treatment with
 levodopa)

 2. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 3 x Upper limit
 of normal or clinically significant hepatic disease

 3. Prior somatostatin analog therapy within 6 months of the screening visit

 4. Other medical therapy for acromegaly for 6 weeks to screening visit

 5. Visual field defects or other neurological symptoms due to tumor mass

 6. Have known or suspected drug or alcohol abuse

 7. Have received an investigational medication within four week prior to screening or is
 scheduled to received any investigational medication during the study

 8. Do not have ability to fully comprehend the nature of the study, to follow
 instructions, cooperate with study procedures, and/or are unable to adhere to the
 visit scheduled outlined in the protocol

 9. Have other severe acute or chronic medical or psychiatry condition or Laboratory
 abnormality that may increase the risk associated with study Participation or study
 drug administration or may interfere with the interpretation of study results and, in
 the judgment of the investigator, would make the subject inappropriate for entry into
 this study

 10. Patient who have known hypersensitivity to Sandostatin acetate or other related drug
 or compound

 11. Patient with current gallstones

 12. Patient who have received supraphysiologic doses of glucocorticoid within the past 6
 months (except for peri-operative (<3 days duration) of dexamethasone) or who
 currently received chemotherapeutics agents, or exogenous growth hormone

 13. Patients who have received other investigational drugs administered or Received within
 30 days of study entry

 14. Patients who exhibit symptoms indicative of intolerance during the 2 weeks Course of
 Sandostatin injection, s.c