Brief Title
Effects of Sandostatin LAR® in Acromegaly
Official Title
Metabolic, Cardiovascular and Body Composition Effects of Sandostatin LAR® Therapy of Acromegaly, Effect of Reduction of Serum Insulin-like Growth Factor 1 (IGF-1) Levels Into a New Normative Range
Brief Summary
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.
Detailed Description
-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.
Study Phase
Phase 4
Study Type
Interventional
Primary Outcome
Change in IGF-1 levels
Secondary Outcome
Change in lab results of cardiovascular risk profile in LAR® treated patients.
Condition
Acromegaly
Intervention
Sandostatin LAR
Study Arms / Comparison Groups
Sandostatin LAR
Description: This is a 9 month, open label dose escalation study of Sandostatin LAR therapy.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
20
Start Date
August 2006
Completion Date
August 2013
Primary Completion Date
August 2012
Eligibility Criteria
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
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Pamela U Freda, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT01424241
Organization ID
AAAC0246
Secondary IDs
CSMS995BUS57
Responsible Party
Principal Investigator
Study Sponsor
Columbia University
Collaborators
Novartis
Study Sponsor
Pamela U Freda, MD, Principal Investigator, Columbia University
Verification Date
August 2012