Effects of Sandostatin LAR® in Acromegaly

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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