Effects of Sandostatin LAR® in Acromegaly

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2012 by Columbia University.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
Pamela U. Freda, Columbia University
ClinicalTrials.gov Identifier:
NCT01424241
First received: August 19, 2011
Last updated: August 8, 2012
Last verified: August 2012
  Purpose

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.


Condition Intervention Phase
Acromegaly
Drug: Sandostatin LAR
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Columbia University:

Primary Outcome Measures:
  • Change in IGF-1 levels [ Time Frame: Up to 9 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in lab results of cardiovascular risk profile in LAR® treated patients. [ Time Frame: Up to 9 months ] [ Designated as safety issue: No ]
    Includes C-reactive protein (CRP), IL-6, as well as homocysteine, lipoprotein, and lipid panel results.


Estimated Enrollment: 20
Study Start Date: August 2006
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sandostatin LAR
This is a 9 month, open label dose escalation study of Sandostatin LAR therapy.
Drug: Sandostatin LAR
This will be a open label dose escalation study of Sandostatin LAR 10 Mg, 20Mg, 30 Mg up to 40 mg if necessary.

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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01424241

Locations
United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
Sponsors and Collaborators
Columbia University
Novartis
Investigators
Principal Investigator: Pamela U Freda, MD Columbia University
  More Information

No publications provided

Responsible Party: Pamela U. Freda, Associate Professor of Medicine, Columbia University
ClinicalTrials.gov Identifier: NCT01424241     History of Changes
Other Study ID Numbers: AAAC0246, CSMS995BUS57
Study First Received: August 19, 2011
Last Updated: August 8, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Columbia University:
Sandostatin LAR

Additional relevant MeSH terms:
Acromegaly
Bone Diseases, Endocrine
Bone Diseases
Musculoskeletal Diseases
Hyperpituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases
Octreotide
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents

ClinicalTrials.gov processed this record on August 21, 2014