Effects of Sandostatin LAR® in Acromegaly

Acromegaly Clinical Trial

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

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT01424241
• Other study ID #: AAAC0246
• Secondary ID: CSMS995BUS57
• Status: Unknown status
• Phase: Phase 4
• First received: August 19, 2011
• Last updated: August 8, 2012
• Start date: August 2006
• Est. completion date: August 2013

Study information

• Verified date: August 2012
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 20
• Est. completion date: August 2013
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acromegaly

Intervention

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.

Locations

Country	Name	City	State
United States	Columbia University Medical Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Columbia University	Novartis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in IGF-1 levels		Up to 9 months
Secondary	Change in lab results of cardiovascular risk profile in LAR® treated patients.	Includes C-reactive protein (CRP), IL-6, as well as homocysteine, lipoprotein, and lipid panel results.	Up to 9 months