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Trial · Interventional

CompletedPhase 4Results postedRegistry data

Effects of Sandostatin LAR® in Acromegaly

NCTNCT01424241 (opens ClinicalTrials.gov in a new tab)Other idAAAC0246Other idCSMS995BUS57

Overview

Status
Completed
Phase
Phase 4
Enrollment
21 participants (actual)
Sponsor
Columbia University · Other
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

United States

Start
Oct 2006
Primary completion
Mar 2013
Completion
Jan 2014
First posted
26 Aug 2011 (estimated)
Last update posted
24 Jul 2024
Conditions
Acromegaly

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20062008201020122014
  1. Ph 4

    Effects of Sandostatin LAR® in Acromegaly

    NCT01424241

    Oct 2006 to Jan 2014

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

This study aims primarily to determine the effect Insulin-like Growth Factor 1 (IGF-1) normalization into current IGF-I normal ranges with Sandostatin LAR® therapy on biochemical metabolic, cardiovascular and body composition parameters in patients with active acromegaly.

Interventions

  • Sandostatin LARDrug

Arms1

  • Experimental

    Sandostatin LAR

    Nine months of open label dose escalation Sandostatin LAR therapy.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. IGF-1 Level on Sandostatin LAR

    Time frame · Up to 9 months

    Registry description

    Mean IGF-1 level on treatment with Sandostatin LAR in whole population and responders (normal IGF1) and non responders(elevated IGF-1)

Secondary outcomes(3)
  1. Cardiovascular Risk Markers on Sandostatin LAR: C-reactive Protein (CRP) Levels

    Time frame · Up to 9 months

    Registry description

    Levels of C-reactive protein (CRP) in whole study group, responders (normal IGF-1) and non responders (elevated IGF-1) groups. Higher values are a worse outcome.

  2. Cardiovascular Risk Markers on Sandostatin LAR: Homocysteine Levels

    Time frame · Up to 9 months

    Registry description

    Levels of homocysteine in whole study group, responders (normal IGF-1) and non responders (elevated IGF-1) groups. Higher values are a worse outcome.

  3. Cardiovascular Risk Markers on Sandostatin LAR: Lipid Levels

    Time frame · Up to 9 months

    Registry description

    Levels of lipid panel (cholesterol, triglycerides, and Lipoprotein A) in whole study group, responders (normal IGF-1) and non responders (elevated IGF-1) groups. Higher values are a worse outcome.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· Up to 9 months

IGF-1 Level on Sandostatin LAR

GroupValue (ng/mL)Spread
Open Label Dose Escalation of Sandostatin LAR Therapy336209
Responders18642.4
Non Responders487200.4
Secondary and other outcome results(3)
Secondary outcomeMean· Up to 9 months

Cardiovascular Risk Markers on Sandostatin LAR: C-reactive Protein (CRP) Levels

GroupValue (mg/L)Spread
Open Label Dose Escalation of Sandostatin LAR Therapy2.053.5
Responders2.894.79
Non Responders1.211.2
Secondary outcomeMean· Up to 9 months

Cardiovascular Risk Markers on Sandostatin LAR: Homocysteine Levels

GroupValue (µmol/L)Spread
Open Label Dose Escalation of Sandostatin LAR Therapy9.985.8
Responders10.575.56
Non Responders9.406.4
Secondary outcomeMean· Up to 9 months

Cardiovascular Risk Markers on Sandostatin LAR: Lipid Levels

GroupValue (mg/dL)Spread
Open Label Dose Escalation of Sandostatin LAR Therapy173.7542.9
Responders182.4449.78
Non Responders162.5732.1

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Open Label Dose Escalation Study of Sandostatin LAR TherapyAcromegaly is a rare disorder due in almost all cases to a GH secreting tumor of the pituitary gland. The initial treatment is typically surgical removal of the tumor, but after this many patients have residual disease requiring additional therapy. For most patients this therapy is medical with a somatostatin analog. In addition to biochemical control, important and often overlooked goals of acromegaly care are to treat its associated co-morbidities in particular insulin resistance and diabetes mellitus, hypertension and cardiovascular (CV) disease. Changes in body composition in acromegaly may be integral to the development of insulin resistance and increased CV risk. Therefore, this study sought to examine the effect of lowering of serum IGF-I levels into the current more stringent normal range during treatment with octreotide LAR on metabolic parameters, body composition and cardiovascular risk profile in patients with acromegaly.–0 / 180 / 18

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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 , 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 growth hormone (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.

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