Effects of Sandostatin LAR® in Acromegaly

What Was Tested

In this phase 4 trial, researchers set out to test Octreotide.

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.

It had 1 arm (groups): Sandostatin LAR (experimental).

The registry classes the interventions as drug.

More on the Plan

A major goal of treatment of acromegaly is to normalize serum IGF-1 levels.

Recently developed new normative data for serum IGF-1 levels has lowered the upper limit of normal for this hormone level.

In addition, an important goal of therapy of acromegaly is to treat co-morbidities of the disease such as insulin resistance, which is common in acromegaly.

Other important morbidities in acromegaly are hypertension and cardiovascular disease such as left ventricular hypertrophy (LVH).

Who Took Part

The registry lists 21 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Adults (age \> 18 years) with diagnosis of Acromegaly ( previously confirmed by an elevated IGF-1 level). If the patient have undergone surgical resection of a pituitary adenoma, A minimum of two months must have elapsed post surgery prior to enrollment. May have a history of radiotherapy. Stable pituitary hormone supplements(x months) prior to baseline visit. If female ,.

The full record lists 9 inclusion and 14 exclusion criteria; among the exclusions: 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); prior somatostatin analog therapy within 6 months of the screening visit; other medical therapy for acromegaly for 6 weeks to screening visit.

How the Study Was Run

The set-up was single-group and open-label.

Being open-label, the Octreotide study did not mask who received what.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2006-10 with completion listed for 2013-03.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: IGF-1 Level on Sandostatin LAR (time frame: Up to 9 months).

It also tracked 3 secondary outcomes, for example Cardiovascular Risk Markers on Sandostatin LAR: C-reactive Protein (CRP) Levels, Cardiovascular Risk Markers on Sandostatin LAR: Homocysteine Levels and Cardiovascular Risk Markers on Sandostatin LAR: Lipid Levels.

What This Means in Plain Language

Put simply, this is a phase 4 trial of Octreotide in 21 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Octreotide compound page, all human trials.