Treatment of Acromegaly With Somatostatin Analogs: GH vs. IGF-I as Primary Biochemical Target

What Was Tested

The trial (phase 4) is built around Octreotide.

Treatment of acromegaly with somatostatin analogs (SA) is well-established and are primarily used after insufficient surgical intervention, but also as primary medical treatment in selected patients.

Evaluation of treatment control is based on monitoring blood levels of growth hormone (GH) and insulin-like growth factor-I (IGF-I).

However, evaluation of disease control during SA treatment is not always straightforward.

It had three arms (groups): SA monitored by GH (experimental), SA monitored by IGF-I (experimental) and Control (no intervention).

Control, patients who have achieved sufficient disease control by surgery alone.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 84 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: Written informed consent. Age \> 18 years. Capable and of age. Diagnosed with acromegaly. Sufficient treated for at least 6 months prior to enrollment.

The full record lists 5 inclusion and 2 exclusion criteria; among the exclusions: pregnancy or nursing; any disease that may compromise the ability to comply with the protocol, as assessed by the investigator.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

Random assignment meant chance, not the researchers, decided who got Octreotide and who got the comparison, which limits bias.

The Octreotide group and the comparison group ran side by side rather than switching.

Everyone knew when Octreotide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2012-06 with completion listed for 2017-01.

It ran at 1 site in Denmark.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change in Quality of Life (time frame: Baseline and after 12 months).

It also tracked 5 secondary outcomes, for example Change in glucose, FFA and insulin, Change in discordant GH/IGF-I levels, New biomarkers of treatment evaluation and New biomarkers of treatment evaluation2.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Octreotide in 84 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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