Acromegaly
Conditions
Keywords
Acromegaly, untreated, newly diagnosed, octreotide LAR
Brief summary
Currently, the first line treatment for acromegaly is surgery, in order to remove the adenoma causing overproduction of growth hormone which leads to acromegaly. Octreotide LAR is approved for treatment of acromegaly after surgery if the disease is not controlled. This study was aimed to test the safety and efficacy of octreotide LAR in acromegalic patients who did not have any previous treatment for acromegaly.
Interventions
DRUGOctreotide LAR
Sponsors
Novartis
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Inclusion criteria
* Newly diagnosed or previously untreated acromegalic patients * Lack of suppression of growth hormone (GH) nadir to \<1.0 µg/L, after oral administration of 75g of glucose (oral glucose tolerance test \[OGTT\]) * Insulin-like growth factor-I (IGF-I) levels above the upper limits of normal, i.e. 97th percentile (adjusted for age and gender)
Exclusion criteria
* Requires surgery for recent significant deterioration in visual fields or other neurological signs, which are related to the pituitary tumor mass * No evidence of pituitary adenoma on magnetic resonance imaging (MRI) * Symptomatic cholelithiasis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean GH and IGF-I at baseline, week 12, 24 and 48 | — |
Secondary
| Measure | Time frame |
|---|---|
| Tumor volume at baseline, week 24 and 48 | — |
| Signs and symptoms of acromegaly at baseline, week 12, 24 and 48 | — |
| Safety and tolerability at any time on treatment | — |
Outcome results
None listed