Trial Outcomes & Findings for Programme of Acromegaly Screening in Patients With Associated Somatic Disorders (NCT NCT02020967)

NCT ID: NCT02020967

Last Updated: 2021-05-26

Results Overview

Acromegaly is an acquired pathological condition related to excessive production of growth hormone and characterized by somatic disfigurement and multiple systemic manifestations. The percentage of participants with acromegaly was determined in participants with a confirmed clinically significant set of associated somatic disorders using biochemical assays (IGF-1, GH, OGTT) and instrumental examination methods (MRI).

• Recruitment status: COMPLETED
• Target enrollment: 367 participants
• Primary outcome timeframe: Participants were screened over approximately 21 months
• Results posted on: 2021-05-26

Participant Flow

This was a non-interventional cross-sectional survey conducted at 2 clinical sites in Russia between 05 December 2013 and 15 September 2015. This survey did not involve any intervention into routine clinical practice, including the use of any investigational therapy or special examination methods.

Adults with somatic disorders associated with acromegaly who were observed as out-patients were eligible, and 367 participants were enrolled in the survey focused on early acromegaly diagnosis. Participants previously diagnosed with acromegaly were excluded.

Participant milestones

Measure	All Participants Participants did not receive any investigational therapy or special examination methods. Participants screening was implemented in the following stages: 1. Questioning stage: Participant's and Investigator's questionnaires. Based on the outcome of this stage, participants proceeded to the stage of examination to confirm acromegaly using biochemical assays. 2. Stage of examination: Insulin-like growth factor 1 (IGF-1) level was measured. In case of increased IGF-1 level, growth hormone (GH) test before and after oral glucose tolerance test (OGTT) was conducted. If acromegaly was confirmed, pituitary magnetic resonance imaging (MRI) with contrast was made.
Overall Study STARTED	367
Overall Study Examined Participants	329
Overall Study COMPLETED	316
Overall Study NOT COMPLETED	51

Reasons for withdrawal

Measure

All Participants Participants did not receive any investigational therapy or special examination methods. Participants screening was implemented in the following stages: 1. Questioning stage: Participant's and Investigator's questionnaires. Based on the outcome of this stage, participants proceeded to the stage of examination to confirm acromegaly using biochemical assays. 2. Stage of examination: Insulin-like growth factor 1 (IGF-1) level was measured. In case of increased IGF-1 level, growth hormone (GH) test before and after oral glucose tolerance test (OGTT) was conducted. If acromegaly was confirmed, pituitary magnetic resonance imaging (MRI) with contrast was made.

Overall Study Withdrawal by Subject

51

Baseline Characteristics

Programme of Acromegaly Screening in Patients With Associated Somatic Disorders

Baseline characteristics by cohort

Measure	Acromegaly Diagnosed n=9 Participants Participants did not receive any investigational therapy or special examination methods. Participants were diagnosed with acromegaly by biochemical assays.	No Acromegaly Diagnosed n=320 Participants Participants did not receive any investigational therapy or special examination methods. Participants were not diagnosed with acromegaly.	Total n=329 Participants Total of all reporting groups
Age, Continuous	58.1 years STANDARD_DEVIATION 8.22 • n=5 Participants	58.0 years STANDARD_DEVIATION 13.11 • n=7 Participants	58.0 years STANDARD_DEVIATION 12.99 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	268 Participants n=7 Participants	275 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	52 Participants n=7 Participants	54 Participants n=5 Participants

PRIMARY outcome

Timeframe: Participants were screened over approximately 21 months

Population: The Examined population included all participants for whom blood samples were taken for the biochemical assays to diagnose acromegaly.

Acromegaly is an acquired pathological condition related to excessive production of growth hormone and characterized by somatic disfigurement and multiple systemic manifestations. The percentage of participants with acromegaly was determined in participants with a confirmed clinically significant set of associated somatic disorders using biochemical assays (IGF-1, GH, OGTT) and instrumental examination methods (MRI).

Outcome measures

Measure	All Participants n=329 Participants Participants did not receive any investigational therapy or special examination methods. Participants screening was implemented in the following stages: 1. Questioning stage: Participant's and Investigator's questionnaires. Based on the outcome of this stage, participants proceeded to the stage of examination to confirm acromegaly using biochemical assays. 2. Stage of examination: IGF-1 level was measured. In case of increased IGF-1 level, GH test before and after OGTT was conducted. If acromegaly was confirmed, pituitary MRI with contrast was made.	No Acromegaly Diagnosed Participants did not receive any investigational therapy or special examination methods. Participants were not diagnosed with acromegaly.
Percentage of Participants Diagnosed With Acromegaly Pituitary MRI	2.4 percentage of participants	—
Percentage of Participants Diagnosed With Acromegaly Biochemical assays	5.8 percentage of participants	—

SECONDARY outcome

Timeframe: Participants were screened over approximately 21 months

Population: The Examined population included all participants for whom blood samples were taken for the biochemical assays to diagnose acromegaly.

Acromegaly is an acquired pathological condition related to excessive production of growth hormone and characterized by somatic disfigurement and multiple systemic manifestations. The number of participants with acromegaly was determined in participants with a confirmed clinically significant set of associated somatic disorders using biochemical assays (IGF-1, GH, OGTT) and instrumental examination methods (MRI).

Outcome measures

Measure	All Participants n=329 Participants Participants did not receive any investigational therapy or special examination methods. Participants screening was implemented in the following stages: 1. Questioning stage: Participant's and Investigator's questionnaires. Based on the outcome of this stage, participants proceeded to the stage of examination to confirm acromegaly using biochemical assays. 2. Stage of examination: IGF-1 level was measured. In case of increased IGF-1 level, GH test before and after OGTT was conducted. If acromegaly was confirmed, pituitary MRI with contrast was made.	No Acromegaly Diagnosed Participants did not receive any investigational therapy or special examination methods. Participants were not diagnosed with acromegaly.
Number of Participants Diagnosed With Acromegaly Using Biochemical Assays (IGF-1, GH, OGTT) and Instrumental Examination Methods (MRI) Pituitary MRI	8 Participants	—
Number of Participants Diagnosed With Acromegaly Using Biochemical Assays (IGF-1, GH, OGTT) and Instrumental Examination Methods (MRI) Biochemical assays	19 Participants	—

SECONDARY outcome

Timeframe: At baseline (Day 1)

Population: The Examined population included all participants for whom blood samples were taken for the biochemical assays to diagnose acromegaly.

The percentage of participants with associated concurrent somatic disorders were reported in relation to confirmation of acromegaly diagnosis. Concurrent disorders were prior history of condition or diagnosis.

Outcome measures

Measure	All Participants n=9 Participants Participants did not receive any investigational therapy or special examination methods. Participants screening was implemented in the following stages: 1. Questioning stage: Participant's and Investigator's questionnaires. Based on the outcome of this stage, participants proceeded to the stage of examination to confirm acromegaly using biochemical assays. 2. Stage of examination: IGF-1 level was measured. In case of increased IGF-1 level, GH test before and after OGTT was conducted. If acromegaly was confirmed, pituitary MRI with contrast was made.	No Acromegaly Diagnosed n=320 Participants Participants did not receive any investigational therapy or special examination methods. Participants were not diagnosed with acromegaly.
Percentage of Participants With Associated Concurrent Somatic Disorders Lips enlargement	22.2 percentage of participants	3.8 percentage of participants
Percentage of Participants With Associated Concurrent Somatic Disorders Typical change of appearance and enlargement of limbs	100.0 percentage of participants	56.9 percentage of participants
Percentage of Participants With Associated Concurrent Somatic Disorders Headache	100.0 percentage of participants	71.9 percentage of participants
Percentage of Participants With Associated Concurrent Somatic Disorders Dyspnoea, decrease of working capacity	55.6 percentage of participants	80.9 percentage of participants

SECONDARY outcome

Timeframe: Participants were screened over approximately 21 months

Population: The Examined population included all participants for whom blood samples were taken for the biochemical assays to diagnose acromegaly.

Participants were counted as having a microadenomas or macroadenomas if they had at least one microadenoma or macroadenoma during the study. Microadenoma is a benign pituitary tumour size <=10 millimeter (mm) and macroadenoma is a benign pituitary tumour size >10 mm. The percentage of participants with microadenomas and macroadenomas registered during pituitary MRI examination were reported.

Outcome measures

Measure	All Participants n=329 Participants Participants did not receive any investigational therapy or special examination methods. Participants screening was implemented in the following stages: 1. Questioning stage: Participant's and Investigator's questionnaires. Based on the outcome of this stage, participants proceeded to the stage of examination to confirm acromegaly using biochemical assays. 2. Stage of examination: IGF-1 level was measured. In case of increased IGF-1 level, GH test before and after OGTT was conducted. If acromegaly was confirmed, pituitary MRI with contrast was made.	No Acromegaly Diagnosed Participants did not receive any investigational therapy or special examination methods. Participants were not diagnosed with acromegaly.
Percentage of Participants With Microadenomas and Macroadenomas Pituitary MRI performed: Microadenoma (<= 10 mm)	0.3 percentage of participants	—
Percentage of Participants With Microadenomas and Macroadenomas Pituitary MRI performed: Macroadenoma (>10 mm)	2.1 percentage of participants	—
Percentage of Participants With Microadenomas and Macroadenomas Pituitary MRI performed: No adenoma detected	2.7 percentage of participants	—
Percentage of Participants With Microadenomas and Macroadenomas No pituitary MRI performed	94.8 percentage of participants	—

SECONDARY outcome

Timeframe: Participants were screened over approximately 21 months

Population: The Examined population included all participants for whom blood samples were taken for the biochemical assays to diagnose acromegaly.

Acromegaly diagnosed based on a clinically significant set of associated somatic disorders and was assessed by logistic regression and canonical discriminant analysis. The likelihood of acromegaly diagnosis, based on a clinically significant set of associated somatic disorders (predictors) was assessed by logistic regression and canonical discriminant analysis. To investigate the extent to which each of the somatic disorders poses a risk factor for acromegaly diagnosis, all predictor variables were entered into each analysis. The percentage of participants predicted to have acromegaly or not is presented for the logistic regression analysis and the canonical discriminant analysis.

Outcome measures

Measure	All Participants n=9 Participants Participants did not receive any investigational therapy or special examination methods. Participants screening was implemented in the following stages: 1. Questioning stage: Participant's and Investigator's questionnaires. Based on the outcome of this stage, participants proceeded to the stage of examination to confirm acromegaly using biochemical assays. 2. Stage of examination: IGF-1 level was measured. In case of increased IGF-1 level, GH test before and after OGTT was conducted. If acromegaly was confirmed, pituitary MRI with contrast was made.	No Acromegaly Diagnosed n=320 Participants Participants did not receive any investigational therapy or special examination methods. Participants were not diagnosed with acromegaly.
Percentage of Participants With the Most Pathognomonic Subjective and Objective Signs for Tracing Acromegaly Canonical discriminant analysis: No acromegaly	1.22 percentage of participants	86.32 percentage of participants
Percentage of Participants With the Most Pathognomonic Subjective and Objective Signs for Tracing Acromegaly Canonical discriminant analysis: Acromegaly	1.52 percentage of participants	10.94 percentage of participants
Percentage of Participants With the Most Pathognomonic Subjective and Objective Signs for Tracing Acromegaly Logistic regression: Acromegaly	0 percentage of participants	0 percentage of participants
Percentage of Participants With the Most Pathognomonic Subjective and Objective Signs for Tracing Acromegaly Logistic regression: No acromegaly	2.74 percentage of participants	97.26 percentage of participants

Adverse Events

All Participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Ipsen Medical Director

Ipsen

Phone: see email

Email: clinical.trials@ipsen.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place