Programme of Acromegaly Screening in Patients With Associated Somatic Disorders

NCT02020967 | Completed Results

• 1 other identifier: A-38-52030-280
• Study Type: observational
• Target: 367
• Locations: 1 country
• Sites: 2

Brief Summary

The primary objective of the protocol is to define percentage of patients with acromegaly in relation to the total number of screened patients with confirmed clinically significant set of associated somatic disorders with the help of laboratory (Insulin-like Growth Factor I, Growth Hormone, Oral Glucose-Tolerance Test \[IGF-1, GH, OGTT\]) and instrumental examination methods (Magnetic Resonance Imaging \[MRI\]).

Conditions

Acromegaly

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Diagnosed With 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).

  Participants were screened over approximately 21 months

Secondary Outcomes (4)

• Number of Participants Diagnosed With Acromegaly Using Biochemical Assays (IGF-1, GH, OGTT) and Instrumental Examination Methods (MRI)

  Participants were screened over approximately 21 months

• Percentage of Participants With Associated Concurrent Somatic Disorders

  At baseline (Day 1)

• Percentage of Participants With Microadenomas and Macroadenomas

  Participants were screened over approximately 21 months

• Percentage of Participants With the Most Pathognomonic Subjective and Objective Signs for Tracing Acromegaly

  Participants were screened over approximately 21 months

Study Arms (1)

Acromegaly patients

Other: Non-interventional cross-sectional survey

Interventions

Non-interventional cross-sectional survey OTHER

This is a survey which does not involve any intervention into routine clinical practice, including the use of any investigational therapy or special examination methods.

Acromegaly patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with somatic disorders associated with acromegaly, who are observed at the Moscow Board of Health Endocrinology dispensary and Endocrinology Hospital at First Moscow State Medical University

You may qualify if:

• Men and women aged 18 years and above with associated somatic disorders observed at the Moscow Endocrinology dispensary or Endocrinology Hospital at First Moscow State Medical University
• Patients who signed the Informed Consent Form for participation in the survey before collection of any information.

You may not qualify if:

• Patient already diagnosed with acromegaly
• Patient's refusal to participate in the survey.

Sponsors & Collaborators

• Ipsen: lead

Study Sites (2)

Moscow Board of Health Endocrinology Dispensary

Moscow, 119034, Russia

Location

Endocrinology Hospital at First Moscow State Medical University

Moscow, 119435, Russia

Location

MeSH Terms

Conditions

Acromegaly

Condition Hierarchy (Ancestors)

Bone Diseases, Endocrine; Bone Diseases; Musculoskeletal Diseases; Hyperpituitarism; Pituitary Diseases; Hypothalamic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Ipsen Medical Director
• Organization: Ipsen

clinical.trials@ipsen.com

see email

Study Officials

• Ipsen Medical Director

  Ipsen

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2013
• First Posted: December 25, 2013
• Study Start: December 5, 2013
• Primary Completion: September 15, 2015
• Study Completion: September 15, 2015
• Last Updated: May 26, 2021
• Results First Posted: April 28, 2021

Record last verified: 2021-05

Locations

RU (2)