N/A
N=367
Programme of Acromegaly Screening in Patients With Associated Somatic Disorders
Acromegaly
Bottom Line
View on ClinicalTrials.gov: NCT02020967 ↗Enrolled (actual)
367
Serious AEs
—
Results posted
Apr 2021
Primary outcome: Primary: Percentage of Participants Diagnosed With Acromegaly — 5.8; 2.4 percentage of participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Non-interventional cross-sectional survey (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Ipsen
- Primary completion
- Sep 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Diagnosed With Acromegaly |
5.8; 2.4 | — |
| SECONDARY Number of Participants Diagnosed With Acromegaly Using Biochemical Assays (IGF-1, GH, OGTT) and Instrumental Examination Methods (MRI) |
19; 8 | — |
| SECONDARY Percentage of Participants With Associated Concurrent Somatic Disorders |
22.2; 3.8; 100.0; 56.9; 100.0; 71.9 | — |
| SECONDARY Percentage of Participants With Microadenomas and Macroadenomas |
0.3; 2.1; 2.7; 94.8 | — |
| SECONDARY Percentage of Participants With the Most Pathognomonic Subjective and Objective Signs for Tracing Acromegaly |
0; 0; 2.74; 97.26; 1.52; 10.94 | 0.0196 sig |
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]).
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- Patient already diagnosed with acromegaly
- Patient's refusal to participate in the survey.
Data sourced from ClinicalTrials.gov (NCT02020967). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.