Treatment Patterns and Treatment Outcomes for Acromegaly

NCT03043586 | Completed

• 1 other identifier: AAAQ6709
• Study Type: observational
• Target: 520
• Locations: 1 country
• Sites: 1

Brief Summary

This is a human, prospective and retrospective, single-center study of patients who have undergone treatment for acromegaly in New York City since 1981. The project will characterize, among other factors, the treatment methods received by patients, who administered the treatments and the success of this therapy in terms of biochemical control.

Conditions

Acromegaly

Keywords

Acromegaly

Outcome Measures

Primary Outcomes (1)

• Percentage of patients that have received surgery as first line therapy

  Frequency of each type of acromegaly therapy and rates of treatment by surgery alone, somatostatin analog, pegvisomant, radiotherapy and combinations of each of these therapies in the cohort will be recorded and determined. The expected result is that more than 90% of our cohort has received surgery as first line therapy and only a minority has received primary medical therapy.

  At 5 years of therapy

Secondary Outcomes (4)

• Number of patients with IGF-1 levels remaining elevated

  At 5 years of therapy

• Hypertension Rate

  At 5 years of therapy

• Diabetes Mellitus Rate

  At 5 years of therapy

• Sleep Apnea Rate

  At 5 years of therapy

Study Arms (1)

Treatment Pattern

The first phase of this study will be to contact all subjects in the cohort by a mailing introducing them to the study. This will be followed by a phone call and administration of a questionnaire by phone or by mail. A phone script will be utilized to obtain verbal informed consent from subjects for this phase of the study. The questionnaire will collect current information on acromegaly treatment, morbidities and other relevant history. Subjects will provide verbal consent to participate in this questionnaire part of the study and review of their medical records by the PI and study staff.

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

The population for this study is a cohort of 520 adult patients who have undergone treatment for acromegaly in NYC since 1981. The cohort is predetermined based on the patients who have previously undergone pituitary surgery for acromegaly with our two collaborating Neurosurgeons. Based on prior studies, the population has no gender predilection and no racial or ethnic predisposition and thus the ethnic mix of the cohort reflects the population of the NY metropolitan area that is referred to the study center.

You may qualify if:

• Adult males and females.
• Ages 18 and over.
• Presenting to the PI or one of the sub-investigators for evaluation of acromegaly.
• Must be an Acromegaly subject that have undergone Pituitary surgery with Dr. Bruce or Dr. Post or Present it to principal investigator Dr. Pamela Freda at the Neuroendocrine Unit at Columbia University Medical Center for evaluation of Acromegaly.

You may not qualify if:

• Subjects who are unwilling to comply with the procedures outlined in the study.
• Subjects who do not have the ability to fully comprehend the nature of the study, to follow instructions, and/or cooperate with study procedures.
• Not being treated for acromegaly either by Dr. Bruce, Dr. Post or Dr. Freda.
• Are unwilling to provide informed consent to participate in the study.

Sponsors & Collaborators

• Columbia University: lead
• Ipsen: collaborator

Study Sites (1)

Neuroendocrine Unit at Columbia University Irving Medical Center

New York, New York, 10032, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood will be sampled for fasting measurements of growth hormone (GH) and insulin Growth Factor 1 (IGF-1) and patients will undergo an oral glucose tolerance test (OGTT) with blood drawn before and 60, 90 and 120 minutes after a 75 g. dextrose drink.

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

Study Officials

• Pamela U Freda, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: January 30, 2017
• First Posted: February 6, 2017
• Study Start: December 1, 2016
• Primary Completion: April 30, 2025
• Study Completion: April 30, 2025
• Last Updated: May 13, 2025

Record last verified: 2025-05

Locations

US (1)