Acromegaly Treatment Quality of Life Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2016 by Massachusetts General Hospital
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Karen Klahr Miller, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01732406
First received: November 19, 2012
Last updated: March 9, 2016
Last verified: March 2016
  Purpose
The investigators hypothesize that treatment of acromegaly will be associated with an improvement in quality of life compared to active acromegaly. At the same time, they will also be studying the effects of different acromegaly treatments on the quality of life.

Condition
Acromegaly

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effect of Growth Hormone Receptor Antagonism and Somatostatin Analog Administration on Quality of Life

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Quality of Life [ Time Frame: baseline ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA
Plasma and blood serum

Estimated Enrollment: 120
Study Start Date: January 2013
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
Acomegaly with Pegvisomant
Patients receiving pegvisomant monotherapy from own doctor to treat acromegaly.
Acromegaly with somatostatin analog
Patients receiving somatostatin analog monotherapy from own doctor to treat acromegaly
Active Acromegaly
Patients not on drugs for treatment of acromegaly

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
There will be 3 groups/cohorts: 1) Patients with active acromegaly (n=30), 2) patients receiving pegvisomant monotherapy to treat acromegaly (n=30), and 3) patients receiving somatostatin analog monotherapy to treat acromegaly (n=60)
Criteria

Inclusion Criteria:

  • Age 18-90
  • Active acromegaly or receiving pegvisomant monotherapy or receiving somatostatin analog monotherapy

Exclusion Criteria:

  • Untreated thyroid or adrenal insufficiency. Subjects on replacement therapy must be stable for at least 3 months prior to entry into the study
  • Initiation or discontinuation of testosterone or estrogen within 3 months of entry
  • Pregnant and nursing women
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01732406

Contacts
Contact: Anu v Gerweck, NP 617-724-1837 avgerweck@partners.org

Locations
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Anu V Gerweck, NP    617-724-1837    avgerweck@partners.org   
Sponsors and Collaborators
Massachusetts General Hospital
Pfizer
Investigators
Principal Investigator: Karen Miller, MD Massachusetts General Hospital
  More Information

Responsible Party: Karen Klahr Miller, MD, Assistant Physician in Medicine, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01732406     History of Changes
Other Study ID Numbers: 2012P001556 
Study First Received: November 19, 2012
Last Updated: March 9, 2016
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Pituitary Diseases
Acromegaly
Bone Diseases, Endocrine
Bone Diseases
Musculoskeletal Diseases
Hyperpituitarism
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases
Somatostatin
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 25, 2016