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Acromegaly Treatment Quality of Life Study

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ClinicalTrials.gov Identifier: NCT01732406
Recruitment Status : Active, not recruiting
First Posted : November 22, 2012
Last Update Posted : March 3, 2017
Information provided by (Responsible Party):
Karen Klahr Miller, MD, Massachusetts General Hospital

Brief Summary:
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 or disease

Study Type : Observational
Actual Enrollment : 134 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effect of Growth Hormone Receptor Antagonism and Somatostatin Analog Administration on Quality of Life
Study Start Date : January 2013
Primary Completion Date : March 2017
Estimated Study Completion Date : August 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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

Primary Outcome Measures :
  1. Quality of Life [ Time Frame: baseline ]

Biospecimen Retention:   Samples Without DNA
Plasma and blood serum

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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)

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01732406

United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Principal Investigator: Karen Miller, MD Massachusetts General Hospital

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
First Posted: November 22, 2012    Key Record Dates
Last Update Posted: March 3, 2017
Last Verified: March 2017

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