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Acromegaly Treatment Quality of Life Study

This study is currently recruiting participants.
Verified January 2013 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: January 14, 2013
Last verified: January 2013
History of Changes
  Purpose

This study investigates the effects of biochemical control of acromegaly by growth hormone (GH) receptor antagonism and somatostatin analogs in a large tertiary care pituitary referral center. The investigators hypothesize that biochemical control of acromegaly will be associated with an improvement in quality of life compared to active acromegaly, regardless of mode of therapy, and that quality of life will be better in patients receiving a GH receptor antagonist than those receiving somatostatin analogs. The investigators also hypothesize that quality of life may be related to measures of glucose homeostasis, as well as to insulin-like growth factor 1 (IGF-1) levels.


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:

U.S. FDA Resources

Further study details as provided by Massachusetts General Hospital:

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

Secondary Outcome Measures:
  • Glucose Homeostasis [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • IGF-1 [ Time Frame: Baseline ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Biospecimens will be collected to test: fasting glucose, insulin, HbA1c, serum IGF-1 levels, total testosterone, free testosterone, free T4


Estimated Enrollment: 120
Study Start Date: January 2013
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Acomegaly with Pegvisomant
Patients receiving pegvisomant monotherapy from own doctor to biochemically control acromegaly
Acromegaly with somatostatin analog
Patients receiving somatostatin analog monotherapy from own doctor resulting in biochemical control of acromegaly
Active Acromegaly
Patients not on drugs for biochemical control of acromegaly

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
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 resulting in biochemical control of acromegaly (n=30), and 3) patients receiving somatostatin analog monotherapy resulting in biochemical control of acromegaly (n=60)

Criteria

Inclusion Criteria:

  • Age 18-75
  • Acromegaly
  • Active acromegaly (N=30)
  • History of acromegaly with biochemical cure documented with a non-elevated IGF-I
  • Receiving GH receptor antagonist (pegvisomant) monotherapy (N=30)
  • Receiving somatostatin analog monotherapy (N=60)

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 gonadal steroid therapy within 3 months of entry
  • Pregnant and nursing women
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01732406

Contacts
Contact: Anu v Gerweck, NP 617-724-1837 avgerweck@partners.org
Contact: Melissa Landa, BA 617-724-0785 mlanda3@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

No publications provided

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: January 14, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Acromegaly
Bone Diseases, Endocrine
Bone Diseases
Musculoskeletal Diseases
Hyperpituitarism
Pituitary Diseases
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
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013