Acromegaly Treatment Quality of Life Study

NCT01732406 | Completed Results

• 1 other identifier: 2012P001556
• Study Type: observational
• Target: 126
• Locations: 1 country
• Sites: 1

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.

Conditions

Acromegaly

Outcome Measures

Primary Outcomes (1)

• Acromegaly Quality of Life (ACROQoL) Global Score

  The Global Score of the Acromegaly Quality of Life (ACROQoL) Survey measures quality of life in patients with acromegaly. Higher scores indicate better QOL. The range is 22-110 units on a scale.

  Cross-sectional at baseline

Secondary Outcomes (3)

• The Gastrointestinal Quality of Life Index (GIQLI) Total Score

  Cross-sectional at baseline

• 36-Item Short Form Survey Instrument (SF-36) Physical Health

  Cross-sectional at baseline

• 36-Item Short Form Survey (SF-36) Mental Health Summary Score

  Cross-sectional at baseline

Study Arms (3)

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 Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

There will be 3 groups/cohorts: 1) Patients with active acromegaly (n=35), 2) patients receiving pegvisomant monotherapy to treat acromegaly (n=31), and 3) patients receiving somatostatin analog monotherapy to treat acromegaly (n=60)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Pfizer: collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma and blood serum

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

Results Point of Contact

• Title: Dr. Karen Miller
• Organization: Massachusetts General Hospital

kkmiller@partners.org

617-726-3870

Study Officials

• Karen Miller, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Physician in Medicine

Study Record Dates

• First Submitted: November 19, 2012
• First Posted: November 22, 2012
• Study Start: January 1, 2013
• Primary Completion: December 19, 2016
• Study Completion: December 19, 2016
• Last Updated: April 29, 2019
• Results First Posted: April 29, 2019

Record last verified: 2019-01

Locations

US (1)