Acromegaly Treatment Quality of Life Study

NCT01732406

Last updated date
Study Location
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Acromegaly
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-75 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Age 18-90

- Active acromegaly or receiving pegvisomant monotherapy or receiving somatostatin analog monotherapy

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

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Advanced Information
Descriptive Information
Brief Title Acromegaly Treatment Quality of Life Study
Official Title Effect of Growth Hormone Receptor Antagonism and Somatostatin Analog Administration on Quality of Life
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Plasma and blood serum
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)
Condition Acromegaly
Intervention Not Provided
Study 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: January 25, 2019)
126
Original Estimated Enrollment
 (submitted: November 19, 2012)
120
Actual Study Completion Date December 19, 2016
Actual Primary Completion Date December 19, 2016   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study:All
Ages 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01732406
Other Study ID Numbers 2012P001556
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Karen Klahr Miller, MD, Massachusetts General Hospital
Study Sponsor Massachusetts General Hospital
Collaborators Pfizer
Investigators
Principal Investigator:Karen Miller, MDMassachusetts General Hospital
PRS Account Massachusetts General Hospital
Verification Date January 2019