N/A
N=126
Acromegaly Treatment Quality of Life Study
Acromegaly
Bottom Line
View on ClinicalTrials.gov: NCT01732406 ↗Enrolled (actual)
126
Serious AEs
0.0%
Results posted
Apr 2019
Primary outcome: Primary: Acromegaly Quality of Life (ACROQoL) Global Score — 57; 60; 54 points on a scale
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Massachusetts General Hospital
- Primary completion
- Dec 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Acromegaly Quality of Life (ACROQoL) Global Score |
57; 60; 54 | — |
| SECONDARY The Gastrointestinal Quality of Life Index (GIQLI) Total Score |
100; 107; 102 | — |
| SECONDARY 36-Item Short Form Survey Instrument (SF-36) Physical Health |
60; 64; 63 | — |
| SECONDARY 36-Item Short Form Survey (SF-36) Mental Health Summary Score |
58; 64; 58 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT01732406). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.