Acromegaly Treatment Quality of Life Study

NCT ID: NCT01732406

Last Updated: 2019-04-29

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

126 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-01-31

Study Completion Date

2016-12-19

Brief Summary

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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

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Conditions

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Acromegaly

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Acomegaly with Pegvisomant

Patients receiving pegvisomant monotherapy from own doctor to treat acromegaly.

No interventions assigned to this group

Acromegaly with somatostatin analog

Patients receiving somatostatin analog monotherapy from own doctor to treat acromegaly

No interventions assigned to this group

Active Acromegaly

Patients not on drugs for treatment of acromegaly

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role collaborator

Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Karen Klahr Miller, MD

Assistant Physician in Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Karen Miller, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

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Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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2012P001556

Identifier Type: -

Identifier Source: org_study_id

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