AcromegalyNCT01732406

Acromegaly Treatment Quality of Life Study

An observational study of Acromegaly, run by Massachusetts General Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Acromegaly
How many people: 126 participants
Where: 1 siteUnited States
Study dates: Jan 2013to 19 Dec 2016
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

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)

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Massachusetts General Hospital
Boston, Massachusetts, 02114

Other trials in United States

About this study

Official title: Effect of Growth Hormone Receptor Antagonism and Somatostatin Analog Administration on Quality of Life

Conditions: Acromegaly
Medical subject headings: Acromegaly

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01732406
Study group	Role	What they receive
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

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Cross-sectional at baseline

Secondary outcomes (3)

The Gastrointestinal Quality of Life Index (GIQLI) Total Score
The total score for the Gastrointestinal Quality of Life Index (GIQLI) measures quality of life with specific attention to gastrointestinal symptoms. The score ranges from 0-144 points on a scale. Higher scores indicating better quality of life.
Measured: Cross-sectional at baseline
36-Item Short Form Survey Instrument (SF-36) Physical Health
The Physical Health Summary Score of the SF-36 is a quality of life measure of physical health. It ranges from 0 to 100 points on a scale. Higher scores indicate better quality of life. This survey is scored as demonstrated at https://www.rand.org/health/surveys_tools/mos/36-item-short-form/scoring.html. The Physical Health Summary Score (Physical Component Summary) is calculated as the mean average of the physically relevant questions.
Measured: Cross-sectional at baseline
36-Item Short Form Survey (SF-36) Mental Health Summary Score
The Mental Health Summary Score of the SF-36 measures quality of life with a focus on mental health. It ranges from 0 to 100 points on a scale. Higher scores indicate better quality of life. This survey is scored as demonstrated at https://www.rand.org/health/surveys_tools/mos/36-item-short-form/scoring.html. The Mental Health Summary Score (Mental Component Summary) is calculated as the mean average of the emotionally relevant questions.
Measured: Cross-sectional at baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 201319 Dec 2016

First posted22 Nov 2012 (estimated)
Study startJan 2013
Primary completion19 Dec 2016
Study completion19 Dec 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for AcromegalyStudies of the same condition, open and under way.
More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 126 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01732406
Sponsor's protocol ID: 2012P001556
Status last verified: Jan 2019
First submitted: 19 Nov 2012
Last updated: 29 Apr 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 1
A Phase 1 Clinical Trial of NTQ6179 Tablets in Healthy Volunteers
Acromegaly
RecruitingObservational study
An Observational Study of Octreotide Subcutaneous Depot in Patients With Acromegaly
Acromegaly
RecruitingPhase 3
A Study to Assess the Efficacy and Safety of Debio 4126 in Participants With Acromegaly Previously Treated With Somatostatin Analogs
Acromegaly
RecruitingObservational study
An Investigation of Pituitary Tumors and Related Hypothalmic Disorders
Panhypopituitarism, Gigantism/Acromegaly
Recruiting
Managing Pasireotide-associated Hyperglycaemia in Acromegaly With Ketogenic Diet
Acromegaly Due to Pituitary Adenoma, Hyperglycemia

All Acromegaly trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of Growth Hormone Receptor Antagonism and Somatostatin Analog Administration on Quality of Life
ClinicalTrials.gov ID: NCT01732406
Acronym / sponsor ID: 2012P001556
Conditions: Acromegaly
Study type: Observational
Recruitment status: Completed
Enrolment: 126 participants (actual)
Lead sponsor: Massachusetts General HospitalUniversity, hospital or other
Collaborators: Pfizer
Study start: Jan 2013
Primary completion: 19 Dec 2016 (actual)
Study completion: 19 Dec 2016 (actual)
First posted: 22 Nov 2012 (estimated)
Results: Posted 29 Apr 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 3

Arm	Type	Receives
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

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
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)

Key inclusion criteria (2 listed)

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

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Acromegaly Quality of Life (ACROQoL) Global Score
Time frame: Cross-sectional at baseline
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.

3 secondary outcomes

The Gastrointestinal Quality of Life Index (GIQLI) Total Score
Time frame: Cross-sectional at baseline
36-Item Short Form Survey Instrument (SF-36) Physical Health
Time frame: Cross-sectional at baseline
36-Item Short Form Survey (SF-36) Mental Health Summary Score
Time frame: Cross-sectional at baseline

Results and safety

Results posted to the registry on 29 Apr 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Acomegaly With Pegvisomant	31	31
Acromegaly With Somatostatin Analog	60	60
Active Acromegaly	35	35

Primary outcome: Acromegaly Quality of Life (ACROQoL) Global Score

Time frame: Cross-sectional at baseline. Mean (Standard Deviation). Unit: points on a scale

Measure	Acromegaly With Pegvisomant n = 29	Acromegaly With Somatostatin Analog n = 55	Active Acromegaly n = 32
Value	57 (19)	60 (21)	54 (22)

Population analysed: Patients receiving either no treatment (active acromegaly), pegvisomant monotherapy or somatostatin analog monotherapy from own doctor to treat acromegaly.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: This was a cross-sectional study. Adverse events were collected at the baseline cross-sectional visit for each subject.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Acromegaly on Pegvisomant	0 of 31 (0%)	0 of 31 (0%)	0 of 31
Acromegaly on Somatostatin Analog	0 of 60 (0%)	0 of 60 (0%)	0 of 60
Active Acromegaly	0 of 35 (0%)	0 of 35 (0%)	0 of 35

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Acromegaly

RecruitingPhase 1
A Phase 1 Clinical Trial of NTQ6179 Tablets in Healthy Volunteers
Acromegaly
RecruitingObservational study
An Observational Study of Octreotide Subcutaneous Depot in Patients With Acromegaly
Acromegaly
RecruitingPhase 3
A Study to Assess the Efficacy and Safety of Debio 4126 in Participants With Acromegaly Previously Treated With Somatostatin Analogs
Acromegaly
RecruitingObservational study
An Investigation of Pituitary Tumors and Related Hypothalmic Disorders
Panhypopituitarism, Gigantism/Acromegaly
Recruiting
Managing Pasireotide-associated Hyperglycaemia in Acromegaly With Ketogenic Diet
Acromegaly Due to Pituitary Adenoma, Hyperglycemia

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Karen Miller, MD principal investigator

Massachusetts General Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Acromegaly, run by Massachusetts General Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Apr 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Acromegaly Quality of Life (ACROQoL) Global Score (time frame: Cross-sectional at baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01732406.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2019.