Bone MicroArchitecture in Acromegaly

July 12, 2021 updated by: Pamela U. Freda, Columbia University

Cross-sectional Study of Bone Density, Bone Microarchitecture, Vertebral Fractures and Trabecular Bone Score in Patients With Acromegaly Treated With Pegvisomant Compared to Patients With Untreated Active Acromegaly

The investigators will conduct a cross-sectional study of bone density, bone microarchitecture, vertebral fractures and trabecular bone score in 25 patients with acromegaly treated with Pegvisomant, the growth hormone (GH) receptor antagonist for at least 1 year and with normal insulin-like growth factor-1 (IGF-1) levels. This study aims to describe the bone architecture and associated biochemical indices of bone turnover and metabolism in patients with active acromegaly and how these are altered with treatment of the disease.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Growth hormone (GH) and Insulin-Like Growth Factor-1 (IGF-1) are important regulators of bone modeling and remodeling, fundamental to maintenance of normal skeletal integrity. In acromegaly, a disease characterized by longstanding exposure to excess GH and IGF-1, these hormones induce marked skeletal changes. Most dual energy X-ray absorptiometry (DXA) studies report that bone mineral density (BMD) is normal in acromegaly. Despite this, however, there is mounting evidence that bone health is adversely affected in patients with both active and successfully treated acromegaly.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
77

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10032
        • Neuroendocrine Unit and Pituitary Center, Columbia University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

25 subjects with acromegaly on pegvisomant therapy with a normal IGF-1 level for at least 1 year will be studied.

Patients will be on stable doses of any pituitary hormone supplements for 3 months prior to study entry including gonadal steroid replacement for men or premenopausal women. Hypogonadal men and premenopausal women will be replaced with clinically appropriate sex steroid replacement. Subjects will be 50% females.

Description

Inclusion Criteria:

  • Individuals with acromegaly
  • On pegvisomant therapy with a normal IGF-1 level for at least 1 year

Exclusion Criteria:

  • Malignancy (except cured basal, squamous cell skin carcinoma or other cured cancers free from recurrence > 3 years)
  • Pregnancy or lactation within last 12 months
  • Untreated primary hyperparathyroidism, hyper- or hypothyroidism
  • Cushing's syndrome
  • Prolactin-secreting pituitary adenoma
  • GH deficiency
  • On current drug therapy for osteoporosis
  • Diabetes mellitus
  • Renal insufficiency
  • Liver disease
  • Current or past use of glucocorticoids (more than physiologic dose), anticonvulsants, anticoagulants, methotrexate, aromatase inhibitors

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Acromegaly patients on pegvisomant
25 subjects with acromegaly on pegvisomant therapy with a normal IGF-1 level for at least 1 year.
Drug: Pegvisomant
Subjects receiving pegvisomant as part of their clinical care for acromegaly will be studied.
Other Names:
  • Somavert

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Volumetric bone mineral density of radius (vBMD)
Time Frame: Measured once at one study visit
Volumetric bone mineral density of radius (vBMD) measured by high resolution peripheral quantitative computed tomography (HRpQCT)
Measured once at one study visit

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Trabecular number of radius (TbN)
Time Frame: Measured once at one study visit
HRpQCT determined bone microarchitecture
Measured once at one study visit
Trabecular Thickness of radius (Tb.Th)
Time Frame: Measured once at one study visit
HRpQCT determined bone microarchitecture
Measured once at one study visit
Trabecular separation of radius (Tb.Sp)
Time Frame: Measured once at one study visit
HRpQCT determined bone microarchitecture
Measured once at one study visit
Cortical density of radius
Time Frame: Measured once at one study visit
HRpQCT determined bone microarchitecture
Measured once at one study visit
Cortical thickness of radius
Time Frame: Measured once at one study visit
HRpQCT determined bone microarchitecture
Measured once at one study visit
Areal bone mineral density (aBMD) of lumbar sacral spine
Time Frame: Measured once at one study visit
Areal bone mineral density of lumbar sacral spine determined by DXA
Measured once at one study visit
Trabecular bone score of LS spine
Time Frame: Measured once at one study visit
Trabecular bone score of lumbar sacral (LS) spine determined by DXA
Measured once at one study visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Columbia University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Pfizer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 3, 2016

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 21, 2019

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 21, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 13, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 19, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 21, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 13, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 12, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AAAE5304

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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