AcromegalyNCT03225040
Bone MicroArchitecture in Acromegaly
An observational study of Acromegaly and Osteoporosis Risk, run by Columbia University at 1 site in United States.
Trial summary
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)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acromegaly, Osteoporosis Risk
- What is being tested?
- Pegvisomant
- How many people
- 77 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Aug 2016to 21 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Individuals with acromegaly
- On pegvisomant therapy with a normal IGF-1 level for at least 1 year
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Neuroendocrine Unit and Pituitary Center, Columbia University
New York, New York, 10032
About this study
Official title: 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.
Read the 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.
- Conditions
- Acromegaly, Osteoporosis Risk
- Being tested
- Pegvisomant
- Keywords
- Acromegaly, Pegvisomant, Osteoporosis
- Medical subject headings
- Acromegaly, Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PegvisomantDrug
Also called Somavert
Subjects receiving pegvisomant as part of their clinical care for acromegaly will be studied.
| Study group | Role | What they receive |
|---|---|---|
| Acromegaly patients on pegvisomant | 25 subjects with acromegaly on pegvisomant therapy with a normal IGF-1 level for at least 1 year. Receives: Drug: Pegvisomant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Volumetric bone mineral density of radius (vBMD)
Volumetric bone mineral density of radius (vBMD) measured by high resolution peripheral quantitative computed tomography (HRpQCT)
Measured: Measured once at one study visit
Secondary outcomes (7)
Trabecular number of radius (TbN)
HRpQCT determined bone microarchitecture
Measured: Measured once at one study visit
Trabecular Thickness of radius (Tb.Th)
HRpQCT determined bone microarchitecture
Measured: Measured once at one study visit
Trabecular separation of radius (Tb.Sp)
HRpQCT determined bone microarchitecture
Measured: Measured once at one study visit
Cortical density of radius
HRpQCT determined bone microarchitecture
Measured: Measured once at one study visit
Cortical thickness of radius
HRpQCT determined bone microarchitecture
Measured: Measured once at one study visit
Areal bone mineral density (aBMD) of lumbar sacral spine
Areal bone mineral density of lumbar sacral spine determined by DXA
Measured: Measured once at one study visit
Trabecular bone score of LS spine
Trabecular bone score of lumbar sacral (LS) spine determined by DXA
Measured: Measured once at one study visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2017
- Study start3 Aug 2016
- Primary completion21 Dec 2019
- Study completion21 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AcromegalyStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe 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
- Cross-sectional
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Principal investigator, Pamela U. Freda, Columbia University
- Investigators
- Pamela Freda, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03225040
- Sponsor's protocol ID
- AAAE5304
- Status last verified
- Jul 2021
- First submitted
- 13 Jul 2017
- Last updated
- 13 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03225040
- Acronym / sponsor ID
- AAAE5304
- Conditions
- Acromegaly, Osteoporosis Risk
- Keywords
- Acromegaly, Pegvisomant, Osteoporosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- 3 Aug 2016 (actual)
- Primary completion
- 21 Dec 2019 (actual)
- Study completion
- 21 Dec 2019 (actual)
- First posted
- 21 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acromegaly patients on pegvisomant | – | Drug: Pegvisomant25 subjects with acromegaly on pegvisomant therapy with a normal IGF-1 level for at least 1 year. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Individuals with acromegaly
- On pegvisomant therapy with a normal IGF-1 level for at least 1 year
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PegvisomantAlso: SomavertSubjects receiving pegvisomant as part of their clinical care for acromegaly will be studied. | Drug | Acromegaly patients on pegvisomant |
Primary outcome
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)
7 secondary outcomes
Trabecular number of radius (TbN)
Time frame: Measured once at one study visit
Trabecular Thickness of radius (Tb.Th)
Time frame: Measured once at one study visit
Trabecular separation of radius (Tb.Sp)
Time frame: Measured once at one study visit
Cortical density of radius
Time frame: Measured once at one study visit
Cortical thickness of radius
Time frame: Measured once at one study visit
Areal bone mineral density (aBMD) of lumbar sacral spine
Time frame: Measured once at one study visit
Trabecular bone score of LS spine
Time frame: Measured once at one study visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2021.
- Individual participant dataSharing planned: Undecided
Related trials for 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
Not yet recruitingPhase 3
PRESTO: A Phase III Randomised Controlled Trial of Dose-escalated Proton Beam Therapy Versus Standard of Care Radiotherapy for Functioning Pituitary Tumours
Acromegaly Due to Pituitary Adenoma, Cushing's Disease
RecruitingObservational study
An Observational Study of Octreotide Subcutaneous Depot in Patients With Acromegaly
Acromegaly
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.
Pamela Freda, MD principal investigator
Columbia University
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 and Osteoporosis Risk, run by Columbia University 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 11 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 13 Jul 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Volumetric bone mineral density of radius (vBMD) (time frame: Measured once at one study visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Jul 2021.