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Trial record 6 of 53 for:    Bone Architecture

Bone MicroArchitecture in Acromegaly

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ClinicalTrials.gov Identifier: NCT03225040
Recruitment Status : Recruiting
First Posted : July 21, 2017
Last Update Posted : July 21, 2017
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Pamela U. Freda, Columbia University

Brief 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) 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.

Condition or disease Intervention/treatment
Acromegaly Osteoporosis Risk Drug: Pegvisomant

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 : Observational
Estimated Enrollment : 25 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
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
Actual Study Start Date : August 3, 2016
Estimated Primary Completion Date : December 30, 2018
Estimated Study Completion Date : December 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bone Density
Drug Information available for: Pegvisomant
U.S. FDA Resources

Group/Cohort Intervention/treatment
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 Name: Somavert



Primary Outcome Measures :
  1. 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 (HR-pQCT)


Secondary Outcome Measures :
  1. Trabecular number of radius (TbN) [ Time Frame: Measured once at one study visit ]
    HRpQCT determined bone microarchitecture

  2. Trabecular Thickness of radius (Tb.Th) [ Time Frame: Measured once at one study visit ]
    HRpQCT determined bone microarchitecture

  3. Trabecular separation of radius (Tb.Sp) [ Time Frame: Measured once at one study visit ]
    HRpQCT determined bone microarchitecture

  4. Cortical density of radius [ Time Frame: Measured once at one study visit ]
    HRpQCT determined bone microarchitecture

  5. Cortical thickness of radius [ Time Frame: Measured once at one study visit ]
    HRpQCT determined bone microarchitecture

  6. 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

  7. Trabecular bone score of LS spine [ Time Frame: Measured once at one study visit ]
    Trabecular bone score of lumbar sacral spine determined by DXA


Biospecimen Retention:   Samples Without DNA
Peripheral blood specimens


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03225040


Contacts
Contact: Carlos Reyes-Vidal, MD 212-305-4921 csr52@columbia.edu
Contact: Pamela Freda, MD 212-305-2254

Locations
United States, New York
Neuroendocrine Unit and Pituitary Center, Columbia University Recruiting
New York, New York, United States, 10032
Contact: Pamela U. Freda, MD    212-305-2254      
Contact: Carlos M. Reyes-Vidal, MD    212-305-4921    csr52@cumc.columbia.edu   
Sponsors and Collaborators
Columbia University
Pfizer
Investigators
Principal Investigator: Pamela Freda, MD Columbia University

Responsible Party: Pamela U. Freda, Professor of Medicine, Columbia University
ClinicalTrials.gov Identifier: NCT03225040     History of Changes
Other Study ID Numbers: AAAE5304
First Posted: July 21, 2017    Key Record Dates
Last Update Posted: July 21, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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

Keywords provided by Pamela U. Freda, Columbia University:
Acromegaly
Pegvisomant
Osteoporosis

Additional relevant MeSH terms:
Bone Diseases, Metabolic
Bone Diseases
Bone Diseases, Endocrine
Osteoporosis
Acromegaly
Musculoskeletal Diseases
Metabolic Diseases
Hyperpituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases