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Trial record 1 of 1 for:    NCT03225040
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Bone MicroArchitecture in Acromegaly

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ClinicalTrials.gov Identifier: NCT03225040
Recruitment Status : Recruiting
First Posted : July 21, 2017
Last Update Posted : February 19, 2019
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Pamela U. Freda, Columbia University

Tracking Information
First Submitted Date July 13, 2017
First Posted Date July 21, 2017
Last Update Posted Date February 19, 2019
Actual Study Start Date August 3, 2016
Estimated Primary Completion Date March 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 16, 2019)
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)
Original Primary Outcome Measures
 (submitted: July 19, 2017)
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)
Change History
Current Secondary Outcome Measures
 (submitted: February 16, 2019)
  • Trabecular number of radius (TbN) [ Time Frame: Measured once at one study visit ]
    HRpQCT determined bone microarchitecture
  • Trabecular Thickness of radius (Tb.Th) [ Time Frame: Measured once at one study visit ]
    HRpQCT determined bone microarchitecture
  • Trabecular separation of radius (Tb.Sp) [ Time Frame: Measured once at one study visit ]
    HRpQCT determined bone microarchitecture
  • Cortical density of radius [ Time Frame: Measured once at one study visit ]
    HRpQCT determined bone microarchitecture
  • Cortical thickness of radius [ Time Frame: Measured once at one study visit ]
    HRpQCT determined bone microarchitecture
  • 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
  • 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
Original Secondary Outcome Measures
 (submitted: July 19, 2017)
  • Trabecular number of radius (TbN) [ Time Frame: Measured once at one study visit ]
    HRpQCT determined bone microarchitecture
  • Trabecular Thickness of radius (Tb.Th) [ Time Frame: Measured once at one study visit ]
    HRpQCT determined bone microarchitecture
  • Trabecular separation of radius (Tb.Sp) [ Time Frame: Measured once at one study visit ]
    HRpQCT determined bone microarchitecture
  • Cortical density of radius [ Time Frame: Measured once at one study visit ]
    HRpQCT determined bone microarchitecture
  • Cortical thickness of radius [ Time Frame: Measured once at one study visit ]
    HRpQCT determined bone microarchitecture
  • 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
  • Trabecular bone score of LS spine [ Time Frame: Measured once at one study visit ]
    Trabecular bone score of lumbar sacral spine determined by DXA
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Bone MicroArchitecture in Acromegaly
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
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.
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
Study Design Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Peripheral blood specimens
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.

Condition
  • Acromegaly
  • Osteoporosis Risk
Intervention Drug: Pegvisomant
Subjects receiving pegvisomant as part of their clinical care for acromegaly will be studied.
Other Name: Somavert
Study Groups/Cohorts Acromegaly patients on pegvisomant
25 subjects with acromegaly on pegvisomant therapy with a normal IGF-1 level for at least 1 year.
Intervention: Drug: Pegvisomant
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: July 19, 2017)
25
Original Estimated Enrollment Same as current
Estimated Study Completion Date March 2020
Estimated Primary Completion Date March 2020   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Carlos Reyes-Vidal, MD 212-305-4921 csr52@columbia.edu
Contact: Pamela Freda, MD 212-305-2254
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03225040
Other Study ID Numbers AAAE5304
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Pamela U. Freda, Columbia University
Study Sponsor Columbia University
Collaborators Pfizer
Investigators
Principal Investigator: Pamela Freda, MD Columbia University
PRS Account Columbia University
Verification Date February 2019