Neuroendocrine Unit and Pituitary Center, Columbia University
New York, 10032, United States
NCT Number: NCT03225040
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.
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Notify Me18 year and older
All sexes
Observational
New York, 10032, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Subjects receiving pegvisomant as part of their clinical care for acromegaly will be studied.
Other names: Somavert
Time frame: Measured once at one study visit
Volumetric bone mineral density of radius (vBMD) measured by high resolution peripheral quantitative computed tomography (HRpQCT)
Time frame: Measured once at one study visit
HRpQCT determined bone microarchitecture
Time frame: Measured once at one study visit
HRpQCT determined bone microarchitecture
Time frame: Measured once at one study visit
HRpQCT determined bone microarchitecture
Time frame: Measured once at one study visit
HRpQCT determined bone microarchitecture
Time frame: Measured once at one study visit
HRpQCT determined bone microarchitecture
Time frame: Measured once at one study visit
Areal bone mineral density of lumbar sacral spine determined by DXA
Time frame: Measured once at one study visit
Trabecular bone score of lumbar sacral (LS) spine determined by DXA
Columbia University
Other
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
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