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| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acromegaly patients on pegvisomant | 25 subjects with acromegaly on pegvisomant therapy with a normal IGF-1 level for at least 1 year. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pegvisomant | Drug | Subjects receiving pegvisomant as part of their clinical care for acromegaly will be studied. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Volumetric bone mineral density of radius (vBMD) | Volumetric bone mineral density of radius (vBMD) measured by high resolution peripheral quantitative computed tomography (HRpQCT) | Measured once at one study visit |
| Measure | Description | Time Frame |
|---|---|---|
| Trabecular number of radius (TbN) | HRpQCT determined bone microarchitecture | Measured once at one study visit |
| Trabecular Thickness of radius (Tb.Th) | HRpQCT determined bone microarchitecture |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Pamela Freda, MD | Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Neuroendocrine Unit and Pituitary Center, Columbia University | New York | New York | 10032 | United States |
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| ID | Term |
|---|---|
| D000172 | Acromegaly |
| D010024 | Osteoporosis |
| ID | Term |
|---|---|
| D001849 | Bone Diseases, Endocrine |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D006964 | Hyperpituitarism |
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| ID | Term |
|---|---|
| C406545 | pegvisomant |
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Peripheral blood specimens
| Measured once at one study visit |
| Trabecular separation of radius (Tb.Sp) | HRpQCT determined bone microarchitecture | Measured once at one study visit |
| Cortical density of radius | HRpQCT determined bone microarchitecture | Measured once at one study visit |
| Cortical thickness of radius | HRpQCT determined bone microarchitecture | 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 once at one study visit |
| Trabecular bone score of LS spine | Trabecular bone score of lumbar sacral (LS) spine determined by DXA | Measured once at one study visit |
| D010900 |
| Pituitary Diseases |
| D007027 | Hypothalamic Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D004700 | Endocrine System Diseases |
| D001851 | Bone Diseases, Metabolic |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |