Bone MicroArchitecture in Acromegaly
| Status: | Recruiting |
|---|---|
| Conditions: | Skin Cancer, Osteoporosis, Endocrine |
| Therapuetic Areas: | Endocrinology, Oncology, Rheumatology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/21/2019 |
| Start Date: | August 3, 2016 |
| End Date: | March 2020 |
| Contact: | Carlos Reyes-Vidal, MD |
| Email: | csr52@columbia.edu |
| Phone: | 212-305-4921 |
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.
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.
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.
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
We found this trial at
1
site
New York, New York 10032
Phone: 212-305-2254
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