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
Overview
- Phase
- Not Applicable
- Intervention
- Pegvisomant
- Conditions
- Acromegaly
- Sponsor
- Columbia University
- Enrollment
- 77
- Locations
- 1
- Primary Endpoint
- Volumetric bone mineral density of radius (vBMD)
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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.
Investigators
Pamela U. Freda
Professor of Medicine
Columbia University
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
Arms & Interventions
Acromegaly patients on pegvisomant
25 subjects with acromegaly on pegvisomant therapy with a normal IGF-1 level for at least 1 year.
Intervention: Pegvisomant
Outcomes
Primary Outcomes
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)
Secondary Outcomes
- Trabecular number of radius (TbN)(Measured once at one study visit)
- Trabecular Thickness of radius (Tb.Th)(Measured once at one study visit)
- Cortical density of radius(Measured once at one study visit)
- Areal bone mineral density (aBMD) of lumbar sacral spine(Measured once at one study visit)
- Cortical thickness of radius(Measured once at one study visit)
- Trabecular separation of radius (Tb.Sp)(Measured once at one study visit)
- Trabecular bone score of LS spine(Measured once at one study visit)