Acromegaly, Osteoporosis Risk
Conditions
Keywords
Acromegaly, Pegvisomant, Osteoporosis
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.
Interventions
DRUGPegvisomant
Subjects receiving pegvisomant as part of their clinical care for acromegaly will be studied.
Sponsors
Pfizer
Columbia University
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Volumetric bone mineral density of radius (vBMD) | Measured once at one study visit | Volumetric bone mineral density of radius (vBMD) measured by high resolution peripheral quantitative computed tomography (HRpQCT) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Trabecular Thickness of radius (Tb.Th) | Measured once at one study visit | HRpQCT determined bone microarchitecture |
| Trabecular separation of radius (Tb.Sp) | Measured once at one study visit | HRpQCT determined bone microarchitecture |
| Cortical density of radius | Measured once at one study visit | HRpQCT determined bone microarchitecture |
| Trabecular number of radius (TbN) | Measured once at one study visit | HRpQCT determined bone microarchitecture |
| Areal bone mineral density (aBMD) of lumbar sacral spine | Measured once at one study visit | Areal bone mineral density of lumbar sacral spine determined by DXA |
| Trabecular bone score of LS spine | Measured once at one study visit | Trabecular bone score of lumbar sacral (LS) spine determined by DXA |
| Cortical thickness of radius | Measured once at one study visit | HRpQCT determined bone microarchitecture |
Countries
United States
Outcome results
None listed