Bone MicroArchitecture in Acromegaly

Acromegaly Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03225040
• Other study ID #: AAAE5304
• Status: Completed
• Start date: August 3, 2016
• Est. completion date: December 21, 2019

Study information

• Verified date: July 2021
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 77
• Est. completion date: December 21, 2019
• Est. primary completion date: December 21, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acromegaly
• Osteoporosis
• Osteoporosis Risk

Intervention

Drug:
• Pegvisomant
Subjects receiving pegvisomant as part of their clinical care for acromegaly will be studied.

Locations

Country	Name	City	State
United States	Neuroendocrine Unit and Pituitary Center, Columbia University	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Columbia University	Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	Trabecular number of radius (TbN)	HRpQCT determined bone microarchitecture	Measured once at one study visit
Secondary	Trabecular Thickness of radius (Tb.Th)	HRpQCT determined bone microarchitecture	Measured once at one study visit
Secondary	Trabecular separation of radius (Tb.Sp)	HRpQCT determined bone microarchitecture	Measured once at one study visit
Secondary	Cortical density of radius	HRpQCT determined bone microarchitecture	Measured once at one study visit
Secondary	Cortical thickness of radius	HRpQCT determined bone microarchitecture	Measured once at one study visit
Secondary	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
Secondary	Trabecular bone score of LS spine	Trabecular bone score of lumbar sacral (LS) spine determined by DXA	Measured once at one study visit