Bone MicroArchitecture in Acromegaly

Completed

• Conditions: Osteoporosis Risk; Acromegaly
• Interventions: Drug: Pegvisomant

• Registration Number: NCT03225040
• Lead Sponsor: Columbia University

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.

Study Timeline

• Study Start: 2016-08-03
• Study First Submitted: 2017-07-13
• Study First Submitted QC: 2017-07-19
• Study First Posted: 2017-07-21
• Primary Completion: 2019-12-21
• Study Completion: 2019-12-21
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-12
• Last Update Posted: 2021-07-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 77

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Acromegaly patients on pegvisomant	Pegvisomant	25 subjects with acromegaly on pegvisomant therapy with a normal IGF-1 level for at least 1 year.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Trabecular number of radius (TbN)	Measured once at one study visit	HRpQCT determined bone microarchitecture
Trabecular Thickness of radius (Tb.Th)	Measured once at one study visit	HRpQCT determined bone microarchitecture
Cortical density of radius	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
Cortical thickness of radius	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
Trabecular bone score of LS spine	Measured once at one study visit	Trabecular bone score of lumbar sacral (LS) spine determined by DXA

Trial Locations

Locations (1)

Neuroendocrine Unit and Pituitary Center, Columbia University; 🇺🇸 New York, New York, United States