Bone MicroArchitecture in Acromegaly

NCT03225040 | Completed

• 1 other identifier: AAAE5304
• Study Type: observational
• Target: 77
• Locations: 1 country
• Sites: 1

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.

Conditions

Acromegaly; Osteoporosis Risk

Keywords

Acromegaly; Pegvisomant; Osteoporosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Trabecular number of radius (TbN)

  Measured once at one study visit

• Trabecular Thickness of radius (Tb.Th)

  Measured once at one study visit

• Trabecular separation of radius (Tb.Sp)

  Measured once at one study visit

• Cortical density of radius

  Measured once at one study visit

• Cortical thickness of radius

  Measured once at one study visit

Study Arms (1)

Acromegaly patients on pegvisomant

25 subjects with acromegaly on pegvisomant therapy with a normal IGF-1 level for at least 1 year.

Drug: Pegvisomant

Interventions

Pegvisomant DRUG

Subjects receiving pegvisomant as part of their clinical care for acromegaly will be studied.

Also known as: Somavert

Acromegaly patients on pegvisomant

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

25 subjects with acromegaly on pegvisomant therapy with a normal IGF-1 level for at least 1 year will be studied. Patients will be on stable doses of any pituitary hormone supplements for 3 months prior to study entry including gonadal steroid replacement for men or premenopausal women. Hypogonadal men and premenopausal women will be replaced with clinically appropriate sex steroid replacement. Subjects will be 50% females.

You may qualify if:

• Individuals with acromegaly
• On pegvisomant therapy with a normal IGF-1 level for at least 1 year

You may not qualify if:

• 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

Sponsors & Collaborators

• Columbia University: lead
• Pfizer: collaborator

Study Sites (1)

Neuroendocrine Unit and Pituitary Center, Columbia University

New York, New York, 10032, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Peripheral blood specimens

MeSH Terms

Conditions

Acromegaly; Osteoporosis

Interventions

pegvisomant

Condition Hierarchy (Ancestors)

Bone Diseases, Endocrine; Bone Diseases; Musculoskeletal Diseases; Hyperpituitarism; Pituitary Diseases; Hypothalamic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases; Bone Diseases, Metabolic; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Pamela Freda, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: July 13, 2017
• First Posted: July 21, 2017
• Study Start: August 3, 2016
• Primary Completion: December 21, 2019
• Study Completion: December 21, 2019
• Last Updated: July 13, 2021

Record last verified: 2021-07

Locations

US (1)