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Completed

NCT Number: NCT03225040

Bone MicroArchitecture in Acromegaly

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Neuroendocrine Unit and Pituitary Center, Columbia University

New York, 10032, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pegvisomant

Drug

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

Other names: Somavert

Primary outcomes

  1. 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

  1. Trabecular number of radius (TbN)

    Time frame: Measured once at one study visit

    HRpQCT determined bone microarchitecture

  2. Trabecular Thickness of radius (Tb.Th)

    Time frame: Measured once at one study visit

    HRpQCT determined bone microarchitecture

  3. Trabecular separation of radius (Tb.Sp)

    Time frame: Measured once at one study visit

    HRpQCT determined bone microarchitecture

  4. Cortical density of radius

    Time frame: Measured once at one study visit

    HRpQCT determined bone microarchitecture

  5. Cortical thickness of radius

    Time frame: Measured once at one study visit

    HRpQCT determined bone microarchitecture

  6. Areal bone mineral density (aBMD) of lumbar sacral spine

    Time frame: Measured once at one study visit

    Areal bone mineral density of lumbar sacral spine determined by DXA

  7. Trabecular bone score of LS spine

    Time frame: Measured once at one study visit

    Trabecular bone score of lumbar sacral (LS) spine determined by DXA

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Collaborators

  • Pfizer

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Jul 21, 2017
Registry last updated
Jul 13, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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