Bone MicroArchitecture in Acromegaly

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Acromegaly
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Novartis Pharmaceuticals – Acromegaly
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Brief Title

Bone MicroArchitecture in Acromegaly

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

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 Type

Observational

Primary Outcome

Volumetric bone mineral density of radius (vBMD)

Secondary Outcome

 Trabecular number of radius (TbN)

Condition

Acromegaly

Intervention

Pegvisomant

Study Arms / Comparison Groups

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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Drug

Estimated Enrollment

77

Start Date

August 3, 2016

Completion Date

December 21, 2019

Primary Completion Date

December 21, 2019

Eligibility Criteria

        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

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Pamela Freda, MD, ,

Location Countries

United States

Location Countries

United States

Administrative Informations

NCT ID

NCT03225040

Organization ID

AAAE5304

Responsible Party

Principal Investigator

Study Sponsor

Columbia University

Collaborators

 Pfizer

Study Sponsor

Pamela Freda, MD, Principal Investigator, Columbia University

Verification Date

July 2021