Calcium Homeostasis in Acromegaly: Effect of Surgical/Medical Treatment and Comparison With Nonfunctioning Pituitary Tumors

This study has been completed.
Information provided by (Responsible Party):
Adriana Ioachimescu, MD, PhD, Emory University Identifier:
First received: March 29, 2012
Last updated: December 4, 2014
Last verified: December 2014
The purpose of the study is to evaluate the Calcium homeostasis in adult patients with uncontrolled acromegaly. The measurements will be repeated 3-6 months after the treatment of acromegaly (surgical or medical). The control group consists of patients with nonfunctioning pituitary tumors who will undergo surgical removal.

Nonfunctioning Pituitary Tumor

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Calcium Homeostasis in Acromegaly: Effect of Surgical/Medical Treatment and Comparison With Nonfunctioning Pituitary Tumors.

Resource links provided by NLM:

Further study details as provided by Emory University:

Primary Outcome Measures:
  • Calcitriol/PTH [ Time Frame: Baseline and 3-6 months after trreatment of pituitary condition ] [ Designated as safety issue: No ]

    To describe baseline calcitriol/PTH status in patients with uncontrolled acromegaly, with subanalyses based on presence of hyperprolactinemia.

    To assess the change in calcitriol/PTH levels after treatment with acromegaly, with subanalyses based on type of therapy (surgical or medical).

    To evaluate the calcium and calcitriol/PTH levels in patients with acromegaly compared to patients with nonfunctioning pituitary adenomas, with subanalyses based on presence of hyperprolactinemia in either group.

Biospecimen Retention:   Samples Without DNA
Blood and urine samples obtained from subjects.

Enrollment: 49
Study Start Date: December 2011
Study Completion Date: August 2014
Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Group 1 - Acromegaly, Group 2 - control
Group 1 - Acromegaly patients, Group 2 - Nonfunctioning pituitary adenoma patients (control)

  Show Detailed Description


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with uncontrolled acromegaly and nonfunctioning pituitary adenomas presenting to the Emory University Pituitary Center for medical or surgical treatment.

Inclusion Criteria:

  • Patients diagnosed with acromegaly or a nonfunctioning pituitary who will receive treatment for the pituitary condition.
  • Study subjects must agree to participate in this study and provide written consent.
  • Site- Emory Clinic/Emory University hospital.
  • Stage of Disease: Patients with active acromegaly that is either newly diagnosed or uncontrolled on current therapy (as shown by GH/IGF-1 levels). Patients with nonfunctioning pituitary adenoma in whom surgical intervention planned based on current guidelines will serve as a control group.
  • Age: Study subjects must be over 18 years of age.

Exclusion Criteria:

  • Age < 18 years old
  • Prior other diseases: Patients chronic renal disease stage 3 or worse (estimated GFR > 60).
  Contacts and Locations
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Please refer to this study by its identifier: NCT01568359

United States, Georgia
Emory Clinic
Atlanta, Georgia, United States, 30322
Emory University Hospital
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
Principal Investigator: Adriana Ioachimescu, MD, PhD Asst Professor
  More Information


Responsible Party: Adriana Ioachimescu, MD, PhD, Associate Professor, Emory University Identifier: NCT01568359     History of Changes
Other Study ID Numbers: IRB00046786
Study First Received: March 29, 2012
Last Updated: December 4, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Pituitary Diseases
Pituitary Neoplasms
Brain Neoplasms
Central Nervous System Neoplasms
Endocrine Gland Neoplasms
Hypothalamic Neoplasms
Neoplasms by Site
Nervous System Neoplasms
Supratentorial Neoplasms
Bone Diseases
Bone Diseases, Endocrine
Brain Diseases
Central Nervous System Diseases
Endocrine System Diseases
Hypothalamic Diseases
Musculoskeletal Diseases
Nervous System Diseases processed this record on November 27, 2015