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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Adriana Ioachimescu, MD, PhD, Emory University
ClinicalTrials.gov Identifier:
NCT01568359
First received: March 29, 2012
Last updated: December 2, 2013
Last verified: December 2013
  Purpose

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.


Condition
Acromegaly
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.


Estimated Enrollment: 44
Study Start Date: December 2011
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Group 1 - Acromegaly, Group 2 - control
Group 1 - Acromegaly patients, Group 2 - Nonfunctioning pituitary adenoma patients (control)

  Show Detailed Description

  Eligibility

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.

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01568359

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

Publications:

Responsible Party: Adriana Ioachimescu, MD, PhD, Associate Professor, Emory University
ClinicalTrials.gov Identifier: NCT01568359     History of Changes
Other Study ID Numbers: IRB00046786
Study First Received: March 29, 2012
Last Updated: December 2, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Pituitary Neoplasms
Pituitary Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Hypothalamic Neoplasms
Supratentorial Neoplasms
Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Acromegaly
Bone Diseases, Endocrine
Bone Diseases
Musculoskeletal Diseases
Hyperpituitarism
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on July 24, 2014