Calcium Homeostasis in Acromegaly: Effect of Surgical/Medical Treatment and Comparison With Nonfunctioning Pituitary Tumors
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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 |
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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. |
- 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: | December 2013 |
Groups/Cohorts |
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Group 1 - Acromegaly, Group 2 - control
Group 1 - Acromegaly patients, Group 2 - Nonfunctioning pituitary adenoma patients (control)
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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).
United States, Georgia | |
Emory Clinic | Recruiting |
Atlanta, Georgia, United States, 30322 | |
Contact: Emilee B. Holland, BS 404-778-3746 emorga9@emory.edu | |
Contact: Adriana Ioachimescu, MD, PhD 404-778-5770 aioachi@emory.edu | |
Principal Investigator: Adriana Ioachimescu, MD, PhD | |
Emory University Hospital | Recruiting |
Atlanta, Georgia, United States, 30322 | |
Contact: Emilee B. Holland, BS 404-778-3746 emorga9@emory.edu | |
Contact: Adriana Ioachimescu, MD, PhD 404-778-5770 aioachi@emory.edu | |
Principal Investigator: Adriana Ioachimescu, MD, PhD |
Principal Investigator: | Adriana Ioachimescu, MD, PhD | Asst Professor |
Publications:
Responsible Party: | Adriana Ioachimescu, MD, PhD, Assistant Professor, Emory University |
ClinicalTrials.gov Identifier: | NCT01568359 History of Changes |
Other Study ID Numbers: | 00046786 |
Study First Received: | March 29, 2012 |
Last Updated: | March 30, 2012 |
Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
Acromegaly Pituitary Neoplasms Bone Diseases, Endocrine Bone Diseases Musculoskeletal Diseases Hyperpituitarism Pituitary Diseases Hypothalamic Diseases Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Endocrine System Diseases Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Hypothalamic Neoplasms Supratentorial Neoplasms Brain Neoplasms Central Nervous System Neoplasms Nervous System Neoplasms |
ClinicalTrials.gov processed this record on October 17, 2012