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Calcium Homeostasis in Acromegaly: Effect of Surgical/Medical Treatment and Comparison With Nonfunctioning Pituitary Tumors
This study has been completed.
Sponsor:
Emory University
Information provided by (Responsible Party):
Adriana Ioachimescu, MD, PhD, Emory University
ClinicalTrials.gov Identifier:
NCT01568359
First received: March 29, 2012
Last updated: December 4, 2014
Last verified: December 2014
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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 Adriana Ioachimescu, MD, PhD, Emory University:
Primary Outcome Measures:
- Calcitriol/PTH [ Time Frame: Baseline and 3-6 months after trreatment of pituitary condition ]
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) |
| 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 (Adult, Senior) |
| Sexes Eligible for Study: | All |
| 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
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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
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 4, 2014 |
Additional relevant MeSH terms:
|
Pituitary Neoplasms Pituitary Diseases Acromegaly Hypothalamic Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases Endocrine System Diseases Bone Diseases, Endocrine Bone Diseases |
Musculoskeletal Diseases Hyperpituitarism 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 June 23, 2017