Calcium Homeostasis in Acromegaly: Effect of Surgical/Medical Treatment and Comparison With Nonfunctioning Pituitary Tumors
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ClinicalTrials.gov Identifier: NCT01568359 |
Recruitment Status :
Completed
First Posted : April 2, 2012
Last Update Posted : December 5, 2014
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Condition or disease |
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Acromegaly Nonfunctioning Pituitary Tumor |

Study Type : | Observational |
Actual Enrollment : | 49 participants |
Observational Model: | Case-Control |
Time Perspective: | Prospective |
Official Title: | Calcium Homeostasis in Acromegaly: Effect of Surgical/Medical Treatment and Comparison With Nonfunctioning Pituitary Tumors. |
Study Start Date : | December 2011 |
Actual Primary Completion Date : | August 2014 |
Actual Study Completion Date : | August 2014 |

Group/Cohort |
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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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- 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

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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).

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01568359
United States, Georgia | |
Emory Clinic | |
Atlanta, Georgia, United States, 30322 | |
Emory University Hospital | |
Atlanta, Georgia, United States, 30322 |
Principal Investigator: | Adriana Ioachimescu, MD, PhD | Asst Professor |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Adriana Ioachimescu, MD, PhD, Associate Professor, Emory University |
ClinicalTrials.gov Identifier: | NCT01568359 |
Other Study ID Numbers: |
IRB00046786 |
First Posted: | April 2, 2012 Key Record Dates |
Last Update Posted: | December 5, 2014 |
Last Verified: | December 2014 |
Pituitary Neoplasms Acromegaly Pituitary Diseases 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 |