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

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT01568359

First Posted: April 2, 2012

Last Update Posted: December 5, 2014

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Information provided by (Responsible Party):

Adriana Ioachimescu, MD, PhD, Emory University

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:

Genetics Home Reference related topics: familial isolated pituitary adenoma

MedlinePlus related topics: Calcium Pituitary Disorders Pituitary Tumors

Genetic and Rare Diseases Information Center resources: Acromegaly

U.S. FDA Resources

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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

Information from the National Library of Medicine

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

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:

Wongsurawat N, Armbrecht HJ, Zenser TV, Forte LR, Davis BB. Effects of hypophysectomy and growth hormone treatment on renal hydroxylation of 25-hydroxycholecalciferol in rats. J Endocrinol. 1984 Jun;101(3):333-8.

Ajibade DV, Dhawan P, Fechner AJ, Meyer MB, Pike JW, Christakos S. Evidence for a role of prolactin in calcium homeostasis: regulation of intestinal transient receptor potential vanilloid type 6, intestinal calcium absorption, and the 25-hydroxyvitamin D(3) 1alpha hydroxylase gene by prolactin. Endocrinology. 2010 Jul;151(7):2974-84. doi: 10.1210/en.2010-0033. Epub 2010 May 12.

Charoenphandhu N, Wongdee K, Krishnamra N. Is prolactin the cardinal calciotropic maternal hormone? Trends Endocrinol Metab. 2010 Jul;21(7):395-401. doi: 10.1016/j.tem.2010.02.002. Epub 2010 Mar 20.

Lancer SR, Bowser EN, Hargis GK. The effect of growth hormone on parathyroid function in rats. Endocrinology. 1976 May;98(5):1289-93.

Cook DM, Ezzat S, Katznelson L, Kleinberg DL, Laws ER Jr, Nippoldt TB, Swearingen B, Vance ML; AACE Acromegaly Guidelines Task Force. AACE Medical Guidelines for Clinical Practice for the diagnosis and treatment of acromegaly. Endocr Pract. 2004 May-Jun;10(3):213-25. Erratum in: Endocr Pract. 2005 Mar-Apr;11(2):144. Endocr Pract. 2008 Sep;14(6):802-3. Cook, David M [added]; Ezzat, Shereen [added]; Katznelson, Laurence [added]; Kleinberg, David L [added]; Laws, Edward R Jr [added]; Nippoldt, Todd B [added]; Swearingen, Brooke [added]; Vance, Mary Lee [added].

Ezzat S, Melmed S, Endres D, Eyre DR, Singer FR. Biochemical assessment of bone formation and resorption in acromegaly. J Clin Endocrinol Metab. 1993 Jun;76(6):1452-7.

Nadarajah A, Hartog M, Redfern B, Thalassinos N, Wright AD, Joplin GF, Fraser TR. Calcium metabolism in acromegaly. Br Med J. 1968 Dec 28;4(5634):797-801.

Sigurdsson G, Nunziata V, Reiner M, Nadarajah A, Joplin GF. Calcium absorption and excretion in the gut in acromegaly. Clin Endocrinol (Oxf). 1973 Jul;2(3):187-92.

Takamoto S, Tsuchiya H, Onishi T, Morimoto S, Imanaka S, Mori S, Seino Y, Uozumi T, Kumahara Y. Changes in calcium homeostasis in acromegaly treated by pituitary adenomectomy. J Clin Endocrinol Metab. 1985 Jul;61(1):7-11.

Halse J, Haugen HN. Calcium and phosphate metabolism in acromegaly. Acta Endocrinol (Copenh). 1980 Aug;94(4):459-67.

Hennessey JV, Jackson IM. Clinical features and differential diagnosis of pituitary tumours with emphasis on acromegaly. Baillieres Clin Endocrinol Metab. 1995 Apr;9(2):271-314. Review.

Brown DJ, Spanos E, MacIntyre I. Role of pituitary hormones in regulating renal vitamin D metabolism in man. Br Med J. 1980 Feb 2;280(6210):277-8.

White HD, Ahmad AM, Durham BH, Chandran S, Patwala A, Fraser WD, Vora JP. Effect of active acromegaly and its treatment on parathyroid circadian rhythmicity and parathyroid target-organ sensitivity. J Clin Endocrinol Metab. 2006 Mar;91(3):913-9. Epub 2005 Dec 13.

Lund B, Eskildsen PC, Lund B, Norman AW, Sørensen OH. Calcium and vitamin D metabolism in acromegaly. Acta Endocrinol (Copenh). 1981 Apr;96(4):444-50.

Parkinson C, Kassem M, Heickendorff L, Flyvbjerg A, Trainer PJ. Pegvisomant-induced serum insulin-like growth factor-I normalization in patients with acromegaly returns elevated markers of bone turnover to normal. J Clin Endocrinol Metab. 2003 Dec;88(12):5650-5.

Chanson P, Salenave S, Kamenicky P, Cazabat L, Young J. Pituitary tumours: acromegaly. Best Pract Res Clin Endocrinol Metab. 2009 Oct;23(5):555-74. doi: 10.1016/j.beem.2009.05.010. Review.


Responsible Party:	Adriana Ioachimescu, MD, PhD, Associate Professor, Emory University
ClinicalTrials.gov Identifier:	NCT01568359 History of Changes
Other Study ID Numbers:	IRB00046786
First Submitted:	March 29, 2012
First Posted:	April 2, 2012
Last Update Posted:	December 5, 2014
Last Verified:	December 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

To Top