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

NCT01568359 | Completed

• 1 other identifier: IRB00046786
• Study Type: observational
• Target: 49
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Acromegaly; Nonfunctioning Pituitary Tumor

Outcome Measures

Primary Outcomes (1)

• Calcitriol/PTH

  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.

  Baseline and 3-6 months after trreatment of pituitary condition

Study Arms (1)

Group 1 - Acromegaly, Group 2 - control

Group 1 - Acromegaly patients, Group 2 - Nonfunctioning pituitary adenoma patients (control)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Age \< 18 years old
• Prior other diseases: Patients chronic renal disease stage 3 or worse (estimated GFR \> 60).

Sponsors & Collaborators

• Emory University: lead

Study Sites (2)

Emory Clinic

Atlanta, Georgia, 30322, United States

Location

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

Related Publications (17)

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  PMID: 1261522 BACKGROUND

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  PMID: 15382339 BACKGROUND

• 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. doi: 10.1210/jcem.76.6.8501150.

  PMID: 8501150 BACKGROUND

• 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. doi: 10.1136/bmj.4.5634.797.

  PMID: 5702295 BACKGROUND

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  PMID: 4760543 BACKGROUND

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  PMID: 3839000 BACKGROUND

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  PMID: 6254298 BACKGROUND

• 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. doi: 10.1016/s0950-351x(95)80338-6.

  PMID: 7625986 BACKGROUND

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• 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. doi: 10.1210/jc.2005-1602. Epub 2005 Dec 13.

  PMID: 16352693 BACKGROUND

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  PMID: 7211102 BACKGROUND

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  PMID: 14671148 BACKGROUND

• 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.

  PMID: 19945023 BACKGROUND

• Constantin T, Tangpricha V, Shah R, Oyesiku NM, Ioachimescu OC, Ritchie J, Ioachimescu AG. Calcium and Bone Turnover Markers in Acromegaly: A Prospective, Controlled Study. J Clin Endocrinol Metab. 2017 Jul 1;102(7):2416-2424. doi: 10.1210/jc.2016-3693.

  PMID: 28407138 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood and urine samples obtained from subjects.

MeSH Terms

Conditions

Acromegaly

Condition Hierarchy (Ancestors)

Bone Diseases, Endocrine; Bone Diseases; Musculoskeletal Diseases; Hyperpituitarism; Pituitary Diseases; Hypothalamic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases

Study Officials

• Adriana Ioachimescu, MD, PhD

  Asst Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 29, 2012
• First Posted: April 2, 2012
• Study Start: December 1, 2011
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: December 5, 2014

Record last verified: 2014-12

Locations

US (2)