Clinical trial · Observational
Calcium Homeostasis in Acromegaly: Effect of Surgical/Medical Treatment and Comparison With Nonfunctioning Pituitary Tumors
Calcium Homeostasis in Acromegaly: Effect of Surgical/Medical Treatment and Comparison With Nonfunctioning Pituitary Tumors.
NCT01568359CI-TRIAL-00016270completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acromegaly | — | UNRESOLVED | — |
| Nonfunctioning Pituitary Tumor | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- Group 1 - Acromegaly, Group 2 - control
- description
- Group 1 - Acromegaly patients, Group 2 - Nonfunctioning pituitary adenoma patients (control)
Primary outcomes (1)
- measure
- Calcitriol/PTH
- timeFrame
- Baseline and 3-6 months after trreatment of pituitary condition
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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).
References
Publications (17)
- BACKGROUNDWongsurawat 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. doi: 10.1677/joe.0.1010333. PMID 6610018
- BACKGROUNDAjibade 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. PMID 20463051
- BACKGROUNDCharoenphandhu 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. PMID 20304671
- BACKGROUNDLancer SR, Bowser EN, Hargis GK. The effect of growth hormone on parathyroid function in rats. Endocrinology. 1976 May;98(5):1289-93. doi: 10.1210/endo-98-5-1289. PMID 1261522
- BACKGROUNDCook 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. doi: 10.4158/EP.10.3.213. No abstract available. PMID 15382339
- BACKGROUNDEzzat 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
- BACKGROUNDNadarajah 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.