Ignite Creation Date:
2025-12-24 @ 2:41 PM
Ignite Modification Date:
2025-12-26 @ 2:03 AM
Study NCT ID:
NCT01568359
Status:
COMPLETED
Last Update Posted:
2014-12-05
First Post:
2012-03-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Calcium Homeostasis in Acromegaly: Effect of Surgical/Medical Treatment and Comparison With Nonfunctioning Pituitary Tumors
Sponsor:
Emory University
Organization:
Study Overview
Official Title:
Calcium Homeostasis in Acromegaly: Effect of Surgical/Medical Treatment and Comparison With Nonfunctioning Pituitary Tumors.
Status:
COMPLETED
Status Verified Date:
2014-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Detailed Description:
Calcitriol is the active form of vitamin D. Parathyroid hormone (PTH) is secreted by the parathyroid glands in the neck. Both these chemicals are responsible for keeping the levels of calcium and phosphorous normal and also play a role in bone health. They can be measured in the blood. In some disorders, PTH or calcitriol levels are elevated, which results in increased calcium absorption from the gut, increased calcium in the bloodstream, and increased calcium excretion in the urine. Increased calcium in the urine can lead to the development of kidney stones. Increased calcium in the bloodstream can have adverse effects on the heart, gut, kidneys, and bones.
Acromegaly is a condition where a pituitary tumor secretes excessive amounts of growth hormone. Patients with acromegaly have been found to have a higher prevalence of kidney stones, urinary calcium, and serum calcium when compared to normal adults. The reason for this is unknown but a suggested mechanism is that growth hormone stimulates the production of calcitriol or PTH. If this is true, then treatment of acromegaly resulting in lower growth hormone levels should also result in lower blood and urine calcium levels. The investigators want to see if patients with acromegaly have high calcitriol, and vitamin D binding protein, or PTH levels and see if they change after treatment of the condition. The investigators also want to assess the amount of calcium in the urine, before and after treatment.
Patients with acromegaly may have disorders of bone health. The reason for this is unknown but a suggested mechanism is that growth hormone affects bone remodeling. The investigators want to see if patients with acromegaly have abnormal bone markers, specifically PINP, CTX, and TRAP, and to see if they change after treatment of the condition.
In order to see if the results are specific to patients with acromegaly, the investigators also want to check these levels in patients who do not have acromegaly, but have a "nonfunctioning" pituitary tumor. A nonfunctioning pituitary tumor is one that does not secrete excessive hormones in the bloodstream.
The specific aims of this study are:
1. To describe baseline calcitriol/PTH status in patients with uncontrolled acromegaly.
2. To assess the change in calcitriol/PTH levels after treatment with acromegaly (surgical or medical).
3. To evaluate the calcium and calcitriol/PTH levels in patients with acromegaly compared to patients with nonfunctioning pituitary adenomas.
This is a voluntary study. Adult patients with a diagnosis of acromegaly or a clinically nonfunctioning pituitary tumor receiving treatment at the Emory University Pituitary center will be given the opportunity to enroll in the study. Those that agree to participate will need to give written informed consent. Approximately 3 tablespoons (44ml) of blood will be drawn at enrollment for testing of vitamin D status and parathyroid hormone. If patients are already undergoing a blood draw for standard laboratory tests, then the volume of 44ml of blood will be obtained at the same time in order to avoid an additional needle stick. In addition, a 24-hour urine collection will be obtained to assess the amount of calcium present in the urine. Please note that medical or surgical therapy for your pituitary condition is determined by your endocrinologist and/or neurosurgeon and not part of the research study.
Within 6 months after treatment for pituitary treatment is initiated, when patients return to Emory University pituitary clinic for routine visit, laboratory data (vitamin D and parathyroid hormone) and repeat urine studies (24 hour urine collection) will be collected.
The confidentiality will be respected in all encounters. No personal identifiers are disclosed in any publications. Hard copy data will be kept securely in a locked office building with limited access and electronic data will always be password protected with access available to study personnel only. If abnormal results are discovered as part of testing done for this study, those results will be released to the patient's primary physician. All patients will be undergoing standard therapy for their pituitary disorder.
Results of this study may have important implications for future studies that are designed to evaluate the mechanism of how growth hormone may increase calcitriol levels.
Acromegaly is a condition where a pituitary tumor secretes excessive amounts of growth hormone. Patients with acromegaly have been found to have a higher prevalence of kidney stones, urinary calcium, and serum calcium when compared to normal adults. The reason for this is unknown but a suggested mechanism is that growth hormone stimulates the production of calcitriol or PTH. If this is true, then treatment of acromegaly resulting in lower growth hormone levels should also result in lower blood and urine calcium levels. The investigators want to see if patients with acromegaly have high calcitriol, and vitamin D binding protein, or PTH levels and see if they change after treatment of the condition. The investigators also want to assess the amount of calcium in the urine, before and after treatment.
Patients with acromegaly may have disorders of bone health. The reason for this is unknown but a suggested mechanism is that growth hormone affects bone remodeling. The investigators want to see if patients with acromegaly have abnormal bone markers, specifically PINP, CTX, and TRAP, and to see if they change after treatment of the condition.
In order to see if the results are specific to patients with acromegaly, the investigators also want to check these levels in patients who do not have acromegaly, but have a "nonfunctioning" pituitary tumor. A nonfunctioning pituitary tumor is one that does not secrete excessive hormones in the bloodstream.
The specific aims of this study are:
1. To describe baseline calcitriol/PTH status in patients with uncontrolled acromegaly.
2. To assess the change in calcitriol/PTH levels after treatment with acromegaly (surgical or medical).
3. To evaluate the calcium and calcitriol/PTH levels in patients with acromegaly compared to patients with nonfunctioning pituitary adenomas.
This is a voluntary study. Adult patients with a diagnosis of acromegaly or a clinically nonfunctioning pituitary tumor receiving treatment at the Emory University Pituitary center will be given the opportunity to enroll in the study. Those that agree to participate will need to give written informed consent. Approximately 3 tablespoons (44ml) of blood will be drawn at enrollment for testing of vitamin D status and parathyroid hormone. If patients are already undergoing a blood draw for standard laboratory tests, then the volume of 44ml of blood will be obtained at the same time in order to avoid an additional needle stick. In addition, a 24-hour urine collection will be obtained to assess the amount of calcium present in the urine. Please note that medical or surgical therapy for your pituitary condition is determined by your endocrinologist and/or neurosurgeon and not part of the research study.
Within 6 months after treatment for pituitary treatment is initiated, when patients return to Emory University pituitary clinic for routine visit, laboratory data (vitamin D and parathyroid hormone) and repeat urine studies (24 hour urine collection) will be collected.
The confidentiality will be respected in all encounters. No personal identifiers are disclosed in any publications. Hard copy data will be kept securely in a locked office building with limited access and electronic data will always be password protected with access available to study personnel only. If abnormal results are discovered as part of testing done for this study, those results will be released to the patient's primary physician. All patients will be undergoing standard therapy for their pituitary disorder.
Results of this study may have important implications for future studies that are designed to evaluate the mechanism of how growth hormone may increase calcitriol levels.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: