AcromegalyNCT01568359
Calcium Homeostasis in Acromegaly: Effect of Surgical/Medical Treatment and Comparison With Nonfunctioning Pituitary Tumors
An observational study of Acromegaly and Nonfunctioning Pituitary Tumor, run by Emory University at 2 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acromegaly, Nonfunctioning Pituitary Tumor
- How many people
- 49 participants
- Where
- 2 sitesUnited States
- Study dates
- Dec 2011to Aug 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with uncontrolled acromegaly and nonfunctioning pituitary adenomas presenting to the Emory University Pituitary Center for medical or surgical treatment.
Who may be able to join
- 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.
Who cannot join
- Age < 18 years old
- Prior other diseases: Patients chronic renal disease stage 3 or worse (estimated GFR > 60).
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Emory Clinic
Atlanta, Georgia, 30322
Emory University Hospital
Atlanta, Georgia, 30322
About this study
Official title: Calcium Homeostasis in Acromegaly: Effect of Surgical/Medical Treatment and Comparison With Nonfunctioning Pituitary Tumors.
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.
Read the 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:
- To describe baseline calcitriol/PTH status in patients with uncontrolled acromegaly.
- To assess the change in calcitriol/PTH levels after treatment with acromegaly (surgical or medical).
- 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.
- Conditions
- Acromegaly, Nonfunctioning Pituitary Tumor
- Medical subject headings
- Acromegaly
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 - Acromegaly, Group 2 - control | Group 1 - Acromegaly patients, Group 2 - Nonfunctioning pituitary adenoma patients (control) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 3-6 months after trreatment of pituitary condition
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2012 (estimated)
- Study startDec 2011
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for AcromegalyStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adriana Ioachimescu, MD, PhD, Emory University
- Investigators
- Adriana Ioachimescu, MD, PhD, Principal investigator, Asst Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01568359
- Sponsor's protocol ID
- IRB00046786
- Status last verified
- Dec 2014
- First submitted
- 29 Mar 2012
- Last updated
- 5 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
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. doi: 10.1677/joe.0.1010333.
PubMed 6610018Ajibade 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.
PubMed 20463051Charoenphandhu 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.
PubMed 20304671Lancer 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.
PubMed 1261522Cook 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.
PubMed 15382339Ezzat 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.
PubMed 8501150Nadarajah 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.
PubMed 5702295Sigurdsson 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. doi: 10.1111/j.1365-2265.1973.tb00418.x. No abstract available.
PubMed 4760543Takamoto 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. doi: 10.1210/jcem-61-1-7.
PubMed 3839000Halse J, Haugen HN. Calcium and phosphate metabolism in acromegaly. Acta Endocrinol (Copenh). 1980 Aug;94(4):459-67. doi: 10.1530/acta.0.0940459.
PubMed 6254298Hennessey 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.
PubMed 7625986Brown 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. doi: 10.1136/bmj.280.6210.277.
PubMed 7357340White 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.
PubMed 16352693Lund B, Eskildsen PC, Lund B, Norman AW, Sorensen OH. Calcium and vitamin D metabolism in acromegaly. Acta Endocrinol (Copenh). 1981 Apr;96(4):444-50. doi: 10.1530/acta.0.0960444.
PubMed 7211102Parkinson 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. doi: 10.1210/jc.2003-030772.
PubMed 14671148
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Calcium Homeostasis in Acromegaly: Effect of Surgical/Medical Treatment and Comparison With Nonfunctioning Pituitary Tumors.
- ClinicalTrials.gov ID
- NCT01568359
- Acronym / sponsor ID
- IRB00046786
- Conditions
- Acromegaly, Nonfunctioning Pituitary Tumor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 2 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To describe baseline calcitriol/PTH status in patients with uncontrolled acromegaly.
- To assess the change in calcitriol/PTH levels after treatment with acromegaly (surgical or medical).
- 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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 - Acromegaly, Group 2 - control | – | –Group 1 - Acromegaly patients, Group 2 - Nonfunctioning pituitary adenoma patients (control) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with uncontrolled acromegaly and nonfunctioning pituitary adenomas presenting to the Emory University Pituitary Center for medical or surgical treatment.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- Age < 18 years old
- Prior other diseases: Patients chronic renal disease stage 3 or worse (estimated GFR > 60).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2014.
- Background: PubMed 6610018Wongsurawat 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.
- Background: PubMed 20463051Ajibade 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.
- Background: PubMed 20304671Charoenphandhu 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.
- Background: PubMed 1261522Lancer 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.
- Background: PubMed 15382339Cook 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.
- Background: PubMed 8501150Ezzat 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.
- Background: PubMed 5702295Nadarajah 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.
- Background: PubMed 4760543Sigurdsson 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. doi: 10.1111/j.1365-2265.1973.tb00418.x. No abstract available.
- Background: PubMed 3839000Takamoto 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. doi: 10.1210/jcem-61-1-7.
- Background: PubMed 6254298Halse J, Haugen HN. Calcium and phosphate metabolism in acromegaly. Acta Endocrinol (Copenh). 1980 Aug;94(4):459-67. doi: 10.1530/acta.0.0940459.
- Background: PubMed 7625986Hennessey 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.
- Background: PubMed 7357340Brown 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. doi: 10.1136/bmj.280.6210.277.
Related trials for Acromegaly
RecruitingPhase 1
A Phase 1 Clinical Trial of NTQ6179 Tablets in Healthy Volunteers
Acromegaly
RecruitingObservational study
An Observational Study of Octreotide Subcutaneous Depot in Patients With Acromegaly
Acromegaly
RecruitingPhase 3
A Study to Assess the Efficacy and Safety of Debio 4126 in Participants With Acromegaly Previously Treated With Somatostatin Analogs
Acromegaly
RecruitingObservational study
An Investigation of Pituitary Tumors and Related Hypothalmic Disorders
Panhypopituitarism, Gigantism/Acromegaly
Recruiting
Managing Pasireotide-associated Hyperglycaemia in Acromegaly With Ketogenic Diet
Acromegaly Due to Pituitary Adenoma, Hyperglycemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adriana Ioachimescu, MD, PhD principal investigator
Asst Professor
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acromegaly and Nonfunctioning Pituitary Tumor, run by Emory University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Calcitriol/PTH (time frame: Baseline and 3-6 months after trreatment of pituitary condition). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01568359, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2014.