MDACC Study Summary 2007-0425

Study Summary
No. 2007-0425:.......Endocrine......Nancy D. Perrier......Surgical Oncology

Study Summary Title



Study Summary Number:	2007-0425

Study Title:	Pilot Study to Detect and Assess the effect of Vitamin D replacement on gland size by 4DCT in Patients with PHPT

Physician

New Patient Referral



Name:	Nancy D. Perrier	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Surgical Oncology	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-792-6940 Contact us about clinical trials

General Information



Disease Group:	Endocrine	Supported By:	AEP Fund for Hyperparathyroidism Research

Phase of Study:	Phase I	Return Visit:	Including standard-of-care visits, participants must come to MDACC a minimum of five times. If at a visit the participant is found to be subtherapeutic on vitamin D, they may need to return for maximum of two more times until they are therapeutic.

Treatment Agents:	Vitamin D	Home Care:	N/A

Treatment Loc:	Only at MDACC

Estimated Length of Stay in Houston:	There is no hospitalization involved in this study.


Description/ Intervention:	The goal of this clinical research study is to learn how the standard practice of giving Vitamin D supplements to patients with a Vitamin D deficiency may affect the size of the parathyroid glands in patients with PHPT and a Vitamin D deficiency.

Study Objectives / Outcomes

Primary hyperparathyroidism (PHPT) is an endocrine disorder that disrupts calcium metabolism. Often coexistent in patients with PHPT is 25-hydroxyvitamin D (25-OHD) deficiency, which can further impact calcium levels. The interaction between these two conditions has not been well-characterized, but use of the new modality of four-dimensional computed tomography (4DCT) may provide some insights.

The primary objective of this pilot study is to obtain preliminary data on the use of 4DCT in patients with concomitant PHPT and 25-OHD deficiency to evaluate the size of parathyroid glands before and after replacement with ergocalciferol (vitamin D2).

Study Status Information



Study Activation / Registration Date:

IRB Review and Approval Date:	10/01/2007

Study Type:	Phase I

Recruitment Status:	Closed

Projected Accrual:	N/A

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:

1) Be diagnosed with PHPT (inappropriate PTH level in the setting of a high or high-normal corrected serum calcium level equal to or greater than 10.0 mg/dL)

2) Be considered an appropriate surgical candidate

3) Be older than 21 years of age

4) Have a vitamin D (25-OHD) level less than or equal to 20ng/ml

5) Female participants of childbearing potential must have a negative pregnancy test (urinary or serum beta-HCG) within two weeks before signing consent

Exclusion Criteria:

1) Have any other functional tumors if they have familial multiple endocrine neoplasia syndrome 1 or 2 (MEN 1 or MEN 2)

2) Have a corrected calcium level greater than 13mg/dL

3) Have a recent history of kidney stones

4) Have a recent history of pancreatitis

5) Have a recent history of cardiac arrhythmia (eg atrial fibrillation)

6) Unable to keep still for 2 minutes without coughing

7) Having a body habitus that prevents adequate images to be obtained through the region of the parathyroids (ie typically weighing in excess of 250Lbs)

8) Have a serum creatinine greater than 2.0 mg/dl

9) Have hypersensitivity to ergocalciferol or any component of the formulation

Links

Registration Number: NCT00538720
Study Information on Clinical Trials Registry (clinicaltrials.gov)