Optimal HCTZ Cessation for Diagnosis of Hyperparathyroidism
Primary Purpose
Hyperparathyroidism
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
HCTZ cessation
Sponsored by
About this trial
This is an interventional diagnostic trial for Hyperparathyroidism
Eligibility Criteria
Inclusion Criteria:
- Elevated calcium on at least two separate draws with coexistent elevated parathyroid hormone (PTH) on at least one occasion.
- Taking Hydrochlorothiazide for hypertension
- Following a "wash period", patients must have a normal range 25-hydroxy Vitamin D level, thyroid stimulation hormone (TSH) and serum magnesium levels.
- Controlled blood pressure
- Willingness to comply with serial sampling
- English as the primary language
- Adults 18 years and older
Exclusion Criteria:
- Unable to cease Hydrochlorothiazide for any reason
- Congestive heart failure
- Renal insufficiency (GFR <60)
- Cardiovascular event in the last 3 months - include myocardial infarction, new onset atrial fibrillation, and new onset bundle branch block
- Take lithium or other diuretic medication in last 3 months
- Positive family history of familial hypocalciuric hypercalcemia (FHH)
Sites / Locations
- University of Missouri
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
HCTZ cessation
Arm Description
Patients will stop taking HCTZ for 3 months while submitting serial blood and 24 hour urine samples
Outcomes
Primary Outcome Measures
Number of days for Calcium/Creatinine Clearance to normalize after stopping HCTZ
Determination of the HCTZ cessation window
Secondary Outcome Measures
Full Information
NCT ID
NCT02591160
First Posted
October 27, 2015
Last Updated
January 4, 2018
Sponsor
University of Missouri-Columbia
1. Study Identification
Unique Protocol Identification Number
NCT02591160
Brief Title
Optimal HCTZ Cessation for Diagnosis of Hyperparathyroidism
Official Title
Optimal Hydrochlorothiazide Cessation in Diagnosis of Hyperparathyroidism
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
May 2015 (Actual)
Primary Completion Date
September 13, 2017 (Actual)
Study Completion Date
September 13, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Missouri-Columbia
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Primary hyperparathyroidism (PHPT) is the most common cause of hypercalcemia in the ambulatory setting. PHPT may be cured with surgery and indications for intervention have been defined and include urinary calcium/creatinine clearance. Hydrochlorothiazide (HCTZ), the most commonly prescribed medication for hypertension, reduces urinary calcium excretion and confounds urinary testing. As a result, it is universally recommended that thiazide diuretics be stopped in advance of urinary testing. To date, no studies are available to provide evidence-based guidance as to how long HCTZ must be held for urinary calcium excretion to return to steady state in PHPT. The objective of this study is to serially calculate urinary calcium/creatinine clearance ration in patients with suspected PHPT while holding HCTZ to determine the minimum duration of medication cessation necessary for urinary calcium clearance to reach steady state.
Detailed Description
In this study, adult patients will submit serum and 24 hour urine samples prior to HCTZ cessation and at the following intervals after cessation: 4-6 days, 14-16 days, 28-30 days, adn 90-92 days. To minimize confounding variable, patients will take supplemental Vitamin D and Calcium, monitor their daily calcium intake, and monitor blood pressure weekly. Alternative, non-diuretic, antihypertensive medication(s) may be prescribed at the discretion of the enrolling provider.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperparathyroidism
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
HCTZ cessation
Arm Type
Other
Arm Description
Patients will stop taking HCTZ for 3 months while submitting serial blood and 24 hour urine samples
Intervention Type
Procedure
Intervention Name(s)
HCTZ cessation
Intervention Description
Patients will stop taking their HCTZ for 3 months
Primary Outcome Measure Information:
Title
Number of days for Calcium/Creatinine Clearance to normalize after stopping HCTZ
Description
Determination of the HCTZ cessation window
Time Frame
2-3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Elevated calcium on at least two separate draws with coexistent elevated parathyroid hormone (PTH) on at least one occasion.
Taking Hydrochlorothiazide for hypertension
Following a "wash period", patients must have a normal range 25-hydroxy Vitamin D level, thyroid stimulation hormone (TSH) and serum magnesium levels.
Controlled blood pressure
Willingness to comply with serial sampling
English as the primary language
Adults 18 years and older
Exclusion Criteria:
Unable to cease Hydrochlorothiazide for any reason
Congestive heart failure
Renal insufficiency (GFR <60)
Cardiovascular event in the last 3 months - include myocardial infarction, new onset atrial fibrillation, and new onset bundle branch block
Take lithium or other diuretic medication in last 3 months
Positive family history of familial hypocalciuric hypercalcemia (FHH)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert P Zitsch, MD
Organizational Affiliation
University of Missouri-Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Missouri
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65212
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Individual participant data will not be shared.
Learn more about this trial
Optimal HCTZ Cessation for Diagnosis of Hyperparathyroidism
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