Optimal HCTZ Cessation for Diagnosis of Hyperparathyroidism

Hyperparathyroidism Clinical Trial

Official title:

Optimal Hydrochlorothiazide Cessation in Diagnosis of Hyperparathyroidism

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02591160
• Other study ID #: 1213821
• Status: Completed
• Phase: N/A
• First received: October 27, 2015
• Last updated: January 4, 2018
• Start date: May 2015
• Est. completion date: September 13, 2017

Study information

• Verified date: January 2018
• Source: University of Missouri-Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2
• Est. completion date: September 13, 2017
• Est. primary completion date: September 13, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Elevated calcium on at least two separate draws with coexistent elevated parathyroid hormone (PTH) on at least one occasion.

2. Taking Hydrochlorothiazide for hypertension

3. Following a "wash period", patients must have a normal range 25-hydroxy Vitamin D level, thyroid stimulation hormone (TSH) and serum magnesium levels.

4. Controlled blood pressure

5. Willingness to comply with serial sampling

6. English as the primary language

7. Adults 18 years and older

Exclusion Criteria:

1. Unable to cease Hydrochlorothiazide for any reason

2. Congestive heart failure

3. Renal insufficiency (GFR <60)

4. Cardiovascular event in the last 3 months - include myocardial infarction, new onset atrial fibrillation, and new onset bundle branch block

5. Take lithium or other diuretic medication in last 3 months

6. Positive family history of familial hypocalciuric hypercalcemia (FHH)

Related Conditions & MeSH terms

• Hyperparathyroidism

Intervention

Procedure:
• HCTZ cessation
Patients will stop taking their HCTZ for 3 months

Locations

Country	Name	City	State
United States	University of Missouri	Columbia	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
University of Missouri-Columbia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of days for Calcium/Creatinine Clearance to normalize after stopping HCTZ	Determination of the HCTZ cessation window	2-3 years