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Optimal HCTZ Cessation for Diagnosis of Hyperparathyroidism

Sponsor
University of Missouri-Columbia (Other)
Overall Status
Completed
CT.gov ID
NCT02591160
Collaborator
(none)
2
Enrollment
1
Location
1
Arm
28.5
Actual Duration (Months)
0.1
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: HCTZ cessation
 N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
2 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Optimal Hydrochlorothiazide Cessation in Diagnosis of Hyperparathyroidism
Actual Study Start Date :
May 1, 2015
Actual Primary Completion Date :
Sep 13, 2017
Actual Study Completion Date :
Sep 13, 2017

Arms and Interventions

Arm Intervention/Treatment
Other: HCTZ cessation

Patients will stop taking HCTZ for 3 months while submitting serial blood and 24 hour urine samples

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

Outcome Measures

Primary Outcome Measures

  1. Number of days for Calcium/Creatinine Clearance to normalize after stopping HCTZ [2-3 years]

    Determination of the HCTZ cessation window

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Missouri Columbia Missouri United States 65212

Sponsors and Collaborators

  • University of Missouri-Columbia

Investigators

  • Principal Investigator: Robert P Zitsch, MD, University of Missouri-Columbia

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Robert P. Zitsch III, William E Davis Professor and Chair, University of Missouri-Columbia
ClinicalTrials.gov Identifier:
NCT02591160
Other Study ID Numbers:
  • 1213821
First Posted:
Oct 29, 2015
Last Update Posted:
Jan 8, 2018
Last Verified:
Jan 1, 2018
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Additional relevant MeSH terms:
Hyperparathyroidism

Study Results

No Results Posted as of Jan 8, 2018