Optimal HCTZ Cessation for Diagnosis of Hyperparathyroidism

NCT02591160 | Completed

• 1 other identifier: 1213821
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Hyperparathyroidism

Outcome Measures

Primary Outcomes (1)

• Number of days for Calcium/Creatinine Clearance to normalize after stopping HCTZ

  Determination of the HCTZ cessation window

  2-3 years

Study Arms (1)

HCTZ cessation

OTHER

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

Procedure: HCTZ cessation

Interventions

HCTZ cessation PROCEDURE

Patients will stop taking their HCTZ for 3 months

HCTZ cessation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Missouri-Columbia: lead

Study Sites (1)

University of Missouri

Columbia, Missouri, 65212, United States

Location

MeSH Terms

Conditions

Hyperparathyroidism

Condition Hierarchy (Ancestors)

Parathyroid Diseases; Endocrine System Diseases

Study Officials

• Robert P Zitsch, MD

  University of Missouri-Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: William E Davis Professor and Chair

Study Record Dates

• First Submitted: October 27, 2015
• First Posted: October 29, 2015
• Study Start: May 1, 2015
• Primary Completion: September 13, 2017
• Study Completion: September 13, 2017
• Last Updated: January 8, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)