The Effect of Diuretics on Mineral and Bone Disorder in Chronic Kidney Disease Patients

NCT03082742 | Unknown

• 1 other identifier: Diuretics - CKD-MBD
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

Chronic kidney disease (CKD) patients often have associated systemic hypertension due to volume retention, as one of the mechanisms, therefore the use of diuretics is widespread in this population. One of the major complications of CKD is mineral and bone metabolism disorder (CKD-MBD), which include changes in the levels of calcium, phosphorus, vitamin D deficiency, increased circulating levels of fibroblast growth factor (FGF-23) and parathyroid hormone (PTH). These alterations are responsible for fractures, cardiovascular disease and mortality among patients with CKD. According to diuretic mechanism of action, sometimes increasing serum calcium (in the case of furosemide), sometimes decreasing it (in the case of thiazide), it is expected that the serum calcium may be altered, even within the range of normality, with consequent impact on the levels of PTH. Although most studies have shown that the use of thiazide diuretics decreases the risk of fractures, some showed the opposite. Similarly, although most studies have shown increased risk of fracture in association to loop diuretics use, some have failed in demonstrated this outcome. Only one study, a cohort study in a population of CKD, showed that furosemide was directly related to increased calciuria and PTH levels and the use of thiazide, in turn, showed completely opposite effect. However, certain issues are still not completely solved, for example, the interference of renal function itself on calciuria. It is possible that calciuria is not a so simple explanation that justifies the PTH levels changes, as no correlation was seen between calciuria and PTH levels. Better understanding of the exact relationship between the use of diuretics and the impact on CKD-MBD may be an alternative intervention, easily accessible and relatively inexpensive. The purpose of this study is to evaluate the impact of diuretic, specifically hydrochlorothiazide and furosemide, on bone architecture and mineral metabolism.

Conditions

Secondary Hyperparathyroidism; Chronic Kidney Disease

Keywords

diuretics; furosemide; hydrochlorothiazide; CKD-MBD; HRpQCT; parathyroid hormone

Outcome Measures

Primary Outcomes (1)

• Parathyroid hormone (PTH) level.

  Bone metabolism

  12 months

Study Arms (2)

Furosemide

ACTIVE COMPARATOR

Use of Furosemide, 40mg (1 tablet) per day, over 12 months

Drug: Furosemide

Hydrochlorothiazide

ACTIVE COMPARATOR

Use of Hydrochlorothiazide, 25mg (1 tablet) per day, over 12 months

Drug: Hydrochlorothiazide

Interventions

Hydrochlorothiazide DRUG

Hydrochlorothiazide

Furosemide DRUG

Furosemide

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Estimated Glomerular Filtration Rate (calculated by CKD-EPI) between 30 and 60 ml/min

You may not qualify if:

• Diabetes;
• chronic use of: steroid, bisphosphonates and calcium carbonate

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (1)

Hospital das Clinicas

São Paulo, São Paulo, 05403-000, Brazil

RECRUITING

MeSH Terms

Conditions

Hyperparathyroidism, Secondary; Renal Insufficiency, Chronic; Chronic Kidney Disease-Mineral and Bone Disorder

Interventions

Hydrochlorothiazide; Furosemide

Condition Hierarchy (Ancestors)

Hyperparathyroidism; Parathyroid Diseases; Endocrine System Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Rickets; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Calcium Metabolism Disorders; Vitamin D Deficiency; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders

Intervention Hierarchy (Ancestors)

Chlorothiazide; Benzothiadiazines; Sulfonamides; Sulfones; Sulfur Compounds; Organic Chemicals; Thiazides; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Sulfanilamides; Amides; Aniline Compounds; Amines

Study Officials

• Rosilene M Elias, M.D., Ph.D

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rosilene M Elias, M.D., Ph.D

CONTACT

+5511 26617167; rosilenemotta@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2017
• First Posted: March 17, 2017
• Study Start: August 1, 2015
• Primary Completion: June 1, 2018
• Study Completion: June 1, 2018
• Last Updated: October 26, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)