The Effect of Thiazide Diuretics on Bone Metabolism, Progression of Osteoporosis and Development of Hyponatremia

Phase 1

• Conditions: The effect of bendroflumethiazide with potassium supplement when used as an adjuvant to oral bisphosphonates in the treatment of newly diagnosed osteoporosis among post-menopausal women above 50 years of age.; MedDRA version: 20.0 Level: PT Classification code 10031282 Term: Osteoporosis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Therapeutic area: Body processes [G] - Bones and nerves physological processes [G11]

• Registration Number: EUCTR2015-001059-63-DK
• Lead Sponsor: Aalborg University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-03-11
• Last Update Posted: 30 April 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 175

Inclusion Criteria

Females above the age of 50 and below the age of 85 years of age.
Caucasian ethnicity.
Menopause for at least two years.
Referred to a DXA-scan at the Osteoporosis Clinic at the Department of
Endocrinology, Aalborg University Hospital.
T-score = -2,5 in total lumbar spine, hip region or femoral neck
Prescribed oral alendronic acid of a dose of 70 mg weekly with
supplement of Calcum and colecalciferol
Appropriate birth control for fertile women as outlined in protocol.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 87
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 87

Exclusion Criteria

Prior traumatic fracture of spine or hip assessed by X-ray or >20%
compression fracture assessed by VFA.
BMI < 17 og > 30.
Prior or current anabolic or antiresorptive osteoporosis treatment other
than bisphosphonates after diagnosis.
Prior or current use of anticonvulsives, lithium, prednisolon.
Prior or current use of thiazides as monotherapy or combination therapy for the previous 5 years
Secondary osteoporosis assessed by investigator.
Primary bone disease assessed by investigator
Renal failure, eGFR < 50 mmol/L/1,73m2.
Inability to participate, complete trial or comprehend information as
assessed by investigator.
Moderate hyponatremia, [Na+] < 130 mmol/L
Hypercalcemia, [Ca2+]-albumin adjusted > 2,7 mmol/L

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified