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

BONATHIAD - Bone Association with Thiazide Diuretics. - BONATHIAD

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-001059-63-DK

Enrollment

175

Registered

2015-03-11

Start date

2015-09-23

Completion date

Unknown

Last updated

2019-04-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

Interventions

Trade Name: Centyl(R) Med Kaliumklorid Product Name: Centyl(R) med Kaliumklorid Pharmaceutical Form: Coated tablet INN or Proposed INN: BENDROFLUMETHIAZ

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria: Prior traumatic fracture of spine or hip assessed by X-ray or >20% compression fracture assessed by VFA. BMI 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 2,7 mmol/L

Design outcomes

Primary

Measure	Time frame
Main Objective: To examine if bendroflumethiazide with potassium supplements augment the effect of oral bisphosphonates on preventing progression of osteoporosis. ; Secondary Objective: To examine who develops hyponatremia and hypercalcemia as sideeffects of treatment on bendroflumethiazide with potassium. ; Primary end point(s): Change in BMD and BMD at the cortical and trabecular bone using QCTscans of lumbar spine and hip. ;Timepoint(s) of evaluation of this end point: 48 weeks of treatment.	—

Measure

Time frame

Main Objective: To examine if bendroflumethiazide with potassium supplements augment the effect of oral bisphosphonates on preventing progression of osteoporosis. ; Secondary Objective: To examine who develops hyponatremia and hypercalcemia as sideeffects of treatment on bendroflumethiazide with potassium. ; Primary end point(s): Change in BMD and BMD at the cortical and trabecular bone using QCTscans of lumbar spine and hip. ;Timepoint(s) of evaluation of this end point: 48 weeks of treatment.

—

Secondary

Measure	Time frame
Secondary end point(s): Risk factors (OR) for development of moderate hyponatremia (below 130 mmol/L) and moderate hypercalcemia (above 2,70 mmol/L albumin-adjusted). ;Timepoint(s) of evaluation of this end point: 48 weeks of treatment.	—

Countries

Denmark

Contacts

Public ContactPeter Vestergaard

Aalborg University

pev@dcm.aau.dk4599403791

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026