E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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. |
|
E.1.1.1 | Medical condition in easily understood language |
Osteoporosis, the lowering of bone mineral density compared to age averages, with increased risk of fractures. |
|
E.1.1.2 | Therapeutic area | Body processes [G] - Bones and nerves physological processes [G11] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10031282 |
E.1.2 | Term | Osteoporosis |
E.1.2 | System Organ Class | 10028395 - Musculoskeletal and connective tissue disorders |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To examine if bendroflumethiazide with potassium supplements augment the effect of oral bisphosphonates on preventing progression of osteoporosis. |
|
E.2.2 | Secondary objectives of the trial |
To examine who develops hyponatremia and hypercalcemia as sideeffects of treatment on bendroflumethiazide with potassium. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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. |
|
E.4 | Principal 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 |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Change in BMD and BMD at the cortical and trabecular bone using QCTscans of lumbar spine and hip. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | 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). |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
48 weeks weeks of treatment or development of majer adverse effects. |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |