E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Osteoporosis |
Knogleskørhed |
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E.1.1.1 | Medical condition in easily understood language |
Osteoporosis |
Knogleskørhed |
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E.1.1.2 | Therapeutic area | Diseases [C] - Hormonal diseases [C19] |
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 | 10031285 |
E.1.2 | Term | Osteoporosis postmenopausal |
E.1.2 | System Organ Class | 10028395 - Musculoskeletal and connective tissue disorders |
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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 |
Changes in gene expression in mesenchymal stem cells |
Ændringer i genekspressionen i mesenchymalcellerne |
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E.2.2 | Secondary objectives of the trial |
Changes in blood pressure and arterial stiffness Changes in quality of sleep Changes in biochemical markers Changes in BMD and bodycomposition |
Ændringer i døgnblodtryk samt PVW Ændringer i søvnkvalitet Ændringer i knogleomsætning, calciumhomeostase, glukose/lipidmetabolisme (biokemi) Ændringer i BMD i ryg og hofte (DXA) Ændringer i kropssammensætning (DXA)
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Postmenopausal women aged 55-75 years. Written consent to participate |
• Kvinder mellem 55-75år • Postmenopausal (ikke haft menstruation i et år) • Skriftligt samtykke samt fuldmagt efter mundtlig og skriftlig information.
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E.4 | Principal exclusion criteria |
• Allergy towards study medicine • Allergy towards local anesthesia • Severely impaired renal function (eGFR <59 ml/l). • Treatment with antiresorptives within 5 years • Treatment with postmenopausal hormons within the last 2 years • Systemic treatment with glucocorticoids (duration >30 days) within the last year • Severely impaired hepatic function (Plasma alanine aminotransferase (ALAT) and/or alkaline phosphatase more the dobbed compared to upper limit of reference value. • Hypercalcemia (p-ion calcium > 1.32 nmol/l) • Previous or present malignancies (except a treated skin cancer that is not melanoma or treated carcinoma in situ, 2 years since last therapy). • Diseases affecting the calcium homeostasis including thyroid diseases. • Coagulationsfactor PP <0,6 • Regular use of medicine affecting the calciumhomeostasis; including diuretics, fenemal, lithium, antiepileptica. • SSRI-product with fluvoxamin • Treatment with hypnoticas • Treatment with beta-blocks • Ongoing treatment with melatonin • Continuously treatment with rifampicin • Severe malabsorption syndrome including gastric or intestinal resection. • Alcohol or drug abuse. • Smokers • Major medical or social problems that will be likely to preclude participation for 3 months.
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• Allergi over for indholdsstoffer i studiemedicinen. • Indtagelse af antiresorptiv eller knogleopbyggende farmaka indenfor de sidste 5 år • Systemisk behandling med postmenopausal hormonsubstitution inden for de sidste 2 år • Systemisk prednisolonbehandling (>30 dage) inden for det sidste 1 år
• Diagnostiseret og behandlet for aktiv malign lidelse inden for de sidste 2 år. Fraset er ukompliceret planocellulært karcinom. • eGFR <59 • Hypercalcæmi (P-ion calcium > 1,32 mmol/l). • Malabsorption, herunder ventrikel/tarmresektion. • Nedsat leverfunktion (basisk fosfatase og ALAT mere end fordoblet i forhold til den øvre værdi i reference intervallet). • INR>1,5 • Svære medicinske eller sociale problemer, som gør det usandsynligt at deltageren kan gennemføre undersøgelsen. • Sygdom (ubehandlet) som vides at kunne påvirke calciumhomeostasen, herunder ubehandlet thyreoideasygdom. • Fast indtag af medicin med kendte virkninger på calciumhomeostasen, herunder diuretika, fenemal, lithium, antiepileptika. • SSRI-produkter indeholdende fluvoxamin. • I behandling med hypnotika • I behandling med beta-blokker • I behandling carbamazepin • Langvarig behandling med rifampicin • Igangværende forbrug af melatonin • Rygere • Misbrug af alkohol (>14 genstande/uge for kvinder) • Indtagelse af euforiserende stoffer. • Manglende evne til at læse/forstå patientinformation.
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E.5 End points |
E.5.1 | Primary end point(s) |
Changes in gene expression in mesenchymal stem cells |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
Changes in blood pressure and arterial stiffness Changes in quality of sleep Changes in biochemical markers Changes in BMD and bodycomposition |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | Yes |
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 | No |
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
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The inclusion ends when 40 study subjects are included. The trial ends at the last visit of the last subject undergoing the trial |
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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 | 0 |
E.8.9.1 | In the Member State concerned days | 0 |