E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Diabetes Mellitus and Osteopenia/Osteoporosis |
Diabetes Mellitus and Osteopeni/Osteoporose |
|
E.1.1.1 | Medical condition in easily understood language |
Diabetes and bone fragility |
Sukkersyge og knogleskørhed |
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E.1.1.2 | Therapeutic area | Diseases [C] - Nutritional and Metabolic Diseases [C18] |
MedDRA Classification |
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 investigate the effect of Alendronate on bone markers and glycemic markers. |
At undersøge effekten af Alendronat på knoglemarkører og glykæmiske markører. |
|
E.2.2 | Secondary objectives of the trial |
To compare type 1 and type 2 diabetes. And to compare different methods of assesing bone in diabetics. |
At sammenligne type 1 og type 2 diabetikere. Samt at sammenligne forskellige metoder til at vurdere knoglevæv blandt diabetikere. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Type 1 diabetes / type 2 diabetes • Age ≥ 50 år. • Same medical diabetes treatment the last six months (dose changes is allowed)and HbA1c changes on ± 1 in the same period. • HbA1c level≥ 6,7% in the last six months. • Body mass index (BMI) between 19 og 35. • DXA T-score: -3,5 til -0,5. |
• Type 1 diabetes / type 2 diabetes • Alder ≥ 50 år. • Uændret medikamentel behandling af diabetes gennem de seneste seks måneder (ingen præparat skift, mindre dosis ændringer tilladt), samt HbA1c udsving på ± 1 i samme periode. • HbA1c niveau ≥ 6,7% (50 mmol/L) gennem de seneste seks måneder. • Body mass index (BMI) mellem 19 og 35. • DXA T-score: -3,5 til -0,5. |
|
E.4 | Principal exclusion criteria |
• HbA1C > 10% • Pregnancy. • Metal implanted at ancle and wrist at all four ekstremities. • Treatment by: Antiresorptives (inkl. HRT) or bone anabolic drugs, glucocorticoids, lithium og anticonvulsives. • Patients with bone disease different from Osteoporosis. • Vertebral fraktur synlig ved VFA. • Patients with kidney disease defined by eGFR < 50. • Other significant medical disease in unstable phase (like cancer or hyperthyroidism) • Heart failure in NYHA class IV. • Previous allergic reactions to the trial drug. • Previous allergic reactions to tetracyklin. • Abnormities in esophagus and other factors, which may delay the transit tim in the esophagus. • Unable to stand or sit for 30 consecutive minutes. • The investigator considers the patient unfit to participate. • Patient with no understanding of the extent of the trial. |
• HbA1C > 10% • Graviditet. • Metal indopereret på ankel og håndledsniveau på alle fire ekstremiteter. • Patienter i behandling med: Antiresorptive (inkl. HRT) eller knogleanabole lægemidler, glukokortikoid, litium og anticonvulsiva. • Patienter kendt med anden knoglesygdom end osteoporose. • Vertebral fraktur synlig ved VFA. • Patient med nyresygdom inklusiv diabetisk nefropati, der defineres ved eGFR < 50. Patienter med mikroalbuminuri ekskluderes ikke. • Anden betydende medicinsk sygdom i ustabil fase (f.eks. cancer, stofskiftesygdom). • Hjerteinsufficiens i NYHA klasse IV. • Allergi overfor et af indholdsstofferne i forsøgsmedicinen. • Allergi over for tetracyklin. • Abnormiteter i oesophagus og andre faktorer, som forsinker spiserørstømning, såsom striktur eller akalasi. • Manglende evne til at stå eller sidde oprejst i mindst 30 minutter. • Patient skønnes af investigator uegnet til at deltage i studiet. • Patient uden forståelse af patientinformationen og omfanget af undersøgelser. |
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E.5 End points |
E.5.1 | Primary end point(s) |
HbA1c and BMD |
HbA1c og BMD |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
HbA1c is evaluated after one and three months and one and two years (the analyses may be done at the end of the study after two years). BMD is measured after one and two years. |
HbA1c bliver målt efter en og tre måneder samt et og to år (analyserne kan blive udført ved afslutningen af studiet efter to år). BMD bliver målt efter et og to år. |
|
E.5.2 | Secondary end point(s) |
Insulin, plasmaglucose, HOMA-IR, hs-CRP, AGE markers, lipids, adiponectin, PTH, 25 og 1,25 vitamin D, bone specific alkaline phosphatase, FSH, LH, testestoron/østradiol, creatinine, GFR, FGF23, sclerostin, osteocalcin, ucOC, P1NP, PICP, CTX, osteoprotegrin, RANKL og pentosidine. Urine albumin/creatinine ratio and urine bone markers. HRpQCT scan results. Analysis results by fat tissue-, muscle tissue- and bone biopsies. Life style questionnaire including diet and physical activity. |
HbA1C, faste-insulin, faste-plasmaglukose, HOMA-IR, hs-CRP, AGE XML File Identifier: oRn9kfjng2GnCPFTqgunVNDlPxc= Page 11/20 markører, lipider, adiponectin, PTH, 25 og 1,25 vitamin D, knoglespecific basisk fosfatase, FSH, LH, testestoron/østradiol, kreatinin, GFR, FGF23, sclerostin, osteocalcin, ucOC, P1NP, PICP, CTX, osteoprotegrin, RANKL og pentosidin. Urin albumin/creatinin ratio og knoglemarkører i urinen. HRpQCT skanningsresultater. Analyse resultater af fedtvævs-, muskelvævs- og knoglevævs biopsier. Livsstils spørgeskema indeholdende blandt andet diæt og fysisk aktivitet. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
The secondary endpoints will be evaluated by the end of the trial. However scanning results and muscle and fat biopsy results may be evaluated after one year. Like some biochemical may be evaluated after one and three months and one year like the primary endpoint HbA1c. The questionnaire will be filled out and evaluated at baseline, 1 month, 3 months, 1 year and 2 years. |
De sekundære endepunkter vil blive evalueret ved afslutningen af studiet. Dog kan scanning og muskelvævs- og fedtvævs biopsi resultaterne blive evalueret efter et år. Nogle biokemiske markører kan blive evalueret efter 1 og 3 mdr og 1 år. Spørgeskemaet vil blive udfyldt og evalueret ved baseline, efter 1 og måneder samt 1 og 2 år. |
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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 | No |
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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
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 | 4 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 3 |
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
|
The end of the trial is at the visit of the last participant after two years. |
Afslutningen af studiet er ved sidste deltagers besøg efter to år. |
|
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 | 3 |
E.8.9.1 | In the Member State concerned days | 0 |