E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Age ≥ 18 years. Patients with new diagnosis or recurrence of lymphoma, which is expected to be treated with one of the listed chemotherapy regimens.
Expected lifespan ≥2 years |
Alder ≥ 18 år. Patienter der er nydiagnosticeret- eller har recidiv af malignt lymfom (lymfeknudekræft) uanset undertype og som forventes at skulle behandles med et af de anførte kemoterapiregimer.
Forventet livslængde ≥2 år
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E.1.1.1 | Medical condition in easily understood language |
Age ≥ 18 years. Patients with new diagnosis or recurrence of lymphoma, which is expected to be treated with one of the listed chemotherapy regimens.
Expected lifespan ≥2 years |
Alder ≥ 18 år. Patienter der er nydiagnosticeret- eller har recidiv af lymfeknudekræft, som forventes at skulle behandles med et af de anførte kemoterapiregimer.
Forventet livslængde ≥2 år
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E.1.1.2 | Therapeutic area | Diseases [C] - Blood and lymphatic diseases [C15] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 19.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10025315 |
E.1.2 | Term | Lymphoma malignant |
E.1.2 | System Organ Class | 100000004864 |
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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 |
The study has as main purpose to investigate whether bisphosphonate treatment
alendronate can prevent the development of osteoporosis expressed
as low T-score by DXA and / or the identity of the spine in patients
Glu-cocortikoidholdig chemotherapy treatment for malignant lymphoma
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Undersøgelsen har som primære formål at undersøge om bisfosfonat be-handling med alendronat kan forebygge udvikling af osteoporose udtrykt som lav T-score ved DXA og/eller sammenfald i ryggen hos patienter i glu-cocortikoidholdig kemoterapibehandling for malignt lymfom. |
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E.2.2 | Secondary objectives of the trial |
As a secondary objective examined whether alendronate have anti-lymphoma
effect
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Som et sekundært formål undersøges om alendronat har antilymfom effekt |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Age ≥ 18 years. Patients who are newly diagnosed- or recurrence of
Malignant lymphoma (lymph node cancer), regardless of the type and expected
to be treated with one of the listed chemotherapy regimens.
Expected lifespan ≥2 years
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Alder ≥ 18 år. Patienter der er nydiagnosticeret- eller har recidiv af malignt lymfom (lymfeknudekræft) uanset undertype og som forventes at skulle behandles med et af de anførte kemoterapiregimer.
Forventet livslængde ≥2 år.
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E.4 | Principal exclusion criteria |
Contraindications to alendronate.
Patients treated with antiresorptive (incl. HRT (hormone funds
sub-institution)) (bisphosphonates, anti-drug therapy (denosumab)
strontium, selective estrogen receptor modulators, estrogens
used to treat postmenopauselle genes) or bone anabolic
drugs (eg teriparatide), lithium and anticonvulsants. Glucocortikoid
treatment for up to 4 weeks prior to inclusion allowed.
Severe renal impairment (GFR <35 ml / min.)
Treatment Severe hypercalcemia at diagnosis.
If one is not expected to undergo chemotherapy treatment
(Plus. Rituximab treatment).
Patient without understanding of patient information and the extent of
investigations-look.
Esophagusabnormaliteter which delay esophagustømning, such as
stricture or achalasia.
Inability to stand or sit upright for at least 30 minutes.
Patients planned autologous bone marrow transplant
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Kontraindikationer til alendronat.
Patienter i behandling med antiresorptive (inkl. HRT (midler til hormon sub-stitution)) (bisfosfonater, anti-stofbehandling (denosumab), strontiumranelat, selektive østrogen receptor modulators, østrogener anvendt til behandling af postmenopauselle gener) eller knogleanabole lægemidler (fx teriparatid), litium og anticonvulsiva. Glucocortikoid behandling i op til 4 uger forud for inklusion tilladt.
Sværere nyreinsufficiens (GFR <35 ml/min.)
Behandlingskrævende hypercalcæmi på diagnosetidspunktet.
Hvis man ikke forventes at kunne gennemgå kemoterapibehandlingen (plus evt. rituximab behandling).
Patient uden forståelse af patientinformationen og omfanget af undersøgel-ser.
Esophagusabnormaliteter som forsinker esophagustømning, som for ek-sempel striktur eller akalasi.
Manglende evne til at stå eller sidde oprejst i mindst 30 minutter.
Patienter som planlægges autolog knoglemarvstransplanteret.
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint is the development of T-score from the start of treatment to
follow-up after one year -
for each patient
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Det primære endepunkt er udvikling i T-score fra start på behandling til opfølgning efter et år - altså
for hver patient.
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
The trial is expected to start March 2016. Recruitment for 3 years. Last patient last treatment one year later. Final study report 5 years after study start.
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Forsøget forventet at påbegynde i marts 2016. Det forventes, at rekruttering varer 3 år og at de sidste patienter afslutter behandlingen et år senere, det vil sige 4 år efter påbegyndelse af studiet. Derefter følger analyser og artikelskrivning. Dette forventes at tage ca. 1 år. Samlet forventet varighed af projektet er maximalt 5 år fra påbegyndelse til det er af-sluttet.
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E.5.2 | Secondary end point(s) |
not applicable |
ikke aktuelt |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
not applicable |
ikke aktuelt |
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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 | Yes |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
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 | 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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 5 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |