En randomiseret kontrolleret undersøgelse af alendronat som forebyggende behandling mod udvikling af glucocorticoid induceret osteoporose hos patienter der behandles for malignt lymfom.

Phase 1

• Conditions: 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; MedDRA version: 19.0Level: LLTClassification code 10025315Term: Lymphoma malignantSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2015-005688-18-DK
• Lead Sponsor: Department of Hematology, Aalborg University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-04-05
• Last Update Posted: 19 April 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 60

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

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 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The study has as main purpose to investigate whether bisphosphonate treatment<br>alendronate can prevent the development of osteoporosis expressed<br>as low T-score by DXA and / or the identity of the spine in patients<br>Glu-cocortikoidholdig chemotherapy treatment for malignant lymphoma<br>;Secondary Objective: As a secondary objective examined whether alendronate have anti-lymphoma<br>effect<br>;Primary end point(s): The primary endpoint is the development of T-score from the start of treatment to<br>follow-up after one year -<br>for each patient<br>;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. <br>

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): not applicable;Timepoint(s) of evaluation of this end point: not applicable