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

A randomized controlled trial of alendronate as preventive treatment against the development of gluco-corticoid-induced osteoporosis in patients being treated for malignant lymphoma - Siesta

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-005688-18-DK

Enrollment

Registered

2016-04-05

Start date

2016-05-25

Completion date

Unknown

Last updated

2021-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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: 19.0 Level: LLT Classification code 10025315 Term: Lymphoma malignant System Organ Class: 100000004864

Interventions

Product Name: alendronat Pharmaceutical Form: Tablet INN or Proposed INN: alendron acid Other descriptive name: ALENDRONIC ACID Concentration unit: mg milligram(s) Concentration type: equal Concentrat

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Main Objective: 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 ;Secondary Objective: As a secondary objective examined whether alendronate have anti-lymphoma effect ;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 ;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.	—

Measure

Time frame

Main Objective: 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 ;Secondary Objective: As a secondary objective examined whether alendronate have anti-lymphoma effect ;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 ;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.

—

Secondary

Measure	Time frame
Secondary end point(s): not applicable;Timepoint(s) of evaluation of this end point: not applicable	—

Countries

Denmark

Contacts

Public ContactPaw Jensen

Department of Hematology

paje@rn.dk004597663860

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026