Clinical trial · Interventional
Effect of Aminobiphosphonates and Statins on Circulating Vgamma9Vdelta2-T Cells
NCT01179464CI-TRIAL-00010717completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to investigate the effects of aminobiphosphonate treatment on the phenotype and function of circulating Vgamma9Vdelta2-T cells and to determine whether these effects are inhibited by simultaneous treatment with statins.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bone Metastases of a Malignant Tumor | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Aminobiphosphonate | Drug | — | UNRESOLVED |
| Simvastatin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Aminobiphosphonates
- description
- Aminobiphosphonates
- interventionNames
- Drug: Aminobiphosphonate
- type
- EXPERIMENTAL
- label
- Aminobiphosphonates and Statin
- description
- Aminobiphosphonates and Statin
- interventionNames
- Drug: Aminobiphosphonate
- Drug: Simvastatin
Primary outcomes (3)
- measure
- Phenotypic (APC markers: CD1d, CD40, CD80, CD83, CD86, HLA-DR; activation/memory markers: CD25, CD27, CD45RA, CD45RO, CCR7)changes in the circulating pool of Vy9Vd2-T cells.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * Patients with an indication for intravenous treatment with an aminobiphosphonate because of a malignant tumor * WHO 0,1,2 performance score Exclusion Criteria: * WHO 3, 4 performance score * prior or current use of aminobisphosphonates -immunosuppressive medication (NSAID allowed) * chemotherapy and/or radiotherapy in 4 weeks prior to start of aminobisphosphonate administration * renal insufficiency (creatinine clearance \< 30 ml/min) * liver enzyme abnormalities: * bilirubin \> 1.5 times ULN (upper limit of normal) * ASAT or ALAT \> 2.5 times ULN (in absence of liver metastases) * ASAT or ALAT \> 5 times ULN (in presence of liver metastases) * concomitant use of strong inhibitors of CYP3A4, such as itraconazole, ketoconazole, erytromycin, clarithromycin, hiv-protease inhibitors or grapefruit juice is contra-indicated.
References
Publications (0)
Data not yet available
No reference posted for this study.