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Effect of aminobisphosphonates and statins on circulating Vy9Vd2-T cells

Effect of aminobisphosphonates and statins on circulating Vy9Vd2-T cells

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2010-018491-24-NL
Enrollment
Unknown
Registered
2010-03-17
Start date
2010-07-15
Completion date
Unknown
Last updated
2012-03-19

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

Conditions

patients with malignant bone metastases MedDRA version: 12.1 Level: LLT Classification code 10005993 Term: Bone metastases

Interventions

Trade Name: simvastatin Product Name: simvastatin Pharmaceutical Form: Tablet

Sponsors

Vrije Universiteit Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: -patients with an indication for intravenous treatment with an aminobisphosphonate because of bone metastases of a malignant tumor. -WHO 0, 1, 2 performance score 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

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 (creatinin clearance 1.5 times ULN (upper limit of normal); -ASAT or ALAT > 2.5 times ULN (in absence of livermetastases); -ASAT or ALAT > 5 times ULN (in presence of livermetastases) -concomitant use of strong inhibitors of CYP3A4, such as itraconazol, ketoconazol, erytromycin, claritromycin, hiv-protease inhibitors or grapefruit juice is contra-indicated.

Design outcomes

Primary

MeasureTime frame
Main Objective: To study (in patients who have an indication for treatment with an intravenous aminobisphosponate because of bone metastases of a malignant tumor) the effects of aminobisphophonate treatment on the phenotype and function on circulating Vy9Vd2-T cells and to determine whether these effects are inhibited by simultaneous treatment with statins.;Secondary Objective: none;Primary end point(s): 1. Phenotypic (APC markers: CD1d, CD40, CD80, CD83, CD86, HLA-DR; activation/memory markers: CD25, CD27, CD45RA, CD45RO, CCR7)and functional (IFN-?, TNF-a, granzyme B) changes in the circulating pool of Vy9Vd2-T cells. 2. Occurrence of a febrile response.—

Countries

Netherlands

Outcome results

None listed

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