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Bone density measurement methods during androgen deprivation


- candidate number15035
- NTR NumberNTR4053
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR24-jun-2013
- Secondary IDs 
- Public TitleBone density measurement methods during androgen deprivation
- Scientific TitleBONE MINERAL DENSITY IN PROSTATE CANCER PATIENTS TREATED WITH ANDROGEN DEPRIVATION THERAPY
- ACRONYMBMD tijdens ADT
- hypothesisBone mineral density decline can comparably be estimated by achilles as with DXA.
- Healt Condition(s) or Problem(s) studiedProstate cancer, Bone density, Androgen deprivation
- Inclusion criteriaAge >18 years
1. Indication for ADT as treatment for nonmetastatic prostate cancer according to the Bolla schedule;
2. Planned ADT or recently started ADT (max 4 weeks before baseline DEXA measurement);
3. Signed informed consent.
- Exclusion criteriaPre-existing indication for osteoporosis treatment, i.e. before the baseline DEXA scan.
1. Current or prior treatment with bisphosphonates and/or RANK ligand inhibitors.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-jun-2013
- planned closingdate1-dec-2014
- Target number of participants51
- InterventionsBy measuring BMD by two different methods, the change in BMD estimated bye ach method will be compared
- Primary outcomeAgreement between the change in Achilles T-scores and the change in DEXA scan T-scores.
- Secondary outcomeAssociation of repeated delta T-scores over time of the DEXA and Achilles scans
Association between (absolute) Achilles T-scores and (absolute) DEXA T-scores at each available time point.
- TimepointsDXA each year and Achilles ultrasound each 3 months.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES A.P. Hamberg
- CONTACT for SCIENTIFIC QUERIES A.P. Hamberg
- Sponsor/Initiator Sint Franciscus Gasthuis (SFG)
- Funding
(Source(s) of Monetary or Material Support)
Sint Franciscus Gasthuis (SFG), Rotterdam
- PublicationsN/A
- Brief summaryTo observe whether the decline in BMD that usually is observed with DXA can be comapravly estimated with the achilles.
- Main changes (audit trail)
- RECORD24-jun-2013 - 10-jul-2013


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