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Molecular determinants of bone mineral density in children with acute lymphoblastic leukemia and the role of intervention by physical activities and calcium and vitamin D supplement as a preventive strategy.


- candidate number1666
- NTR NumberNTR477
- ISRCTNISRCTN23173889
- Date ISRCTN created27-jan-2006
- date ISRCTN requested18-nov-2005
- Date Registered NTR14-sep-2005
- Secondary IDsMEC nr 193.291/2000/144 and 114.720/1991/62 
- Public TitleMolecular determinants of bone mineral density in children with acute lymphoblastic leukemia and the role of intervention by physical activities and calcium and vitamin D supplement as a preventive strategy.
- Scientific TitleMolecular determinants of bone mineral density in children with acute lymphoblastic leukemia(ALL) and the role of intervention by physical activities and calcium and vitamin D supplement as a preventive strategy.
- ACRONYMintervention study on BMD in ALL
- hypothesisIntervention with adequate calcium and vitamin D and physical activities will influence BMD and fracture rate in a positive way during and after treatment for childhood ALL.
- Healt Condition(s) or Problem(s) studiedAcute Lymphoblastic Leukemia
- Inclusion criteriaPatients 4-18 with ALL, without a physical handicap.
- Exclusion criteriaAge < 3 years.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-sep-2001
- planned closingdate1-okt-2004
- Target number of participants80
- InterventionsControlled physical actievities.
- Primary outcomeIncrease of BMD.
- Secondary outcomeDecrease of fracture rate.
- TimepointsN/A
- Trial web siteN/A
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIES R.D. Beek, van
- CONTACT for SCIENTIFIC QUERIESDr. M.M. Heuvel-Eibrink, van den
- Sponsor/Initiator Erasmus Medical Center, Sophia Children's Hospital, Children Oncology Center Rotterdam (KOCR)
- Funding
(Source(s) of Monetary or Material Support)
Erasmus Medical Center / Sophia, Children Oncology Center Rotterdam (KOCR)
- PublicationsN/A
- Brief summaryThe treatment of pediatric ALL results in decrease of BMD and an elevated fracture rate. This study investigates whether intervention with physical activity improves BMD and reduces fracture rate during and after treatment for pediatric ALL.
- Main changes (audit trail)
- RECORD15-sep-2005 - 16-jun-2008


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