Molecular determinants of bone mineral density (BMD) in children with acute lymphoblastic leukemia (ALL) and the role of intervention by physical activities and calcium and vitamin D supplements as a preventive strategy

ISRCTN ISRCTN23173889
DOI https://doi.org/10.1186/ISRCTN23173889
Secondary identifying numbers NTR477; MEC number 193.291/2000/144 and 114.720/1991/62
Submission date
27/01/2006
Registration date
27/01/2006
Last edited
14/08/2009
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr R.D. Beek, van
Scientific

Erasmus Medical Center
Sophia Children’s Hospital
Department of Pediatrics
P.O. Box 2060
Rotterdam
3000 CB
Netherlands

r.d.vanbeek@erasmusmc.nl

Study information

Study designRandomised single blind placebo controlled parallel group trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study objectivesIntervention 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.
Ethics approval(s)Received from local medical ethics committee
Health condition(s) or problem(s) studiedAcute Lymphoblastic Leukemia (ALL)
InterventionControlled physical activities
Intervention typeOther
Primary outcome measureIncrease of BMD
Secondary outcome measuresDecrease of fracture rate
Overall study start date01/09/2001
Completion date01/10/2004

Eligibility

Participant type(s)Patient
Age groupChild
Lower age limit4 Years
Upper age limit18 Years
SexAll
Target number of participants80
Key inclusion criteriaPatients aged 4-18 with ALL
Key exclusion criteria1. Physical handicap
2. Age <3 years
Date of first enrolment01/09/2001
Date of final enrolment01/10/2004

Locations

Countries of recruitment

  • Netherlands

Study participating centre

Erasmus Medical Center
Rotterdam
3000 CB
Netherlands

Sponsor information

Funders

Funder type

Hospital/treatment centre

Erasmus Medical Centre, Sophia Children's Oncology Centre, Rotterdam (KOCR)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan
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