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 |
| Protocol serial number | NTR477; MEC number 193.291/2000/144 and 114.720/1991/62 |
| Sponsor | Erasmus Medical Center, Sophia Children's Oncology Center Rotterdam (KOCR) (Netherlands) |
| Funder | Erasmus Medical Centre, Sophia Children's Oncology Centre, Rotterdam (KOCR) |
- 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
Scientific
Erasmus Medical Center
Sophia Childrens Hospital
Department of Pediatrics
P.O. Box 2060
Rotterdam
3000 CB
Netherlands
| r.d.vanbeek@erasmusmc.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised single blind placebo controlled parallel group trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | Intervention 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) studied | Acute Lymphoblastic Leukemia (ALL) |
| Intervention | Controlled physical activities |
| Intervention type | Other |
| Primary outcome measure(s) |
Increase of BMD |
| Key secondary outcome measure(s) |
Decrease of fracture rate |
| Completion date | 01/10/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 4 Years |
| Upper age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 80 |
| Key inclusion criteria | Patients aged 4-18 with ALL |
| Key exclusion criteria | 1. Physical handicap 2. Age <3 years |
| Date of first enrolment | 01/09/2001 |
| Date of final enrolment | 01/10/2004 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Erasmus Medical Center
Rotterdam
3000 CB
Netherlands
3000 CB
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
