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
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
| Study design | Randomised single blind placebo controlled parallel group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 | Increase of BMD |
| Secondary outcome measures | Decrease of fracture rate |
| Overall study start date | 01/09/2001 |
| Completion date | 01/10/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 4 Years |
| Upper age limit | 18 Years |
| Sex | Both |
| Target number of participants | 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
Sponsor information
Erasmus Medical Center, Sophia Children's Oncology Center Rotterdam (KOCR) (Netherlands)
Not defined
Not defined
P.O. Box 2060
Rotterdam
3000 CB
Netherlands
| Phone | +31 (0)10 4636691 |
|---|---|
| j.dito@erasmusmc.nl | |
"ROR" |
https://ror.org/018906e22 |
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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
