Denosumab for Prevention of Bone Complications After Bone Marrow Transplantation in Children

• Status: Withdrawn
• Trial end date: 2018-09-04
• Target enrollment: 0
• Participant gender: All

Summary

Children treated by bone marrow transplantation (BMT) experience bone toxicity. Those bone damages are caused by both a decrease of bone formation and an increase of bone destruction after BMT.For long term survivors, bone complications are major determinants of impaired quality of life. No standard treatment currently exists to prevent those bone injuries. Denosumab is a treatment which specifically blocks bone destruction for 4 to 6 months in adults. This trial will study whether it is safe to prescribe Denosumab to children after BMT in the aim of preventing bone complications.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: St. Justine's Hospital
• Treatments: Denosumab

Criteria

Inclusion Criteria:

• Age from 2 year to 21 years

• Allogenic hematopoietic stem cell transplantation (allo-HSCT) planned within 1 month.

• Informed consent signed by participant more than 18 year old, or parents or his/her legal guardian

• Teeth examination by a dentist in order to rule out or to treat latent teeth infections before allo-HSCT

Exclusion Criteria:

• Refusal of signing informed consent

• Prior inclusion in another therapeutic trial with a time elapsed from the last research drug dose to Denosumab, shorter than 7 half-lifes of the research drug

• Osteopetrosis

• Bisphosphonates treatment within 12 months before entering the trial

• Tooth infection not treated before allo-HSCT

• Child-bearing and breastfeeding women