Ignite Creation Date:
2025-12-24 @ 9:09 PM
Ignite Modification Date:
2025-12-25 @ 6:59 PM
Study NCT ID:
NCT00391404
Status:
UNKNOWN
Last Update Posted:
2008-05-23
First Post:
2006-10-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Fosamax for Childhood Cancer Survivors
Sponsor:
Chinese University of Hong Kong
Organization:
Study Overview
Official Title:
Randomized Controlled Study on the Benefits and Safety of Bisphosphonate Treatment in Childhood Cancer Survivors
Status:
UNKNOWN
Status Verified Date:
2008-05
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Survivors of childhood cancers face a variety of long-term problems. The investigators' recent study found that osteoporosis and osteopenia were common among these patients. The factors leading to, as well as the best treatment option for, this morbidity are unclear. Bisphosphonates are currently the standard therapy for osteoporosis in the elderly. However, the efficacy and safety of bisphosphonates for treating osteoporosis in long-term cancer survivors have not been tested. The investigators hypothesize that alendronate, an orally active bisphosphonate, is efficacious and safe in the treatment of osteoporosis in these patients.
Detailed Description:
The modern treatment for childhood malignancy includes surgery and chemoradiotherapy either individually or in combination. Despite the great achievement in improving patient survival, these treatments also greatly enhance the adverse effects on the unfortunate children. Our research group has recently conducted a pioneer study on the bone mineralization and bone mineral density (BMD) study in longterm childhood cancer survivors in local patients who have completed anti-cancer treatment for at least five years. This landmark study showed that persistent treatment-related adverse effects on skeletal development are common (up to 50%) in local long-term survivors of childhood cancers. Thus, it is important during this critical period of rapid somatic growth in adolescents and young adults that these cancer survivors achieve their peak potential for bone mineralization and strengthening. In this proposed study, we investigate with a randomized and controlled study design on the efficacy of a second-generation oral bisphosphonate, alendronate, to improve BMD over a 36-week period in long-term survivors of childhood cancers in Hong Kong. In addition to alendronate, all subjects in the active and control groups will receive alfacalcidol (vitamin D) and calcium carbonate throughout the whole study period. The study results will help paediatric oncologists to decide on the optimal remedial treatments against osteoporosis in long-term cancer survivors.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: