Randomized Controlled Study on the Benefits and Safety of Bisphosphonate Treatment in Childhood Cancer Survivors
15 Years
N/A
Both
Osteoporosis
Trial Information
Randomized Controlled Study on the Benefits and Safety of Bisphosphonate Treatment in Childhood Cancer Survivors
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.
Inclusion Criteria:
- Chinese patients who completed treatments for childhood cancers for at least 5 years
- Currently followed up in the Department of Paediatrics of Prince of Wales Hospital
- Younger than 18 years old at the time of diagnosis of underlying cancers
- Evidence of osteoporosis (i.e. BMD T- or Z-score < -2.5 at lumbar spine)
- Older than 15 years of age at the time of recruitment
Exclusion Criteria:
- Current treatment (i.e. within 6 months) with maintenance systemic or high-dose
inhaled corticosteroids
- Subjects who cannot cooperate for BMD measurements
- Pregnant female patients
- Subjects with prior history of allergy to alendronate or in whom alendronate
treatment is contraindicated
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
The percent change in bone mineral density (BMD) at lumbar spine at 36-weeks in subjects who receive active and control treatments
Outcome Time Frame:
36 weeks
Principal Investigator
Ting Fan Leung, MBChB, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Department of Pediatrics, The Chinese University of Hong Kong
Authority:
Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee
Study ID:
HK-CCFGrants2005.TFL
NCT ID:
NCT00391404
Start Date:
May 2006
Completion Date:
October 2008
Related Keywords:
- Osteoporosis
- Childhood cancer survivors
- Osteoporosis
- Bone mineral density
- Therapy
- Bisphosphonate
- Randomized controlled trial
- Osteoporosis
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