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Fosamax for Childhood Cancer Survivors

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2008 by Chinese University of Hong Kong.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Chinese University of Hong Kong
ClinicalTrials.gov Identifier:
NCT00391404
First received: October 23, 2006
Last updated: May 22, 2008
Last verified: May 2008

October 23, 2006
May 22, 2008
May 2006
Not Provided
The percent change in bone mineral density (BMD) at lumbar spine at 36-weeks in subjects who receive active and control treatments [ Time Frame: 36 weeks ]
The percent change in BMD at lumbar spine at 36-week in subjects who receive active and control treatments
Complete list of historical versions of study NCT00391404 on ClinicalTrials.gov Archive Site
  • Changes in BMD at femoral neck [ Time Frame: 36 weeks ]
  • Changes in biochemical markers of bone turnover [ Time Frame: 36 weeks ]
  • Occurrence of clinical bone-related symptoms at 12-weeks and end of this study [ Time Frame: 36 weeks ]
  • Changes in BMD at femoral neck
  • T and Z scores of BMD at lumbar spine and femoral neck
  • Changes in biochemical markers of bone turnover
  • Occurrence of clinical bone-related symptoms at 12-week and end of this study
Not Provided
Not Provided
 
Fosamax for Childhood Cancer Survivors
Randomized Controlled Study on the Benefits and Safety of Bisphosphonate Treatment in Childhood Cancer Survivors

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Osteoporosis
  • Drug: Alendronate
    Alendronate 70 mg weekly (oral)
    Other Name: Fosamax
  • Drug: Placebo
    Placebo
  • Active Comparator: Alendronate
    Oral alendronate 70 mg weekly
    Intervention: Drug: Alendronate
  • Placebo Comparator: Placebo
    Conventional drug treatment
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
October 2008
Not Provided

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
Both
15 Years and older
No
Contact: Ting Fan Leung, MBChB, MD 852-2632 2981 tfleung@cuhk.edu.hk
Hong Kong
 
NCT00391404
HK-CCFGrants2005.TFL
No
Not Provided
Chinese University of Hong Kong
Not Provided
Principal Investigator: Ting Fan Leung, MBChB, MD Department of Pediatrics, The Chinese University of Hong Kong
Chinese University of Hong Kong
May 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP