- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00391404
Fosamax for Childhood Cancer Survivors
May 22, 2008 updated by: Chinese University of Hong Kong
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.
Study Overview
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 Type
Interventional
Enrollment (Anticipated)
100
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Ting Fan Leung, MBChB, MD
- Phone Number: 852-2632 2981
- Email: tfleung@cuhk.edu.hk
Study Locations
-
-
-
Hong Kong, Hong Kong
- Recruiting
- Prince of Wales Hospital, Shatin, N.T.
-
Sub-Investigator:
- Patrick MP Yuen, MD, FRCPC
-
Sub-Investigator:
- Chi Kong Li, MBBS, MD
-
Sub-Investigator:
- Christopher WK Lam, PhD
-
Sub-Investigator:
- Vincent Lee, MBChB
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
15 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Alendronate
Oral alendronate 70 mg weekly
|
Alendronate 70 mg weekly (oral)
Other Names:
|
Placebo Comparator: Placebo
Conventional drug treatment
|
Placebo
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
36 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Changes in BMD at femoral neck
Time Frame: 36 weeks
|
36 weeks
|
Changes in biochemical markers of bone turnover
Time Frame: 36 weeks
|
36 weeks
|
Occurrence of clinical bone-related symptoms at 12-weeks and end of this study
Time Frame: 36 weeks
|
36 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ting Fan Leung, MBChB, MD, Department of Pediatrics, The Chinese University of Hong Kong
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2006
Study Completion (Anticipated)
October 1, 2008
Study Registration Dates
First Submitted
October 23, 2006
First Submitted That Met QC Criteria
October 23, 2006
First Posted (Estimate)
October 24, 2006
Study Record Updates
Last Update Posted (Estimate)
May 23, 2008
Last Update Submitted That Met QC Criteria
May 22, 2008
Last Verified
May 1, 2008
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HK-CCFGrants2005.TFL
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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