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Fosamax for Childhood Cancer Survivors

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ClinicalTrials.gov Identifier: NCT00391404
Recruitment Status : Unknown
Verified May 2008 by Chinese University of Hong Kong.
Recruitment status was:  Recruiting
First Posted : October 24, 2006
Last Update Posted : May 23, 2008
Sponsor:
Information provided by:
Chinese University of Hong Kong

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.

Condition or disease Intervention/treatment Phase
Osteoporosis Drug: Alendronate Drug: Placebo Phase 3

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  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Controlled Study on the Benefits and Safety of Bisphosphonate Treatment in Childhood Cancer Survivors
Study Start Date : May 2006
Estimated Study Completion Date : October 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Alendronate
Oral alendronate 70 mg weekly
Drug: Alendronate
Alendronate 70 mg weekly (oral)
Other Name: Fosamax
Placebo Comparator: Placebo
Conventional drug treatment
Drug: Placebo
Placebo



Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Changes in BMD at femoral neck [ Time Frame: 36 weeks ]
  2. Changes in biochemical markers of bone turnover [ Time Frame: 36 weeks ]
  3. Occurrence of clinical bone-related symptoms at 12-weeks and end of this study [ Time Frame: 36 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00391404


Contacts
Contact: Ting Fan Leung, MBChB, MD 852-2632 2981 tfleung@cuhk.edu.hk

Locations
Hong Kong
Prince of Wales Hospital, Shatin, N.T. Recruiting
Hong Kong, Hong Kong
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         
Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
Principal Investigator: Ting Fan Leung, MBChB, MD Department of Pediatrics, The Chinese University of Hong Kong

ClinicalTrials.gov Identifier: NCT00391404     History of Changes
Other Study ID Numbers: HK-CCFGrants2005.TFL
First Posted: October 24, 2006    Key Record Dates
Last Update Posted: May 23, 2008
Last Verified: May 2008

Keywords provided by Chinese University of Hong Kong:
Childhood cancer survivors
Osteoporosis
Bone mineral density
Therapy
Bisphosphonate
Randomized controlled trial

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Alendronate
Diphosphonates
Bone Density Conservation Agents
Physiological Effects of Drugs