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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
  Purpose

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 Intervention Phase
Osteoporosis
Drug: Alendronate
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Controlled Study on the Benefits and Safety of Bisphosphonate Treatment in Childhood Cancer Survivors

Resource links provided by NLM:


Further study details as provided by Chinese University of Hong Kong:

Primary Outcome Measures:
  • 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:
  • 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 ]

Estimated Enrollment: 100
Study Start Date: May 2006
Estimated Study Completion Date: October 2008
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00391404     History of Changes
Other Study ID Numbers: HK-CCFGrants2005.TFL
Study First Received: October 23, 2006
Last Updated: May 22, 2008
Health Authority: Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee

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
Bone Diseases, Metabolic
Musculoskeletal Diseases
Alendronate
Bone Density Conservation Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 20, 2014