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.

Study Overview

• Status: Unknown
• Conditions: Osteoporosis
• Intervention / Treatment: Drug: Placebo; Drug: Alendronate

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

Study Locations

• Hong Kong
  • 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

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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Alendronate; Oral alendronate 70 mg weekly	Drug: Alendronate; Alendronate 70 mg weekly (oral); Other Names: Fosamax
Placebo Comparator: Placebo; Conventional drug treatment	Drug: Placebo; 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	36 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Changes in BMD at femoral neck	36 weeks
Changes in biochemical markers of bone turnover	36 weeks
Occurrence of clinical bone-related symptoms at 12-weeks and end of this study	36 weeks

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong
• Investigators: Principal Investigator: Ting Fan Leung, MBChB, MD, Department of Pediatrics, The Chinese University of Hong Kong

Study record dates

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: Randomized controlled trial; Therapy; Osteoporosis; Bone mineral density; Bisphosphonate; Childhood cancer survivors
• Additional Relevant MeSH Terms: Metabolic Diseases; Musculoskeletal Diseases; Bone Diseases; Bone Diseases, Metabolic; Osteoporosis; Physiological Effects of Drugs; Bone Density Conservation Agents; Alendronate
• Other Study ID Numbers: HK-CCFGrants2005.TFL