Fosamax for Childhood Cancer Survivors

NCT ID: NCT00391404

Last Updated: 2008-05-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-05-31
• Study Completion Date: 2008-10-31

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.

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.

Conditions

Osteoporosis

Keywords

Childhood cancer survivors; Osteoporosis; Bone mineral density; Therapy; Bisphosphonate; Randomized controlled trial

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Alendronate

Oral alendronate 70 mg weekly

Group Type: ACTIVE_COMPARATOR

Alendronate

Intervention Type: DRUG

Alendronate 70 mg weekly (oral)

Placebo

Conventional drug treatment

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo

Interventions

Alendronate

Alendronate 70 mg weekly (oral)

Intervention Type: DRUG

Placebo

Placebo

Intervention Type: DRUG

Other Intervention Names

Fosamax

Eligibility 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

• Minimum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chinese University of Hong Kong

OTHER

Sponsor Role: lead

Principal Investigators

Ting Fan Leung, MBChB, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Pediatrics, The Chinese University of Hong Kong

Locations

Prince of Wales Hospital, Shatin, N.T.

Hong Kong, , Hong Kong

Site Status: RECRUITING

Countries

Hong Kong

Central Contacts

Ting Fan Leung, MBChB, MD

Role: CONTACT

Phone: 852-2632 2981

Email: tfleung@cuhk.edu.hk

Other Identifiers

HK-CCFGrants2005.TFL

Identifier Type: -

Identifier Source: org_study_id