Fosamax for Childhood Cancer Survivors

NCT00391404 | Unknown Phase 3

• 1 other identifier: HK-CCFGrants2005.TFL
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoporosis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

Study Arms (2)

Alendronate

ACTIVE COMPARATOR

Oral alendronate 70 mg weekly

Drug: Alendronate

Placebo

PLACEBO COMPARATOR

Conventional drug treatment

Drug: Placebo

Interventions

Alendronate DRUG

Alendronate 70 mg weekly (oral)

Also known as: Fosamax

Alendronate

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Prince of Wales Hospital, Shatin, N.T.

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Osteoporosis

Interventions

Alendronate

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals

Study Officials

• Ting Fan Leung, MBChB, MD

  Department of Pediatrics, The Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ting Fan Leung, MBChB, MD

CONTACT

852-2632 2981; tfleung@cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 23, 2006
• First Posted: October 24, 2006
• Study Start: May 1, 2006
• Study Completion: October 1, 2008
• Last Updated: May 23, 2008

Record last verified: 2008-05

Locations

HK (1)