Osteoporosis | Fosamax for Childhood Cancer Survivors
Osteoporosis research study
What is the primary objective of this study?
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.
Who is eligible to participate?
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
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:AlendronateAlendronate 70 mg weekly (oral)
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
AlendronateOral alendronate 70 mg weekly
PlaceboConventional drug treatment
Start Date: May 2006
Completed Date: October 2008
Phase: Phase 3
Primary Outcome: The percent change in bone mineral density (BMD) at lumbar spine at 36-weeks in subjects who receive active and control treatments
Secondary Outcome: Changes in BMD at femoral neck
Study sponsors, principal investigator, and references
Principal Investigator: Ting Fan Leung, MBChB, MD
Lead Sponsor: Chinese University of Hong Kong