PatientsVille.com LogoPatientsVille.com

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?

Osteoporosis

Study Interventions

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)

Drug:PlaceboPlacebo

Study Arms

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

Study Status

Unknown status

Start Date: May 2006

Completed Date: October 2008

Phase: Phase 3

Type: Interventional

Design:

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

Collaborator:

More information:https://clinicaltrials.gov/show/NCT00391404

Discuss Fosamax