Fosamax for Childhood Cancer Survivors - Full Text View

Sponsored by:	Chinese University of Hong Kong
Information provided by:	Chinese University of Hong Kong
ClinicalTrials.gov Identifier:	NCT00391404

Purpose

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.

Condition	Intervention	Phase
Osteoporosis	Drug: Alendronate Drug: Placebo	Phase III

MedlinePlus related topics: Cancer Minerals Osteoporosis

Drug Information available for: Alendronate Alendronate sodium

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Randomized Controlled Study on the Benefits and Safety of Bisphosphonate Treatment in Childhood Cancer Survivors

Further study details as provided by Chinese University of Hong Kong:

Primary Outcome Measures:

The percent change in bone mineral density (BMD) at lumbar spine at 36-weeks in subjects who receive active and control treatments [ Time Frame: 36 weeks ]

Secondary Outcome Measures:

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

Estimated Enrollment:	100
Study Start Date:	May 2006
Estimated Study Completion Date:	October 2008

Arms	Assigned Interventions
Alendronate: Active Comparator Oral alendronate 70 mg weekly	Drug: Alendronate Alendronate 70 mg weekly (oral)
Placebo: Placebo Comparator Conventional drug treatment	Drug: Placebo Placebo

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.

Eligibility

Ages Eligible for Study:	15 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00391404

Contacts

Contact: Ting Fan Leung, MBChB, MD

852-2632 2981

tfleung@cuhk.edu.hk

Locations

Hong Kong
Prince of Wales Hospital, Shatin, N.T.	Recruiting
Hong Kong, Hong Kong
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

Sponsors and Collaborators

Chinese University of Hong Kong

Investigators

Principal Investigator:

Ting Fan Leung, MBChB, MD

Department of Pediatrics, The Chinese University of Hong Kong

More Information

Study ID Numbers:	HK-CCFGrants2005.TFL
Study First Received:	October 23, 2006
Last Updated:	May 22, 2008
ClinicalTrials.gov Identifier:	NCT00391404
Health Authority:	Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee

Keywords provided by Chinese University of Hong Kong:

Childhood cancer survivors
Osteoporosis
Bone mineral density

Therapy
Bisphosphonate
Randomized controlled trial

Study placed in the following topic categories:

Diphosphonates
Musculoskeletal Diseases
Alendronate

Osteoporosis
Bone Diseases, Metabolic
Bone Diseases

Additional relevant MeSH terms:

Physiological Effects of Drugs
Bone Density Conservation Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009