Study of Adults With Low Growth Hormone Who Survived Childhood Cancer Where Treatment Caused Low Bone Density

• Status: Terminated
• Trial end date: 2008-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this project is to evaluate the hypothesis that bisphosphonate treatment given to growth hormone deficient patients (regardless of current growth hormone replacement therapy status and without changing that status) significantly increases total body bone mineral density during an eighteen month period of treatment combined with calcium and Vitamin D when compared to calcium and Vitamin D treatment alone.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: State University of New York - Upstate Medical University
• Collaborator: Genentech, Inc.
• Treatments: Calcium; Calcium Carbonate; Calcium, Dietary; Diphosphonates; Ergocalciferols; Hormones; Risedronate Sodium; Risedronic Acid; Vitamin D; Vitamins

Criteria

Inclusion Criteria:

• Growth hormone deficiency as a complication of treatment for pediatric malignancy

• Dexa (bone densitometry)with z-scores of < -1.0 in at least one site

Exclusion Criteria:

• Dexa (bone densitometry)with z-scores < -1.0 in at least one site

• Subjects <18 years old

• Pregnant or lactating patients

• Any contraindication for or unwillingness to consider bisphosphonate treatment

• Inability or unwillingness to undergo bone density evaluation

• Other correctable causes of decreased bone mineral density