Trial Information

Treatment of Childhood Cancer Therapy-induced Osteopenia in Growth Hormone Deficient Adult Survivors: Does Bisphosphonate Treatment Improve Bone Mineral Density?

Adult patients with Dexa scan (bone scan) z-scores < -1.0 (meaning low bone density) in at
least one site will be selected for randomization. All patients who qualify for
randomization will undergo baseline bloodwork for serum bone specific alkaline phosphatase
(BSAP) and n-terminal telopeptides of collagen (NTX) levels. Recent bloodwork obtained as
part of their ongoing long-term Pediatric Oncology and/or Endocrine clinic follow-up
evaluation will be reviewed to exclude any baseline correctable confounding causes of
osteopenia (low bone density). All women of childbearing potential will have a pregnancy
test.

For those patients already on growth hormone replacement therapy, growth hormone will be
administered as per standard of care, with standard dose ranges adjusted based upon
IGF-1(Insulin like growth factor) monitoring. Those patients not currently receiving
growth hormone replacement therapy will not be placed on therapy as a part of this study.
Patients on and off growth hormone replacement therapy will be randomized in a block design
to the two treatment arms to assure equal numbers in each treatment arm. The bisphosphonate
to be utilized will be provided to the Arm II patients at no charge. All Arm II patients
will receive the same bisphosphonate regimen, Risedronate 35 mg per oral once weekly for 18
months. All patients on arms I and II will also receive Vitamin D (400 IU p.o. daily) and
calcium carbonate (500 mg p.o. twice daily) free of charge for eighteen months.