Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00145704
Status:
TERMINATED
Last Update Posted:
2013-04-08
First Post:
2005-09-01
Brief Title:
Study of Adults With Low Growth Hormone Who Survived Childhood Cancer Where Treatment Caused Low Bone Density
Sponsor:
State University of New York - Upstate Medical University
Organization:
State University of New York - Upstate Medical University
Study Overview
Official Title:
Treatment of Childhood Cancer Therapy-induced Osteopenia in Growth Hormone Deficient Adult Survivors Does Bisphosphonate Treatment Improve Bone Mineral Density
Status:
TERMINATED
Status Verified Date:
2013-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
due to low enrollment participants are no longer being examined or treated
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
Adult patients with Dexa scan bone scan z-scores -10 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 andor 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-1Insulin 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 po daily and calcium carbonate 500 mg po twice daily free of charge for eighteen months
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-1Insulin 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 po daily and calcium carbonate 500 mg po twice daily free of charge for eighteen months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None