Trial Outcomes & Findings for Study of Adults With Low Growth Hormone Who Survived Childhood Cancer Where Treatment Caused Low Bone Density (NCT NCT00145704)
NCT ID: NCT00145704
Last Updated: 2013-04-08
Results Overview
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 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.
TERMINATED
NA
6 participants
18 months
2013-04-08
Participant Flow
Adult pts from Upstate Med Univ who have known growth hormone deficiency as a complication of treatment for pediatric malignancy will be selected after chart review from their Kids Not on Treatment(KNOT)Clinic records prior to their routine follow up appt.Pts will receive info about this study on their routine f/w up appts at the KNOT Clinic.
Participant milestones
| Measure |
Bisphosphonate and Growth Hormone
bisphosphonate use and growth hormone use
|
Growth Hormone Only
Growth hormone only, no bisphosphonate will be used
|
|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of Adults With Low Growth Hormone Who Survived Childhood Cancer Where Treatment Caused Low Bone Density
Baseline characteristics by cohort
| Measure |
Bisphosphonate and Growth Hormone Use
n=3 Participants
bisphosphonate use and growth hormone use
|
Growth Hormone Only
n=3 Participants
Growth hormone use only, no bisphosphonate used
|
Total
n=6 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
25 years
n=5 Participants
|
25 years
n=7 Participants
|
25 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 18 monthsPopulation: Data analyis halted, due to low enrollment,no outcomes to report
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 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.
Outcome measures
Outcome data not reported
Adverse Events
Bisphosphonate and Growth Hormone Use
Growth Hormone Only
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place