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Trial record 90 of 101 for:    Risedronate

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

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ClinicalTrials.gov Identifier: NCT00145704
Recruitment Status : Terminated (due to low enrollment, participants are no longer being examined or treated)
First Posted : September 5, 2005
Results First Posted : April 8, 2013
Last Update Posted : April 8, 2013
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
Timothy Damron, M.D., State University of New York - Upstate Medical University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Osteopenia
Interventions Drug: bisphosphonate therapy (risedronate)
Dietary Supplement: Vitamin D supplement
Dietary Supplement: Calcium
Enrollment 6
Recruitment Details 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.
Pre-assignment Details  
Arm/Group Title Bisphosphonate and Growth Hormone Growth Hormone Only
Hide Arm/Group Description bisphosphonate use and growth hormone use Growth hormone only, no bisphosphonate will be used
Period Title: Overall Study
Started 3 3
Completed 0 0
Not Completed 3 3
Arm/Group Title Bisphosphonate and Growth Hormone Use Growth Hormone Only Total
Hide Arm/Group Description bisphosphonate use and growth hormone use Growth hormone use only, no bisphosphonate used Total of all reporting groups
Overall Number of Baseline Participants 3 3 6
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 3 participants 3 participants 6 participants
25
(18 to 40)
25
(18 to 40)
25
(18 to 40)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 3 participants 6 participants
Female
1
  33.3%
1
  33.3%
2
  33.3%
Male
2
  66.7%
2
  66.7%
4
  66.7%
1.Primary Outcome
Title Change in Total Body Bone Mineral Density During an 18 Month Period
Hide Description 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.
Time Frame 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
Data analyis halted, due to low enrollment,no outcomes to report
Arm/Group Title Bisphosphonate and Growth Hormone Use Growth Hormone Only
Hide Arm/Group Description:
bisphosphonate use and growth hormone use
Growth hormone use only, no bisphosphonate used
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame May, 2002 to October 2008
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Bisphosphonate and Growth Hormone Use Growth Hormone Only
Hide Arm/Group Description bisphosphonate use and growth hormone use Growth hormone use only, no bisphosphonate used
All-Cause Mortality
Bisphosphonate and Growth Hormone Use Growth Hormone Only
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Bisphosphonate and Growth Hormone Use Growth Hormone Only
Affected / at Risk (%) Affected / at Risk (%)
Total   0/3 (0.00%)   0/3 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Bisphosphonate and Growth Hormone Use Growth Hormone Only
Affected / at Risk (%) Affected / at Risk (%)
Total   0/3 (0.00%)   0/3 (0.00%) 
Early termination due to low enrollment, and lost to follow up of three subjects. Data was limited and therefore not reviewed/analyzed
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Timothy A. Damron
Organization: Upstate Orthopedics
Phone: 315-464-8602
Responsible Party: Timothy Damron, M.D., State University of New York - Upstate Medical University
ClinicalTrials.gov Identifier: NCT00145704     History of Changes
Other Study ID Numbers: SUNY UMU IRB # 4689
First Submitted: September 1, 2005
First Posted: September 5, 2005
Results First Submitted: October 26, 2010
Results First Posted: April 8, 2013
Last Update Posted: April 8, 2013