- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00145704
Study of Adults With Low Growth Hormone Who Survived Childhood Cancer Where Treatment Caused Low Bone Density
Treatment of Childhood Cancer Therapy-induced Osteopenia in Growth Hormone Deficient Adult Survivors: Does Bisphosphonate Treatment Improve Bone Mineral Density?
Study Overview
Status
Conditions
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New York
-
Syracuse, New York, United States, 13210
- Upstate Medical University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Growth Hormone only
No bisphosphonate therapy given, participants will take Vitamin D 400 IU daily for 18 months, as well as calcium carbonate 500 mg twice a day for 18 months.
|
Vitamin D given to patients with growth hormone deficiency
Other Names:
calcium supplement given to patients with growth hormone deficiency
|
Experimental: Growth Hormone & Bisphosphonate Therapy
Bisphosphonate Therapy-Risedronate 35 mg once a week for 18 months, Vitamin D 400 IU daily for 18 months and calcium carbonate 500 mg twice daily for 18 months
|
Vitamin D given to patients with growth hormone deficiency
Other Names:
calcium supplement given to patients with growth hormone deficiency
Bisphosphonate therapy given to patients with growth hormone deficiency
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Total Body Bone Mineral Density During an 18 Month Period
Time Frame: 18 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-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.
|
18 months
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Timothy A Damron, MD, State University of New York - Upstate Medical University
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Metabolic Diseases
- Musculoskeletal Diseases
- Bone Diseases
- Bone Diseases, Metabolic
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Micronutrients
- Membrane Transport Modulators
- Bone Density Conservation Agents
- Calcium-Regulating Hormones and Agents
- Calcium Channel Blockers
- Vitamin D
- Cholecalciferol
- Vitamins
- Risedronic Acid
- Ergocalciferols
- Diphosphonates
Other Study ID Numbers
- SUNY UMU IRB # 4689
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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