Osteopenia
Conditions
Keywords
osteopenia, growth hormone deficiency, pediatric malignancy
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 \< -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.
Interventions
DRUGbisphosphonate therapy (risedronate)
Bisphosphonate therapy given to patients with growth hormone deficiency
DIETARY_SUPPLEMENTVitamin D supplement
Vitamin D given to patients with growth hormone deficiency
DIETARY_SUPPLEMENTCalcium
calcium supplement given to patients with growth hormone deficiency
Sponsors
Genentech, Inc.
State University of New York - Upstate Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Total Body Bone Mineral Density During an 18 Month Period | 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. |
Countries
United States
Participant flow
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.
Participants by arm
| Arm | Count |
|---|---|
| Bisphosphonate and Growth Hormone Use bisphosphonate use and growth hormone use | 3 |
| Growth Hormone Only Growth hormone use only, no bisphosphonate used | 3 |
| Total | 6 |
Baseline characteristics
| Characteristic | Bisphosphonate and Growth Hormone Use | Growth Hormone Only | Total |
|---|---|---|---|
| Age Continuous | 25 years | 25 years | 25 years |
| Sex: Female, Male Female | 1 Participants | 1 Participants | 2 Participants |
| Sex: Female, Male Male | 2 Participants | 2 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 3 | 0 / 3 |
| serious Total, serious adverse events | 0 / 3 | 0 / 3 |
Outcome results
Primary
Change in Total Body Bone Mineral Density During an 18 Month Period
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
Population: Data analyis halted, due to low enrollment,no outcomes to report