Ignite Creation Date:
2024-05-05 @ 4:43 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00301873
Status:
COMPLETED
Last Update Posted:
2013-02-18
First Post:
2006-03-09
Brief Title:
Zoledronate in Preventing Osteoporosis in Patients With Primary Malignant Glioma
Sponsor:
Duke University
Organization:
Duke University
Study Overview
Official Title:
Phase II Study of Zometa Zoledronic Acid to Prevent Osteoporosis in Patients With Brain Tumors
Status:
COMPLETED
Status Verified Date:
2013-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Zoledronate may prevent bone loss in patients with primary malignant glioma
PURPOSE This phase II trial is studying how well zoledronate works in preventing osteoporosis in patients with primary malignant glioma
PURPOSE This phase II trial is studying how well zoledronate works in preventing osteoporosis in patients with primary malignant glioma
Detailed Description:
This is an open-labeled trial to determine the incidence of osteoporosis in brain tumor patients and effect of Zometa every three months Zometa will be given at 4 mg intravenously over 15 minutes every 3 months for 1 year The patients will undergo a baseline bone densitometry test that will be repeated at six months and one year Information on the patients tolerability of Zometa as well as any skeletal-related complications that happen will be collected Data with respect to the dose and duration of glucocorticoids and anticonvulsants will be collected since both of these therapies have shown to directly affect bone density Serial markers N-telopeptide of bone turn over will be collected at baseline and every 3 months prior to the infusion of Zometa Karnofsky performance status will be monitored as a function of mobility
Accrual Goal 60 patients over a 18-month period averaging 3-4 new enrollees per month Thirty-five patients to reach the 6-month assessment
OBJECTIVES
To determine the bone mineral density of the patients at baseline and any changes over 12 months while receiving Zometa every 3 months
To determine the incidence of skeletal-related complications in this cohort of brain tumor patients
To determine the safety and tolerability of Zometa in brain tumor patients
To determine the effects of glucocorticoids and anticonvulsants on bone density
Response Criteria The primary efficacy endpoint will be the patients bone densitometry and how it changes over the course of one year of Zometa therapy The bone densitometry after 6 months and 12 months of Zometa will be compared to the baseline The secondary efficacy variable will be the prevention of skeletal-related events compression fracture any fracture requiring surgery which given the heterogeneity of the patient population will be a qualitative variable Date with respect to the dose and duration of glucocorticoids and anticonvulsants will be collected since both of these therapies have shown to directly affect bone density Serial markers N-telopeptide of bone turn over will be collected
Outcome assessment The patients bone densitometry will be determined by Dexa-scan at the baseline after six months of Zometa and after one year of Zometa The bone density Dexa- scan will be reviewed by the outside radiologist or Duke radiology in conjunction with the primary investigator A decrease of -05 on the T-score will be coded as a treatment failure and patients will be discontinued from the study and referred to Endocrinology or Orthopedic Surgery for best clinical management In addition any skeletal-related event fractures will be coded as a treatment failure The patient population will be heterogeneous in terms of their functional capacity exercise capacity anticonvulsant and glucocorticoid dos
Accrual Goal 60 patients over a 18-month period averaging 3-4 new enrollees per month Thirty-five patients to reach the 6-month assessment
OBJECTIVES
To determine the bone mineral density of the patients at baseline and any changes over 12 months while receiving Zometa every 3 months
To determine the incidence of skeletal-related complications in this cohort of brain tumor patients
To determine the safety and tolerability of Zometa in brain tumor patients
To determine the effects of glucocorticoids and anticonvulsants on bone density
Response Criteria The primary efficacy endpoint will be the patients bone densitometry and how it changes over the course of one year of Zometa therapy The bone densitometry after 6 months and 12 months of Zometa will be compared to the baseline The secondary efficacy variable will be the prevention of skeletal-related events compression fracture any fracture requiring surgery which given the heterogeneity of the patient population will be a qualitative variable Date with respect to the dose and duration of glucocorticoids and anticonvulsants will be collected since both of these therapies have shown to directly affect bone density Serial markers N-telopeptide of bone turn over will be collected
Outcome assessment The patients bone densitometry will be determined by Dexa-scan at the baseline after six months of Zometa and after one year of Zometa The bone density Dexa- scan will be reviewed by the outside radiologist or Duke radiology in conjunction with the primary investigator A decrease of -05 on the T-score will be coded as a treatment failure and patients will be discontinued from the study and referred to Endocrinology or Orthopedic Surgery for best clinical management In addition any skeletal-related event fractures will be coded as a treatment failure The patient population will be heterogeneous in terms of their functional capacity exercise capacity anticonvulsant and glucocorticoid dos
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| P50NS020023 | NIH | None | httpsreporternihgovquickSearchP50NS020023 |