Zoledronate in Preventing Osteoporosis in Patients With Primary Malignant Glioma

Osteoporosis Clinical Trial

Official title: Phase II Study of Zometa (Zoledronic Acid) to Prevent Osteoporosis in Patients With Brain Tumors

Status Completed

Clinical Trial 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.

Clinical Trial 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 patient's 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 patient's 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 patient's 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 > -0.5 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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Brain Neoplasms
• Brain Tumors
• Central Nervous System(CNS)Malignancies
• Osteoporosis

• NCT number: NCT00301873
• Study type: Interventional
• Source: Duke University
• Status: Completed
• Phase: Phase 2
• Start date: May 2006
• Completion date: September 2012