A Phase 2 interventional study of IV Zometa in Brain Tumors, Osteoporosis and Central Nervous System(CNS)Malignancies, sponsored by Duke University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-02-18.
Sponsored by Duke University · Phase 2, Interventional, and Supportive care
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.
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:
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
1,960 studies on the registry are indexed under Brain Neoplasms; 516 are open to participants now.
This study's enrollment of 60 is above the median of 40 across 1,458 interventional studies indexed under Brain Neoplasms.
Browse Brain Neoplasms studies →Duke University is the lead sponsor of 2,025 studies on the registry; 275 are open to participants now.
Of its 194 completed or terminated interventional studies of FDA-regulated products, 159 (82%) have results posted.
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Adequate renal and liver function as demonstrated by laboratory values performed within 14 days, inclusive, prior to the administration of Zometa, except for the creatinine, which will be within 72 hs of Zometa administration:
Exclusion Criteria:
Zometa will be given at 4 mg intravenously over 15 minutes every 3 months for 1 year.
Drug: IV Zometa
Zometa will be given at 4 mg intravenously over 15 minutes every 3 months for 1 year.
Also known as: zolondronic acid
Percent of Patients With Change in Combined Bone Mass Density T-score <= -0.5.
Percent of patients who failed treatment as defined by a decrease of 0.5 or more from baseline in the combined T-score as measured by Dexa-scan. The patient's bone densitometry was determined by Dexa-scan at baseline, after 6 months of Zometa and after 1 year of Zometa. The t-score, which is a comparison of a person's bone density with that of a healthy 30-year-old of the same sex, was generated by Dexa-scan for the spine and femur. The combined T-score is the minimum of the T-score for the spine and femur. A lower t-score implies a lower BMD.
Time frame: 6 and 12 months
Skeletal-related Complications
Number of patients who experience skeletal-related complications during the administration of Zoledronate.
Time frame: 1 year
Mean Change in Bone Mass Density (BMD)
Mean change in the combined t-score was measured by Dexa-scan. The patients bone density was determined by Dexa-scan at baseline, after 6 months Zometa and after 12 months of Zometa. The t-score, which is a comparison of a person's bone density with that of a healthy 30-year old of the same sex, was generated by Dexa-scan for the spine and femur. A lower t-score implies a lower BMD. The combined t-score is the minimum of the t-score for the spine and that for the femur. BMD change from baseline at 6 and 12 months in the combined t-score was defined as the follow-up combined t-score minus the baseline combined t-score.
Time frame: 6 & 12 months
Patients were accrued between February 2006 and January 2008 within the clinic at Duke Comprehensive Cancer Center.
| Milestone | IV Zometa |
|---|---|
| Started | 59 |
| Completed | 59 |
| Not completed | 0 |
Percent of patients who failed treatment as defined by a decrease of 0.5 or more from baseline in the combined T-score as measured by Dexa-scan. The patient's bone densitometry was determined by Dexa-scan at baseline, after 6 months of Zometa and after 1 year of Zometa. The t-score, which is a comparison of a person's bone density with that of a healthy 30-year-old of the same sex, was generated by Dexa-scan for the spine and femur. The combined T-score is the minimum of the T-score for the spine and femur. A lower t-score implies a lower BMD.
| percentage of patients | IV Zometa |
|---|---|
| At 6 months (n=27) | 3.7 |
| At 12 months (n=19) | 10.5 |
Number of patients who experience skeletal-related complications during the administration of Zoledronate.
| participants | IV Zometa |
|---|---|
| Skeletal-related Complications | 0 |
Mean change in the combined t-score was measured by Dexa-scan. The patients bone density was determined by Dexa-scan at baseline, after 6 months Zometa and after 12 months of Zometa. The t-score, which is a comparison of a person's bone density with that of a healthy 30-year old of the same sex, was generated by Dexa-scan for the spine and femur. A lower t-score implies a lower BMD. The combined t-score is the minimum of the t-score for the spine and that for the femur. BMD change from baseline at 6 and 12 months in the combined t-score was defined as the follow-up combined t-score minus the baseline combined t-score.
| T score units | IV Zometa |
|---|---|
| Change in combined BMD at 6 months (n=27) | .01 ± .21 |
| Change in combined BMD at 12 months (n=19) | -.06 ± .31 |
Collected over All Adverse Events regardless of grade over a period of 1 year. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| IV Zometa | — | 16/59 (27.1%) | 31/59 (52.5%) |
| Event | IV Zometa |
|---|---|
| feverGeneral disorders | 5/59 |
| seizureNervous system disorders | 4/59 |
| infections and infestations-otherInfections and infestations | 3/59 |
| Depressed level of consciousnessNervous system disorders | 3/59 |
| headacheNervous system disorders | 3/59 |
| thrombo embolic eventVascular disorders | 3/59 |
| diarrheaGastrointestinal disorders | 2/59 |
| Skin infectionInfections and infestations | 2/59 |
| Vascular access complicationInjury, poisoning and procedural complications | 2/59 |
| Skin ulcerationSkin and subcutaneous tissue disorders | 1/59 |
| Event | IV Zometa |
|---|---|
| fatigueGeneral disorders | 14/59 |
| memory impairmentNervous system disorders | 11/59 |
| confusionPsychiatric disorders | 10/59 |
| headacheNervous system disorders | 9/59 |
| constipationGastrointestinal disorders | 8/59 |
| Peripheral motor neuropathyNervous system disorders | 8/59 |
| dysphasiaNervous system disorders | 8/59 |
| insomniaPsychiatric disorders | 7/59 |
| Generalized muscle weaknessMusculoskeletal and connective tissue disorders | 7/59 |
| erectile dysfunctionRenal and urinary disorders | 7/59 |
| Age, Categorical(Participants) | IV Zometa |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 49 |
| >=65 years | 10 |
| Age Continuous(years) | IV Zometa |
|---|---|
| Mean | 54.7 ± 9.4 |
| Sex: Female, Male(Participants) | IV Zometa |
|---|---|
| Female | 21 |
| Male | 38 |
| Anticonvulsant use(participants) | IV Zometa |
|---|---|
| yes | 54 |
| no | 5 |
| Steroid use(participants) | IV Zometa |
|---|---|
| yes | 41 |
| no | 18 |
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