Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.

Zoledronate in Preventing Osteoporosis in Patients With Primary Malignant Glioma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00301873
Recruitment Status : Completed
First Posted : March 13, 2006
Results First Posted : January 16, 2013
Last Update Posted : February 18, 2013
Sponsor:
Collaborators:
Novartis
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Duke University

Tracking Information
First Submitted Date  ICMJE March 9, 2006
First Posted Date  ICMJE March 13, 2006
Results First Submitted Date  ICMJE October 15, 2012
Results First Posted Date  ICMJE January 16, 2013
Last Update Posted Date February 18, 2013
Study Start Date  ICMJE May 2006
Actual Primary Completion Date February 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 10, 2012)
Percent of Patients With Change in Combined Bone Mass Density T-score <= -0.5. [ Time Frame: 6 and 12 months ]
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.
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00301873 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 10, 2012)
  • Skeletal-related Complications [ Time Frame: 1 year ]
    Number of patients who experience skeletal-related complications during the administration of Zoledronate.
  • Mean Change in Bone Mass Density (BMD) [ Time Frame: 6 & 12 months ]
    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.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Zoledronate in Preventing Osteoporosis in Patients With Primary Malignant Glioma
Official Title  ICMJE Phase II Study of Zometa (Zoledronic Acid) to Prevent Osteoporosis in Patients With Brain Tumors
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.

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 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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Brain Tumors
  • Osteoporosis
  • Central Nervous System(CNS)Malignancies
Intervention  ICMJE Drug: IV Zometa
Zometa will be given at 4 mg intravenously over 15 minutes every 3 months for 1 year.
Other Name: zolondronic acid
Study Arms  ICMJE Experimental: IV Zometa
Zometa will be given at 4 mg intravenously over 15 minutes every 3 months for 1 year.
Intervention: Drug: IV Zometa
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 16, 2012)
60
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE September 2012
Actual Primary Completion Date February 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Patients must have histologically confirmed diagnosis of a primary brain tumor.
  2. Patients must be on Depakote ( Valproic Acid) or one of the following enzyme inducing anticonvulsants (EIAC) therapies. Phenobarbital, Dilantin, Trileptal, Tegretol and/or on more than physiologic replacement steroid therapy (Dexamethasone >0.75 mg/d, prednisone >5 mg/d or hydrocortisone >20 mg/d).
  3. Age > 18 years.
  4. Karnofsky performance score > 60%
  5. 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:

    • Serum creatinine < 2.0 mg/dl and calculated creatinine clearance of >60 mL/min
    • Total serum bilirubin < 1.5 times upper limit of laboratory normal
    • Serum glutamoc-oxaloacetic transaminase (SGOT) and serum glutamic pyruvic transaminase (SGPT) < 2.5 times upper limit of laboratory normal
    • Alkaline phosphatase of <2 times upper limit of laboratory normal
  6. Patients must have recovered from any effects of major surgery.
  7. Patients must have a life expectancy of greater than 12 weeks.
  8. Patients or legal guardian must give written, informed consent.

Exclusion Criteria:

  1. Patients who are poor medical risks because of non-malignant systemic disease as well as those with acute infection treated with intravenous antibiotics.
  2. Previous or concurrent malignancies at other sites with the exception of surgically cured carcinoma in-situ of the cervix and basal or squamous cell carcinoma of the skin.
  3. Known HIV positivity or AIDS-related illness.
  4. Pregnant or nursing women.
  5. Women of childbearing potential who are not using an effective method of contraception. Women of childbearing potential must have a negative serum pregnancy test 72hours prior to administration of study and be practicing medically approved contraceptive precautions.
  6. Men who are not advised to use and effective method of contraception.
  7. Patients previously diagnosed with osteoporosis requiring oral bisphosphonates.
  8. Known hypersensitivity to Zometa® (zoledronic acid) or other bisphosphonates
  9. Current active dental problems including infection of the teeth or jawbone osteonecrosis of the jaw (ONJ), of exposed bone in the mouth, or of slow healing after dental procedures.
  10. Recent (within 6 weeks) or planned dental or jaw surgery (e.g.. extraction, implants).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00301873
Other Study ID Numbers  ICMJE Pro00010125
P50NS020023 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Duke University
Study Sponsor  ICMJE Duke University
Collaborators  ICMJE
  • Novartis
  • National Institute of Neurological Disorders and Stroke (NINDS)
Investigators  ICMJE
Study Chair: James J. Vredenburgh, MD Duke University
PRS Account Duke University
Verification Date February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP