Brain TumorsPhase 2NCT00301873
Zoledronate in Preventing Osteoporosis in Patients With Primary Malignant Glioma
A Phase 2 study testing IV Zometa in people with Brain Tumors and Osteoporosis, run by Duke University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Tumors, Osteoporosis, Central Nervous System(CNS)Malignancies
- What is being tested?
- IV Zometa
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- May 2006to Sep 2012
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have histologically confirmed diagnosis of a primary brain tumor.
- 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).
- Age > 18 years.
- Karnofsky performance score > 60%
- 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
Show all 12Show fewer
- 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
- Patients must have recovered from any effects of major surgery.
- Patients must have a life expectancy of greater than 12 weeks.
- Patients or legal guardian must give written, informed consent.
Who cannot join
- Patients who are poor medical risks because of non-malignant systemic disease as well as those with acute infection treated with intravenous antibiotics.
- 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.
- Known HIV positivity or AIDS-related illness.
- Pregnant or nursing women.
- 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.
- Men who are not advised to use and effective method of contraception.
Show all 10Show fewer
- Patients previously diagnosed with osteoporosis requiring oral bisphosphonates.
- Known hypersensitivity to Zometa® (zoledronic acid) or other bisphosphonates
- 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.
- Recent (within 6 weeks) or planned dental or jaw surgery (e.g.. extraction, implants).
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke Comprehensive Cancer Center
Durham, North Carolina, 27710
About this study
Official title: Phase II Study of Zometa (Zoledronic Acid) to Prevent Osteoporosis in Patients With Brain Tumors
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.
Read the 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
- Being tested
- IV Zometa
- Keywords
- osteoporosis, adult anaplastic astrocytoma, adult giant cell glioblastoma, adult anaplastic oligodendroglioma, adult gliosarcoma, adult mixed glioma, recurrent adult brain tumor, adult glioblastoma
- Medical subject headings
- Brain Neoplasms, Osteoporosis, Astrocytoma, Glioblastoma, Oligodendroglioma, Gliosarcoma, Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IV ZometaDrug
Also called zolondronic acid
Zometa will be given at 4 mg intravenously over 15 minutes every 3 months for 1 year.
| Study group | Role | What they receive |
|---|---|---|
| IV Zometa | Experimental | Zometa will be given at 4 mg intravenously over 15 minutes every 3 months for 1 year. Receives: Drug: IV Zometa |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 and 12 months
Secondary outcomes (2)
Skeletal-related Complications
Number of patients who experience skeletal-related complications during the administration of Zoledronate.
Measured: 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.
Measured: 6 & 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2006 (estimated)
- Study startMay 2006
- Primary completionFeb 2011
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Brain TumorsStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis, National Institute of Neurological Disorders and Stroke (NINDS)
- Responsible party
- Sponsor
- Investigators
- James J. Vredenburgh, MD, Study chair, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00301873
- Sponsor's protocol ID
- Pro00010125
- Other IDs
- P50NS020023
- Status last verified
- Feb 2013
- First submitted
- 9 Mar 2006
- Last updated
- 18 Feb 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Zometa (Zoledronic Acid) to Prevent Osteoporosis in Patients With Brain Tumors
- ClinicalTrials.gov ID
- NCT00301873
- Acronym / sponsor ID
- Pro00010125
- Keywords
- osteoporosis, adult anaplastic astrocytoma, adult giant cell glioblastoma, adult anaplastic oligodendroglioma, adult gliosarcoma, adult mixed glioma, recurrent adult brain tumor, adult glioblastoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Novartis, National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- May 2006
- Primary completion
- Feb 2011 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 13 Mar 2006 (estimated)
- Results
- Posted 16 Jan 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IV Zometa | Experimental | Drug: IV ZometaZometa will be given at 4 mg intravenously over 15 minutes every 3 months for 1 year. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Patients must have histologically confirmed diagnosis of a primary brain tumor.
- 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).
- Age > 18 years.
- Karnofsky performance score > 60%
- 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:
Key exclusion criteria (10 listed)
- Patients who are poor medical risks because of non-malignant systemic disease as well as those with acute infection treated with intravenous antibiotics.
- 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.
- Known HIV positivity or AIDS-related illness.
- Pregnant or nursing women.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IV ZometaAlso: zolondronic acidZometa will be given at 4 mg intravenously over 15 minutes every 3 months for 1 year. | Drug | IV Zometa |
Primary outcome
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.
2 secondary outcomes
Skeletal-related Complications
Time frame: 1 year
Mean Change in Bone Mass Density (BMD)
Time frame: 6 & 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Brain Tumors
RecruitingPhase 3
Beginning Radiation Immediately With GammaTile at GBM Excision Versus Standard of Care
Glioblastoma
RecruitingPhase 2
BrAin Metastasis in tripLe Negateive Breast Cancer: IvoneScimab and Trop2 ADC
Triple-Negative Breast Cancer (TNBC), Brain Metastases
RecruitingPhase 1/2
Testing the Addition of an Anti-cancer Drug, Selinexor, to the Usual Chemotherapy Treatment (Temozolomide) for Brain Tumors That Have Returned After Previous Treatment
Recurrent Glioblastoma, IDH-Wildtype, Recurrent MGMT-Methylated Glioblastoma
Active, not recruiting
Effects of Whole-body Electrical Muscle Stimulation Exercise on Adults With Neuromuscular Disease
Neuromuscular Diseases (NMD), Amyotrophic Lateral Sclerosis
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James J. Vredenburgh, MD study chair
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing IV Zometa in people with Brain Tumors and Osteoporosis, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Jan 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent of Patients With Change in Combined Bone Mass Density T-score <= -0.5. (time frame: 6 and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2013.