Non-Hodgkin's LymphomaPhase 3NCT00352846
Effect of Zoledronic Acid on Chemotherapy Induced Bone Loss
A Phase 3 study testing Zoledronic Acid, Vitamin D and Calcium Carbonate in people with Non-Hodgkin's Lymphoma and Lymphoma, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
Primary Objective: Evaluate the effect of zoledronate on change in bone mineral density (BMD) at the total lumbar spine and femoral neck. Secondary Objectives: Evaluate the effect of zoledronate on change in BMD at the total hip Evaluate risk factors for developing osteoporosis on chemotherapy Determine correlative… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Hodgkin's Lymphoma, Lymphoma
- What is being tested?
- Zoledronic Acid, Vitamin D and Calcium Carbonate
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2006to Sep 2011
- Phase
- Phase 3
- 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
- Diagnosis of Non-Hodgkin's Lymphoma (B- or T-cell) or Hodgkin's lymphoma.
- Prior Chemotherapy</= 4 weeks of treatment.
- Age >/= 18 years old.
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-3.
- Estimated creatinine clearance >/= 60 ml/min.
- Must sign an informed consent form.
Who cannot join
- Radiologic evidence of vertebral or hip fracture.
- BMD T-score less than (i.e., worse than or more negative than) -2.0 at any of the following sites: lumbar spine, femoral neck, or total hip.
- Patients with secondary non-lymphomatous cancers metastatic to bone. However, other secondary cancers are allowed.
- Spinal cord compression due to vertebral collapse.
- Bisphosphonate treatment in the prior 6 months or steroid use (greater than 35 mg of prednisone equivalent steroids) in the prior 3 months. The use of topical, inhaled, or nasal steroids is allowed.
- Primary hyperparathyroidism.
Show all 19Show fewer
- Active osteomalacia.
- Untreated hypocalcemia (ionized, iCa), Ionized Ca level must be within normal limits prior to enrollment.
- Untreated secondary hyperparathyroidism, Patients with abnormal parathyroid hormone (PTH) levels may be enrolled as long as they are being treated.
- Untreated vitamin D deficiency, Vitamin D level may be abnormal and patient may be enrolled as long as they are being treated.
- Untreated low testosterone (test in men only), testosterone level may be abnormal and patient may be enrolled as long as they are being treated.
- Paget's disease.
- Pregnant or breast-feeding.
- Radiotherapy involving the mandible.
- Current active dental problems including infection of the teeth or jawbone (maxilla or mandibular); dental or fixture trauma, or a current or prior diagnosis of osteonecrosis of the jaw (ONJ), or of exposed bone in the mouth, or of slow healing after dental procedures.
- Recent (within 3 weeks) or planned dental or jaw surgery (e.g.. extraction, implants).
- Patients with abnormal renal function as evidenced by either a serum creatinine greater than 3 mg/dL or by a calculated creatinine clearance of < 60 mL/minute.
- Known hypersensitivity to zoledronic acid or other bisphosphonates.
- Hypercalcemia: corrected Ca > 10.2 mg/dL or ionized Ca > 1.32 mmol/L
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Zoledronic Acid on Chemotherapy Induced Bone Loss in Non-Hodgkin's Lymphoma Patients Receiving Chemotherapy
Primary Objective:
- Evaluate the effect of zoledronate on change in bone mineral density (BMD) at the total lumbar spine and femoral neck.
Secondary Objectives:
- Evaluate the effect of zoledronate on change in BMD at the total hip
- Evaluate risk factors for developing osteoporosis on chemotherapy
- Determine correlative markers for response to zoledronate 4. Evaluate zoledronate effect on new bone fractures 5. Evaluate the cost-effectiveness of zoledronic acid (with calcium and vitamin D) versus standard treatment (calcium and vitamin D alone).
Read the detailed description
Medicines called "bisphosphonates" have been shown to help people with cancer that has spread to their bones. Zoledronic acid is a "bisphosphonate". Some bisphosphonates are pills that can be swallowed. Other bisphosphonates such as zoledronic acid need to be given by vein (or intravenously). Some studies have shown that people with multiple myeloma, breast cancer, and prostate cancer that had spread to the bone had less side effects from their bone disease when they were treated with bisphosphonates by vein.
If you are found to be eligible to take part in this study, you will be randomly assigned (as in the toss of a coin) to one of two treatment groups. Participants in one group will receive standard care with calcium and Vitamin D alone. Participants in the other group will receive standard care with calcium and Vitamin D plus zoledronic acid. There is an equal chance of being assigned to either group. Both you and your study doctor will know if you are being treated with zoledronic acid.
You will be asked to come to the doctor's clinic 5 times over about 12 months (at the start of the study [baseline] and then every 3 months). Each visit should take about 1 hour. Participants in the zoledronic acid group will receive an infusion of zoledronic acid by vein at baseline and at 6 months into the study. The infusion will last about 30 minutes. This infusion procedure may or may not be done at the same time as your already scheduled chemotherapy treatment.
You will take calcium and Vitamin D pills while on study at amounts recommended for prevention of osteoporosis.
You will have a physical exam done at every visit. Various x-rays and/or bone density scans will be repeated after 12 months. Your doctor may also want to do additional bone density or x-ray scans if you have new symptoms or your symptoms get worse.
Before each treatment, you will have a blood test (about 1-2 teaspoons of blood) to make sure your kidneys are okay before each treatment with zoledronic acid. At each visit. your doctor or nurse will ask you how you are feeling and will ask about any medications you are taking or any medical problems you have had since your last visit. You will be asked to complete questionnaires about how you are feeling at certain visits. These questionnaires are 1 page long and should only take a few minutes to complete.
It is anticipated that your participation in this study will be 12 months. If your cancer gets worse, or if your doctor feels that you should be treated with a different medicine, you will be taken off of this study and your doctor will talk to you about other medicines that may be better for you.
Participants who received Zoledronic Acid will be contacted regularly to ask about any experience of osteonecrosis (bone death), for 10 years from the time they enroll on study. They will be interviewed by telephone call every 6 months.
This is an investigational study. Zoledronic acid is approved by the FDA for the treatment of high calcium levels in the blood. Zoledronic acid has not been approved by the FDA for what it is being used for in this study. After the treatment ends, you may continue to receive zoledronic acid or a similar drug, if your cancer doctor feels that it would help you. About 72 patients will take part in this study. All will be enrolled at M. D. Anderson.
- Conditions
- Non-Hodgkin's Lymphoma, Lymphoma
- Being tested
- Zoledronic Acid, Vitamin D, Calcium Carbonate
- Keywords
- Non-Hodgkin's Lymphoma, Lymphoma, Zoledronic Acid, Zoledronate, Zometa, Vitamin D, Calcium Carbonate, Bone Loss
- Medical subject headings
- Lymphoma, Non-Hodgkin, Lymphoma, Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zoledronic AcidDrug
Also called Zometa, Zoledronate
4 mg/m^2 by vein over 30 Minutes at baseline and 6 months.
Vitamin DDrug
400 mg by mouth daily
Calcium CarbonateDrug
1200 mg by mouth daily
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D + Calcium Carbonate | Experimental | Oral Vitamin D 400 mg daily + Calcium 1200 mg daily Receives: Drug: Vitamin D; Drug: Calcium Carbonate |
| Vitamin D + Calcium Carbonate + Zoledronic Acid | Experimental | Oral Vitamin D 400 mg daily and Calcium 1200 mg daily; Zoledronic Acid 4 mg/m^2 intravenous at baseline and 6 months. Receives: Drug: Zoledronic Acid; Drug: Vitamin D; Drug: Calcium Carbonate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage Change in Bone Mineral Density (BMD) T-Score From Baseline to 12 Months
The 12-month change from baseline in BMD at the total lumbar spine. BMD evaluation was performed at baseline and at 12 months after initiation of therapy at the lumbar spine. BMD was measured by dual-energy, x-ray absorptiometry scanners. T-Score is the number of standard deviations above or below the mean. A T-score >= -1 indicates a normal BMD, while T-scores between -1 and -2.5 indicate osteopenia and T-scores <= -2.5 indicate osteoporosis.
Measured: From baseline to 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2006 (estimated)
- Study startJan 2006
- Primary completionSep 2011
- Study completionSep 2011
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-Hodgkin's LymphomaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis
- Responsible party
- Sponsor
- Investigators
- Fredrick Hagemeister, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00352846
- Sponsor's protocol ID
- 2005-0698
- Status last verified
- Jun 2013
- First submitted
- 13 Jul 2006
- Last updated
- 2 Jul 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Westin JR, Thompson MA, Cataldo VD, Fayad LE, Fowler N, Fanale MA, Neelapu S, Samaniego F, Romaguera J, Shah J, McLaughlin P, Pro B, Kwak LW, Sanjorjo P, Murphy WA, Jimenez C, Toth B, Dong W, Hagemeister FB. Zoledronic acid for prevention of bone loss in patients receiving primary therapy for lymphomas: a prospective, randomized controlled phase III trial. Clin Lymphoma Myeloma Leuk. 2013 Apr;13(2):99-105. doi: 10.1016/j.clml.2012.11.002. Epub 2012 Dec 29.
PubMed 23276888
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Zoledronic Acid on Chemotherapy Induced Bone Loss in Non-Hodgkin's Lymphoma Patients Receiving Chemotherapy
- ClinicalTrials.gov ID
- NCT00352846
- Acronym / sponsor ID
- 2005-0698
- Conditions
- Non-Hodgkin's Lymphoma, Lymphoma
- Keywords
- Non-Hodgkin's Lymphoma, Lymphoma, Zoledronic Acid, Zoledronate, Zometa, Vitamin D, Calcium Carbonate, Bone Loss
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Novartis
- Study start
- Jan 2006
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 17 Jul 2006 (estimated)
- Results
- Posted 20 Jun 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary Objective:
- Evaluate the effect of zoledronate on change in bone mineral density (BMD) at the total lumbar spine and femoral neck.
Secondary Objectives:
- Evaluate the effect of zoledronate on change in BMD at the total hip
- Evaluate risk factors for developing osteoporosis on chemotherapy
- Determine correlative markers for response to zoledronate 4. Evaluate zoledronate effect on new bone fractures 5. Evaluate the cost-effectiveness of zoledronic acid (with calcium and vitamin D) versus standard treatment (calcium and vitamin D alone).
Detailed description
Medicines called "bisphosphonates" have been shown to help people with cancer that has spread to their bones. Zoledronic acid is a "bisphosphonate". Some bisphosphonates are pills that can be swallowed. Other bisphosphonates such as zoledronic acid need to be given by vein (or intravenously). Some studies have shown that people with multiple myeloma, breast cancer, and prostate cancer that had spread to the bone had less side effects from their bone disease when they were treated with bisphosphonates by vein.
If you are found to be eligible to take part in this study, you will be randomly assigned (as in the toss of a coin) to one of two treatment groups. Participants in one group will receive standard care with calcium and Vitamin D alone. Participants in the other group will receive standard care with calcium and Vitamin D plus zoledronic acid. There is an equal chance of being assigned to either group. Both you and your study doctor will know if you are being treated with zoledronic acid.
You will be asked to come to the doctor's clinic 5 times over about 12 months (at the start of the study [baseline] and then every 3 months). Each visit should take about 1 hour. Participants in the zoledronic acid group will receive an infusion of zoledronic acid by vein at baseline and at 6 months into the study. The infusion will last about 30 minutes. This infusion procedure may or may not be done at the same time as your already scheduled chemotherapy treatment.
You will take calcium and Vitamin D pills while on study at amounts recommended for prevention of osteoporosis.
You will have a physical exam done at every visit. Various x-rays and/or bone density scans will be repeated after 12 months. Your doctor may also want to do additional bone density or x-ray scans if you have new symptoms or your symptoms get worse.
Before each treatment, you will have a blood test (about 1-2 teaspoons of blood) to make sure your kidneys are okay before each treatment with zoledronic acid. At each visit. your doctor or nurse will ask you how you are feeling and will ask about any medications you are taking or any medical problems you have had since your last visit. You will be asked to complete questionnaires about how you are feeling at certain visits. These questionnaires are 1 page long and should only take a few minutes to complete.
It is anticipated that your participation in this study will be 12 months. If your cancer gets worse, or if your doctor feels that you should be treated with a different medicine, you will be taken off of this study and your doctor will talk to you about other medicines that may be better for you.
Participants who received Zoledronic Acid will be contacted regularly to ask about any experience of osteonecrosis (bone death), for 10 years from the time they enroll on study. They will be interviewed by telephone call every 6 months.
This is an investigational study. Zoledronic acid is approved by the FDA for the treatment of high calcium levels in the blood. Zoledronic acid has not been approved by the FDA for what it is being used for in this study. After the treatment ends, you may continue to receive zoledronic acid or a similar drug, if your cancer doctor feels that it would help you. About 72 patients will take part in this study. All will be enrolled at M. D. Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin D + Calcium Carbonate | Experimental | Drug: Vitamin D, Drug: Calcium CarbonateOral Vitamin D 400 mg daily + Calcium 1200 mg daily |
| Vitamin D + Calcium Carbonate + Zoledronic Acid | Experimental | Drug: Zoledronic Acid, Drug: Vitamin D, Drug: Calcium CarbonateOral Vitamin D 400 mg daily and Calcium 1200 mg daily; Zoledronic Acid 4 mg/m^2 intravenous at baseline and 6 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosis of Non-Hodgkin's Lymphoma (B- or T-cell) or Hodgkin's lymphoma.
- Prior Chemotherapy</= 4 weeks of treatment.
- Age >/= 18 years old.
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-3.
- Estimated creatinine clearance >/= 60 ml/min.
Key exclusion criteria (19 listed)
- Radiologic evidence of vertebral or hip fracture.
- BMD T-score less than (i.e., worse than or more negative than) -2.0 at any of the following sites: lumbar spine, femoral neck, or total hip.
- Patients with secondary non-lymphomatous cancers metastatic to bone. However, other secondary cancers are allowed.
- Spinal cord compression due to vertebral collapse.
- Bisphosphonate treatment in the prior 6 months or steroid use (greater than 35 mg of prednisone equivalent steroids) in the prior 3 months. The use of topical, inhaled, or nasal steroids is allowed.
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 |
|---|---|---|
| Zoledronic AcidAlso: Zometa, Zoledronate4 mg/m^2 by vein over 30 Minutes at baseline and 6 months. | Drug | Vitamin D + Calcium Carbonate + Zoledronic Acid |
| Vitamin D400 mg by mouth daily | Drug | Vitamin D + Calcium Carbonate, Vitamin D + Calcium Carbonate + Zoledronic Acid |
| Calcium Carbonate1200 mg by mouth daily | Drug | Vitamin D + Calcium Carbonate, Vitamin D + Calcium Carbonate + Zoledronic Acid |
Primary outcome
Percentage Change in Bone Mineral Density (BMD) T-Score From Baseline to 12 Months
Time frame: From baseline to 12 Months
The 12-month change from baseline in BMD at the total lumbar spine. BMD evaluation was performed at baseline and at 12 months after initiation of therapy at the lumbar spine. BMD was measured by dual-energy, x-ray absorptiometry scanners. T-Score is the number of standard deviations above or below the mean. A T-score >= -1 indicates a normal BMD, while T-scores between -1 and -2.5 indicate osteopenia and T-scores <= -2.5 indicate osteoporosis.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 23276888Westin JR, Thompson MA, Cataldo VD, Fayad LE, Fowler N, Fanale MA, Neelapu S, Samaniego F, Romaguera J, Shah J, McLaughlin P, Pro B, Kwak LW, Sanjorjo P, Murphy WA, Jimenez C, Toth B, Dong W, Hagemeister FB. Zoledronic acid for prevention of bone loss in patients receiving primary therapy for lymphomas: a prospective, randomized controlled phase III trial. Clin Lymphoma Myeloma Leuk. 2013 Apr;13(2):99-105. doi: 10.1016/j.clml.2012.11.002. Epub 2012 Dec 29.
- MD Anderson Cancer CenterLink provided by the sponsor.
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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.
Fredrick Hagemeister, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Zoledronic Acid, Vitamin D and Calcium Carbonate in people with Non-Hodgkin's Lymphoma and Lymphoma, run by M.D. Anderson Cancer Center 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 6 inclusion and 19 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 2 Jul 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 20 Jun 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?
Percentage Change in Bone Mineral Density (BMD) T-Score From Baseline to 12 Months (time frame: From baseline to 12 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00352846, which also lists 1 linked publication.
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 2 Jul 2013.