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Effect of Zoledronic Acid on Chemotherapy Induced Bone Loss
This study is currently recruiting participants.
Verified by M.D. Anderson Cancer Center, December 2008
Sponsors and Collaborators: M.D. Anderson Cancer Center
Novartis
Information provided by: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00352846
  Purpose

Primary Objective:

-Evaluate the effect of zoledronate on change in 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.
  • Evaluate zoledronate effect on new bone fractures.
  • Evaluate the cost-effectiveness of zoledronic acid (with calcium and vitamin D) versus standard treatment (calcium and vitamin D alone).

Condition Intervention Phase
Non-Hodgkin's Lymphoma
Lymphoma
Drug: Zoledronic Acid
Drug: Vitamin D
Drug: Calcium Carbonate
Phase III

MedlinePlus related topics: Calcium Cancer Lymphoma Osteoporosis
Drug Information available for: Zoledronic acid Calcium gluconate Vitamin D Ergocalciferol Calcium carbonate BaseLine
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title: Effect of Zoledronic Acid on Chemotherapy Induced Bone Loss in Non-Hodgkin's Lymphoma Patients Receiving Chemotherapy

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • To learn if the drug zoledronic acid (Zometa™) can help decrease the risk of osteoporosis (bone loss) in people who are receiving chemotherapy for the treatment of NHL. [ Time Frame: 4 Years ] [ Designated as safety issue: No ]

Estimated Enrollment: 106
Study Start Date: January 2006
Estimated Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
Vitamin D + Calcium Carbonate
Drug: Vitamin D
400 mg PO Daily
Drug: Calcium Carbonate
1200 mg PO Daily
2: Experimental
Vitamin D + Calcium Carbonate + Zoledronic Acid
Drug: Zoledronic Acid
4 mg/m^2 IV Over 30 Minutes at baseline and 6 months.
Drug: Vitamin D
400 mg PO Daily
Drug: Calcium Carbonate
1200 mg PO Daily

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.

Before you can start treatment on this study, you will have what are called "screening tests." These tests will help the doctor decide if you are eligible to take part in this study. You will be asked questions about your health and any medications you are taking, and your medical history will be recorded. You will have a physical exam, including measurement of height, weight, blood pressure, and heart rate. You will have blood (about 2 tablespoons) and urine samples taken for routine tests. X-rays and bone density scans will be done to look for bone fractures, bone health, and to measure your bone. Women who are able to have children must have a negative blood or urine pregnancy test.

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 twice daily 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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of Non-Hodgkin's Lymphoma (B- or T-cell) or Hodgkin's lymphoma.
  • Prior Chemotherapy</= 4 weeks of treatment.
  • Age >/= 18 years old.
  • ECOG Performance Status 0-3.
  • Estimated creatinine clearance >/= 60 ml/min.
  • Must sign an informed consent form.

Exclusion Criteria:

  • 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.
  • Active osteomalacia.
  • Untreated hypocalcemia (ionized, iCa), Ionized Ca level must be within normal limits prior to enrollment.
  • Untreated secondary hyperparathyroidism, Patients with abnormal PTH levels may be enrolled as long as they are being treated.
  • Untreated vitamin D deficiency, Vit. 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00352846

Contacts
Contact: Fredrick Hagemeister, MD 713-792-2860

Locations
United States, Texas
U.T.M.D. Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Fredrick Hagemeister, MD            
Sponsors and Collaborators
M.D. Anderson Cancer Center
Novartis
Investigators
Principal Investigator: Fredrick Hagemeister, MD U.T.M.D. Anderson Cancer Center
  More Information

MD Anderson Cancer Center  This link exits the ClinicalTrials.gov site

Responsible Party: U.T.M.D. Anderson Cancer Center ( Fredrick Hagemeister, MD/Professor )
Study ID Numbers: 2005-0698
Study First Received: July 13, 2006
Last Updated: December 12, 2008
ClinicalTrials.gov Identifier: NCT00352846  
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Non-Hodgkin's Lymphoma
Lymphoma
Zoledronic Acid
Vitamin D
Calcium Carbonate
Zometa
Bone Loss

Study placed in the following topic categories:
Calcium, Dietary
Lymphatic Diseases
Diphosphonates
Vitamin D
Zoledronic acid
Immunoproliferative Disorders
Ergocalciferols
Lymphoma, small cleaved-cell, diffuse
Calcium Carbonate
Lymphoproliferative Disorders
Lymphoma, Non-Hodgkin
Lymphoma

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Growth Substances
Vitamins
Physiological Effects of Drugs
Bone Density Conservation Agents
Antacids
Micronutrients
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009