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| ID | Type | Description | Link |
|---|---|---|---|
| UMN-0506M70866 | Other Identifier | IRB, University of Minnesota | |
| UMN-MT2005-06 | Other Identifier | Blood and Marrow Transplantation Program | |
| NOVARTIS-CZOL446EUS29 | Other Identifier | Novartis |
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RATIONALE: Zoledronic acid, vitamin D, and calcium may prevent bone loss in patients who are undergoing donor stem cell transplant.
PURPOSE: This randomized phase II trial is studying how well zoledronic acid works in preventing osteoporosis in patients undergoing donor stem cell transplant.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter, open-label, prospective, randomized, controlled study. Patients are stratified according to participating center and type of transplant (myeloablative vs nonmyeloablative). Patients are randomized to 1 of 2 treatment arms.
In both arms, treatment continues in the absence of unacceptable toxicity.
After completion of study treatment, patients are followed periodically for up to 12 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (control) | Active Comparator | Patients receive oral cholecalciferol (vitamin D) and oral calcium once a day for 12 months. |
|
| Arm II (treatment) | Experimental | Patients receive vitamin D and calcium as in arm I. Patients also receive zoledronic acid intravenously (IV) over 15-30 minutes at 28 days prior to stem cell transplantation and at 3 and 6 months after transplantation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| calcium | Dietary Supplement | All randomized patients (control and study drug) will take 1000 mg of calcium and 400 - 500 International Units (IU) of vitamin D orally each day, beginning as soon as possible after study enrollment. These supplements may be taken either in the morning or in the evening with food. Participants will continue taking the supplements on a daily basis until the final study visit (approximately 12 months after the transplant date). |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change in Bone Mineral Density | Change in bone mineral density of the femoral neck measured from baseline to 12 months after transplant utilizing Dual-energy X-ray absorptiometry (DEXA) scan. Comparison of difference between the standard of care group (receiving calcium and vitamin D)and the Zometa group. The measurement consists of baseline bone mineral density measurements with followup measurements at 12 months. This will be analyzed as a continuous variable. Percent change in bone mineral density (BMD) will be calculated as (BMD change) x 100/BMD baseline. | From Time of Transplant to 12 Months Post-Transplant |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change in Serum Osteocalcin | Change in bone resorption markers of bone metabolism measured at baseline and 12 months post transplant for all enrolled patients. As osteocalcin is produced by osteoblasts, it is often used as a marker for the bone formation process. | From Time of Transplant to 12 Months Post-Transplant |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Linda J. Burns, MD | Masonic Cancer Center, University of Minnesota | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Masonic Cancer Center at University of Minnesota | Minneapolis | Minnesota | 55455 | United States | ||
| University of Wisconsin Paul P. Carbone Comprehensive Cancer Center |
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Patients undergoing allogeneic hematopoietic stem cell transplantation (HCT) at participating institutions were offered this trial. If the patient met study requirements, the patient was registered and randomized.
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm I (Standard of Care) | Patients receive oral cholecalciferol (vitamin D) and oral calcium once a day for 12 months. |
| FG001 | Arm II (Treatment With Zometa) | Patients receive vitamin D and calcium as in arm I. Patients also receive zoledronic acid IV over 15-30 minutes at 28 days prior to stem cell transplantation and at 3 and 6 months after transplantation. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm I (Standard of Care) | Patients receive oral cholecalciferol (vitamin D) and oral calcium once a day for 12 months. |
| BG001 | Arm II (Treatment With Zometa) | Patients receive vitamin D and calcium as in arm I. Patients also receive zoledronic acid IV over 15-30 minutes at 28 days prior to stem cell transplantation and at 3 and 6 months after transplantation. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Change in Bone Mineral Density | Change in bone mineral density of the femoral neck measured from baseline to 12 months after transplant utilizing Dual-energy X-ray absorptiometry (DEXA) scan. Comparison of difference between the standard of care group (receiving calcium and vitamin D)and the Zometa group. The measurement consists of baseline bone mineral density measurements with followup measurements at 12 months. This will be analyzed as a continuous variable. Percent change in bone mineral density (BMD) will be calculated as (BMD change) x 100/BMD baseline. | Posted | Mean | Standard Deviation | percent | From Time of Transplant to 12 Months Post-Transplant |
|
Serious adverse events are collected from first dose of study medication through 30 days of the last dose of treatment. Any death that occured within one year of first treatment is also included.
Adverse reactions to Zometa® (zoledronic acid for injection) are usually mild and transient and similar to those reported for other bisphosphonates. Therefore, only serious events were collected.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm I (Standard of Care) | Patients receive oral cholecalciferol (vitamin D) and oral calcium once a day for 12 months. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | General disorders | CTCAE (3.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Linda Burns, M.D. | Masonic Cancer Center, University of Minnesota | 612-624-8144 | burns023@umn.edu |
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| ID | Term |
|---|---|
| D007938 | Leukemia |
| D008223 | Lymphoma |
| D009190 | Myelodysplastic Syndromes |
| D010024 | Osteoporosis |
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D002118 | Calcium |
| D002119 | Calcium Carbonate |
| D019355 | Calcium Citrate |
| D002125 | Calcium Gluconate |
| D002762 | Cholecalciferol |
| D000077211 | Zoledronic Acid |
| ID | Term |
|---|---|
| D008673 | Metals, Alkaline Earth |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D008670 | Metals |
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|
|
| cholecalciferol | Dietary Supplement | Given orally |
|
| zoledronic acid | Drug | Zoledronic acid (Zometa®) will be administered after randomization (but within 28 days prior to transplant) and at 3 and 6 months after the transplant for a total of 3 doses. The dose of Zometa will be 4 mg intravenous in 100 ml of sterile 0.9% sodium chloride, United States Pharmacopeia (USP), or 5% dextrose, USP infused over a minimum of 15 minutes for patients with a calculated creatinine clearance of ≥60 mL/min. The drug may be administered through a peripheral or a central intravenous line. |
|
|
| Mean Change in Serum Bone Specific Alkaline Phosphate |
Change in bone resorption markers of bone metabolism measured at baseline and 12 months post transplant for all enrolled patients. The decrease in serum bone-specific alkaline phosphatase predicts bone mineral density response to hormone replacement therapy in early postmenopausal women. |
| From Time of Transplant to 12 Months Post-Transplant |
| Mean Change in Urinary N-terminal Telopeptide | Change in bone resorption markers of bone metabolism measured at baseline and 12 months post transplant for all enrolled patients. In bone physiology, the N-terminal telopeptide is a biomarker used to measure the rate of bone turnover. | From Time of Transplant to 12 Months Post-Transplant |
| Mean Change in Luteinizing Hormone | Change in bone resorption markers of bone metabolism measured at baseline and 12 months post transplant for all enrolled patients. Luteinizing hormone is a hormone produced by the anterior pituitary gland. | From Time of Transplant to 12 Months Post-Transplant |
| Mean Change in Follicle-Stimulating Hormone | Change in bone resorption markers of bone metabolism measured at baseline and 12 months post transplant for all enrolled patients. Follicle-stimulating hormone is a hormone produced by the anterior pituitary gland. | From Time of Transplant to 12 Months Post-Transplant |
| Mean Change in Thyroid Function Test 4 | Change in bone resorption markers of bone metabolism measured at baseline and 12 months post transplant for all enrolled patients. Individuals who have hyperthyroidism will have an elevated thyroxine (FT4). Low serum thyroxine can also indicate a pituitary problem. | From Time of Transplant to 12 Months Post-Transplant |
| Mean Change in Ultrasensitive Estradiol | Change in bone resorption markers of bone metabolism measured at baseline and 12 months post transplant for all enrolled patients. In women estradiol is responsible for growth of the breast and reproductive epithelia, maturation of long bones and development of the secondary sexual characteristics. | From Time of Transplant to 12 Months Post-Transplant |
| Mean Change in Total Testosterone | Change in bone resorption markers of bone metabolism measured at baseline and 12 months post transplant for all enrolled patients. Testosterone affects the brain, bone and muscle mass, fat distribution, the vascular system, energy levels, genital tissues, and sexual functioning. | From Time of Transplant to 12 Months Post-Transplant |
| Madison |
| Wisconsin |
| 53792-6164 |
| United States |
| Early relapse |
|
| Missing data |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Arm II (Treatment With Zometa) |
Patients receive vitamin D and calcium as in arm I. Patients also receive zoledronic acid intravenously (IV) over 15-30 minutes at 28 days prior to stem cell transplantation and at 3 and 6 months after transplantation. |
|
|
| Secondary | Mean Change in Serum Osteocalcin | Change in bone resorption markers of bone metabolism measured at baseline and 12 months post transplant for all enrolled patients. As osteocalcin is produced by osteoblasts, it is often used as a marker for the bone formation process. | Posted | Mean | Standard Deviation | ng/ml | From Time of Transplant to 12 Months Post-Transplant |
|
|
|
| Secondary | Mean Change in Serum Bone Specific Alkaline Phosphate | Change in bone resorption markers of bone metabolism measured at baseline and 12 months post transplant for all enrolled patients. The decrease in serum bone-specific alkaline phosphatase predicts bone mineral density response to hormone replacement therapy in early postmenopausal women. | Posted | Mean | Standard Deviation | U/L | From Time of Transplant to 12 Months Post-Transplant |
|
|
|
| Secondary | Mean Change in Urinary N-terminal Telopeptide | Change in bone resorption markers of bone metabolism measured at baseline and 12 months post transplant for all enrolled patients. In bone physiology, the N-terminal telopeptide is a biomarker used to measure the rate of bone turnover. | Posted | Mean | Standard Deviation | nM Bone Collagen Equivalents/mM creatini | From Time of Transplant to 12 Months Post-Transplant |
|
|
|
| Secondary | Mean Change in Luteinizing Hormone | Change in bone resorption markers of bone metabolism measured at baseline and 12 months post transplant for all enrolled patients. Luteinizing hormone is a hormone produced by the anterior pituitary gland. | Posted | Mean | Standard Deviation | IU/L | From Time of Transplant to 12 Months Post-Transplant |
|
|
|
| Secondary | Mean Change in Follicle-Stimulating Hormone | Change in bone resorption markers of bone metabolism measured at baseline and 12 months post transplant for all enrolled patients. Follicle-stimulating hormone is a hormone produced by the anterior pituitary gland. | Posted | Mean | Standard Deviation | IU/L | From Time of Transplant to 12 Months Post-Transplant |
|
|
|
| Secondary | Mean Change in Thyroid Function Test 4 | Change in bone resorption markers of bone metabolism measured at baseline and 12 months post transplant for all enrolled patients. Individuals who have hyperthyroidism will have an elevated thyroxine (FT4). Low serum thyroxine can also indicate a pituitary problem. | Posted | Mean | Standard Deviation | ng/dL | From Time of Transplant to 12 Months Post-Transplant |
|
|
|
| Secondary | Mean Change in Ultrasensitive Estradiol | Change in bone resorption markers of bone metabolism measured at baseline and 12 months post transplant for all enrolled patients. In women estradiol is responsible for growth of the breast and reproductive epithelia, maturation of long bones and development of the secondary sexual characteristics. | Posted | Mean | Standard Deviation | pg/ml | From Time of Transplant to 12 Months Post-Transplant |
|
|
|
| Secondary | Mean Change in Total Testosterone | Change in bone resorption markers of bone metabolism measured at baseline and 12 months post transplant for all enrolled patients. Testosterone affects the brain, bone and muscle mass, fat distribution, the vascular system, energy levels, genital tissues, and sexual functioning. | Posted | Mean | Standard Deviation | ng/dL | From Time of Transplant to 12 Months Post-Transplant |
|
|
|
| 8 |
| 29 |
| 0 |
| 0 |
| EG001 | Arm II (Treatment With Zometa) | Patients receive vitamin D and calcium as in arm I. Patients also receive zoledronic acid IV over 15-30 minutes at 28 days prior to stem cell transplantation and at 3 and 6 months after transplantation. | 21 | 32 | 0 | 0 |
| Graft-versus-host disease | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Idiopathic pulmonary syndrome | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Infection with unknown absolute neutrophil count | Infections and infestations | CTCAE (3.0) | Systematic Assessment | Pneumonia |
|
| New Malignancy | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (3.0) | Systematic Assessment |
|
| Nosebleed | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Pseudomonas sepsis | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
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| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D001855 | Bone Marrow Diseases |
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D001779 |
| Blood Coagulation Factors |
| D001685 | Biological Factors |
| D017610 | Calcium Compounds |
| D002254 | Carbonates |
| D002255 | Carbonic Acid |
| D017554 | Carbon Compounds, Inorganic |
| D008903 | Minerals |
| D019343 | Citric Acid |
| D002951 | Citrates |
| D014233 | Tricarboxylic Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D005942 | Gluconates |
| D013400 | Sugar Acids |
| D006880 | Hydroxy Acids |
| D002241 | Carbohydrates |
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |
| D004164 | Diphosphonates |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |