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Both the calcitriol and exercise interventions are aimed at reducing fracture risk by maintaining proper bone density, thereby preventing osteoporotic/osteopenic conditions and increasing muscle mass. Both calcitriol and exercise are efficacious in maintaining proper bone health and muscle mass among the general population, but little research has been done on breast cancer patients and survivors. The combination of calcitriol and exercise, which function through different but similar mechanisms, could produce interactive effects in reducing fracture risk among breast cancer survivors.
Hypothesis: A combination of calcitriol along with a structured home-based walking and progressive resistance exercise program will be efficacious in preventing bone resorption and in increasing bone formation among survivors of invasive breast cancer.
Primary Objective
To collect data on the efficacy and feasibility of a supplementation of calcitriol with/without an accompanying structured home-based walking/progressive resistance exercise program for improving bone health among breast cancer survivors.
Secondary Objectives
To collect data on the efficacy and feasibility of a supplementation of calcitriol with/without an accompanying structured home-based walking/progressive resistance exercise program for increasing strength among breast cancer survivors.
To collect data on the efficacy and feasibility of a supplementation of calcitriol with/without an accompanying structured home-based walking/progressive resistance exercise program for improving skeletal muscle mass among breast cancer survivors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Multivitamin | Active Comparator | Multivitamin used as control group. |
|
| Exercise | Experimental | Exercise consisting of progressive walking and resistance band training. |
|
| Calcitriol | Experimental | Calcitriol pill taken once per week. |
|
| Calcitriol and Exercise | Experimental | Calcitriol pill taken once per week plus Exercise consisting of progressive walking and resistance band training. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Calcitriol | Drug | Calcitriol tablet taken once per week. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Bone Resorption (Exercise) | Bone Resorption using Serum NTx (Exercise comparison) Serum NTx level is used to aid in predicting skeletal response (bone mineral density) to antiresorptive therapy and in monitoring bone resorption changes following initiation of antiresorptive therapy. Elevated levels of serum NTx indicate elevated bone resorption. Elevated bone resorption is the primary cause of agerelated bone loss and that low bone mass often results in osteopenia and is the major cause of osteoporosis. The measurement range is in nanoMoles (NM) Bone Collagen Equivalents (BCE). | Week 12 |
| Bone Resorption (Calcitriol) | Bone Resorption using Serum NTx (Calcitriol comparison) Serum NTx level is used to aid in predicting skeletal response (bone mineral density) to antiresorptive therapy and in monitoring bone resorption changes following initiation of antiresorptive therapy. Elevated levels of serum NTx indicate elevated bone resorption. Elevated bone resorption is the primary cause of agerelated bone loss and that low bone mass often results in osteopenia and is the major cause of osteoporosis. The measurement range is in nanoMoles (nm) Bone Collagen Equivalents (BCE). | Week 12 |
| Bone Formation (Exercise) | Bone Formation using Serum BSAP (Exercise comparison) The Bone-Specific Alkaline Phosphatase (BSAP) assay provides a general index of bone formation and a specific index of total osteoblast activity. BSAP and osteocalcin are the most effective markers of bone formation and are particularly useful for monitoring bone formation therapies and antiresorptive therapies. | Week 12 |
| Bone Formation (Calcitriol) | Bone Formation using Serum BSAP (Calcitriol comparison) The Bone-Specific Alkaline Phosphatase (BSAP) assay provides a general index of bone formation and a specific index of total osteoblast activity. BSAP and osteocalcin are the most effective markers of bone formation and are particularly useful for monitoring bone formation therapies and antiresorptive therapies. |
| Measure | Description | Time Frame |
|---|---|---|
| Handgrip (kg) Strength - (Exercise) | Handgrip (kg) Strength (Exercise comparison) Hand grip strength can be quantified by measuring the amount of static force that the hand can squeeze around a dynamometer. It is typically measured in kilograms or pounds and varies by sex and age. Normative data for females is AGE 35-39 --> 20.3-34.1kg; AGE 40-44 --> 18.9-32.7kg; AGE 45-49 --> 18.6-32.4kg; AGE 50-54 --> 18.1-31.9kg; AGE 55-59 --> 17.7-31.5kg; AGE 60-64 --> 17.2-31.0kg; AGE 65-69 --> 15.4-27.2kg; AGE 70-99 --> 14.7-24.5kg. Values less than the normal range are considered weak strength. Values greater than the normal range are considered strong strength. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Luke J Peppone, Ph.D. | University of Rochester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Rochester Medical Center | Rochester | New York | 14642 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Multivitamin | Multivitamin used as control group. Multivitamin |
| FG001 | Exericse | Exercise consisting of progressive walking and resistance band training. Exercise: Exercise consisting of progressive walking and resistance band training |
| FG002 | Calcitriol | Calcitriol pill taken once per week. Calcitriol: Calcitriol tablet taken once per week. |
| FG003 | Calcitriol and Exercise | Calcitriol pill taken once per week plus Exercise consisting of progressive walking and resistance band training. Calcitriol: Calcitriol tablet taken once per week. Exercise: Exercise consisting of progressive walking and resistance band training |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Multivitamin | Multivitamin used as control group. Multivitamin |
| BG001 | Exericse | Exercise consisting of progressive walking and resistance band training. Exercise: Exercise consisting of progressive walking and resistance band training |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Bone Resorption (Exercise) | Bone Resorption using Serum NTx (Exercise comparison) Serum NTx level is used to aid in predicting skeletal response (bone mineral density) to antiresorptive therapy and in monitoring bone resorption changes following initiation of antiresorptive therapy. Elevated levels of serum NTx indicate elevated bone resorption. Elevated bone resorption is the primary cause of agerelated bone loss and that low bone mass often results in osteopenia and is the major cause of osteoporosis. The measurement range is in nanoMoles (NM) Bone Collagen Equivalents (BCE). | No Exercise group consists of Multivitamin and Calcitriol arms N=20; Exercise group consists of Exercise and Calcitriol+Exercise arms N=19** ** 2 subjects have missing data for this outcome. | Posted | Least Squares Mean | Standard Error | nm BCE | Week 12 |
|
12 weeks
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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 | Multivitamin | Multivitamin used as control group. Multivitamin | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypercalcemia - Grade 1 | Blood and lymphatic system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Luke J Peppone, PhD, MPH | University of Rochester | 585-275-7827 | Luke_Peppone@urmc.rochester.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 4, 2009 | Feb 13, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D002117 | Calcitriol |
| D015444 | Exercise |
| C067316 | Geritol |
| ID | Term |
|---|---|
| D004100 | Dihydroxycholecalciferols |
| D006887 | Hydroxycholecalciferols |
| D002762 | Cholecalciferol |
| D002782 | Cholestenes |
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| Exercise | Behavioral | Exercise consisting of progressive walking and resistance band training |
|
| Multivitamin | Dietary Supplement |
|
|
| Week 12 |
| Week 12 |
| Handgrip (kg) Strength - (Calcitriol) | Handgrip (kg) Strength - (Calcitriol comparison) Hand grip strength can be quantified by measuring the amount of static force that the hand can squeeze around a dynamometer. It is typically measured in kilograms or pounds and varies by sex and age. Normative data for females is AGE 35-39 --> 20.3-34.1kg; AGE 40-44 --> 18.9-32.7kg; AGE 45-49 --> 18.6-32.4kg; AGE 50-54 --> 18.1-31.9kg; AGE 55-59 --> 17.7-31.5kg; AGE 60-64 --> 17.2-31.0kg; AGE 65-69 --> 15.4-27.2kg; AGE 70-99 --> 14.7-24.5kg. Values less than the normal range are considered weak strength. Values greater than the normal range are considered strong strength. | Week 12 |
| Body Mass Index (Exercise) | Body Mass Index (BMI) - (Exercise Comparison) Measure Description: Body Mass Index (BMI) is a person's weight in kilograms divided by the square of height in meters. Values below 18.5 represent "Underweight", 18.5 to 24.9 represent "Normal or Healthy Weight", 25.0 to 29.9 represent "Overweight" and 30.0 and above represent "Obese". | Week 12 |
| Body Mass Index (Calcitriol) | Body Mass Index(BMI) - (Calcitriol comparison) Measure Description: Body Mass Index (BMI) is a person's weight in kilograms divided by the square of height in meters. Values below 18.5 represent "Underweight", 18.5 to 24.9 represent "Normal or Healthy Weight", 25.0 to 29.9 represent "Overweight" and 30.0 and above represent "Obese". | Week 12 |
| Physician Decision |
|
| Unable to obtain final blood draw |
|
| BG002 | Calcitriol | Calcitriol pill taken once per week. Calcitriol: Calcitriol tablet taken once per week. |
| BG003 | Calcitriol and Exercise | Calcitriol pill taken once per week plus Exercise consisting of progressive walking and resistance band training. Calcitriol: Calcitriol tablet taken once per week. Exercise: Exercise consisting of progressive walking and resistance band training |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Marital Status | Count of Participants | Participants |
|
| Menopausal Status | Count of Participants | Participants |
|
| Hormonal Therapy | Subject did not received hormone therapy. | Count of Participants | Participants |
|
| Stage of Cancer | Stage 0. This stage describes cancer in situ, which means "in place." Stage 0 cancers are located in the place they started and have not spread to nearby tissues. Stage I. This stage is usually a small cancer that has not grown deeply into nearby tissues. Stage II and Stage III. In general, these 2 stages indicate larger cancers that have grown more deeply into nearby tissue. They may have also spread to lymph nodes but not to other parts of the body. Stage IV. This stage means that the cancer has spread to other organs or parts of the body. Stage 0 is best, Stage IV is worst. | Count of Participants | Participants |
|
| Prior Chemotherapy | Count of Participants | Participants |
|
| Prior Radiotherapy | Count of Participants | Participants |
|
| Current Cardiovascular Exercise | Count of Participants | Participants |
|
| Current Resistance Training | Count of Participants | Participants |
|
| Body Mass Index (BMI) | Measure Description: Body Mass Index (BMI) is a person's weight in kilograms divided by the square of height in meters. Values below 18.5 represent "Underweight", 18.5 to 24.9 represent "Normal or Healthy Weight", 25.0 to 29.9 represent "Overweight" and 30.0 and above represent "Obese". | There were 5 subjects who did not have a body weight available (4 subjects in the multivitamin arm and 1 subject in the Calcitriol and Exercise arm) and therefore a BMI was not possible to calculate. | Mean | Standard Deviation | kg/m^2 |
|
| Serum NTx - Bone Resorption | Serum NTx level is used to aid in predicting skeletal response (bone mineral density) to antiresorptive therapy and in monitoring bone resorption changes following initiation of antiresorptive therapy. The measurement range is in nanoMoles (nm) Bone Collagen Equivalents (BCE). | Serum NTx not recorded for two subjects in the Calcitriol and Exercise arm because their values were out of range and were not used per the instructions of the assay kit used for Serum NTx analysis. | Mean | Standard Deviation | nm BCE |
|
| Serum BSAP - Bone Formation | The Bone-Specific Alkaline Phosphatase (BSAP) assay provides a general index of bone formation and a specific index of total osteoblast activity. BSAP and osteocalcin are the most effective markers of bone formation and are particularly useful for monitoring bone formation therapies and antiresorptive therapies. | Serum BSAP not recorded for 1 subject in the Calcitriol and Exercise arm because the values were out of range and were not used per the instructions of the Serum BSAP assay kit. | Mean | Standard Deviation | ng/ml |
|
| Serum BMOI - Bone Metabolism Index | BMOI is defined as follows: ΔZ BSAP - ΔZ NTx, where ZBSAP = (BSAPObserved-BSAPμ at baseline)/σ (standard deviation) at baseline, and ZNTx = (NTxObserved-NTxμ at baseline)/σ at baseline. A positive number for the BMOI indicates a net bone gain: i.e., resorption decreased and formation increased over the course of the intervention. A negative number for the BMOI indicates net bone loss: i.e., resorption increased and formation decreased over the course of the intervention. | Serum BMOI not recorded for two subjects in the Calcitriol and Exercise arm because their values were out of range and were not used per the instructions of the Serum BMOI assay kit. | Mean | Standard Deviation | Z-Score |
|
| OG001 | Exercise | Exercise Arm: Exercise consisting of progressive walking and resistance band training Calcitriol+ Exercise Arm: Calcitriol pill taken once per week + Exercise |
|
|
|
| Primary | Bone Resorption (Calcitriol) | Bone Resorption using Serum NTx (Calcitriol comparison) Serum NTx level is used to aid in predicting skeletal response (bone mineral density) to antiresorptive therapy and in monitoring bone resorption changes following initiation of antiresorptive therapy. Elevated levels of serum NTx indicate elevated bone resorption. Elevated bone resorption is the primary cause of agerelated bone loss and that low bone mass often results in osteopenia and is the major cause of osteoporosis. The measurement range is in nanoMoles (nm) Bone Collagen Equivalents (BCE). | No Calcitriol group consists of Multivitamin arm and Exercise arm N=20; Calcitriol group consists of Calcitriol and Calcitriol+Exercise arms N=19** ** 2 subjects have missing data for this outcome. | Posted | Least Squares Mean | Standard Error | nm BCE | Week 12 |
|
|
|
|
| Primary | Bone Formation (Exercise) | Bone Formation using Serum BSAP (Exercise comparison) The Bone-Specific Alkaline Phosphatase (BSAP) assay provides a general index of bone formation and a specific index of total osteoblast activity. BSAP and osteocalcin are the most effective markers of bone formation and are particularly useful for monitoring bone formation therapies and antiresorptive therapies. | No Exercise group consists of Multivitamin and Calcitriol arms N=20; Exercise group consists of Exercise and Calcitriol+Exercise arms N=20** **1 subject has missing data for this outcome. | Posted | Least Squares Mean | Standard Error | ng/ml | Week 12 |
|
|
|
|
| Primary | Bone Formation (Calcitriol) | Bone Formation using Serum BSAP (Calcitriol comparison) The Bone-Specific Alkaline Phosphatase (BSAP) assay provides a general index of bone formation and a specific index of total osteoblast activity. BSAP and osteocalcin are the most effective markers of bone formation and are particularly useful for monitoring bone formation therapies and antiresorptive therapies. | No Calcitriol group consists of Multivitamin arm and Exercise arm N=20; Calcitriol group consists of Calcitriol and Calcitriol+Exercise arms N=20** ** 1 subject has missing data for this outcome. | Posted | Least Squares Mean | Standard Error | ng/ml | Week 12 |
|
|
|
|
| Secondary | Handgrip (kg) Strength - (Exercise) | Handgrip (kg) Strength (Exercise comparison) Hand grip strength can be quantified by measuring the amount of static force that the hand can squeeze around a dynamometer. It is typically measured in kilograms or pounds and varies by sex and age. Normative data for females is AGE 35-39 --> 20.3-34.1kg; AGE 40-44 --> 18.9-32.7kg; AGE 45-49 --> 18.6-32.4kg; AGE 50-54 --> 18.1-31.9kg; AGE 55-59 --> 17.7-31.5kg; AGE 60-64 --> 17.2-31.0kg; AGE 65-69 --> 15.4-27.2kg; AGE 70-99 --> 14.7-24.5kg. Values less than the normal range are considered weak strength. Values greater than the normal range are considered strong strength. | No Exercise group consists of Multivitamin and Calcitriol arms N=14*; Exercise group consists of Exercise and Calcitriol+Exercise arms N=17** * 6 subjects have missing data for this outcome. ** 4 subjects have missing data for this outcome. | Posted | Mean | Standard Error | kg | Week 12 |
|
|
|
|
| Secondary | Handgrip (kg) Strength - (Calcitriol) | Handgrip (kg) Strength - (Calcitriol comparison) Hand grip strength can be quantified by measuring the amount of static force that the hand can squeeze around a dynamometer. It is typically measured in kilograms or pounds and varies by sex and age. Normative data for females is AGE 35-39 --> 20.3-34.1kg; AGE 40-44 --> 18.9-32.7kg; AGE 45-49 --> 18.6-32.4kg; AGE 50-54 --> 18.1-31.9kg; AGE 55-59 --> 17.7-31.5kg; AGE 60-64 --> 17.2-31.0kg; AGE 65-69 --> 15.4-27.2kg; AGE 70-99 --> 14.7-24.5kg. Values less than the normal range are considered weak strength. Values greater than the normal range are considered strong strength. | No Calcitriol group consists of Multivitamin arm and Exercise arm N=14*; Calcitriol group consists of Calcitriol and Calcitriol+Exercise arms N=17** * 6 subjects have missing data for this outcome. ** 4 subjects have missing data for this outcome. | Posted | Mean | Standard Error | kg | Week 12 |
|
|
|
|
| Secondary | Body Mass Index (Exercise) | Body Mass Index (BMI) - (Exercise Comparison) Measure Description: Body Mass Index (BMI) is a person's weight in kilograms divided by the square of height in meters. Values below 18.5 represent "Underweight", 18.5 to 24.9 represent "Normal or Healthy Weight", 25.0 to 29.9 represent "Overweight" and 30.0 and above represent "Obese". | No Exercise group consists of Multivitamin and Calcitriol arms N=16*; Exercise group consists of Exercise and Calcitriol+Exercise arms N=20** *4 subjects have missing data for this outcome. **1 subject has missing data for this outcome. | Posted | Mean | Standard Error | kg/m^2 | Week 12 |
|
|
|
|
| Secondary | Body Mass Index (Calcitriol) | Body Mass Index(BMI) - (Calcitriol comparison) Measure Description: Body Mass Index (BMI) is a person's weight in kilograms divided by the square of height in meters. Values below 18.5 represent "Underweight", 18.5 to 24.9 represent "Normal or Healthy Weight", 25.0 to 29.9 represent "Overweight" and 30.0 and above represent "Obese". | No Calcitriol group consists of Multivitamin arm and Exercise arm N=16*; Calcitriol group consists of Calcitriol and Calcitriol+Exercise arms N=20** * 4 subjects have missing data for this outcome. ** 1 subject has missing data for this outcome. | Posted | Mean | Standard Error | kg/m^2 | Week 12 |
|
|
|
|
| 10 |
| 0 |
| 10 |
| 6 |
| 10 |
| EG001 | Exericse | Exercise consisting of progressive walking and resistance band training. Exercise: Exercise consisting of progressive walking and resistance band training | 0 | 10 | 0 | 10 | 6 | 10 |
| EG002 | Calcitriol | Calcitriol pill taken once per week. Calcitriol: Calcitriol tablet taken once per week. | 0 | 10 | 0 | 10 | 5 | 10 |
| EG003 | Calcitriol and Exercise | Calcitriol pill taken once per week plus Exercise consisting of progressive walking and resistance band training. Calcitriol: Calcitriol tablet taken once per week. Exercise: Exercise consisting of progressive walking and resistance band training | 0 | 11 | 0 | 11 | 5 | 11 |
| Creatinine Elevation - Grade 1 | Blood and lymphatic system disorders | Systematic Assessment |
|
| Hyperkalemia - Grade 1 | Blood and lymphatic system disorders | Systematic Assessment |
|
| Hypernatremia - Grade 1 | Blood and lymphatic system disorders | Systematic Assessment |
|
| Hypergycemia - Grade 1 | Blood and lymphatic system disorders | Systematic Assessment |
|
| Hyperglycemia - Grade 2 | Blood and lymphatic system disorders | Systematic Assessment |
|
| Blood Urea Nitrogen Elevation - Grade 1 | Blood and lymphatic system disorders | Systematic Assessment |
|
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| D017437 |
| Skin and Connective Tissue Diseases |
| D002776 |
| Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
| Male |
|
| Not White |
|
| Single/Divorced/Widowed |
|
| Postmenopausal |
|
| Aromatase Inhibitor |
|
| II |
|
| III |
|
| No |
|
| No |
|
| No |
|
| No |
|