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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
41
Calcitriol tablet taken once per week.
Exercise consisting of progressive walking and resistance band training
University of Rochester Medical Center
Rochester, New York, United States
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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: Week 12
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.
Time frame: 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.
Time frame: 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".
Time frame: 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".
Time frame: Week 12
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