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Calcitriol, Physical Activity, and Bone Health in Cancer Survivors

Sponsor
University of Rochester (Other)
Overall Status
Completed
CT.gov ID
NCT00904033
Collaborator
(none)
41
Enrollment
1
Location
4
Arms
109
Actual Duration (Months)
0.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

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 Design

Study Type:
Interventional
Actual Enrollment :
41 participants
Allocation:
Randomized
Intervention Model:
Factorial Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
A Pilot Study of the Effects of High-Dose Oral Calcitriol and Physical Activity on Bone Health in Breast Cancer Survivors
Actual Study Start Date :
Dec 1, 2008
Actual Primary Completion Date :
Jan 1, 2018
Actual Study Completion Date :
Jan 1, 2018

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Multivitamin

Multivitamin used as control group.

Dietary Supplement: Multivitamin
Other Names:
  • Control

    		•
    Experimental: Exercise

    Exercise consisting of progressive walking and resistance band training.

    Behavioral: Exercise
    Exercise consisting of progressive walking and resistance band training
    Experimental: Calcitriol

    Calcitriol pill taken once per week.

    Drug: Calcitriol
    Calcitriol tablet taken once per week.
    Experimental: Calcitriol and Exercise

    Calcitriol pill taken once per week plus Exercise consisting of progressive walking and resistance band training.

    Drug: Calcitriol
    Calcitriol tablet taken once per week.

    Behavioral: Exercise
    Exercise consisting of progressive walking and resistance band training

    Outcome Measures

    Primary Outcome Measures

    1. Bone Resorption (Exercise) [Week 12]

      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).

    2. Bone Resorption (Calcitriol) [Week 12]

      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).

    3. Bone Formation (Exercise) [Week 12]

      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.

    4. Bone Formation (Calcitriol) [Week 12]

      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.

    Secondary Outcome Measures

    1. Handgrip (kg) Strength - (Exercise) [Week 12]

      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.

    2. Handgrip (kg) Strength - (Calcitriol) [Week 12]

      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.

    3. Body Mass Index (Exercise) [Week 12]

      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".

    4. Body Mass Index (Calcitriol) [Week 12]

      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".

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Must be female.

    • Women of child-bearing potential (i.e. women who are pre-menopausal or not surgically sterile) must use acceptable contraceptive methods (abstinence, intrauterine device (IUD), or double barrier device) and must have a negative serum or urine pregnancy test within 1 week prior to beginning treatment on this trial. Contraceptive use needs to be continued at least 1 month after the trial has ended.

    • Must provide informed consent.

    • Must be willing to discontinue use of calcium and/or vitamin D supplements.

    • Participants must have an ionized serum calcium level within normal limits (1.19-1.29mmol/L) and a total corrected serum calcium of < 10.2mg/dl.

    • Must have a functional capacity rating of ≤ 2 on the Eastern Cooperative Oncology Group (ECOG) performance status when assessed at baseline.

    • Must have the approval of their treating physician (or physician's nurse practitioner or physician's assistant) to participate in sub-maximal physiological fitness testing and a low to moderate home-based walking and progressive resistance exercise program and to receive the 12-week supplementation of calcitriol 45 μg. Participants assigned to either of the calcitriol treatment arms will be instructed to stop taking calcium and/or vitamin D supplements.

    • Must be less than five years from the diagnosis of breast cancer and have received chemotherapy, radiation therapy, and/or hormonal therapy. Chemotherapy and radiation therapy, if received, must have been completed prior to study enrollment. Hormonal therapy may be ongoing.

    Exclusion Criteria:

    • Subjects with life-threatening conditions that would preclude them from breast cancer treatment including chronic cardiac failure, which is unstable despite medication use, uncontrolled hypertension, uncontrolled diabetes mellitus, or unstable coronary artery disease.

    • Patients who had a myocardial infarction within the past year.

    • Patients with severe metabolic disorders, which includes phenylketonuria (PKU), homocystinuria, and Fabry's disease, that would preclude them from taking calcitriol.

    • Patients with impaired renal function (CRCL < 60 mL/min) or who had kidney stones (calcium salt) within the past 5 years.

    • Patients with hypercalcemia (corrected serum Ca > 10.2 mg/dl) or a history of hypercalcemia or vitamin D toxicity.

    • Patients currently taking calcium supplements or aluminum-based antacids must be willing to discontinue their use if they are to enroll in the study.

    • Patients currently taking vitamin D supplements must immediately discontinue their use if they are to enroll in the study.

    • Patients with a known sensitivity to calcitriol.

    • Women who are pregnant or lactating.

    • Previously verified diagnosed of osteoporosis.

    • Women on antiresorptive drugs (e.g. bisphosphonates) within the past year.

    • Patients not capable of participating in an exercise intervention due to severe knee arthrosis or ligament/cartilage injuries of the lower extremities.

    • Women currently using oral contraception.

    • Women with malabsorptive syndromes (i.e. cystic fibrosis, chronic pancreatitis) or taking medications that decrease the absorption of fat soluble vitamins (i.e. Orlistat, Questran).

    • Participants assigned to calcitriol who are routinely taking a multivitamin supplement may continue the supplement as long as the amount of vitamin D in the supplement is not in excess of the RDA (recommended daily allowance) of 400 IU or 10 μg. If they are not taking a multivitamin supplement, they will be asked to not start supplementation while on study.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Rochester Medical Center Rochester New York United States 14642

    Sponsors and Collaborators

    • University of Rochester

    Investigators

    • Principal Investigator: Luke J Peppone, Ph.D., University of Rochester

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Luke Peppone, Research Assistant Professor, University of Rochester
    ClinicalTrials.gov Identifier:
    NCT00904033
    Other Study ID Numbers:
    • RSRB00025478
    First Posted:
    May 19, 2009
    Last Update Posted:
    Apr 23, 2019
    Last Verified:
    Apr 1, 2019
    Additional relevant MeSH terms:
    Breast Neoplasms
    Calcitriol

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title Multivitamin Exericse Calcitriol Calcitriol and Exercise
    Arm/Group Description Multivitamin used as control group. Multivitamin Exercise consisting of progressive walking and resistance band training. Exercise: Exercise consisting of progressive walking and resistance band training Calcitriol pill taken once per week. Calcitriol: Calcitriol tablet taken once per week. 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
    Period Title: Overall Study
    STARTED 10 10 10 11
    COMPLETED 9 9 9 9
    NOT COMPLETED 1 1 1 2

    Baseline Characteristics

    Arm/Group Title Multivitamin Exericse Calcitriol Calcitriol and Exercise Total
    Arm/Group Description Multivitamin used as control group. Multivitamin Exercise consisting of progressive walking and resistance band training. Exercise: Exercise consisting of progressive walking and resistance band training Calcitriol pill taken once per week. Calcitriol: Calcitriol tablet taken once per week. 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 Total of all reporting groups
    Overall Participants 10 10 10 11 41
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    50.9
    (8.2)
    55.8
    (6.7)
    52.0
    (6.8)
    55.1
    (8.7)
    53.5
    (7.8)
    Sex: Female, Male (Count of Participants)
    Female
    10
    100%
    10
    100%
    10
    100%
    11
    100%
    41
    100%
    Male
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Race/Ethnicity, Customized (Count of Participants)
    White
    9
    90%
    10
    100%
    8
    80%
    11
    100%
    38
    92.7%
    Not White
    1
    10%
    0
    0%
    2
    20%
    0
    0%
    3
    7.3%
    Marital Status (Count of Participants)
    Married
    6
    60%
    7
    70%
    9
    90%
    11
    100%
    33
    80.5%
    Single/Divorced/Widowed
    4
    40%
    3
    30%
    1
    10%
    0
    0%
    8
    19.5%
    Menopausal Status (Count of Participants)
    Premenopausal
    6
    60%
    1
    10%
    5
    50%
    3
    27.3%
    15
    36.6%
    Postmenopausal
    4
    40%
    9
    90%
    5
    50%
    8
    72.7%
    26
    63.4%
    Hormonal Therapy (Count of Participants)
    Tamoxifen
    7
    70%
    4
    40%
    6
    60%
    4
    36.4%
    21
    51.2%
    Aromatase Inhibitor
    3
    30%
    5
    50%
    4
    40%
    7
    63.6%
    19
    46.3%
    Stage of Cancer (Count of Participants)
    0 / I
    3
    30%
    2
    20%
    5
    50%
    7
    63.6%
    17
    41.5%
    II
    4
    40%
    6
    60%
    4
    40%
    3
    27.3%
    17
    41.5%
    III
    3
    30%
    2
    20%
    1
    10%
    1
    9.1%
    7
    17.1%
    Prior Chemotherapy (Count of Participants)
    Yes
    7
    70%
    7
    70%
    7
    70%
    6
    54.5%
    27
    65.9%
    No
    3
    30%
    3
    30%
    3
    30%
    5
    45.5%
    14
    34.1%
    Prior Radiotherapy (Count of Participants)
    Yes
    10
    100%
    10
    100%
    10
    100%
    11
    100%
    41
    100%
    No
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Current Cardiovascular Exercise (Count of Participants)
    Yes
    5
    50%
    6
    60%
    6
    60%
    7
    63.6%
    24
    58.5%
    No
    5
    50%
    4
    40%
    4
    40%
    4
    36.4%
    17
    41.5%
    Current Resistance Training (Count of Participants)
    Yes
    2
    20%
    0
    0%
    2
    20%
    3
    27.3%
    7
    17.1%
    No
    8
    80%
    10
    100%
    8
    80%
    8
    72.7%
    34
    82.9%
    Body Mass Index (BMI) (kg/m^2) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [kg/m^2]
    31.3
    (6.0)
    32.4
    (7.5)
    28.4
    (5.5)
    28.1
    (3.6)
    29.9
    (5.9)
    Serum NTx - Bone Resorption (nm BCE) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [nm BCE]
    12.2
    (10.0)
    11.6
    (5.7)
    13.4
    (8.1)
    14.4
    (9.5)
    12.9
    (8.2)
    Serum BSAP - Bone Formation (ng/ml) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [ng/ml]
    12.2
    (7.1)
    13.8
    (7.2)
    12.2
    (7.4)
    12.0
    (5.6)
    12.6
    (6.7)
    Serum BMOI - Bone Metabolism Index (Z-Score) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [Z-Score]
    0.03
    (1.25)
    0.34
    (1.05)
    -0.12
    (1.44)
    -0.26
    (0.96)
    0.01
    (1.17)

    Outcome Measures

    1. Primary Outcome
    Title Bone Resorption (Exercise)
    Description 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

    Outcome Measure Data

    Analysis Population Description
    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.
    Arm/Group Title No Exercise Exercise
    Arm/Group Description Multivitamin Arm + Calcitriol Arm:Calcitriol pill taken once per week Exercise Arm: Exercise consisting of progressive walking and resistance band training Calcitriol+ Exercise Arm: Calcitriol pill taken once per week + Exercise
    Measure Participants 20 19
    Least Squares Mean (Standard Error) [nm BCE]
    13.8
    (1.656)
    14.7
    (1.033)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection No Exercise, Exercise
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.86
    Comments
    Method ANCOVA
    Comments Main Effects Results only for No Exercise vs Exercise
    2. Primary Outcome
    Title Bone Resorption (Calcitriol)
    Description 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

    Outcome Measure Data

    Analysis Population Description
    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.
    Arm/Group Title No Calcitriol Calcitriol
    Arm/Group Description Multivitamin Arm + Exercise Arm:Exercise consisting of progressive walking and resistance band training Calcitriol Arm: Calcitriol pill taken once per week and Calcitriol+Exercise Arm:Exercise consisting of progressive walking and resistance band training
    Measure Participants 20 19
    Least Squares Mean (Standard Error) [nm BCE]
    12.5
    (1.785)
    15.0
    (1.113)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection No Exercise, Exercise
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.19
    Comments
    Method ANCOVA
    Comments
    3. Primary Outcome
    Title Bone Formation (Exercise)
    Description 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

    Outcome Measure Data

    Analysis Population Description
    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.
    Arm/Group Title No Exercise Exercise
    Arm/Group Description Multivitamin Arm + Calcitriol Arm:Calcitriol pill taken once per week Exercise Arm: Exercise consisting of progressive walking and resistance band training Calcitriol+ Exercise Arm: Calcitriol pill taken once per week + Exercise
    Measure Participants 20 20
    Least Squares Mean (Standard Error) [ng/ml]
    13.8
    (1.513)
    14.7
    (0.957)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection No Exercise, Exercise
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.49
    Comments
    Method ANCOVA
    Comments
    4. Primary Outcome
    Title Bone Formation (Calcitriol)
    Description 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

    Outcome Measure Data

    Analysis Population Description
    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.
    Arm/Group Title No Calcitriol Calcitriol
    Arm/Group Description Multivitamin Arm + Exercise Arm:Exercise consisting of progressive walking and resistance band training Calcitriol Arm: Calcitriol pill taken once per week and Calcitriol+ Exercise Arm:Exercise consisting of progressive walking and resistance band training
    Measure Participants 20 20
    Least Squares Mean (Standard Error) [ng/ml]
    12.0
    (1.268)
    16.3
    (0.802)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection No Exercise, Exercise
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value <0.01
    Comments
    Method ANCOVA
    Comments
    5. Secondary Outcome
    Title Handgrip (kg) Strength - (Exercise)
    Description 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

    Outcome Measure Data

    Analysis Population Description
    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.
    Arm/Group Title No Exercise Exercise
    Arm/Group Description Multivitamin Arm + Calcitriol Arm:Calcitriol pill taken once per week Exercise Arm: Exercise consisting of progressive walking and resistance band training Calcitriol+ Exercise Arm: Calcitriol pill taken once per week + Exercise
    Measure Participants 14 17
    Mean (Standard Error) [kg]
    26.6
    (1.633)
    27.8
    (0.919)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection No Exercise, Exercise
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.16
    Comments
    Method t-test, 2 sided
    Comments
    6. Secondary Outcome
    Title Handgrip (kg) Strength - (Calcitriol)
    Description 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

    Outcome Measure Data

    Analysis Population Description
    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.
    Arm/Group Title No Calcitriol Calcitriol
    Arm/Group Description Multivitamin Arm + Exercise Arm:Exercise consisting of progressive walking and resistance band training Calcitriol Arm: Calcitriol pill taken once per week and Calcitriol+Exercise Arm:Exercise consisting of progressive walking and resistance band training
    Measure Participants 14 17
    Mean (Standard Error) [kg]
    27.4
    (1.441)
    27.1
    (0.804)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection No Exercise, Exercise
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.84
    Comments
    Method t-test, 2 sided
    Comments
    7. Secondary Outcome
    Title Body Mass Index (Exercise)
    Description 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

    Outcome Measure Data

    Analysis Population Description
    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.
    Arm/Group Title No Exercise Exercise
    Arm/Group Description Multivitamin Arm + Calcitriol Arm:Calcitriol pill taken once per week Exercise Arm: Exercise consisting of progressive walking and resistance band training Calcitriol+ Exercise Arm: Calcitriol pill taken once per week + Exercise
    Measure Participants 16 20
    Mean (Standard Error) [kg/m^2]
    30.0
    (0.312)
    30.2
    (0.185)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection No Exercise, Exercise
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.38
    Comments
    Method t-test, 2 sided
    Comments
    8. Secondary Outcome
    Title Body Mass Index (Calcitriol)
    Description 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

    Outcome Measure Data

    Analysis Population Description
    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.
    Arm/Group Title No Calcitriol Calcitriol
    Arm/Group Description Multivitamin Arm + Exercise Arm:Exercise consisting of progressive walking and resistance band training Calcitriol Arm: Calcitriol pill taken once per week and Calcitriol+Exercise Arm:Exercise consisting of progressive walking and resistance band training
    Measure Participants 16 20
    Mean (Standard Error) [kg/m^2]
    30.1
    (0.284)
    30.1
    (0.161)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection No Exercise, Exercise
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.92
    Comments
    Method t-test, 2 sided
    Comments

    Adverse Events

    Time Frame 12 weeks
    Adverse Event Reporting Description
    Arm/Group Title Multivitamin Exericse Calcitriol Calcitriol and Exercise
    Arm/Group Description Multivitamin used as control group. Multivitamin Exercise consisting of progressive walking and resistance band training. Exercise: Exercise consisting of progressive walking and resistance band training Calcitriol pill taken once per week. Calcitriol: Calcitriol tablet taken once per week. 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
    All Cause Mortality
    Multivitamin Exericse Calcitriol Calcitriol and Exercise
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/11 (0%)
    Serious Adverse Events
    Multivitamin Exericse Calcitriol Calcitriol and Exercise
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/11 (0%)
    Other (Not Including Serious) Adverse Events
    Multivitamin Exericse Calcitriol Calcitriol and Exercise
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 6/10 (60%) 6/10 (60%) 5/10 (50%) 5/11 (45.5%)
    Blood and lymphatic system disorders
    Hypercalcemia - Grade 1 0/10 (0%) 0/10 (0%) 1/10 (10%) 2/11 (18.2%)
    Creatinine Elevation - Grade 1 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/11 (0%)
    Hyperkalemia - Grade 1 1/10 (10%) 0/10 (0%) 0/10 (0%) 1/11 (9.1%)
    Hypernatremia - Grade 1 0/10 (0%) 1/10 (10%) 0/10 (0%) 0/11 (0%)
    Hypergycemia - Grade 1 2/10 (20%) 3/10 (30%) 2/10 (20%) 1/11 (9.1%)
    Hyperglycemia - Grade 2 0/10 (0%) 1/10 (10%) 0/10 (0%) 0/11 (0%)
    Blood Urea Nitrogen Elevation - Grade 1 3/10 (30%) 1/10 (10%) 2/10 (20%) 2/11 (18.2%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title Luke J Peppone, PhD, MPH
    Organization University of Rochester
    Phone 585-275-7827
    Email Luke_Peppone@urmc.rochester.edu
    Responsible Party:
    Luke Peppone, Research Assistant Professor, University of Rochester
    ClinicalTrials.gov Identifier:
    NCT00904033
    Other Study ID Numbers:
    • RSRB00025478
    First Posted:
    May 19, 2009
    Last Update Posted:
    Apr 23, 2019
    Last Verified:
    Apr 1, 2019