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Calcitriol, Physical Activity, and Bone Health in Cancer Survivors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00904033
Recruitment Status : Completed
First Posted : May 19, 2009
Results First Posted : April 23, 2019
Last Update Posted : April 23, 2019
Sponsor:
Information provided by (Responsible Party):
Luke Peppone, University of Rochester

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Factorial Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Conditions Breast Neoplasms
Bone and Bones
Interventions Drug: Calcitriol
Behavioral: Exercise
Dietary Supplement: Multivitamin
Enrollment 41
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Multivitamin Exericse Calcitriol Calcitriol and Exercise
Hide 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
Reason Not Completed
Withdrawal by Subject             1             1             0             0
Physician Decision             0             0             1             0
Unable to obtain final blood draw             0             0             0             2
Arm/Group Title Multivitamin Exericse Calcitriol Calcitriol and Exercise Total
Hide 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 Number of Baseline Participants 10 10 10 11 41
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 10 participants 10 participants 10 participants 11 participants 41 participants
50.9  (8.2) 55.8  (6.7) 52.0  (6.8) 55.1  (8.7) 53.5  (7.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 10 participants 11 participants 41 participants
Female
10
 100.0%
10
 100.0%
10
 100.0%
11
 100.0%
41
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 10 participants 11 participants 41 participants
White
9
  90.0%
10
 100.0%
8
  80.0%
11
 100.0%
38
  92.7%
Not White
1
  10.0%
0
   0.0%
2
  20.0%
0
   0.0%
3
   7.3%
Marital Status  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 10 participants 11 participants 41 participants
Married
6
  60.0%
7
  70.0%
9
  90.0%
11
 100.0%
33
  80.5%
Single/Divorced/Widowed
4
  40.0%
3
  30.0%
1
  10.0%
0
   0.0%
8
  19.5%
Menopausal Status  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 10 participants 11 participants 41 participants
Premenopausal
6
  60.0%
1
  10.0%
5
  50.0%
3
  27.3%
15
  36.6%
Postmenopausal
4
  40.0%
9
  90.0%
5
  50.0%
8
  72.7%
26
  63.4%
Hormonal Therapy   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 9 participants 10 participants 11 participants 40 participants
Tamoxifen
7
  70.0%
4
  44.4%
6
  60.0%
4
  36.4%
21
  52.5%
Aromatase Inhibitor
3
  30.0%
5
  55.6%
4
  40.0%
7
  63.6%
19
  47.5%
[1]
Measure Analysis Population Description: Subject did not received hormone therapy.
Stage of Cancer   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 10 participants 11 participants 41 participants
0 / I
3
  30.0%
2
  20.0%
5
  50.0%
7
  63.6%
17
  41.5%
II
4
  40.0%
6
  60.0%
4
  40.0%
3
  27.3%
17
  41.5%
III
3
  30.0%
2
  20.0%
1
  10.0%
1
   9.1%
7
  17.1%
[1]
Measure Description:

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.

Prior Chemotherapy  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 10 participants 11 participants 41 participants
Yes
7
  70.0%
7
  70.0%
7
  70.0%
6
  54.5%
27
  65.9%
No
3
  30.0%
3
  30.0%
3
  30.0%
5
  45.5%
14
  34.1%
Prior Radiotherapy  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 10 participants 11 participants 41 participants
Yes
10
 100.0%
10
 100.0%
10
 100.0%
11
 100.0%
41
 100.0%
No
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Current Cardiovascular Exercise  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 10 participants 11 participants 41 participants
Yes
5
  50.0%
6
  60.0%
6
  60.0%
7
  63.6%
24
  58.5%
No
5
  50.0%
4
  40.0%
4
  40.0%
4
  36.4%
17
  41.5%
Current Resistance Training  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 10 participants 11 participants 41 participants
Yes
2
  20.0%
0
   0.0%
2
  20.0%
3
  27.3%
7
  17.1%
No
8
  80.0%
10
 100.0%
8
  80.0%
8
  72.7%
34
  82.9%
Body Mass Index (BMI)   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 6 participants 10 participants 10 participants 10 participants 36 participants
31.3  (6.0) 32.4  (7.5) 28.4  (5.5) 28.1  (3.6) 29.9  (5.9)
[1]
Measure Description: 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".
[2]
Measure Analysis Population Description: 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.
Serum NTx - Bone Resorption   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Nm BCE
Number Analyzed 10 participants 10 participants 10 participants 9 participants 39 participants
12.2  (10.0) 11.6  (5.7) 13.4  (8.1) 14.4  (9.5) 12.9  (8.2)
[1]
Measure Description: 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).
[2]
Measure Analysis Population Description: 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.
Serum BSAP - Bone Formation   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Ng/ml
Number Analyzed 10 participants 10 participants 10 participants 10 participants 40 participants
12.2  (7.1) 13.8  (7.2) 12.2  (7.4) 12.0  (5.6) 12.6  (6.7)
[1]
Measure Description: 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.
[2]
Measure Analysis Population Description: 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.
Serum BMOI - Bone Metabolism Index   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Z-Score
Number Analyzed 10 participants 10 participants 10 participants 9 participants 39 participants
0.03  (1.25) 0.34  (1.05) -0.12  (1.44) -0.26  (0.96) 0.01  (1.17)
[1]
Measure Description:

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.

[2]
Measure Analysis Population Description: 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.
1.Primary Outcome
Title Bone Resorption (Exercise)
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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

Overall Number of Participants Analyzed 20 19
Least Squares Mean (Standard Error)
Unit of Measure: nm BCE
13.8  (1.656) 14.7  (1.033)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection No Exercise, Exercise
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.86
Comments [Not Specified]
Method ANCOVA
Comments Main Effects Results only for No Exercise vs Exercise
2.Primary Outcome
Title Bone Resorption (Calcitriol)
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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

Overall Number of Participants Analyzed 20 19
Least Squares Mean (Standard Error)
Unit of Measure: nm BCE
12.5  (1.785) 15.0  (1.113)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection No Calcitriol, Calcitriol
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.19
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
3.Primary Outcome
Title Bone Formation (Exercise)
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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

Overall Number of Participants Analyzed 20 20
Least Squares Mean (Standard Error)
Unit of Measure: ng/ml
13.8  (1.513) 14.7  (0.957)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection No Exercise, Exercise
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.49
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
4.Primary Outcome
Title Bone Formation (Calcitriol)
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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

Overall Number of Participants Analyzed 20 20
Least Squares Mean (Standard Error)
Unit of Measure: ng/ml
12.0  (1.268) 16.3  (0.802)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection No Calcitriol, Calcitriol
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
5.Secondary Outcome
Title Handgrip (kg) Strength - (Exercise)
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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

Overall Number of Participants Analyzed 14 17
Mean (Standard Error)
Unit of Measure: kg
26.6  (1.633) 27.8  (0.919)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection No Exercise, Exercise
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.16
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
6.Secondary Outcome
Title Handgrip (kg) Strength - (Calcitriol)
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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

Overall Number of Participants Analyzed 14 17
Mean (Standard Error)
Unit of Measure: kg
27.4  (1.441) 27.1  (0.804)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection No Calcitriol, Calcitriol
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.84
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
7.Secondary Outcome
Title Body Mass Index (Exercise)
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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

Overall Number of Participants Analyzed 16 20
Mean (Standard Error)
Unit of Measure: kg/m^2
30.0  (0.312) 30.2  (0.185)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection No Exercise, Exercise
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.38
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
8.Secondary Outcome
Title Body Mass Index (Calcitriol)
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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

Overall Number of Participants Analyzed 16 20
Mean (Standard Error)
Unit of Measure: kg/m^2
30.1  (0.284) 30.1  (0.161)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection No Calcitriol, Calcitriol
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.92
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Time Frame 12 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Multivitamin Exericse Calcitriol Calcitriol and Exercise
Hide 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 (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)   0/10 (0.00%)   0/10 (0.00%)   0/11 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Multivitamin Exericse Calcitriol Calcitriol and Exercise
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)   0/10 (0.00%)   0/10 (0.00%)   0/11 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Multivitamin Exericse Calcitriol Calcitriol and Exercise
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   6/10 (60.00%)   6/10 (60.00%)   5/10 (50.00%)   5/11 (45.45%) 
Blood and lymphatic system disorders         
Hypercalcemia - Grade 1   0/10 (0.00%)  0/10 (0.00%)  1/10 (10.00%)  2/11 (18.18%) 
Creatinine Elevation - Grade 1   0/10 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/11 (0.00%) 
Hyperkalemia - Grade 1   1/10 (10.00%)  0/10 (0.00%)  0/10 (0.00%)  1/11 (9.09%) 
Hypernatremia - Grade 1   0/10 (0.00%)  1/10 (10.00%)  0/10 (0.00%)  0/11 (0.00%) 
Hypergycemia - Grade 1   2/10 (20.00%)  3/10 (30.00%)  2/10 (20.00%)  1/11 (9.09%) 
Hyperglycemia - Grade 2   0/10 (0.00%)  1/10 (10.00%)  0/10 (0.00%)  0/11 (0.00%) 
Blood Urea Nitrogen Elevation - Grade 1   3/10 (30.00%)  1/10 (10.00%)  2/10 (20.00%)  2/11 (18.18%) 
Indicates events were collected by systematic assessment
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
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Name/Title: Luke J Peppone, PhD, MPH
Organization: University of Rochester
Phone: 585-275-7827
EMail: Luke_Peppone@urmc.rochester.edu
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Responsible Party: Luke Peppone, University of Rochester
ClinicalTrials.gov Identifier: NCT00904033     History of Changes
Other Study ID Numbers: RSRB00025478
First Submitted: May 15, 2009
First Posted: May 19, 2009
Results First Submitted: February 14, 2019
Results First Posted: April 23, 2019
Last Update Posted: April 23, 2019