Trial Outcomes & Findings for Calcitriol, Physical Activity, and Bone Health in Cancer Survivors (NCT NCT00904033)
NCT ID: NCT00904033
Last Updated: 2019-04-23
Results Overview
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).
COMPLETED
PHASE2
41 participants
Week 12
2019-04-23
Participant Flow
Participant milestones
| Measure |
Multivitamin
Multivitamin used as control group.
Multivitamin
|
Exericse
Exercise consisting of progressive walking and resistance band training.
Exercise: Exercise consisting of progressive walking and resistance band training
|
Calcitriol
Calcitriol pill taken once per week.
Calcitriol: Calcitriol tablet taken once per week.
|
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
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
10
|
11
|
|
Overall Study
COMPLETED
|
9
|
9
|
9
|
9
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
1
|
2
|
Reasons for withdrawal
| Measure |
Multivitamin
Multivitamin used as control group.
Multivitamin
|
Exericse
Exercise consisting of progressive walking and resistance band training.
Exercise: Exercise consisting of progressive walking and resistance band training
|
Calcitriol
Calcitriol pill taken once per week.
Calcitriol: Calcitriol tablet taken once per week.
|
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
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
0
|
0
|
|
Overall Study
Physician Decision
|
0
|
0
|
1
|
0
|
|
Overall Study
Unable to obtain final blood draw
|
0
|
0
|
0
|
2
|
Baseline Characteristics
Subject did not received hormone therapy.
Baseline characteristics by cohort
| Measure |
Multivitamin
n=10 Participants
Multivitamin used as control group.
Multivitamin
|
Exericse
n=10 Participants
Exercise consisting of progressive walking and resistance band training.
Exercise: Exercise consisting of progressive walking and resistance band training
|
Calcitriol
n=10 Participants
Calcitriol pill taken once per week.
Calcitriol: Calcitriol tablet taken once per week.
|
Calcitriol and Exercise
n=11 Participants
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
n=41 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
50.9 years
STANDARD_DEVIATION 8.2 • n=10 Participants
|
55.8 years
STANDARD_DEVIATION 6.7 • n=10 Participants
|
52.0 years
STANDARD_DEVIATION 6.8 • n=10 Participants
|
55.1 years
STANDARD_DEVIATION 8.7 • n=11 Participants
|
53.5 years
STANDARD_DEVIATION 7.8 • n=41 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=10 Participants
|
10 Participants
n=10 Participants
|
10 Participants
n=10 Participants
|
11 Participants
n=11 Participants
|
41 Participants
n=41 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=41 Participants
|
|
Race/Ethnicity, Customized
White
|
9 Participants
n=10 Participants
|
10 Participants
n=10 Participants
|
8 Participants
n=10 Participants
|
11 Participants
n=11 Participants
|
38 Participants
n=41 Participants
|
|
Race/Ethnicity, Customized
Not White
|
1 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
2 Participants
n=10 Participants
|
0 Participants
n=11 Participants
|
3 Participants
n=41 Participants
|
|
Marital Status
Married
|
6 Participants
n=10 Participants
|
7 Participants
n=10 Participants
|
9 Participants
n=10 Participants
|
11 Participants
n=11 Participants
|
33 Participants
n=41 Participants
|
|
Marital Status
Single/Divorced/Widowed
|
4 Participants
n=10 Participants
|
3 Participants
n=10 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=11 Participants
|
8 Participants
n=41 Participants
|
|
Menopausal Status
Premenopausal
|
6 Participants
n=10 Participants
|
1 Participants
n=10 Participants
|
5 Participants
n=10 Participants
|
3 Participants
n=11 Participants
|
15 Participants
n=41 Participants
|
|
Menopausal Status
Postmenopausal
|
4 Participants
n=10 Participants
|
9 Participants
n=10 Participants
|
5 Participants
n=10 Participants
|
8 Participants
n=11 Participants
|
26 Participants
n=41 Participants
|
|
Hormonal Therapy
Tamoxifen
|
7 Participants
n=10 Participants • Subject did not received hormone therapy.
|
4 Participants
n=9 Participants • Subject did not received hormone therapy.
|
6 Participants
n=10 Participants • Subject did not received hormone therapy.
|
4 Participants
n=11 Participants • Subject did not received hormone therapy.
|
21 Participants
n=40 Participants • Subject did not received hormone therapy.
|
|
Hormonal Therapy
Aromatase Inhibitor
|
3 Participants
n=10 Participants • Subject did not received hormone therapy.
|
5 Participants
n=9 Participants • Subject did not received hormone therapy.
|
4 Participants
n=10 Participants • Subject did not received hormone therapy.
|
7 Participants
n=11 Participants • Subject did not received hormone therapy.
|
19 Participants
n=40 Participants • Subject did not received hormone therapy.
|
|
Stage of Cancer
0 / I
|
3 Participants
n=10 Participants
|
2 Participants
n=10 Participants
|
5 Participants
n=10 Participants
|
7 Participants
n=11 Participants
|
17 Participants
n=41 Participants
|
|
Stage of Cancer
II
|
4 Participants
n=10 Participants
|
6 Participants
n=10 Participants
|
4 Participants
n=10 Participants
|
3 Participants
n=11 Participants
|
17 Participants
n=41 Participants
|
|
Stage of Cancer
III
|
3 Participants
n=10 Participants
|
2 Participants
n=10 Participants
|
1 Participants
n=10 Participants
|
1 Participants
n=11 Participants
|
7 Participants
n=41 Participants
|
|
Prior Chemotherapy
Yes
|
7 Participants
n=10 Participants
|
7 Participants
n=10 Participants
|
7 Participants
n=10 Participants
|
6 Participants
n=11 Participants
|
27 Participants
n=41 Participants
|
|
Prior Chemotherapy
No
|
3 Participants
n=10 Participants
|
3 Participants
n=10 Participants
|
3 Participants
n=10 Participants
|
5 Participants
n=11 Participants
|
14 Participants
n=41 Participants
|
|
Prior Radiotherapy
Yes
|
10 Participants
n=10 Participants
|
10 Participants
n=10 Participants
|
10 Participants
n=10 Participants
|
11 Participants
n=11 Participants
|
41 Participants
n=41 Participants
|
|
Prior Radiotherapy
No
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=41 Participants
|
|
Current Cardiovascular Exercise
Yes
|
5 Participants
n=10 Participants
|
6 Participants
n=10 Participants
|
6 Participants
n=10 Participants
|
7 Participants
n=11 Participants
|
24 Participants
n=41 Participants
|
|
Current Cardiovascular Exercise
No
|
5 Participants
n=10 Participants
|
4 Participants
n=10 Participants
|
4 Participants
n=10 Participants
|
4 Participants
n=11 Participants
|
17 Participants
n=41 Participants
|
|
Current Resistance Training
Yes
|
2 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
2 Participants
n=10 Participants
|
3 Participants
n=11 Participants
|
7 Participants
n=41 Participants
|
|
Current Resistance Training
No
|
8 Participants
n=10 Participants
|
10 Participants
n=10 Participants
|
8 Participants
n=10 Participants
|
8 Participants
n=11 Participants
|
34 Participants
n=41 Participants
|
|
Body Mass Index (BMI)
|
31.3 kg/m^2
STANDARD_DEVIATION 6.0 • n=6 Participants • 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.
|
32.4 kg/m^2
STANDARD_DEVIATION 7.5 • n=10 Participants • 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.
|
28.4 kg/m^2
STANDARD_DEVIATION 5.5 • n=10 Participants • 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.
|
28.1 kg/m^2
STANDARD_DEVIATION 3.6 • n=10 Participants • 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.
|
29.9 kg/m^2
STANDARD_DEVIATION 5.9 • n=36 Participants • 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
|
12.2 nm BCE
STANDARD_DEVIATION 10.0 • n=10 Participants • 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.
|
11.6 nm BCE
STANDARD_DEVIATION 5.7 • n=10 Participants • 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.
|
13.4 nm BCE
STANDARD_DEVIATION 8.1 • n=10 Participants • 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.
|
14.4 nm BCE
STANDARD_DEVIATION 9.5 • n=9 Participants • 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.
|
12.9 nm BCE
STANDARD_DEVIATION 8.2 • n=39 Participants • 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
|
12.2 ng/ml
STANDARD_DEVIATION 7.1 • n=10 Participants • 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.
|
13.8 ng/ml
STANDARD_DEVIATION 7.2 • n=10 Participants • 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.
|
12.2 ng/ml
STANDARD_DEVIATION 7.4 • n=10 Participants • 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.
|
12.0 ng/ml
STANDARD_DEVIATION 5.6 • n=10 Participants • 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.
|
12.6 ng/ml
STANDARD_DEVIATION 6.7 • n=40 Participants • 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
|
0.03 Z-Score
STANDARD_DEVIATION 1.25 • n=10 Participants • 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.
|
0.34 Z-Score
STANDARD_DEVIATION 1.05 • n=10 Participants • 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.
|
-0.12 Z-Score
STANDARD_DEVIATION 1.44 • n=10 Participants • 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.
|
-0.26 Z-Score
STANDARD_DEVIATION 0.96 • n=9 Participants • 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.
|
0.01 Z-Score
STANDARD_DEVIATION 1.17 • n=39 Participants • 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.
|
PRIMARY outcome
Timeframe: Week 12Population: 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.
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).
Outcome measures
| Measure |
No Exercise
n=20 Participants
Multivitamin Arm + Calcitriol Arm:Calcitriol pill taken once per week
|
Exercise
n=19 Participants
Exercise Arm: Exercise consisting of progressive walking and resistance band training
Calcitriol+ Exercise Arm: Calcitriol pill taken once per week + Exercise
|
|---|---|---|
|
Bone Resorption (Exercise)
|
13.8 nm BCE
Standard Error 1.656
|
14.7 nm BCE
Standard Error 1.033
|
PRIMARY outcome
Timeframe: Week 12Population: 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.
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).
Outcome measures
| Measure |
No Exercise
n=20 Participants
Multivitamin Arm + Calcitriol Arm:Calcitriol pill taken once per week
|
Exercise
n=19 Participants
Exercise Arm: Exercise consisting of progressive walking and resistance band training
Calcitriol+ Exercise Arm: Calcitriol pill taken once per week + Exercise
|
|---|---|---|
|
Bone Resorption (Calcitriol)
|
12.5 nm BCE
Standard Error 1.785
|
15.0 nm BCE
Standard Error 1.113
|
PRIMARY outcome
Timeframe: Week 12Population: 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.
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.
Outcome measures
| Measure |
No Exercise
n=20 Participants
Multivitamin Arm + Calcitriol Arm:Calcitriol pill taken once per week
|
Exercise
n=20 Participants
Exercise Arm: Exercise consisting of progressive walking and resistance band training
Calcitriol+ Exercise Arm: Calcitriol pill taken once per week + Exercise
|
|---|---|---|
|
Bone Formation (Exercise)
|
13.8 ng/ml
Standard Error 1.513
|
14.7 ng/ml
Standard Error 0.957
|
PRIMARY outcome
Timeframe: Week 12Population: 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.
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.
Outcome measures
| Measure |
No Exercise
n=20 Participants
Multivitamin Arm + Calcitriol Arm:Calcitriol pill taken once per week
|
Exercise
n=20 Participants
Exercise Arm: Exercise consisting of progressive walking and resistance band training
Calcitriol+ Exercise Arm: Calcitriol pill taken once per week + Exercise
|
|---|---|---|
|
Bone Formation (Calcitriol)
|
12.0 ng/ml
Standard Error 1.268
|
16.3 ng/ml
Standard Error 0.802
|
SECONDARY outcome
Timeframe: Week 12Population: 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.
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.
Outcome measures
| Measure |
No Exercise
n=14 Participants
Multivitamin Arm + Calcitriol Arm:Calcitriol pill taken once per week
|
Exercise
n=17 Participants
Exercise Arm: Exercise consisting of progressive walking and resistance band training
Calcitriol+ Exercise Arm: Calcitriol pill taken once per week + Exercise
|
|---|---|---|
|
Handgrip (kg) Strength - (Exercise)
|
26.6 kg
Standard Error 1.633
|
27.8 kg
Standard Error 0.919
|
SECONDARY outcome
Timeframe: Week 12Population: 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.
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.
Outcome measures
| Measure |
No Exercise
n=14 Participants
Multivitamin Arm + Calcitriol Arm:Calcitriol pill taken once per week
|
Exercise
n=17 Participants
Exercise Arm: Exercise consisting of progressive walking and resistance band training
Calcitriol+ Exercise Arm: Calcitriol pill taken once per week + Exercise
|
|---|---|---|
|
Handgrip (kg) Strength - (Calcitriol)
|
27.4 kg
Standard Error 1.441
|
27.1 kg
Standard Error 0.804
|
SECONDARY outcome
Timeframe: Week 12Population: 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.
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".
Outcome measures
| Measure |
No Exercise
n=16 Participants
Multivitamin Arm + Calcitriol Arm:Calcitriol pill taken once per week
|
Exercise
n=20 Participants
Exercise Arm: Exercise consisting of progressive walking and resistance band training
Calcitriol+ Exercise Arm: Calcitriol pill taken once per week + Exercise
|
|---|---|---|
|
Body Mass Index (Exercise)
|
30.0 kg/m^2
Standard Error 0.312
|
30.2 kg/m^2
Standard Error 0.185
|
SECONDARY outcome
Timeframe: Week 12Population: 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.
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".
Outcome measures
| Measure |
No Exercise
n=16 Participants
Multivitamin Arm + Calcitriol Arm:Calcitriol pill taken once per week
|
Exercise
n=20 Participants
Exercise Arm: Exercise consisting of progressive walking and resistance band training
Calcitriol+ Exercise Arm: Calcitriol pill taken once per week + Exercise
|
|---|---|---|
|
Body Mass Index (Calcitriol)
|
30.1 kg/m^2
Standard Error 0.284
|
30.1 kg/m^2
Standard Error 0.161
|
Adverse Events
Multivitamin
Exericse
Calcitriol
Calcitriol and Exercise
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Multivitamin
n=10 participants at risk
Multivitamin used as control group.
Multivitamin
|
Exericse
n=10 participants at risk
Exercise consisting of progressive walking and resistance band training.
Exercise: Exercise consisting of progressive walking and resistance band training
|
Calcitriol
n=10 participants at risk
Calcitriol pill taken once per week.
Calcitriol: Calcitriol tablet taken once per week.
|
Calcitriol and Exercise
n=11 participants at risk
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
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Hypercalcemia - Grade 1
|
0.00%
0/10 • 12 weeks
|
0.00%
0/10 • 12 weeks
|
10.0%
1/10 • 12 weeks
|
18.2%
2/11 • 12 weeks
|
|
Blood and lymphatic system disorders
Creatinine Elevation - Grade 1
|
0.00%
0/10 • 12 weeks
|
0.00%
0/10 • 12 weeks
|
0.00%
0/10 • 12 weeks
|
0.00%
0/11 • 12 weeks
|
|
Blood and lymphatic system disorders
Hyperkalemia - Grade 1
|
10.0%
1/10 • 12 weeks
|
0.00%
0/10 • 12 weeks
|
0.00%
0/10 • 12 weeks
|
9.1%
1/11 • 12 weeks
|
|
Blood and lymphatic system disorders
Hypernatremia - Grade 1
|
0.00%
0/10 • 12 weeks
|
10.0%
1/10 • 12 weeks
|
0.00%
0/10 • 12 weeks
|
0.00%
0/11 • 12 weeks
|
|
Blood and lymphatic system disorders
Hypergycemia - Grade 1
|
20.0%
2/10 • 12 weeks
|
30.0%
3/10 • 12 weeks
|
20.0%
2/10 • 12 weeks
|
9.1%
1/11 • 12 weeks
|
|
Blood and lymphatic system disorders
Hyperglycemia - Grade 2
|
0.00%
0/10 • 12 weeks
|
10.0%
1/10 • 12 weeks
|
0.00%
0/10 • 12 weeks
|
0.00%
0/11 • 12 weeks
|
|
Blood and lymphatic system disorders
Blood Urea Nitrogen Elevation - Grade 1
|
30.0%
3/10 • 12 weeks
|
10.0%
1/10 • 12 weeks
|
20.0%
2/10 • 12 weeks
|
18.2%
2/11 • 12 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place