Trial Outcomes & Findings for Heartland Osteoporosis Prevention Study (NCT NCT02186600)
NCT ID: NCT02186600
Last Updated: 2023-10-05
Results Overview
Change in Bone Strength Index (BSI) of the distal tibia based on randomization to Control, Risedronate, or Exercise group. BSI (mg2/mm4) at the 4% tibial site will be measured using peripheral quantitative computed tomography (pQCT).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
276 participants
Primary outcome timeframe
Baseline, 6, and 12 months
Results posted on
2023-10-05
Participant Flow
Participant milestones
| Measure |
Control
Women randomized to the control group will receive calcium and vitamin D intake for 12 months. Calcium intake will be determined by analyzing 3 day dietary intake of calcium at baseline and then prescribing calcium carbonate supplements to ensure women have \~1200 mg of calcium daily. Vitamin D intake will be determined using baseline measures of Serum 25 (OH) D. Subjects who have serum D levels of 30 ng/ml or greater will be prescribed 1,000 IU vitamin D3 daily; subjects with levels of 20-29 ng/ml will be prescribed 2,000 IU Vitamin D3; and subjects with levels of 10-19 ng/ml will be prescribed 3,000 IU Vitamin D3.
Calcium Carbonate: Used as daily supplement to ensure subject obtains 1200 mg of calcium per day (diet + supplement)
Vitamin D3: Subjects will receive Vitamin D3 supplements to ensure serum level of Vitamin D is at least 30 ng/ml.
|
Risedronate
Subjects in the risedronate group will take 35 mg of the bisphosphonate "risedronate" weekly for 12 months plus CaD. They will be asked to follow the protocol for administration of risedronate including taking the medication upon arising in the morning with an 8 ounce glass of water, remaining upright for at least 30 minutes, and having no oral intake except water for at least 30 minutes.
Calcium Carbonate: Used as daily supplement to ensure subject obtains 1200 mg of calcium per day (diet + supplement)
Vitamin D3: Subjects will receive Vitamin D3 supplements to ensure serum level of Vitamin D is at least 30 ng/ml.
Risedronate: Risedronate 35 mg orally will be ingested weekly by subjects in Risedronate group.
|
Exercise
Subjects in the exercise group will participate in bone-loading exercises three times weekly in addition to taking CaD for 12 months. Women will exercise at community Young Men's Christian Association's fitness centers (YMCA) and exercises will be monitored by on-site Exercise Trainers. Exercises will consist of high-impact weight-bearing exercises (jogging with weighted vests) and resistance exercises for upper and lower extremities. Progressive increases in weight loads will be prescribed to provide maximal strength gains.
Calcium Carbonate: Used as daily supplement to ensure subject obtains 1200 mg of calcium per day (diet + supplement)
Vitamin D3: Subjects will receive Vitamin D3 supplements to ensure serum level of Vitamin D is at least 30 ng/ml.
Bone-loading exercises: Subjects will participate in bone loading exercises (weight-bearing and resistance) three times weekly at community YMCAs.
|
|---|---|---|---|
|
Overall Study
STARTED
|
93
|
91
|
92
|
|
Overall Study
COMPLETED
|
77
|
78
|
72
|
|
Overall Study
NOT COMPLETED
|
16
|
13
|
20
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Heartland Osteoporosis Prevention Study
Baseline characteristics by cohort
| Measure |
Control
n=93 Participants
Women randomized to the control group will receive calcium and vitamin D intake for 12 months. Calcium intake will be determined by analyzing 3 day dietary intake of calcium at baseline and then prescribing calcium carbonate supplements to ensure women have \~1200 mg of calcium daily. Vitamin D intake will be determined using baseline measures of Serum 25 (OH) D. Subjects who have serum D levels of 30 ng/ml or greater will be prescribed 1,000 IU vitamin D3 daily; subjects with levels of 20-29 ng/ml will be prescribed 2,000 IU Vitamin D3; and subjects with levels of 10-19 ng/ml will be prescribed 3,000 IU Vitamin D3.
Calcium Carbonate: Used as daily supplement to ensure subject obtains 1200 mg of calcium per day (diet + supplement)
Vitamin D3: Subjects will receive Vitamin D3 supplements to ensure serum level of Vitamin D is at least 30 ng/ml.
|
Risedronate
n=91 Participants
Subjects in the risedronate group will take 35 mg of the bisphosphonate "risedronate" weekly for 12 months plus CaD. They will be asked to follow the protocol for administration of risedronate including taking the medication upon arising in the morning with an 8 ounce glass of water, remaining upright for at least 30 minutes, and having no oral intake except water for at least 30 minutes.
Calcium Carbonate: Used as daily supplement to ensure subject obtains 1200 mg of calcium per day (diet + supplement)
Vitamin D3: Subjects will receive Vitamin D3 supplements to ensure serum level of Vitamin D is at least 30 ng/ml.
Risedronate: Risedronate 35 mg orally will be ingested weekly by subjects in Risedronate group.
|
Exercise
n=92 Participants
Subjects in the exercise group will participate in bone-loading exercises three times weekly in addition to taking CaD for 12 months. Women will exercise at community Young Men's Christian Association's fitness centers (YMCA) and exercises will be monitored by on-site Exercise Trainers. Exercises will consist of high-impact weight-bearing exercises (jogging with weighted vests) and resistance exercises for upper and lower extremities. Progressive increases in weight loads will be prescribed to provide maximal strength gains.
Calcium Carbonate: Used as daily supplement to ensure subject obtains 1200 mg of calcium per day (diet + supplement)
Vitamin D3: Subjects will receive Vitamin D3 supplements to ensure serum level of Vitamin D is at least 30 ng/ml.
Bone-loading exercises: Subjects will participate in bone loading exercises (weight-bearing and resistance) three times weekly at community YMCAs.
|
Total
n=276 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
54.34 years
STANDARD_DEVIATION 3.30 • n=5 Participants
|
54.53 years
STANDARD_DEVIATION 3.07 • n=7 Participants
|
54.47 years
STANDARD_DEVIATION 3.11 • n=5 Participants
|
54.4 years
STANDARD_DEVIATION 3.1 • n=4 Participants
|
|
Sex: Female, Male
Female
|
93 Participants
n=5 Participants
|
91 Participants
n=7 Participants
|
92 Participants
n=5 Participants
|
276 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
31 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
85 Participants
n=5 Participants
|
80 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
245 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
89 Participants
n=5 Participants
|
84 Participants
n=7 Participants
|
88 Participants
n=5 Participants
|
261 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Family History of Low Bone Mass or Osteoporosis
|
57 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
162 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline, 6, and 12 monthsPopulation: Intent-to-treat
Change in Bone Strength Index (BSI) of the distal tibia based on randomization to Control, Risedronate, or Exercise group. BSI (mg2/mm4) at the 4% tibial site will be measured using peripheral quantitative computed tomography (pQCT).
Outcome measures
| Measure |
Control
n=93 Participants
Women randomized to the control group will receive calcium and vitamin D intake for 12 months. Calcium intake will be determined by analyzing 3 day dietary intake of calcium at baseline and then prescribing calcium carbonate supplements to ensure women have \~1200 mg of calcium daily. Vitamin D intake will be determined using baseline measures of Serum 25 (OH) D. Subjects who have serum D levels of 30 ng/ml or greater will be prescribed 1,000 IU vitamin D3 daily; subjects with levels of 20-29 ng/ml will be prescribed 2,000 IU Vitamin D3; and subjects with levels of 10-19 ng/ml will be prescribed 3,000 IU Vitamin D3.
Calcium Carbonate: Used as daily supplement to ensure subject obtains 1200 mg of calcium per day (diet + supplement)
Vitamin D3: Subjects will receive Vitamin D3 supplements to ensure serum level of Vitamin D is at least 30 ng/ml.
|
Risedronate
n=91 Participants
Subjects in the risedronate group will take 35 mg of the bisphosphonate "risedronate" weekly for 12 months plus CaD. They will be asked to follow the protocol for administration of risedronate including taking the medication upon arising in the morning with an 8 ounce glass of water, remaining upright for at least 30 minutes, and having no oral intake except water for at least 30 minutes.
Calcium Carbonate: Used as daily supplement to ensure subject obtains 1200 mg of calcium per day (diet + supplement)
Vitamin D3: Subjects will receive Vitamin D3 supplements to ensure serum level of Vitamin D is at least 30 ng/ml.
Risedronate: Risedronate 35 mg orally will be ingested weekly by subjects in Risedronate group.
|
Exercise
n=92 Participants
Subjects in the exercise group will participate in bone-loading exercises three times weekly in addition to taking CaD for 12 months. Women will exercise at community Young Men's Christian Association's fitness centers (YMCA) and exercises will be monitored by on-site Exercise Trainers. Exercises will consist of high-impact weight-bearing exercises (jogging with weighted vests) and resistance exercises for upper and lower extremities. Progressive increases in weight loads will be prescribed to provide maximal strength gains.
Calcium Carbonate: Used as daily supplement to ensure subject obtains 1200 mg of calcium per day (diet + supplement)
Vitamin D3: Subjects will receive Vitamin D3 supplements to ensure serum level of Vitamin D is at least 30 ng/ml.
Bone-loading exercises: Subjects will participate in bone loading exercises (weight-bearing and resistance) three times weekly at community YMCAs.
|
|---|---|---|---|
|
Change in Bone Strength Index of the Distal Tibia Based on Randomization to Control, Risedronate, or Exercise Group.
12 Months
|
2107.2 mg^2/mm^4
Standard Deviation 326.4
|
2014.2 mg^2/mm^4
Standard Deviation 306.7
|
2009.2 mg^2/mm^4
Standard Deviation 280.4
|
|
Change in Bone Strength Index of the Distal Tibia Based on Randomization to Control, Risedronate, or Exercise Group.
Baseline
|
2098.7 mg^2/mm^4
Standard Deviation 334.7
|
1993.3 mg^2/mm^4
Standard Deviation 292.3
|
2001 mg^2/mm^4
Standard Deviation 332.1
|
|
Change in Bone Strength Index of the Distal Tibia Based on Randomization to Control, Risedronate, or Exercise Group.
6 Months
|
2105.89 mg^2/mm^4
Standard Deviation 322.822
|
1997.32 mg^2/mm^4
Standard Deviation 307.103
|
1987.42 mg^2/mm^4
Standard Deviation 300.136
|
SECONDARY outcome
Timeframe: Baseline,6, and 12 monthsPopulation: Intent to treat analysis
Bone mineral density is the gold standard for diagnosis of low bone mass and osteoporosis and will be measured at the spine using Dual Energy X-ray Absorptiometry (DXA).
Outcome measures
| Measure |
Control
n=93 Participants
Women randomized to the control group will receive calcium and vitamin D intake for 12 months. Calcium intake will be determined by analyzing 3 day dietary intake of calcium at baseline and then prescribing calcium carbonate supplements to ensure women have \~1200 mg of calcium daily. Vitamin D intake will be determined using baseline measures of Serum 25 (OH) D. Subjects who have serum D levels of 30 ng/ml or greater will be prescribed 1,000 IU vitamin D3 daily; subjects with levels of 20-29 ng/ml will be prescribed 2,000 IU Vitamin D3; and subjects with levels of 10-19 ng/ml will be prescribed 3,000 IU Vitamin D3.
Calcium Carbonate: Used as daily supplement to ensure subject obtains 1200 mg of calcium per day (diet + supplement)
Vitamin D3: Subjects will receive Vitamin D3 supplements to ensure serum level of Vitamin D is at least 30 ng/ml.
|
Risedronate
n=91 Participants
Subjects in the risedronate group will take 35 mg of the bisphosphonate "risedronate" weekly for 12 months plus CaD. They will be asked to follow the protocol for administration of risedronate including taking the medication upon arising in the morning with an 8 ounce glass of water, remaining upright for at least 30 minutes, and having no oral intake except water for at least 30 minutes.
Calcium Carbonate: Used as daily supplement to ensure subject obtains 1200 mg of calcium per day (diet + supplement)
Vitamin D3: Subjects will receive Vitamin D3 supplements to ensure serum level of Vitamin D is at least 30 ng/ml.
Risedronate: Risedronate 35 mg orally will be ingested weekly by subjects in Risedronate group.
|
Exercise
n=92 Participants
Subjects in the exercise group will participate in bone-loading exercises three times weekly in addition to taking CaD for 12 months. Women will exercise at community Young Men's Christian Association's fitness centers (YMCA) and exercises will be monitored by on-site Exercise Trainers. Exercises will consist of high-impact weight-bearing exercises (jogging with weighted vests) and resistance exercises for upper and lower extremities. Progressive increases in weight loads will be prescribed to provide maximal strength gains.
Calcium Carbonate: Used as daily supplement to ensure subject obtains 1200 mg of calcium per day (diet + supplement)
Vitamin D3: Subjects will receive Vitamin D3 supplements to ensure serum level of Vitamin D is at least 30 ng/ml.
Bone-loading exercises: Subjects will participate in bone loading exercises (weight-bearing and resistance) three times weekly at community YMCAs.
|
|---|---|---|---|
|
Change in Bone Mineral Density (BMD) at the Spine (L1-L4) Based on Randomization to Control, Risedronate, or Exercise Group.
Baseline
|
0.889 g/cm^2
Standard Deviation 0.076
|
0.892 g/cm^2
Standard Deviation 0.06
|
0.886 g/cm^2
Standard Deviation 0.064
|
|
Change in Bone Mineral Density (BMD) at the Spine (L1-L4) Based on Randomization to Control, Risedronate, or Exercise Group.
6 Months
|
.887 g/cm^2
Standard Deviation .0755
|
.907 g/cm^2
Standard Deviation .0666
|
.878 g/cm^2
Standard Deviation .0619
|
|
Change in Bone Mineral Density (BMD) at the Spine (L1-L4) Based on Randomization to Control, Risedronate, or Exercise Group.
12 Months
|
0.885 g/cm^2
Standard Deviation 0.070
|
0.911 g/cm^2
Standard Deviation 0.070
|
0.885 g/cm^2
Standard Deviation 0.065
|
SECONDARY outcome
Timeframe: Baseline, 6, 12 monthsPopulation: Intention to treat for persons who had valid data at baseline
Bone turnover is the process of removing old bone (resorption by osteoclasts) and replacing it with new bone (formation by osteoblasts). Menopause results in a brief period (\~5 years) of accelerated turnover with resorption far exceeding formation. In this study, resorption will be measured by Serum NTx.
Outcome measures
| Measure |
Control
n=80 Participants
Women randomized to the control group will receive calcium and vitamin D intake for 12 months. Calcium intake will be determined by analyzing 3 day dietary intake of calcium at baseline and then prescribing calcium carbonate supplements to ensure women have \~1200 mg of calcium daily. Vitamin D intake will be determined using baseline measures of Serum 25 (OH) D. Subjects who have serum D levels of 30 ng/ml or greater will be prescribed 1,000 IU vitamin D3 daily; subjects with levels of 20-29 ng/ml will be prescribed 2,000 IU Vitamin D3; and subjects with levels of 10-19 ng/ml will be prescribed 3,000 IU Vitamin D3.
Calcium Carbonate: Used as daily supplement to ensure subject obtains 1200 mg of calcium per day (diet + supplement)
Vitamin D3: Subjects will receive Vitamin D3 supplements to ensure serum level of Vitamin D is at least 30 ng/ml.
|
Risedronate
n=78 Participants
Subjects in the risedronate group will take 35 mg of the bisphosphonate "risedronate" weekly for 12 months plus CaD. They will be asked to follow the protocol for administration of risedronate including taking the medication upon arising in the morning with an 8 ounce glass of water, remaining upright for at least 30 minutes, and having no oral intake except water for at least 30 minutes.
Calcium Carbonate: Used as daily supplement to ensure subject obtains 1200 mg of calcium per day (diet + supplement)
Vitamin D3: Subjects will receive Vitamin D3 supplements to ensure serum level of Vitamin D is at least 30 ng/ml.
Risedronate: Risedronate 35 mg orally will be ingested weekly by subjects in Risedronate group.
|
Exercise
n=77 Participants
Subjects in the exercise group will participate in bone-loading exercises three times weekly in addition to taking CaD for 12 months. Women will exercise at community Young Men's Christian Association's fitness centers (YMCA) and exercises will be monitored by on-site Exercise Trainers. Exercises will consist of high-impact weight-bearing exercises (jogging with weighted vests) and resistance exercises for upper and lower extremities. Progressive increases in weight loads will be prescribed to provide maximal strength gains.
Calcium Carbonate: Used as daily supplement to ensure subject obtains 1200 mg of calcium per day (diet + supplement)
Vitamin D3: Subjects will receive Vitamin D3 supplements to ensure serum level of Vitamin D is at least 30 ng/ml.
Bone-loading exercises: Subjects will participate in bone loading exercises (weight-bearing and resistance) three times weekly at community YMCAs.
|
|---|---|---|---|
|
Change in Serum Measures of Bone Resorption (Serum NTx) Based on Randomization to Control, Risedronate, or Exercise Group.
6 Months
|
12.16 nanoMolar Bone Collagen Equivalents/L
Standard Deviation 3.84
|
10.30 nanoMolar Bone Collagen Equivalents/L
Standard Deviation 3.93
|
13.36 nanoMolar Bone Collagen Equivalents/L
Standard Deviation 5.83
|
|
Change in Serum Measures of Bone Resorption (Serum NTx) Based on Randomization to Control, Risedronate, or Exercise Group.
12 Months
|
12.36 nanoMolar Bone Collagen Equivalents/L
Standard Deviation 3.48
|
11.42 nanoMolar Bone Collagen Equivalents/L
Standard Deviation 4.71
|
13.92 nanoMolar Bone Collagen Equivalents/L
Standard Deviation 5.84
|
|
Change in Serum Measures of Bone Resorption (Serum NTx) Based on Randomization to Control, Risedronate, or Exercise Group.
Baseline
|
13.99 nanoMolar Bone Collagen Equivalents/L
Standard Deviation 4.22
|
14.31 nanoMolar Bone Collagen Equivalents/L
Standard Deviation 4.44
|
15.03 nanoMolar Bone Collagen Equivalents/L
Standard Deviation 5.45
|
Adverse Events
Control
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Risedronate
Serious events: 0 serious events
Other events: 30 other events
Deaths: 0 deaths
Exercise
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Control
n=93 participants at risk
Women randomized to the control group will receive calcium and vitamin D intake for 12 months. Calcium intake will be determined by analyzing 3 day dietary intake of calcium at baseline and then prescribing calcium carbonate supplements to ensure women have \~1200 mg of calcium daily. Vitamin D intake will be determined using baseline measures of Serum 25 (OH) D. Subjects who have serum D levels of 30 ng/ml or greater will be prescribed 1,000 IU vitamin D3 daily; subjects with levels of 20-29 ng/ml will be prescribed 2,000 IU Vitamin D3; and subjects with levels of 10-19 ng/ml will be prescribed 3,000 IU Vitamin D3.
Calcium Carbonate: Used as daily supplement to ensure subject obtains 1200 mg of calcium per day (diet + supplement)
Vitamin D3: Subjects will receive Vitamin D3 supplements to ensure serum level of Vitamin D is at least 30 ng/ml.
|
Risedronate
n=91 participants at risk
Subjects in the risedronate group will take 35 mg of the bisphosphonate "risedronate" weekly for 12 months plus CaD. They will be asked to follow the protocol for administration of risedronate including taking the medication upon arising in the morning with an 8 ounce glass of water, remaining upright for at least 30 minutes, and having no oral intake except water for at least 30 minutes.
Calcium Carbonate: Used as daily supplement to ensure subject obtains 1200 mg of calcium per day (diet + supplement)
Vitamin D3: Subjects will receive Vitamin D3 supplements to ensure serum level of Vitamin D is at least 30 ng/ml.
Risedronate: Risedronate 35 mg orally will be ingested weekly by subjects in Risedronate group.
|
Exercise
n=92 participants at risk
Subjects in the exercise group will participate in bone-loading exercises three times weekly in addition to taking CaD for 12 months. Women will exercise at community Young Men's Christian Association's fitness centers (YMCA) and exercises will be monitored by on-site Exercise Trainers. Exercises will consist of high-impact weight-bearing exercises (jogging with weighted vests) and resistance exercises for upper and lower extremities. Progressive increases in weight loads will be prescribed to provide maximal strength gains.
Calcium Carbonate: Used as daily supplement to ensure subject obtains 1200 mg of calcium per day (diet + supplement)
Vitamin D3: Subjects will receive Vitamin D3 supplements to ensure serum level of Vitamin D is at least 30 ng/ml.
Bone-loading exercises: Subjects will participate in bone loading exercises (weight-bearing and resistance) three times weekly at community YMCAs.
|
|---|---|---|---|
|
Gastrointestinal disorders
Constipation
|
9.7%
9/93 • Number of events 9 • 12 months for each participant
At each study visit, participants were asked if they had any new health conditions or events. We had questionnaires that evaluated tolerance to the treatments which allowed us to communicate with those who experienced symptoms as a result of the intervention.
|
14.3%
13/91 • Number of events 13 • 12 months for each participant
At each study visit, participants were asked if they had any new health conditions or events. We had questionnaires that evaluated tolerance to the treatments which allowed us to communicate with those who experienced symptoms as a result of the intervention.
|
2.2%
2/92 • Number of events 2 • 12 months for each participant
At each study visit, participants were asked if they had any new health conditions or events. We had questionnaires that evaluated tolerance to the treatments which allowed us to communicate with those who experienced symptoms as a result of the intervention.
|
|
Gastrointestinal disorders
Gi disturbances
|
0.00%
0/93 • 12 months for each participant
At each study visit, participants were asked if they had any new health conditions or events. We had questionnaires that evaluated tolerance to the treatments which allowed us to communicate with those who experienced symptoms as a result of the intervention.
|
4.4%
4/91 • Number of events 4 • 12 months for each participant
At each study visit, participants were asked if they had any new health conditions or events. We had questionnaires that evaluated tolerance to the treatments which allowed us to communicate with those who experienced symptoms as a result of the intervention.
|
0.00%
0/92 • 12 months for each participant
At each study visit, participants were asked if they had any new health conditions or events. We had questionnaires that evaluated tolerance to the treatments which allowed us to communicate with those who experienced symptoms as a result of the intervention.
|
|
Musculoskeletal and connective tissue disorders
muscle or joint pain
|
0.00%
0/93 • 12 months for each participant
At each study visit, participants were asked if they had any new health conditions or events. We had questionnaires that evaluated tolerance to the treatments which allowed us to communicate with those who experienced symptoms as a result of the intervention.
|
12.1%
11/91 • Number of events 11 • 12 months for each participant
At each study visit, participants were asked if they had any new health conditions or events. We had questionnaires that evaluated tolerance to the treatments which allowed us to communicate with those who experienced symptoms as a result of the intervention.
|
2.2%
2/92 • Number of events 2 • 12 months for each participant
At each study visit, participants were asked if they had any new health conditions or events. We had questionnaires that evaluated tolerance to the treatments which allowed us to communicate with those who experienced symptoms as a result of the intervention.
|
|
Cardiac disorders
Chest Pain or Dizziness
|
0.00%
0/93 • 12 months for each participant
At each study visit, participants were asked if they had any new health conditions or events. We had questionnaires that evaluated tolerance to the treatments which allowed us to communicate with those who experienced symptoms as a result of the intervention.
|
2.2%
2/91 • Number of events 2 • 12 months for each participant
At each study visit, participants were asked if they had any new health conditions or events. We had questionnaires that evaluated tolerance to the treatments which allowed us to communicate with those who experienced symptoms as a result of the intervention.
|
0.00%
0/92 • 12 months for each participant
At each study visit, participants were asked if they had any new health conditions or events. We had questionnaires that evaluated tolerance to the treatments which allowed us to communicate with those who experienced symptoms as a result of the intervention.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place