Trial Outcomes & Findings for Nutritional Supplements and Hormonal Manipulations for Breast Cancer Prevention (NCT NCT00723398)
NCT ID: NCT00723398
Last Updated: 2018-11-01
Results Overview
Change of absolute breast density as indicated by mammography from baseline to Year +1 and completion of study (Year +2). No other mammograms will be obtained or used for the purpose of this study. Absolute breast density volume is based on breast thickness and the x-ray attenuation at each pixel of the image.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
266 participants
Primary outcome timeframe
2 years
Results posted on
2018-11-01
Participant Flow
Participant milestones
| Measure |
Group 1: Control
Control, no intervention
|
Group 2: Raloxifene 60 mg
Raloxifene 60 mg Orally Daily
|
Group 3: Raloxifene 30 mg
Raloxifene 30 mg Orally Daily
|
Group 4: Lovaza 4 gm
Lovaza 4 gm/day Orally with Meals
|
Group 5: Lovaza 4 gm and Raloxifene 30 mg
Lovaza 4 gm/day orally with meals plus Raloxifene 30 mg orally daily
|
|---|---|---|---|---|---|
|
Overall Study
NOT COMPLETED
|
6
|
15
|
17
|
5
|
9
|
|
Overall Study
STARTED
|
53
|
53
|
53
|
54
|
53
|
|
Overall Study
COMPLETED
|
47
|
38
|
36
|
49
|
44
|
Reasons for withdrawal
| Measure |
Group 1: Control
Control, no intervention
|
Group 2: Raloxifene 60 mg
Raloxifene 60 mg Orally Daily
|
Group 3: Raloxifene 30 mg
Raloxifene 30 mg Orally Daily
|
Group 4: Lovaza 4 gm
Lovaza 4 gm/day Orally with Meals
|
Group 5: Lovaza 4 gm and Raloxifene 30 mg
Lovaza 4 gm/day orally with meals plus Raloxifene 30 mg orally daily
|
|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
6
|
4
|
4
|
4
|
|
Overall Study
Protocol Violation
|
2
|
1
|
5
|
0
|
0
|
|
Overall Study
Physician Decision
|
2
|
2
|
5
|
0
|
1
|
|
Overall Study
Adverse Event
|
0
|
5
|
3
|
1
|
4
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
0
|
0
|
0
|
Baseline Characteristics
Nutritional Supplements and Hormonal Manipulations for Breast Cancer Prevention
Baseline characteristics by cohort
| Measure |
Group 1: Control
n=53 Participants
Control, no intervention
|
Group 2: Raloxifene 60 mg
n=53 Participants
Raloxifene 60 mg Orally Daily
|
Group 3: Raloxifene 30 mg
n=53 Participants
Raloxifene 30 mg Orally Daily
|
Group 4: Lovaza 4 gm
n=54 Participants
Lovaza 4 gm/day Orally with Meals
|
Group 5: Lovaza 4 gm and Raloxifene 30 mg
n=53 Participants
Lovaza 4 gm/day orally with meals plus Raloxifene 30 mg orally daily
|
Total
n=266 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
49 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
45 Participants
n=4 Participants
|
46 Participants
n=21 Participants
|
231 Participants
n=8 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
35 Participants
n=8 Participants
|
|
Sex: Female, Male
Female
|
53 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
54 Participants
n=4 Participants
|
53 Participants
n=21 Participants
|
266 Participants
n=8 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
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
52 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
53 Participants
n=4 Participants
|
53 Participants
n=21 Participants
|
264 Participants
n=8 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
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=8 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
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
51 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
51 Participants
n=4 Participants
|
53 Participants
n=21 Participants
|
259 Participants
n=8 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
|
0 Participants
n=21 Participants
|
0 Participants
n=8 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
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: 2 yearsPopulation: The decrease in the population groups is accounted for through subject withdrawals, subjects lost to follow-up, and other reasons for not completing study.
Change of absolute breast density as indicated by mammography from baseline to Year +1 and completion of study (Year +2). No other mammograms will be obtained or used for the purpose of this study. Absolute breast density volume is based on breast thickness and the x-ray attenuation at each pixel of the image.
Outcome measures
| Measure |
Group 1: Control
n=53 Participants
Control, no intervention
|
Group 2: Raloxifene 60 mg
n=53 Participants
Raloxifene 60 mg Orally Daily
|
Group 3: Raloxifene 30 mg
n=53 Participants
Raloxifene 30 mg Orally Daily
|
Group 4: Lovaza 4 gm
n=54 Participants
Lovaza 4 gm/day Orally with Meals
|
Group 5: Lovaza 4 gm and Raloxifene 30 mg
n=53 Participants
Lovaza 4 gm/day orally with meals plus Raloxifene 30 mg orally daily
|
|---|---|---|---|---|---|
|
Change in Absolute Breast Density
Absolute density at baseline
|
65.53 cm squared
Standard Deviation 59.43
|
64.39 cm squared
Standard Deviation 39.95
|
65.08 cm squared
Standard Deviation 34.47
|
56.35 cm squared
Standard Deviation 22.61
|
63.81 cm squared
Standard Deviation 29.81
|
|
Change in Absolute Breast Density
Absolute density at 1 year
|
59.29 cm squared
Standard Deviation 40.72
|
60.48 cm squared
Standard Deviation 38.89
|
59.53 cm squared
Standard Deviation 30.32
|
58.87 cm squared
Standard Deviation 22.21
|
60.93 cm squared
Standard Deviation 24.64
|
|
Change in Absolute Breast Density
Absolute density at 2 years
|
54.34 cm squared
Standard Deviation 20.11
|
60.57 cm squared
Standard Deviation 35.10
|
58.86 cm squared
Standard Deviation 27.93
|
57.60 cm squared
Standard Deviation 20.77
|
28.53 cm squared
Standard Deviation 25.18
|
SECONDARY outcome
Timeframe: 1 yearPopulation: Biomarker measurements were not taken for the entire population of the study due to non-significant trends for treatment effects found in this population (n = 47).
Changes in biomarkers for oxidative stress. Specific time points for evaluation are baseline and Year +1 (only). Urinary 8-(isoprostane) F-2α as measured through urine analysis.
Outcome measures
| Measure |
Group 1: Control
n=8 Participants
Control, no intervention
|
Group 2: Raloxifene 60 mg
n=10 Participants
Raloxifene 60 mg Orally Daily
|
Group 3: Raloxifene 30 mg
n=10 Participants
Raloxifene 30 mg Orally Daily
|
Group 4: Lovaza 4 gm
n=11 Participants
Lovaza 4 gm/day Orally with Meals
|
Group 5: Lovaza 4 gm and Raloxifene 30 mg
n=8 Participants
Lovaza 4 gm/day orally with meals plus Raloxifene 30 mg orally daily
|
|---|---|---|---|---|---|
|
Changes in Biomarkers for Oxidative Stress:Urinary 8-(Isoprostane) F-2α
Baseline
|
544 pg/mg creatinine
Standard Error 105
|
366 pg/mg creatinine
Standard Error 39.7
|
530 pg/mg creatinine
Standard Error 107
|
440 pg/mg creatinine
Standard Error 30.8
|
444 pg/mg creatinine
Standard Error 54.6
|
|
Changes in Biomarkers for Oxidative Stress:Urinary 8-(Isoprostane) F-2α
1 year
|
484 pg/mg creatinine
Standard Error 77.3
|
360 pg/mg creatinine
Standard Error 33.8
|
538 pg/mg creatinine
Standard Error 67.0
|
313 pg/mg creatinine
Standard Error 45.1
|
396 pg/mg creatinine
Standard Error 40.6
|
SECONDARY outcome
Timeframe: 1 yearPopulation: Biomarker measurements were not taken for the entire population of the study due to non-significant trends for treatment effects found in this population (n = 47).
Changes in biomarkers for oxidative stress. Specific time points for evaluation are baseline and Year +1 (only). Urinary 8-hydroxy-deoxyguansine as measured through urinary analysis.
Outcome measures
| Measure |
Group 1: Control
n=8 Participants
Control, no intervention
|
Group 2: Raloxifene 60 mg
n=10 Participants
Raloxifene 60 mg Orally Daily
|
Group 3: Raloxifene 30 mg
n=10 Participants
Raloxifene 30 mg Orally Daily
|
Group 4: Lovaza 4 gm
n=11 Participants
Lovaza 4 gm/day Orally with Meals
|
Group 5: Lovaza 4 gm and Raloxifene 30 mg
n=8 Participants
Lovaza 4 gm/day orally with meals plus Raloxifene 30 mg orally daily
|
|---|---|---|---|---|---|
|
Changes in Biomarkers for Oxidative Stress: Urinary 8-hydroxy-deoxyguansine
Baseline
|
255 ng/mg creatinine
Standard Error 63.6
|
285 ng/mg creatinine
Standard Error 47.7
|
213 ng/mg creatinine
Standard Error 91.0
|
184 ng/mg creatinine
Standard Error 25.6
|
355 ng/mg creatinine
Standard Error 79.7
|
|
Changes in Biomarkers for Oxidative Stress: Urinary 8-hydroxy-deoxyguansine
1 year
|
224 ng/mg creatinine
Standard Error 31.8
|
309 ng/mg creatinine
Standard Error 69.0
|
246 ng/mg creatinine
Standard Error 108
|
177 ng/mg creatinine
Standard Error 17.3
|
297 ng/mg creatinine
Standard Error 90.2
|
SECONDARY outcome
Timeframe: 1 yearPopulation: Biomarker measurements were not taken for the entire population of the study due to non-significant trends for treatment effects found in this population (n = 47).
Changes in biomarkers for estrogen metabolism: 2-hydroxy estrone (Urinary 2-OHE1) and 16-α-hydroxy estrone (16α-OHE1) as measured by urinary analysis. Specific time points for evaluation are baseline and Year +1 (only).
Outcome measures
| Measure |
Group 1: Control
n=8 Participants
Control, no intervention
|
Group 2: Raloxifene 60 mg
n=10 Participants
Raloxifene 60 mg Orally Daily
|
Group 3: Raloxifene 30 mg
n=10 Participants
Raloxifene 30 mg Orally Daily
|
Group 4: Lovaza 4 gm
n=11 Participants
Lovaza 4 gm/day Orally with Meals
|
Group 5: Lovaza 4 gm and Raloxifene 30 mg
n=8 Participants
Lovaza 4 gm/day orally with meals plus Raloxifene 30 mg orally daily
|
|---|---|---|---|---|---|
|
Changes in Biomarkers for Estrogen Metabolism: 2-hydroxy Estrone (Urinary 2-OHE1) and 16-α-hydroxy Estrone (16α-OHE1)
Baseline: Urinary 2-OHE1
|
10.57 ng/mg creatinine
Standard Deviation 2.3
|
8.58 ng/mg creatinine
Standard Deviation 1.0
|
8.82 ng/mg creatinine
Standard Deviation 1.4
|
7.15 ng/mg creatinine
Standard Deviation 1.1
|
15.6 ng/mg creatinine
Standard Deviation 4.5
|
|
Changes in Biomarkers for Estrogen Metabolism: 2-hydroxy Estrone (Urinary 2-OHE1) and 16-α-hydroxy Estrone (16α-OHE1)
1 year: Urinary 2-OHE1
|
7.46 ng/mg creatinine
Standard Deviation 1.4
|
10.03 ng/mg creatinine
Standard Deviation 1.0
|
9.10 ng/mg creatinine
Standard Deviation 1.4
|
7.49 ng/mg creatinine
Standard Deviation 1.0
|
13.2 ng/mg creatinine
Standard Deviation 3.7
|
|
Changes in Biomarkers for Estrogen Metabolism: 2-hydroxy Estrone (Urinary 2-OHE1) and 16-α-hydroxy Estrone (16α-OHE1)
Baseline: 16α-OHE1
|
6.22 ng/mg creatinine
Standard Deviation 0.7
|
5.08 ng/mg creatinine
Standard Deviation 0.5
|
6.86 ng/mg creatinine
Standard Deviation 1.8
|
5.24 ng/mg creatinine
Standard Deviation 0.5
|
6.6 ng/mg creatinine
Standard Deviation 0.9
|
|
Changes in Biomarkers for Estrogen Metabolism: 2-hydroxy Estrone (Urinary 2-OHE1) and 16-α-hydroxy Estrone (16α-OHE1)
1 year: 16α-OHE1
|
5.68 ng/mg creatinine
Standard Deviation 0.7
|
4.35 ng/mg creatinine
Standard Deviation 0.5
|
7.46 ng/mg creatinine
Standard Deviation 1.4
|
4.79 ng/mg creatinine
Standard Deviation 0.3
|
5.68 ng/mg creatinine
Standard Deviation 0.9
|
SECONDARY outcome
Timeframe: 1 YearPopulation: Biomarker measurements were not taken for the entire population of the study (N = 266) due to non-significant trends for treatment effects found in this initial population (n = 89).
Changes in serum biomarkers for inflammation including highly sensitive C-reactive protein and IL-6 obtained through a blood draw. Specific time points for evaluation are baseline and Year +1 (only).
Outcome measures
| Measure |
Group 1: Control
n=17 Participants
Control, no intervention
|
Group 2: Raloxifene 60 mg
n=17 Participants
Raloxifene 60 mg Orally Daily
|
Group 3: Raloxifene 30 mg
n=18 Participants
Raloxifene 30 mg Orally Daily
|
Group 4: Lovaza 4 gm
n=21 Participants
Lovaza 4 gm/day Orally with Meals
|
Group 5: Lovaza 4 gm and Raloxifene 30 mg
n=16 Participants
Lovaza 4 gm/day orally with meals plus Raloxifene 30 mg orally daily
|
|---|---|---|---|---|---|
|
Changes in Serum Biomarkers for Inflammation From Levels of High Sensitivity C-reactive Protein (hsCRP) and Interleukin 6 (IL-6)
Baseline: Serum hsCRP
|
2.39 pg/ml
Standard Deviation 0.87
|
0.91 pg/ml
Standard Deviation 0.26
|
1.67 pg/ml
Standard Deviation 0.63
|
1.22 pg/ml
Standard Deviation 0.31
|
4.28 pg/ml
Standard Deviation 1.61
|
|
Changes in Serum Biomarkers for Inflammation From Levels of High Sensitivity C-reactive Protein (hsCRP) and Interleukin 6 (IL-6)
1 year: Serum hsCRP
|
2.19 pg/ml
Standard Deviation 0.63
|
1.04 pg/ml
Standard Deviation 0.34
|
1.34 pg/ml
Standard Deviation 0.34
|
1.69 pg/ml
Standard Deviation 0.59
|
2.59 pg/ml
Standard Deviation 0.89
|
|
Changes in Serum Biomarkers for Inflammation From Levels of High Sensitivity C-reactive Protein (hsCRP) and Interleukin 6 (IL-6)
Baseline: Serum IL-6
|
1.27 pg/ml
Standard Deviation 0.3
|
1.14 pg/ml
Standard Deviation 0.23
|
1.04 pg/ml
Standard Deviation 0.22
|
1.32 pg/ml
Standard Deviation 0.45
|
1.84 pg/ml
Standard Deviation 0.52
|
|
Changes in Serum Biomarkers for Inflammation From Levels of High Sensitivity C-reactive Protein (hsCRP) and Interleukin 6 (IL-6)
1 year: Serum IL-6
|
1.03 pg/ml
Standard Deviation 0.19
|
1.13 pg/ml
Standard Deviation 0.26
|
1.11 pg/ml
Standard Deviation 0.2
|
1.49 pg/ml
Standard Deviation 0.41
|
1.32 pg/ml
Standard Deviation 0.34
|
SECONDARY outcome
Timeframe: 1 yearPopulation: Measurements were not taken for the entire population of the study due to non-significant trends for treatment effects found in this population (n = 46).
Changes in insulin-like growth factor-1 (IGF-1) and insulin-like growth factor-1 binding protein-3 (IGFBP-3) obtained through blood sample. Specific time points for evaluation are baseline and Year +1 (only).
Outcome measures
| Measure |
Group 1: Control
n=8 Participants
Control, no intervention
|
Group 2: Raloxifene 60 mg
n=9 Participants
Raloxifene 60 mg Orally Daily
|
Group 3: Raloxifene 30 mg
n=10 Participants
Raloxifene 30 mg Orally Daily
|
Group 4: Lovaza 4 gm
n=11 Participants
Lovaza 4 gm/day Orally with Meals
|
Group 5: Lovaza 4 gm and Raloxifene 30 mg
n=8 Participants
Lovaza 4 gm/day orally with meals plus Raloxifene 30 mg orally daily
|
|---|---|---|---|---|---|
|
Changes in Insulin-like Growth Factor-1 (IGF-1) and Insulin-like Growth Factor-1 Binding Protein-3 (IGFBP-3)
Baseline: IGF-1
|
4.96 ng/mL
Standard Deviation 0.37
|
4.63 ng/mL
Standard Deviation 0.28
|
4.80 ng/mL
Standard Deviation 0.23
|
4.95 ng/mL
Standard Deviation 0.41
|
4.89 ng/mL
Standard Deviation 0.49
|
|
Changes in Insulin-like Growth Factor-1 (IGF-1) and Insulin-like Growth Factor-1 Binding Protein-3 (IGFBP-3)
1 year: IGF-1
|
5.05 ng/mL
Standard Deviation 0.44
|
4.40 ng/mL
Standard Deviation 0.25
|
4.76 ng/mL
Standard Deviation 0.24
|
4.96 ng/mL
Standard Deviation 031
|
4.82 ng/mL
Standard Deviation 0.52
|
|
Changes in Insulin-like Growth Factor-1 (IGF-1) and Insulin-like Growth Factor-1 Binding Protein-3 (IGFBP-3)
Baseline: IGFBP-3
|
7.67 ng/mL
Standard Deviation 0.32
|
7.53 ng/mL
Standard Deviation 0.19
|
7.69 ng/mL
Standard Deviation 0.21
|
7.83 ng/mL
Standard Deviation 0.20
|
7.57 ng/mL
Standard Deviation 0.23
|
|
Changes in Insulin-like Growth Factor-1 (IGF-1) and Insulin-like Growth Factor-1 Binding Protein-3 (IGFBP-3)
1 year: IGFBP-3
|
7.75 ng/mL
Standard Deviation 0.26
|
7.55 ng/mL
Standard Deviation 0.12
|
7.79 ng/mL
Standard Deviation 0.24
|
7.83 ng/mL
Standard Deviation 0.17
|
7.61 ng/mL
Standard Deviation 0.23
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: The decrease in the population groups is accounted for through subject withdrawals, subjects lost to follow-up, and other reasons for not completing study.
Changes in serum lipid levels as measured through total cholesterol, low-density lipoprotein (LDL) cholesterol, high-density lipoprotein (HDL) cholesterol, and triglycerides. Specific time points for evaluation are baseline, Year +1, and Year 2.
Outcome measures
| Measure |
Group 1: Control
n=53 Participants
Control, no intervention
|
Group 2: Raloxifene 60 mg
n=51 Participants
Raloxifene 60 mg Orally Daily
|
Group 3: Raloxifene 30 mg
n=52 Participants
Raloxifene 30 mg Orally Daily
|
Group 4: Lovaza 4 gm
n=54 Participants
Lovaza 4 gm/day Orally with Meals
|
Group 5: Lovaza 4 gm and Raloxifene 30 mg
n=52 Participants
Lovaza 4 gm/day orally with meals plus Raloxifene 30 mg orally daily
|
|---|---|---|---|---|---|
|
Changes in Serum Lipid Levels
Baseline: Total Cholesterol
|
207.3 mg/dL
Standard Deviation 41.18
|
203.6 mg/dL
Standard Deviation 29.98
|
204.3 mg/dL
Standard Deviation 36.29
|
197.7 mg/dL
Standard Deviation 33.2
|
197.6 mg/dL
Standard Deviation 38.68
|
|
Changes in Serum Lipid Levels
1 year: Total Cholestrol
|
208.8 mg/dL
Standard Deviation 34.39
|
198.3 mg/dL
Standard Deviation 29.33
|
199.6 mg/dL
Standard Deviation 28.43
|
199.6 mg/dL
Standard Deviation 30.45
|
189.4 mg/dL
Standard Deviation 33.45
|
|
Changes in Serum Lipid Levels
2 year: Total Cholesterol
|
207.5 mg/dL
Standard Deviation 36.41
|
196.6 mg/dL
Standard Deviation 30.64
|
202.3 mg/dL
Standard Deviation 25.58
|
200.2 mg/dL
Standard Deviation 34.55
|
192.6 mg/dL
Standard Deviation 30.02
|
|
Changes in Serum Lipid Levels
Baseline: LDL Cholesterol
|
114 mg/dL
Standard Deviation 38.07
|
114.7 mg/dL
Standard Deviation 27.53
|
111.2 mg/dL
Standard Deviation 31.83
|
106.6 mg/dL
Standard Deviation 31.96
|
108.1 mg/dL
Standard Deviation 35.87
|
|
Changes in Serum Lipid Levels
1 year: LDL Cholesterol
|
115.1 mg/dL
Standard Deviation 31.99
|
106.8 mg/dL
Standard Deviation 25.98
|
106.2 mg/dL
Standard Deviation 24.38
|
109.7 mg/dL
Standard Deviation 29.22
|
96.58 mg/dL
Standard Deviation 26.37
|
|
Changes in Serum Lipid Levels
2 year: LDL Cholesterol
|
115.3 mg/dL
Standard Deviation 29.21
|
104.7 mg/dL
Standard Deviation 28.13
|
106.1 mg/dL
Standard Deviation 25.4
|
110.4 mg/dL
Standard Deviation 29.2
|
99.48 mg/dL
Standard Deviation 25.2
|
|
Changes in Serum Lipid Levels
Baseline: HDL Cholesterol
|
68.75 mg/dL
Standard Deviation 18.83
|
66.18 mg/dL
Standard Deviation 15.47
|
70.92 mg/dL
Standard Deviation 18.54
|
68.06 mg/dL
Standard Deviation 16.89
|
68.9 mg/dL
Standard Deviation 17.68
|
|
Changes in Serum Lipid Levels
1 year: HDL Cholesterol
|
70.71 mg/dL
Standard Deviation 18.87
|
68.88 mg/dL
Standard Deviation 14.06
|
70.59 mg/dL
Standard Deviation 16.63
|
70.59 mg/dL
Standard Deviation 18.31
|
76.11 mg/dL
Standard Deviation 18.61
|
|
Changes in Serum Lipid Levels
2 year: HDL Cholestrol
|
70.19 mg/dL
Standard Deviation 19.35
|
68.63 mg/dL
Standard Deviation 15.04
|
73.17 mg/dL
Standard Deviation 18.01
|
70.67 mg/dL
Standard Deviation 19.38
|
75.77 mg/dL
Standard Deviation 17.8
|
|
Changes in Serum Lipid Levels
Baseline: Triglycerides
|
122.7 mg/dL
Standard Deviation 54.57
|
113.2 mg/dL
Standard Deviation 48.39
|
110.6 mg/dL
Standard Deviation 50.49
|
115.1 mg/dL
Standard Deviation 52.33
|
103.6 mg/dL
Standard Deviation 38.79
|
|
Changes in Serum Lipid Levels
1 year: Triglycerides
|
114.5 mg/dL
Standard Deviation 62.95
|
113.2 mg/dL
Standard Deviation 55.08
|
113.7 mg/dL
Standard Deviation 49.76
|
96.22 mg/dL
Standard Deviation 42.94
|
83.71 mg/dL
Standard Deviation 31.08
|
|
Changes in Serum Lipid Levels
2 year: Triglycerides
|
110.1 mg/dL
Standard Deviation 44.25
|
116.9 mg/dL
Standard Deviation 50.17
|
115.8 mg/dL
Standard Deviation 58.48
|
95.41 mg/dL
Standard Deviation 49.6
|
86.43 mg/dL
Standard Deviation 35
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: The decrease in the population groups is accounted for through subject withdrawals, subjects lost to follow-up, and other reasons for not completing study.
Changes in complete blood count levels as measured through red blood cells (RBC). Specific time points for evaluation are baseline, Year +1, and Year 2.
Outcome measures
| Measure |
Group 1: Control
n=53 Participants
Control, no intervention
|
Group 2: Raloxifene 60 mg
n=51 Participants
Raloxifene 60 mg Orally Daily
|
Group 3: Raloxifene 30 mg
n=50 Participants
Raloxifene 30 mg Orally Daily
|
Group 4: Lovaza 4 gm
n=51 Participants
Lovaza 4 gm/day Orally with Meals
|
Group 5: Lovaza 4 gm and Raloxifene 30 mg
n=50 Participants
Lovaza 4 gm/day orally with meals plus Raloxifene 30 mg orally daily
|
|---|---|---|---|---|---|
|
Changes in Complete Blood Count: Red Blood Cells
Baseline: RBC
|
4.31 millions of cells per microliter
Standard Deviation 0.33
|
4.25 millions of cells per microliter
Standard Deviation 0.30
|
4.30 millions of cells per microliter
Standard Deviation 0.33
|
4.33 millions of cells per microliter
Standard Deviation 0.43
|
4.24 millions of cells per microliter
Standard Deviation 0.31
|
|
Changes in Complete Blood Count: Red Blood Cells
1 year: RBC
|
4.27 millions of cells per microliter
Standard Deviation 0.32
|
4.19 millions of cells per microliter
Standard Deviation 0.25
|
4.25 millions of cells per microliter
Standard Deviation 0.30
|
4.36 millions of cells per microliter
Standard Deviation 0.44
|
4.20 millions of cells per microliter
Standard Deviation 0.32
|
|
Changes in Complete Blood Count: Red Blood Cells
2 year: RBC
|
4.32 millions of cells per microliter
Standard Deviation 0.36
|
4.20 millions of cells per microliter
Standard Deviation 0.23
|
4.24 millions of cells per microliter
Standard Deviation 0.35
|
4.33 millions of cells per microliter
Standard Deviation 0.45
|
4.23 millions of cells per microliter
Standard Deviation 0.31
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: The decrease in the population groups is accounted for through subject withdrawals, subjects lost to follow-up, and other reasons for not completing study.
Changes in complete blood count levels as measured through hemoglobin. Specific time points for evaluation are baseline, Year +1, and Year 2.
Outcome measures
| Measure |
Group 1: Control
n=53 Participants
Control, no intervention
|
Group 2: Raloxifene 60 mg
n=51 Participants
Raloxifene 60 mg Orally Daily
|
Group 3: Raloxifene 30 mg
n=50 Participants
Raloxifene 30 mg Orally Daily
|
Group 4: Lovaza 4 gm
n=51 Participants
Lovaza 4 gm/day Orally with Meals
|
Group 5: Lovaza 4 gm and Raloxifene 30 mg
n=50 Participants
Lovaza 4 gm/day orally with meals plus Raloxifene 30 mg orally daily
|
|---|---|---|---|---|---|
|
Changes in Complete Blood Count: Hemoglobin
1 year: Hemoglobin
|
12.97 g/dL
Standard Deviation 1.49
|
12.97 g/dL
Standard Deviation 1.61
|
12.95 g/dL
Standard Deviation 0.96
|
13.33 g/dL
Standard Deviation 0.97
|
13.10 g/dL
Standard Deviation 1.65
|
|
Changes in Complete Blood Count: Hemoglobin
Baseline: Hemoglobin
|
13.09 g/dL
Standard Deviation 1.56
|
13.11 g/dL
Standard Deviation 1.48
|
12.73 g/dL
Standard Deviation 2.02
|
13.25 g/dL
Standard Deviation 0.99
|
13.35 g/dL
Standard Deviation 0.86
|
|
Changes in Complete Blood Count: Hemoglobin
2 year: Hemoglobin
|
13.10 g/dL
Standard Deviation 0.87
|
13.07 g/dL
Standard Deviation 0.71
|
12.82 g/dL
Standard Deviation 0.96
|
13.16 g/dL
Standard Deviation 0.91
|
13.22 g/dL
Standard Deviation 0.95
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: The decrease in the population groups is accounted for through subject withdrawals, subjects lost to follow-up, and other reasons for not completing study.
Changes in complete blood count levels as measured through hematocrit percentage. Specific time points for evaluation are baseline, Year +1, and Year 2.
Outcome measures
| Measure |
Group 1: Control
n=53 Participants
Control, no intervention
|
Group 2: Raloxifene 60 mg
n=51 Participants
Raloxifene 60 mg Orally Daily
|
Group 3: Raloxifene 30 mg
n=50 Participants
Raloxifene 30 mg Orally Daily
|
Group 4: Lovaza 4 gm
n=51 Participants
Lovaza 4 gm/day Orally with Meals
|
Group 5: Lovaza 4 gm and Raloxifene 30 mg
n=50 Participants
Lovaza 4 gm/day orally with meals plus Raloxifene 30 mg orally daily
|
|---|---|---|---|---|---|
|
Changes in Complete Blood Count: Hematocrit
Baseline: Hematocrit
|
39.14 volume percentage
Standard Deviation 2.50
|
38.95 volume percentage
Standard Deviation 2.49
|
38.79 volume percentage
Standard Deviation 3.06
|
39.09 volume percentage
Standard Deviation 2.70
|
39.20 volume percentage
Standard Deviation 2.48
|
|
Changes in Complete Blood Count: Hematocrit
1 year: Hematocrit
|
38.83 volume percentage
Standard Deviation 2.25
|
38.79 volume percentage
Standard Deviation 2.14
|
38.43 volume percentage
Standard Deviation 2.69
|
39.52 volume percentage
Standard Deviation 2.72
|
39.14 volume percentage
Standard Deviation 2.52
|
|
Changes in Complete Blood Count: Hematocrit
2 year: Hematocrit
|
39.00 volume percentage
Standard Deviation 2.47
|
38.86 volume percentage
Standard Deviation 2.28
|
38.31 volume percentage
Standard Deviation 2.84
|
38.59 volume percentage
Standard Deviation 5.72
|
39.14 volume percentage
Standard Deviation 2.74
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: The decrease in the population groups is accounted for through subject withdrawals, subjects lost to follow-up, and other reasons for not completing study.
Changes in complete blood count levels as measured through white blood cells (WBC) and platelets. Specific time points for evaluation are baseline, Year +1, and Year 2.
Outcome measures
| Measure |
Group 1: Control
n=53 Participants
Control, no intervention
|
Group 2: Raloxifene 60 mg
n=51 Participants
Raloxifene 60 mg Orally Daily
|
Group 3: Raloxifene 30 mg
n=50 Participants
Raloxifene 30 mg Orally Daily
|
Group 4: Lovaza 4 gm
n=51 Participants
Lovaza 4 gm/day Orally with Meals
|
Group 5: Lovaza 4 gm and Raloxifene 30 mg
n=50 Participants
Lovaza 4 gm/day orally with meals plus Raloxifene 30 mg orally daily
|
|---|---|---|---|---|---|
|
Changes in Complete Blood Count: White Blood Cells and Platelets
Baseline: WBC
|
5.13 thousand cells/mL
Standard Deviation 1.29
|
5.47 thousand cells/mL
Standard Deviation 1.57
|
5.00 thousand cells/mL
Standard Deviation 1.20
|
5.04 thousand cells/mL
Standard Deviation 1.64
|
5.27 thousand cells/mL
Standard Deviation 1.24
|
|
Changes in Complete Blood Count: White Blood Cells and Platelets
1 year: WBC
|
5.15 thousand cells/mL
Standard Deviation 1.76
|
5.51 thousand cells/mL
Standard Deviation 1.54
|
4.78 thousand cells/mL
Standard Deviation 1.04
|
4.95 thousand cells/mL
Standard Deviation 1.37
|
4.91 thousand cells/mL
Standard Deviation 1.18
|
|
Changes in Complete Blood Count: White Blood Cells and Platelets
2 year: WBC
|
5.14 thousand cells/mL
Standard Deviation 1.32
|
5.42 thousand cells/mL
Standard Deviation 1.39
|
4.90 thousand cells/mL
Standard Deviation 1.10
|
4.90 thousand cells/mL
Standard Deviation 1.26
|
4.91 thousand cells/mL
Standard Deviation 1.19
|
|
Changes in Complete Blood Count: White Blood Cells and Platelets
Baseline: Platelets
|
270.70 thousand cells/mL
Standard Deviation 277.46
|
235.22 thousand cells/mL
Standard Deviation 52.06
|
240.42 thousand cells/mL
Standard Deviation 41.32
|
237.33 thousand cells/mL
Standard Deviation 51.41
|
235.76 thousand cells/mL
Standard Deviation 53.07
|
|
Changes in Complete Blood Count: White Blood Cells and Platelets
1 year: Platelets
|
237.02 thousand cells/mL
Standard Deviation 55.05
|
228.02 thousand cells/mL
Standard Deviation 50.71
|
230.61 thousand cells/mL
Standard Deviation 39.40
|
231.42 thousand cells/mL
Standard Deviation 49.58
|
221.49 thousand cells/mL
Standard Deviation 55.50
|
|
Changes in Complete Blood Count: White Blood Cells and Platelets
2 year: Platelets
|
234.02 thousand cells/mL
Standard Deviation 47.55
|
226.16 thousand cells/mL
Standard Deviation 51.14
|
232.09 thousand cells/mL
Standard Deviation 44.10
|
232.47 thousand cells/mL
Standard Deviation 54.22
|
223.27 thousand cells/mL
Standard Deviation 49.18
|
Adverse Events
Group 1: Control
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Group 2: Raloxifene 60 mg
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Group 3: Raloxifene 30 mg
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Group 4: Lovaza 4 gm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group 5: Lovaza 4 gm and Raloxifene 30 mg
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group 1: Control
n=53 participants at risk
Control, no intervention
|
Group 2: Raloxifene 60 mg
n=53 participants at risk
Raloxifene 60 mg Orally Daily
|
Group 3: Raloxifene 30 mg
n=53 participants at risk
Raloxifene 30 mg Orally Daily
|
Group 4: Lovaza 4 gm
n=54 participants at risk
Lovaza 4 gm/day Orally with Meals
|
Group 5: Lovaza 4 gm and Raloxifene 30 mg
n=53 participants at risk
Lovaza 4 gm/day orally with meals plus Raloxifene 30 mg orally daily
|
|---|---|---|---|---|---|
|
Reproductive system and breast disorders
Endometrial Cancer
|
0.00%
0/53 • Participants who did not meet an off study criterion were followed until 2 years post initiation of the study medication regimen.
|
1.9%
1/53 • Number of events 1 • Participants who did not meet an off study criterion were followed until 2 years post initiation of the study medication regimen.
|
0.00%
0/53 • Participants who did not meet an off study criterion were followed until 2 years post initiation of the study medication regimen.
|
0.00%
0/54 • Participants who did not meet an off study criterion were followed until 2 years post initiation of the study medication regimen.
|
0.00%
0/53 • Participants who did not meet an off study criterion were followed until 2 years post initiation of the study medication regimen.
|
Other adverse events
| Measure |
Group 1: Control
n=53 participants at risk
Control, no intervention
|
Group 2: Raloxifene 60 mg
n=53 participants at risk
Raloxifene 60 mg Orally Daily
|
Group 3: Raloxifene 30 mg
n=53 participants at risk
Raloxifene 30 mg Orally Daily
|
Group 4: Lovaza 4 gm
n=54 participants at risk
Lovaza 4 gm/day Orally with Meals
|
Group 5: Lovaza 4 gm and Raloxifene 30 mg
n=53 participants at risk
Lovaza 4 gm/day orally with meals plus Raloxifene 30 mg orally daily
|
|---|---|---|---|---|---|
|
Endocrine disorders
Hot flashes
|
0.00%
0/53 • Participants who did not meet an off study criterion were followed until 2 years post initiation of the study medication regimen.
|
18.9%
10/53 • Number of events 10 • Participants who did not meet an off study criterion were followed until 2 years post initiation of the study medication regimen.
|
13.2%
7/53 • Number of events 7 • Participants who did not meet an off study criterion were followed until 2 years post initiation of the study medication regimen.
|
0.00%
0/54 • Participants who did not meet an off study criterion were followed until 2 years post initiation of the study medication regimen.
|
11.3%
6/53 • Number of events 6 • Participants who did not meet an off study criterion were followed until 2 years post initiation of the study medication regimen.
|
|
General disorders
Night Sweating (diaphoresis)
|
0.00%
0/53 • Participants who did not meet an off study criterion were followed until 2 years post initiation of the study medication regimen.
|
11.3%
6/53 • Number of events 6 • Participants who did not meet an off study criterion were followed until 2 years post initiation of the study medication regimen.
|
5.7%
3/53 • Number of events 3 • Participants who did not meet an off study criterion were followed until 2 years post initiation of the study medication regimen.
|
0.00%
0/54 • Participants who did not meet an off study criterion were followed until 2 years post initiation of the study medication regimen.
|
3.8%
2/53 • Number of events 2 • Participants who did not meet an off study criterion were followed until 2 years post initiation of the study medication regimen.
|
|
Skin and subcutaneous tissue disorders
Rosacea
|
1.9%
1/53 • Number of events 1 • Participants who did not meet an off study criterion were followed until 2 years post initiation of the study medication regimen.
|
3.8%
2/53 • Number of events 2 • Participants who did not meet an off study criterion were followed until 2 years post initiation of the study medication regimen.
|
0.00%
0/53 • Participants who did not meet an off study criterion were followed until 2 years post initiation of the study medication regimen.
|
0.00%
0/54 • Participants who did not meet an off study criterion were followed until 2 years post initiation of the study medication regimen.
|
1.9%
1/53 • Number of events 1 • Participants who did not meet an off study criterion were followed until 2 years post initiation of the study medication regimen.
|
|
Reproductive system and breast disorders
Vaginal Spotting
|
0.00%
0/53 • Participants who did not meet an off study criterion were followed until 2 years post initiation of the study medication regimen.
|
3.8%
2/53 • Number of events 2 • Participants who did not meet an off study criterion were followed until 2 years post initiation of the study medication regimen.
|
0.00%
0/53 • Participants who did not meet an off study criterion were followed until 2 years post initiation of the study medication regimen.
|
0.00%
0/54 • Participants who did not meet an off study criterion were followed until 2 years post initiation of the study medication regimen.
|
1.9%
1/53 • Number of events 2 • Participants who did not meet an off study criterion were followed until 2 years post initiation of the study medication regimen.
|
|
General disorders
Leg cramping
|
0.00%
0/53 • Participants who did not meet an off study criterion were followed until 2 years post initiation of the study medication regimen.
|
7.5%
4/53 • Number of events 5 • Participants who did not meet an off study criterion were followed until 2 years post initiation of the study medication regimen.
|
0.00%
0/53 • Participants who did not meet an off study criterion were followed until 2 years post initiation of the study medication regimen.
|
0.00%
0/54 • Participants who did not meet an off study criterion were followed until 2 years post initiation of the study medication regimen.
|
1.9%
1/53 • Number of events 1 • Participants who did not meet an off study criterion were followed until 2 years post initiation of the study medication regimen.
|
|
Nervous system disorders
Headache
|
0.00%
0/53 • Participants who did not meet an off study criterion were followed until 2 years post initiation of the study medication regimen.
|
3.8%
2/53 • Number of events 2 • Participants who did not meet an off study criterion were followed until 2 years post initiation of the study medication regimen.
|
1.9%
1/53 • Number of events 1 • Participants who did not meet an off study criterion were followed until 2 years post initiation of the study medication regimen.
|
0.00%
0/54 • Participants who did not meet an off study criterion were followed until 2 years post initiation of the study medication regimen.
|
1.9%
1/53 • Number of events 1 • Participants who did not meet an off study criterion were followed until 2 years post initiation of the study medication regimen.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place