Breast Cancer
Conditions
Keywords
omega-3 fatty acids, antiestrogens, breast cancer prevention, breast density, biomarkers of mammary carcinogenesis
Brief summary
The overall hypothesis is that the combination of a low dose of the antiestrogen Raloxifene with omega-3 fatty acids will exert a synergistic breast cancer chemopreventive effect due to the crosstalk of their downstream cellular effects leading to decreased proliferation and increased apoptosis of premalignant mammary cells. Based on the investigators hypothesis that upregulation of functional estrogen receptors in the premalignant lesions is also responsible for the development of hormone independent tumors, the investigators postulate that the combination of antiestrogens and omega-3 fatty acids will reduce the development of both hormone-dependent and -independent tumors. At present, there are no known interventions able to decrease the development of hormone-independent tumors, which are more prevalent, more aggressive, leading to the patient's demise. In addition, the investigators postulate that this approach will be safe since it will combine a lower and hence a less toxic dose of Raloxifene with the administration of omega-3 fatty acids which are known to have health benefits, i.e., reduction in cardiovascular risk, beyond their possible chemo preventive effect in breast cancer.
Detailed description
The main objectives of this study are to determine the individual and combined effects of Raloxifene and omega-3 fatty acids on surrogate markers of breast cancer development in healthy, postmenopausal women. The primary endpoint will be mammographic density for which the study has been powered. Breast density is a major risk factor for breast cancer and hence it is chosen to evaluate the potential chemopreventive efficacy of our interventions. Secondary endpoints would include markers of oxidative stress, parameters of estrogen metabolism, markers of inflammation, and markers of IGF-I signaling, all of which have been shown in the literature to have an influence on mammary carcinogenesis. Study Population: Healthy, postmenopausal women between the ages of 35-70 years, undergoing yearly mammograms as part of routine screening practice. Method of Identification of Subjects/Samples/Medical Records: Women reporting for yearly mammograms will be considered for this protocol. They will be given first a screening questionnaire to rule out any co-existing medical condition that would predispose them to thromboembolic events.
Interventions
DRUGRaloxifene 60 Mg Oral Tablet
60 mg orally every day for two years
DIETARY_SUPPLEMENTLovaza 4gm oral
Dietary supplement; Take 4 mg oral capsules daily
DRUGRaloxifene 30 Mg Oral Tablet
30 mg orally daily for two years
DRUGLovaza 4gm & Raloxifene 30mg
Lovaza 4gm and Raloxifene 30 Mg orally once per day for 2 years
Sponsors
Milton S. Hershey Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
35 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* Postmenopausal status defined as history of at least 12 months without spontaneous menstrual bleeding or a documented hysterectomy and bilateral salpingo oophorectomy * Breast density greater than 25% * No hormone replacement therapy for at least six months prior to entry into this study * Non-smokers.
Exclusion criteria
* History of stroke, pulmonary embolism or deep vein thrombosis * History of atherosclerotic heart disease * Presence of any known hypercoagulable state either congenital (e.g., protein S deficiency) or acquired (e.g., corticosteroid treatment) * Diabetes mellitus * Uncontrolled hypertension (BP ≥140/90) * Presence of a psychiatric condition that would interfere with adherence to the protocol.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Absolute Breast Density | 2 years | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Biomarkers for Oxidative Stress:Urinary 8-(Isoprostane) F-2α | 1 year | 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. |
| Changes in Biomarkers for Estrogen Metabolism: 2-hydroxy Estrone (Urinary 2-OHE1) and 16-α-hydroxy Estrone (16α-OHE1) | 1 year | 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). |
| Changes in Serum Biomarkers for Inflammation From Levels of High Sensitivity C-reactive Protein (hsCRP) and Interleukin 6 (IL-6) | 1 Year | 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). |
| Changes in Insulin-like Growth Factor-1 (IGF-1) and Insulin-like Growth Factor-1 Binding Protein-3 (IGFBP-3) | 1 year | 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). |
| Changes in Biomarkers for Oxidative Stress: Urinary 8-hydroxy-deoxyguansine | 1 year | 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. |
| Changes in Complete Blood Count: Red Blood Cells | 2 years | 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. |
| Changes in Complete Blood Count: Hemoglobin | 2 years | Changes in complete blood count levels as measured through hemoglobin. Specific time points for evaluation are baseline, Year +1, and Year 2. |
| Changes in Complete Blood Count: Hematocrit | 2 years | Changes in complete blood count levels as measured through hematocrit percentage. Specific time points for evaluation are baseline, Year +1, and Year 2. |
| Changes in Complete Blood Count: White Blood Cells and Platelets | 2 years | 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. |
| Changes in Serum Lipid Levels | 2 years | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Group 1: Control Control, no intervention | 53 |
| Group 2: Raloxifene 60 mg Raloxifene 60 mg Orally Daily | 53 |
| Group 3: Raloxifene 30 mg Raloxifene 30 mg Orally Daily | 53 |
| Group 4: Lovaza 4 gm Lovaza 4 gm/day Orally with Meals | 54 |
| Group 5: Lovaza 4 gm and Raloxifene 30 mg Lovaza 4 gm/day orally with meals plus Raloxifene 30 mg orally daily | 53 |
| Total | 266 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 5 | 3 | 1 | 4 |
| Overall Study | Lost to Follow-up | 0 | 1 | 0 | 0 | 0 |
| Overall Study | Physician Decision | 2 | 2 | 5 | 0 | 1 |
| Overall Study | Protocol Violation | 2 | 1 | 5 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 2 | 6 | 4 | 4 | 4 |
Baseline characteristics
| Characteristic | Group 1: Control | Group 2: Raloxifene 60 mg | Group 3: Raloxifene 30 mg | Group 4: Lovaza 4 gm | Group 5: Lovaza 4 gm and Raloxifene 30 mg | Total |
|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 4 Participants | 10 Participants | 5 Participants | 9 Participants | 7 Participants | 35 Participants |
| Age, Categorical Between 18 and 65 years | 49 Participants | 43 Participants | 48 Participants | 45 Participants | 46 Participants | 231 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 52 Participants | 53 Participants | 53 Participants | 53 Participants | 53 Participants | 264 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 1 Participants | 1 Participants | 1 Participants | 0 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 51 Participants | 52 Participants | 52 Participants | 51 Participants | 53 Participants | 259 Participants |
| Sex: Female, Male Female | 53 Participants | 53 Participants | 53 Participants | 54 Participants | 53 Participants | 266 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 1 / 53 | 10 / 53 | 7 / 53 | 0 / 54 | 6 / 53 |
| serious Total, serious adverse events | 0 / 53 | 1 / 53 | 0 / 53 | 0 / 54 | 0 / 53 |
Outcome results
Primary
Change in Absolute Breast Density
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.
Time frame: 2 years
Population: The decrease in the population groups is accounted for through subject withdrawals, subjects lost to follow-up, and other reasons for not completing study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 1: Control | Change in Absolute Breast Density | Absolute density at baseline | 65.53 cm squared | Standard Deviation 59.43 |
| Group 1: Control | Change in Absolute Breast Density | Absolute density at 2 years | 54.34 cm squared | Standard Deviation 20.11 |
| Group 1: Control | Change in Absolute Breast Density | Absolute density at 1 year | 59.29 cm squared | Standard Deviation 40.72 |
| Group 2: Raloxifene 60 mg | Change in Absolute Breast Density | Absolute density at 1 year | 60.48 cm squared | Standard Deviation 38.89 |
| Group 2: Raloxifene 60 mg | Change in Absolute Breast Density | Absolute density at baseline | 64.39 cm squared | Standard Deviation 39.95 |
| Group 2: Raloxifene 60 mg | Change in Absolute Breast Density | Absolute density at 2 years | 60.57 cm squared | Standard Deviation 35.1 |
| Group 3: Raloxifene 30 mg | Change in Absolute Breast Density | Absolute density at 1 year | 59.53 cm squared | Standard Deviation 30.32 |
| Group 3: Raloxifene 30 mg | Change in Absolute Breast Density | Absolute density at baseline | 65.08 cm squared | Standard Deviation 34.47 |
| Group 3: Raloxifene 30 mg | Change in Absolute Breast Density | Absolute density at 2 years | 58.86 cm squared | Standard Deviation 27.93 |
| Group 4: Lovaza 4 gm | Change in Absolute Breast Density | Absolute density at baseline | 56.35 cm squared | Standard Deviation 22.61 |
| Group 4: Lovaza 4 gm | Change in Absolute Breast Density | Absolute density at 2 years | 57.60 cm squared | Standard Deviation 20.77 |
| Group 4: Lovaza 4 gm | Change in Absolute Breast Density | Absolute density at 1 year | 58.87 cm squared | Standard Deviation 22.21 |
| Group 5: Lovaza 4 gm and Raloxifene 30 mg | Change in Absolute Breast Density | Absolute density at 1 year | 60.93 cm squared | Standard Deviation 24.64 |
| Group 5: Lovaza 4 gm and Raloxifene 30 mg | Change in Absolute Breast Density | Absolute density at baseline | 63.81 cm squared | Standard Deviation 29.81 |
| Group 5: Lovaza 4 gm and Raloxifene 30 mg | Change in Absolute Breast Density | Absolute density at 2 years | 28.53 cm squared | Standard Deviation 25.18 |
Secondary
Changes in Biomarkers for Estrogen Metabolism: 2-hydroxy Estrone (Urinary 2-OHE1) and 16-α-hydroxy Estrone (16α-OHE1)
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).
Time frame: 1 year
Population: 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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 1: Control | 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 |
| Group 1: Control | 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 |
| Group 1: Control | 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 |
| Group 1: Control | 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 |
| Group 2: Raloxifene 60 mg | Changes in Biomarkers for Estrogen Metabolism: 2-hydroxy Estrone (Urinary 2-OHE1) and 16-α-hydroxy Estrone (16α-OHE1) | Baseline: Urinary 2-OHE1 | 8.58 ng/mg creatinine | Standard Deviation 1 |
| Group 2: Raloxifene 60 mg | Changes in Biomarkers for Estrogen Metabolism: 2-hydroxy Estrone (Urinary 2-OHE1) and 16-α-hydroxy Estrone (16α-OHE1) | 1 year: 16α-OHE1 | 4.35 ng/mg creatinine | Standard Deviation 0.5 |
| Group 2: Raloxifene 60 mg | Changes in Biomarkers for Estrogen Metabolism: 2-hydroxy Estrone (Urinary 2-OHE1) and 16-α-hydroxy Estrone (16α-OHE1) | 1 year: Urinary 2-OHE1 | 10.03 ng/mg creatinine | Standard Deviation 1 |
| Group 2: Raloxifene 60 mg | Changes in Biomarkers for Estrogen Metabolism: 2-hydroxy Estrone (Urinary 2-OHE1) and 16-α-hydroxy Estrone (16α-OHE1) | Baseline: 16α-OHE1 | 5.08 ng/mg creatinine | Standard Deviation 0.5 |
| Group 3: Raloxifene 30 mg | Changes in Biomarkers for Estrogen Metabolism: 2-hydroxy Estrone (Urinary 2-OHE1) and 16-α-hydroxy Estrone (16α-OHE1) | 1 year: 16α-OHE1 | 7.46 ng/mg creatinine | Standard Deviation 1.4 |
| Group 3: Raloxifene 30 mg | Changes in Biomarkers for Estrogen Metabolism: 2-hydroxy Estrone (Urinary 2-OHE1) and 16-α-hydroxy Estrone (16α-OHE1) | 1 year: Urinary 2-OHE1 | 9.10 ng/mg creatinine | Standard Deviation 1.4 |
| Group 3: Raloxifene 30 mg | Changes in Biomarkers for Estrogen Metabolism: 2-hydroxy Estrone (Urinary 2-OHE1) and 16-α-hydroxy Estrone (16α-OHE1) | Baseline: 16α-OHE1 | 6.86 ng/mg creatinine | Standard Deviation 1.8 |
| Group 3: Raloxifene 30 mg | Changes in Biomarkers for Estrogen Metabolism: 2-hydroxy Estrone (Urinary 2-OHE1) and 16-α-hydroxy Estrone (16α-OHE1) | Baseline: Urinary 2-OHE1 | 8.82 ng/mg creatinine | Standard Deviation 1.4 |
| Group 4: Lovaza 4 gm | Changes in Biomarkers for Estrogen Metabolism: 2-hydroxy Estrone (Urinary 2-OHE1) and 16-α-hydroxy Estrone (16α-OHE1) | Baseline: Urinary 2-OHE1 | 7.15 ng/mg creatinine | Standard Deviation 1.1 |
| Group 4: Lovaza 4 gm | Changes in Biomarkers for Estrogen Metabolism: 2-hydroxy Estrone (Urinary 2-OHE1) and 16-α-hydroxy Estrone (16α-OHE1) | 1 year: Urinary 2-OHE1 | 7.49 ng/mg creatinine | Standard Deviation 1 |
| Group 4: Lovaza 4 gm | Changes in Biomarkers for Estrogen Metabolism: 2-hydroxy Estrone (Urinary 2-OHE1) and 16-α-hydroxy Estrone (16α-OHE1) | 1 year: 16α-OHE1 | 4.79 ng/mg creatinine | Standard Deviation 0.3 |
| Group 4: Lovaza 4 gm | Changes in Biomarkers for Estrogen Metabolism: 2-hydroxy Estrone (Urinary 2-OHE1) and 16-α-hydroxy Estrone (16α-OHE1) | Baseline: 16α-OHE1 | 5.24 ng/mg creatinine | Standard Deviation 0.5 |
| Group 5: Lovaza 4 gm and Raloxifene 30 mg | 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 0.9 |
| Group 5: Lovaza 4 gm and Raloxifene 30 mg | Changes in Biomarkers for Estrogen Metabolism: 2-hydroxy Estrone (Urinary 2-OHE1) and 16-α-hydroxy Estrone (16α-OHE1) | Baseline: 16α-OHE1 | 6.6 ng/mg creatinine | Standard Deviation 0.9 |
| Group 5: Lovaza 4 gm and Raloxifene 30 mg | Changes in Biomarkers for Estrogen Metabolism: 2-hydroxy Estrone (Urinary 2-OHE1) and 16-α-hydroxy Estrone (16α-OHE1) | 1 year: Urinary 2-OHE1 | 13.2 ng/mg creatinine | Standard Deviation 3.7 |
| Group 5: Lovaza 4 gm and Raloxifene 30 mg | Changes in Biomarkers for Estrogen Metabolism: 2-hydroxy Estrone (Urinary 2-OHE1) and 16-α-hydroxy Estrone (16α-OHE1) | Baseline: Urinary 2-OHE1 | 15.6 ng/mg creatinine | Standard Deviation 4.5 |
Secondary
Changes in Biomarkers for Oxidative Stress: Urinary 8-hydroxy-deoxyguansine
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.
Time frame: 1 year
Population: 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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 1: Control | Changes in Biomarkers for Oxidative Stress: Urinary 8-hydroxy-deoxyguansine | Baseline | 255 ng/mg creatinine | Standard Error 63.6 |
| Group 1: Control | Changes in Biomarkers for Oxidative Stress: Urinary 8-hydroxy-deoxyguansine | 1 year | 224 ng/mg creatinine | Standard Error 31.8 |
| Group 2: Raloxifene 60 mg | Changes in Biomarkers for Oxidative Stress: Urinary 8-hydroxy-deoxyguansine | Baseline | 285 ng/mg creatinine | Standard Error 47.7 |
| Group 2: Raloxifene 60 mg | Changes in Biomarkers for Oxidative Stress: Urinary 8-hydroxy-deoxyguansine | 1 year | 309 ng/mg creatinine | Standard Error 69 |
| Group 3: Raloxifene 30 mg | Changes in Biomarkers for Oxidative Stress: Urinary 8-hydroxy-deoxyguansine | Baseline | 213 ng/mg creatinine | Standard Error 91 |
| Group 3: Raloxifene 30 mg | Changes in Biomarkers for Oxidative Stress: Urinary 8-hydroxy-deoxyguansine | 1 year | 246 ng/mg creatinine | Standard Error 108 |
| Group 4: Lovaza 4 gm | Changes in Biomarkers for Oxidative Stress: Urinary 8-hydroxy-deoxyguansine | 1 year | 177 ng/mg creatinine | Standard Error 17.3 |
| Group 4: Lovaza 4 gm | Changes in Biomarkers for Oxidative Stress: Urinary 8-hydroxy-deoxyguansine | Baseline | 184 ng/mg creatinine | Standard Error 25.6 |
| Group 5: Lovaza 4 gm and Raloxifene 30 mg | Changes in Biomarkers for Oxidative Stress: Urinary 8-hydroxy-deoxyguansine | Baseline | 355 ng/mg creatinine | Standard Error 79.7 |
| Group 5: Lovaza 4 gm and Raloxifene 30 mg | Changes in Biomarkers for Oxidative Stress: Urinary 8-hydroxy-deoxyguansine | 1 year | 297 ng/mg creatinine | Standard Error 90.2 |
Secondary
Changes in Biomarkers for Oxidative Stress:Urinary 8-(Isoprostane) F-2α
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.
Time frame: 1 year
Population: 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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 1: Control | Changes in Biomarkers for Oxidative Stress:Urinary 8-(Isoprostane) F-2α | Baseline | 544 pg/mg creatinine | Standard Error 105 |
| Group 1: Control | Changes in Biomarkers for Oxidative Stress:Urinary 8-(Isoprostane) F-2α | 1 year | 484 pg/mg creatinine | Standard Error 77.3 |
| Group 2: Raloxifene 60 mg | Changes in Biomarkers for Oxidative Stress:Urinary 8-(Isoprostane) F-2α | Baseline | 366 pg/mg creatinine | Standard Error 39.7 |
| Group 2: Raloxifene 60 mg | Changes in Biomarkers for Oxidative Stress:Urinary 8-(Isoprostane) F-2α | 1 year | 360 pg/mg creatinine | Standard Error 33.8 |
| Group 3: Raloxifene 30 mg | Changes in Biomarkers for Oxidative Stress:Urinary 8-(Isoprostane) F-2α | Baseline | 530 pg/mg creatinine | Standard Error 107 |
| Group 3: Raloxifene 30 mg | Changes in Biomarkers for Oxidative Stress:Urinary 8-(Isoprostane) F-2α | 1 year | 538 pg/mg creatinine | Standard Error 67 |
| Group 4: Lovaza 4 gm | Changes in Biomarkers for Oxidative Stress:Urinary 8-(Isoprostane) F-2α | 1 year | 313 pg/mg creatinine | Standard Error 45.1 |
| Group 4: Lovaza 4 gm | Changes in Biomarkers for Oxidative Stress:Urinary 8-(Isoprostane) F-2α | Baseline | 440 pg/mg creatinine | Standard Error 30.8 |
| Group 5: Lovaza 4 gm and Raloxifene 30 mg | Changes in Biomarkers for Oxidative Stress:Urinary 8-(Isoprostane) F-2α | Baseline | 444 pg/mg creatinine | Standard Error 54.6 |
| Group 5: Lovaza 4 gm and Raloxifene 30 mg | Changes in Biomarkers for Oxidative Stress:Urinary 8-(Isoprostane) F-2α | 1 year | 396 pg/mg creatinine | Standard Error 40.6 |
Secondary
Changes in Complete Blood Count: Hematocrit
Changes in complete blood count levels as measured through hematocrit percentage. Specific time points for evaluation are baseline, Year +1, and Year 2.
Time frame: 2 years
Population: The decrease in the population groups is accounted for through subject withdrawals, subjects lost to follow-up, and other reasons for not completing study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 1: Control | Changes in Complete Blood Count: Hematocrit | Baseline: Hematocrit | 39.14 volume percentage | Standard Deviation 2.5 |
| Group 1: Control | Changes in Complete Blood Count: Hematocrit | 2 year: Hematocrit | 39.00 volume percentage | Standard Deviation 2.47 |
| Group 1: Control | Changes in Complete Blood Count: Hematocrit | 1 year: Hematocrit | 38.83 volume percentage | Standard Deviation 2.25 |
| Group 2: Raloxifene 60 mg | Changes in Complete Blood Count: Hematocrit | 1 year: Hematocrit | 38.79 volume percentage | Standard Deviation 2.14 |
| Group 2: Raloxifene 60 mg | Changes in Complete Blood Count: Hematocrit | Baseline: Hematocrit | 38.95 volume percentage | Standard Deviation 2.49 |
| Group 2: Raloxifene 60 mg | Changes in Complete Blood Count: Hematocrit | 2 year: Hematocrit | 38.86 volume percentage | Standard Deviation 2.28 |
| Group 3: Raloxifene 30 mg | Changes in Complete Blood Count: Hematocrit | 1 year: Hematocrit | 38.43 volume percentage | Standard Deviation 2.69 |
| Group 3: Raloxifene 30 mg | Changes in Complete Blood Count: Hematocrit | Baseline: Hematocrit | 38.79 volume percentage | Standard Deviation 3.06 |
| Group 3: Raloxifene 30 mg | Changes in Complete Blood Count: Hematocrit | 2 year: Hematocrit | 38.31 volume percentage | Standard Deviation 2.84 |
| Group 4: Lovaza 4 gm | Changes in Complete Blood Count: Hematocrit | Baseline: Hematocrit | 39.09 volume percentage | Standard Deviation 2.7 |
| Group 4: Lovaza 4 gm | Changes in Complete Blood Count: Hematocrit | 2 year: Hematocrit | 38.59 volume percentage | Standard Deviation 5.72 |
| Group 4: Lovaza 4 gm | Changes in Complete Blood Count: Hematocrit | 1 year: Hematocrit | 39.52 volume percentage | Standard Deviation 2.72 |
| Group 5: Lovaza 4 gm and Raloxifene 30 mg | Changes in Complete Blood Count: Hematocrit | 1 year: Hematocrit | 39.14 volume percentage | Standard Deviation 2.52 |
| Group 5: Lovaza 4 gm and Raloxifene 30 mg | Changes in Complete Blood Count: Hematocrit | Baseline: Hematocrit | 39.20 volume percentage | Standard Deviation 2.48 |
| Group 5: Lovaza 4 gm and Raloxifene 30 mg | Changes in Complete Blood Count: Hematocrit | 2 year: Hematocrit | 39.14 volume percentage | Standard Deviation 2.74 |
Secondary
Changes in Complete Blood Count: Hemoglobin
Changes in complete blood count levels as measured through hemoglobin. Specific time points for evaluation are baseline, Year +1, and Year 2.
Time frame: 2 years
Population: The decrease in the population groups is accounted for through subject withdrawals, subjects lost to follow-up, and other reasons for not completing study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 1: Control | Changes in Complete Blood Count: Hemoglobin | Baseline: Hemoglobin | 13.09 g/dL | Standard Deviation 1.56 |
| Group 1: Control | Changes in Complete Blood Count: Hemoglobin | 2 year: Hemoglobin | 13.10 g/dL | Standard Deviation 0.87 |
| Group 1: Control | Changes in Complete Blood Count: Hemoglobin | 1 year: Hemoglobin | 12.97 g/dL | Standard Deviation 1.49 |
| Group 2: Raloxifene 60 mg | Changes in Complete Blood Count: Hemoglobin | 1 year: Hemoglobin | 12.97 g/dL | Standard Deviation 1.61 |
| Group 2: Raloxifene 60 mg | Changes in Complete Blood Count: Hemoglobin | Baseline: Hemoglobin | 13.11 g/dL | Standard Deviation 1.48 |
| Group 2: Raloxifene 60 mg | Changes in Complete Blood Count: Hemoglobin | 2 year: Hemoglobin | 13.07 g/dL | Standard Deviation 0.71 |
| Group 3: Raloxifene 30 mg | Changes in Complete Blood Count: Hemoglobin | 1 year: Hemoglobin | 12.95 g/dL | Standard Deviation 0.96 |
| Group 3: Raloxifene 30 mg | Changes in Complete Blood Count: Hemoglobin | Baseline: Hemoglobin | 12.73 g/dL | Standard Deviation 2.02 |
| Group 3: Raloxifene 30 mg | Changes in Complete Blood Count: Hemoglobin | 2 year: Hemoglobin | 12.82 g/dL | Standard Deviation 0.96 |
| Group 4: Lovaza 4 gm | Changes in Complete Blood Count: Hemoglobin | Baseline: Hemoglobin | 13.25 g/dL | Standard Deviation 0.99 |
| Group 4: Lovaza 4 gm | Changes in Complete Blood Count: Hemoglobin | 2 year: Hemoglobin | 13.16 g/dL | Standard Deviation 0.91 |
| Group 4: Lovaza 4 gm | Changes in Complete Blood Count: Hemoglobin | 1 year: Hemoglobin | 13.33 g/dL | Standard Deviation 0.97 |
| Group 5: Lovaza 4 gm and Raloxifene 30 mg | Changes in Complete Blood Count: Hemoglobin | 1 year: Hemoglobin | 13.10 g/dL | Standard Deviation 1.65 |
| Group 5: Lovaza 4 gm and Raloxifene 30 mg | Changes in Complete Blood Count: Hemoglobin | Baseline: Hemoglobin | 13.35 g/dL | Standard Deviation 0.86 |
| Group 5: Lovaza 4 gm and Raloxifene 30 mg | Changes in Complete Blood Count: Hemoglobin | 2 year: Hemoglobin | 13.22 g/dL | Standard Deviation 0.95 |
Secondary
Changes in Complete Blood Count: Red Blood Cells
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.
Time frame: 2 years
Population: The decrease in the population groups is accounted for through subject withdrawals, subjects lost to follow-up, and other reasons for not completing study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 1: Control | Changes in Complete Blood Count: Red Blood Cells | Baseline: RBC | 4.31 millions of cells per microliter | Standard Deviation 0.33 |
| Group 1: Control | Changes in Complete Blood Count: Red Blood Cells | 2 year: RBC | 4.32 millions of cells per microliter | Standard Deviation 0.36 |
| Group 1: Control | Changes in Complete Blood Count: Red Blood Cells | 1 year: RBC | 4.27 millions of cells per microliter | Standard Deviation 0.32 |
| Group 2: Raloxifene 60 mg | Changes in Complete Blood Count: Red Blood Cells | 1 year: RBC | 4.19 millions of cells per microliter | Standard Deviation 0.25 |
| Group 2: Raloxifene 60 mg | Changes in Complete Blood Count: Red Blood Cells | Baseline: RBC | 4.25 millions of cells per microliter | Standard Deviation 0.3 |
| Group 2: Raloxifene 60 mg | Changes in Complete Blood Count: Red Blood Cells | 2 year: RBC | 4.20 millions of cells per microliter | Standard Deviation 0.23 |
| Group 3: Raloxifene 30 mg | Changes in Complete Blood Count: Red Blood Cells | 1 year: RBC | 4.25 millions of cells per microliter | Standard Deviation 0.3 |
| Group 3: Raloxifene 30 mg | Changes in Complete Blood Count: Red Blood Cells | Baseline: RBC | 4.30 millions of cells per microliter | Standard Deviation 0.33 |
| Group 3: Raloxifene 30 mg | Changes in Complete Blood Count: Red Blood Cells | 2 year: RBC | 4.24 millions of cells per microliter | Standard Deviation 0.35 |
| Group 4: Lovaza 4 gm | Changes in Complete Blood Count: Red Blood Cells | Baseline: RBC | 4.33 millions of cells per microliter | Standard Deviation 0.43 |
| Group 4: Lovaza 4 gm | Changes in Complete Blood Count: Red Blood Cells | 2 year: RBC | 4.33 millions of cells per microliter | Standard Deviation 0.45 |
| Group 4: Lovaza 4 gm | Changes in Complete Blood Count: Red Blood Cells | 1 year: RBC | 4.36 millions of cells per microliter | Standard Deviation 0.44 |
| Group 5: Lovaza 4 gm and Raloxifene 30 mg | Changes in Complete Blood Count: Red Blood Cells | 1 year: RBC | 4.20 millions of cells per microliter | Standard Deviation 0.32 |
| Group 5: Lovaza 4 gm and Raloxifene 30 mg | Changes in Complete Blood Count: Red Blood Cells | Baseline: RBC | 4.24 millions of cells per microliter | Standard Deviation 0.31 |
| Group 5: Lovaza 4 gm and Raloxifene 30 mg | Changes in Complete Blood Count: Red Blood Cells | 2 year: RBC | 4.23 millions of cells per microliter | Standard Deviation 0.31 |
Secondary
Changes in Complete Blood Count: White Blood Cells and Platelets
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.
Time frame: 2 years
Population: The decrease in the population groups is accounted for through subject withdrawals, subjects lost to follow-up, and other reasons for not completing study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 1: Control | Changes in Complete Blood Count: White Blood Cells and Platelets | Baseline: WBC | 5.13 thousand cells/mL | Standard Deviation 1.29 |
| Group 1: Control | Changes in Complete Blood Count: White Blood Cells and Platelets | 1 year: WBC | 5.15 thousand cells/mL | Standard Deviation 1.76 |
| Group 1: Control | Changes in Complete Blood Count: White Blood Cells and Platelets | 2 year: WBC | 5.14 thousand cells/mL | Standard Deviation 1.32 |
| Group 1: Control | Changes in Complete Blood Count: White Blood Cells and Platelets | Baseline: Platelets | 270.70 thousand cells/mL | Standard Deviation 277.46 |
| Group 1: Control | Changes in Complete Blood Count: White Blood Cells and Platelets | 1 year: Platelets | 237.02 thousand cells/mL | Standard Deviation 55.05 |
| Group 1: Control | Changes in Complete Blood Count: White Blood Cells and Platelets | 2 year: Platelets | 234.02 thousand cells/mL | Standard Deviation 47.55 |
| Group 2: Raloxifene 60 mg | Changes in Complete Blood Count: White Blood Cells and Platelets | 1 year: Platelets | 228.02 thousand cells/mL | Standard Deviation 50.71 |
| Group 2: Raloxifene 60 mg | Changes in Complete Blood Count: White Blood Cells and Platelets | 2 year: Platelets | 226.16 thousand cells/mL | Standard Deviation 51.14 |
| Group 2: Raloxifene 60 mg | Changes in Complete Blood Count: White Blood Cells and Platelets | Baseline: WBC | 5.47 thousand cells/mL | Standard Deviation 1.57 |
| Group 2: Raloxifene 60 mg | Changes in Complete Blood Count: White Blood Cells and Platelets | 2 year: WBC | 5.42 thousand cells/mL | Standard Deviation 1.39 |
| Group 2: Raloxifene 60 mg | Changes in Complete Blood Count: White Blood Cells and Platelets | Baseline: Platelets | 235.22 thousand cells/mL | Standard Deviation 52.06 |
| Group 2: Raloxifene 60 mg | Changes in Complete Blood Count: White Blood Cells and Platelets | 1 year: WBC | 5.51 thousand cells/mL | Standard Deviation 1.54 |
| Group 3: Raloxifene 30 mg | Changes in Complete Blood Count: White Blood Cells and Platelets | Baseline: Platelets | 240.42 thousand cells/mL | Standard Deviation 41.32 |
| Group 3: Raloxifene 30 mg | Changes in Complete Blood Count: White Blood Cells and Platelets | 1 year: Platelets | 230.61 thousand cells/mL | Standard Deviation 39.4 |
| Group 3: Raloxifene 30 mg | Changes in Complete Blood Count: White Blood Cells and Platelets | Baseline: WBC | 5.00 thousand cells/mL | Standard Deviation 1.2 |
| Group 3: Raloxifene 30 mg | Changes in Complete Blood Count: White Blood Cells and Platelets | 2 year: WBC | 4.90 thousand cells/mL | Standard Deviation 1.1 |
| Group 3: Raloxifene 30 mg | Changes in Complete Blood Count: White Blood Cells and Platelets | 1 year: WBC | 4.78 thousand cells/mL | Standard Deviation 1.04 |
| Group 3: Raloxifene 30 mg | Changes in Complete Blood Count: White Blood Cells and Platelets | 2 year: Platelets | 232.09 thousand cells/mL | Standard Deviation 44.1 |
| Group 4: Lovaza 4 gm | Changes in Complete Blood Count: White Blood Cells and Platelets | Baseline: Platelets | 237.33 thousand cells/mL | Standard Deviation 51.41 |
| Group 4: Lovaza 4 gm | Changes in Complete Blood Count: White Blood Cells and Platelets | 1 year: WBC | 4.95 thousand cells/mL | Standard Deviation 1.37 |
| Group 4: Lovaza 4 gm | Changes in Complete Blood Count: White Blood Cells and Platelets | 2 year: WBC | 4.90 thousand cells/mL | Standard Deviation 1.26 |
| Group 4: Lovaza 4 gm | Changes in Complete Blood Count: White Blood Cells and Platelets | 2 year: Platelets | 232.47 thousand cells/mL | Standard Deviation 54.22 |
| Group 4: Lovaza 4 gm | Changes in Complete Blood Count: White Blood Cells and Platelets | 1 year: Platelets | 231.42 thousand cells/mL | Standard Deviation 49.58 |
| Group 4: Lovaza 4 gm | Changes in Complete Blood Count: White Blood Cells and Platelets | Baseline: WBC | 5.04 thousand cells/mL | Standard Deviation 1.64 |
| Group 5: Lovaza 4 gm and Raloxifene 30 mg | Changes in Complete Blood Count: White Blood Cells and Platelets | 1 year: Platelets | 221.49 thousand cells/mL | Standard Deviation 55.5 |
| Group 5: Lovaza 4 gm and Raloxifene 30 mg | Changes in Complete Blood Count: White Blood Cells and Platelets | 2 year: WBC | 4.91 thousand cells/mL | Standard Deviation 1.19 |
| Group 5: Lovaza 4 gm and Raloxifene 30 mg | Changes in Complete Blood Count: White Blood Cells and Platelets | 1 year: WBC | 4.91 thousand cells/mL | Standard Deviation 1.18 |
| Group 5: Lovaza 4 gm and Raloxifene 30 mg | Changes in Complete Blood Count: White Blood Cells and Platelets | 2 year: Platelets | 223.27 thousand cells/mL | Standard Deviation 49.18 |
| Group 5: Lovaza 4 gm and Raloxifene 30 mg | Changes in Complete Blood Count: White Blood Cells and Platelets | Baseline: Platelets | 235.76 thousand cells/mL | Standard Deviation 53.07 |
| Group 5: Lovaza 4 gm and Raloxifene 30 mg | Changes in Complete Blood Count: White Blood Cells and Platelets | Baseline: WBC | 5.27 thousand cells/mL | Standard Deviation 1.24 |
Secondary
Changes in Insulin-like Growth Factor-1 (IGF-1) and Insulin-like Growth Factor-1 Binding Protein-3 (IGFBP-3)
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).
Time frame: 1 year
Population: 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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 1: Control | 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 |
| Group 1: Control | 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 |
| Group 1: Control | 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 |
| Group 1: Control | 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 |
| Group 2: Raloxifene 60 mg | Changes in Insulin-like Growth Factor-1 (IGF-1) and Insulin-like Growth Factor-1 Binding Protein-3 (IGFBP-3) | Baseline: IGF-1 | 4.63 ng/mL | Standard Deviation 0.28 |
| Group 2: Raloxifene 60 mg | Changes in Insulin-like Growth Factor-1 (IGF-1) and Insulin-like Growth Factor-1 Binding Protein-3 (IGFBP-3) | 1 year: IGFBP-3 | 7.55 ng/mL | Standard Deviation 0.12 |
| Group 2: Raloxifene 60 mg | Changes in Insulin-like Growth Factor-1 (IGF-1) and Insulin-like Growth Factor-1 Binding Protein-3 (IGFBP-3) | 1 year: IGF-1 | 4.40 ng/mL | Standard Deviation 0.25 |
| Group 2: Raloxifene 60 mg | Changes in Insulin-like Growth Factor-1 (IGF-1) and Insulin-like Growth Factor-1 Binding Protein-3 (IGFBP-3) | Baseline: IGFBP-3 | 7.53 ng/mL | Standard Deviation 0.19 |
| Group 3: Raloxifene 30 mg | Changes in Insulin-like Growth Factor-1 (IGF-1) and Insulin-like Growth Factor-1 Binding Protein-3 (IGFBP-3) | 1 year: IGFBP-3 | 7.79 ng/mL | Standard Deviation 0.24 |
| Group 3: Raloxifene 30 mg | Changes in Insulin-like Growth Factor-1 (IGF-1) and Insulin-like Growth Factor-1 Binding Protein-3 (IGFBP-3) | 1 year: IGF-1 | 4.76 ng/mL | Standard Deviation 0.24 |
| Group 3: Raloxifene 30 mg | Changes in Insulin-like Growth Factor-1 (IGF-1) and Insulin-like Growth Factor-1 Binding Protein-3 (IGFBP-3) | Baseline: IGFBP-3 | 7.69 ng/mL | Standard Deviation 0.21 |
| Group 3: Raloxifene 30 mg | Changes in Insulin-like Growth Factor-1 (IGF-1) and Insulin-like Growth Factor-1 Binding Protein-3 (IGFBP-3) | Baseline: IGF-1 | 4.80 ng/mL | Standard Deviation 0.23 |
| Group 4: Lovaza 4 gm | Changes in Insulin-like Growth Factor-1 (IGF-1) and Insulin-like Growth Factor-1 Binding Protein-3 (IGFBP-3) | Baseline: IGF-1 | 4.95 ng/mL | Standard Deviation 0.41 |
| Group 4: Lovaza 4 gm | Changes in Insulin-like Growth Factor-1 (IGF-1) and Insulin-like Growth Factor-1 Binding Protein-3 (IGFBP-3) | 1 year: IGF-1 | 4.96 ng/mL | Standard Deviation 31 |
| Group 4: Lovaza 4 gm | Changes in Insulin-like Growth Factor-1 (IGF-1) and Insulin-like Growth Factor-1 Binding Protein-3 (IGFBP-3) | 1 year: IGFBP-3 | 7.83 ng/mL | Standard Deviation 0.17 |
| Group 4: Lovaza 4 gm | Changes in Insulin-like Growth Factor-1 (IGF-1) and Insulin-like Growth Factor-1 Binding Protein-3 (IGFBP-3) | Baseline: IGFBP-3 | 7.83 ng/mL | Standard Deviation 0.2 |
| Group 5: Lovaza 4 gm and Raloxifene 30 mg | Changes in Insulin-like Growth Factor-1 (IGF-1) and Insulin-like Growth Factor-1 Binding Protein-3 (IGFBP-3) | 1 year: IGFBP-3 | 7.61 ng/mL | Standard Deviation 0.23 |
| Group 5: Lovaza 4 gm and Raloxifene 30 mg | Changes in Insulin-like Growth Factor-1 (IGF-1) and Insulin-like Growth Factor-1 Binding Protein-3 (IGFBP-3) | Baseline: IGFBP-3 | 7.57 ng/mL | Standard Deviation 0.23 |
| Group 5: Lovaza 4 gm and Raloxifene 30 mg | Changes in Insulin-like Growth Factor-1 (IGF-1) and Insulin-like Growth Factor-1 Binding Protein-3 (IGFBP-3) | 1 year: IGF-1 | 4.82 ng/mL | Standard Deviation 0.52 |
| Group 5: Lovaza 4 gm and Raloxifene 30 mg | Changes in Insulin-like Growth Factor-1 (IGF-1) and Insulin-like Growth Factor-1 Binding Protein-3 (IGFBP-3) | Baseline: IGF-1 | 4.89 ng/mL | Standard Deviation 0.49 |
Secondary
Changes in Serum Biomarkers for Inflammation From Levels of High Sensitivity C-reactive Protein (hsCRP) and Interleukin 6 (IL-6)
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).
Time frame: 1 Year
Population: 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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 1: Control | 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 |
| Group 1: Control | 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 |
| Group 1: Control | 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 |
| Group 1: Control | 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 |
| Group 2: Raloxifene 60 mg | Changes in Serum Biomarkers for Inflammation From Levels of High Sensitivity C-reactive Protein (hsCRP) and Interleukin 6 (IL-6) | Baseline: Serum hsCRP | 0.91 pg/ml | Standard Deviation 0.26 |
| Group 2: Raloxifene 60 mg | 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 | 1.13 pg/ml | Standard Deviation 0.26 |
| Group 2: Raloxifene 60 mg | Changes in Serum Biomarkers for Inflammation From Levels of High Sensitivity C-reactive Protein (hsCRP) and Interleukin 6 (IL-6) | 1 year: Serum hsCRP | 1.04 pg/ml | Standard Deviation 0.34 |
| Group 2: Raloxifene 60 mg | Changes in Serum Biomarkers for Inflammation From Levels of High Sensitivity C-reactive Protein (hsCRP) and Interleukin 6 (IL-6) | Baseline: Serum IL-6 | 1.14 pg/ml | Standard Deviation 0.23 |
| Group 3: Raloxifene 30 mg | 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 | 1.11 pg/ml | Standard Deviation 0.2 |
| Group 3: Raloxifene 30 mg | Changes in Serum Biomarkers for Inflammation From Levels of High Sensitivity C-reactive Protein (hsCRP) and Interleukin 6 (IL-6) | 1 year: Serum hsCRP | 1.34 pg/ml | Standard Deviation 0.34 |
| Group 3: Raloxifene 30 mg | Changes in Serum Biomarkers for Inflammation From Levels of High Sensitivity C-reactive Protein (hsCRP) and Interleukin 6 (IL-6) | Baseline: Serum IL-6 | 1.04 pg/ml | Standard Deviation 0.22 |
| Group 3: Raloxifene 30 mg | Changes in Serum Biomarkers for Inflammation From Levels of High Sensitivity C-reactive Protein (hsCRP) and Interleukin 6 (IL-6) | Baseline: Serum hsCRP | 1.67 pg/ml | Standard Deviation 0.63 |
| Group 4: Lovaza 4 gm | Changes in Serum Biomarkers for Inflammation From Levels of High Sensitivity C-reactive Protein (hsCRP) and Interleukin 6 (IL-6) | Baseline: Serum hsCRP | 1.22 pg/ml | Standard Deviation 0.31 |
| Group 4: Lovaza 4 gm | Changes in Serum Biomarkers for Inflammation From Levels of High Sensitivity C-reactive Protein (hsCRP) and Interleukin 6 (IL-6) | 1 year: Serum hsCRP | 1.69 pg/ml | Standard Deviation 0.59 |
| Group 4: Lovaza 4 gm | 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 | 1.49 pg/ml | Standard Deviation 0.41 |
| Group 4: Lovaza 4 gm | Changes in Serum Biomarkers for Inflammation From Levels of High Sensitivity C-reactive Protein (hsCRP) and Interleukin 6 (IL-6) | Baseline: Serum IL-6 | 1.32 pg/ml | Standard Deviation 0.45 |
| Group 5: Lovaza 4 gm and Raloxifene 30 mg | 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 | 1.32 pg/ml | Standard Deviation 0.34 |
| Group 5: Lovaza 4 gm and Raloxifene 30 mg | Changes in Serum Biomarkers for Inflammation From Levels of High Sensitivity C-reactive Protein (hsCRP) and Interleukin 6 (IL-6) | Baseline: Serum IL-6 | 1.84 pg/ml | Standard Deviation 0.52 |
| Group 5: Lovaza 4 gm and Raloxifene 30 mg | Changes in Serum Biomarkers for Inflammation From Levels of High Sensitivity C-reactive Protein (hsCRP) and Interleukin 6 (IL-6) | 1 year: Serum hsCRP | 2.59 pg/ml | Standard Deviation 0.89 |
| Group 5: Lovaza 4 gm and Raloxifene 30 mg | Changes in Serum Biomarkers for Inflammation From Levels of High Sensitivity C-reactive Protein (hsCRP) and Interleukin 6 (IL-6) | Baseline: Serum hsCRP | 4.28 pg/ml | Standard Deviation 1.61 |
Secondary
Changes in Serum Lipid Levels
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.
Time frame: 2 years
Population: The decrease in the population groups is accounted for through subject withdrawals, subjects lost to follow-up, and other reasons for not completing study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 1: Control | Changes in Serum Lipid Levels | 1 year: HDL Cholesterol | 70.71 mg/dL | Standard Deviation 18.87 |
| Group 1: Control | Changes in Serum Lipid Levels | 1 year: Triglycerides | 114.5 mg/dL | Standard Deviation 62.95 |
| Group 1: Control | Changes in Serum Lipid Levels | Baseline: Total Cholesterol | 207.3 mg/dL | Standard Deviation 41.18 |
| Group 1: Control | Changes in Serum Lipid Levels | Baseline: LDL Cholesterol | 114 mg/dL | Standard Deviation 38.07 |
| Group 1: Control | Changes in Serum Lipid Levels | 2 year: LDL Cholesterol | 115.3 mg/dL | Standard Deviation 29.21 |
| Group 1: Control | Changes in Serum Lipid Levels | 2 year: Triglycerides | 110.1 mg/dL | Standard Deviation 44.25 |
| Group 1: Control | Changes in Serum Lipid Levels | Baseline: Triglycerides | 122.7 mg/dL | Standard Deviation 54.57 |
| Group 1: Control | Changes in Serum Lipid Levels | 2 year: Total Cholesterol | 207.5 mg/dL | Standard Deviation 36.41 |
| Group 1: Control | Changes in Serum Lipid Levels | 1 year: LDL Cholesterol | 115.1 mg/dL | Standard Deviation 31.99 |
| Group 1: Control | Changes in Serum Lipid Levels | Baseline: HDL Cholesterol | 68.75 mg/dL | Standard Deviation 18.83 |
| Group 1: Control | Changes in Serum Lipid Levels | 1 year: Total Cholestrol | 208.8 mg/dL | Standard Deviation 34.39 |
| Group 1: Control | Changes in Serum Lipid Levels | 2 year: HDL Cholestrol | 70.19 mg/dL | Standard Deviation 19.35 |
| Group 2: Raloxifene 60 mg | Changes in Serum Lipid Levels | 2 year: Triglycerides | 116.9 mg/dL | Standard Deviation 50.17 |
| Group 2: Raloxifene 60 mg | Changes in Serum Lipid Levels | 2 year: LDL Cholesterol | 104.7 mg/dL | Standard Deviation 28.13 |
| Group 2: Raloxifene 60 mg | Changes in Serum Lipid Levels | 1 year: Total Cholestrol | 198.3 mg/dL | Standard Deviation 29.33 |
| Group 2: Raloxifene 60 mg | Changes in Serum Lipid Levels | Baseline: HDL Cholesterol | 66.18 mg/dL | Standard Deviation 15.47 |
| Group 2: Raloxifene 60 mg | Changes in Serum Lipid Levels | Baseline: Total Cholesterol | 203.6 mg/dL | Standard Deviation 29.98 |
| Group 2: Raloxifene 60 mg | Changes in Serum Lipid Levels | 1 year: Triglycerides | 113.2 mg/dL | Standard Deviation 55.08 |
| Group 2: Raloxifene 60 mg | Changes in Serum Lipid Levels | 2 year: Total Cholesterol | 196.6 mg/dL | Standard Deviation 30.64 |
| Group 2: Raloxifene 60 mg | Changes in Serum Lipid Levels | 1 year: HDL Cholesterol | 68.88 mg/dL | Standard Deviation 14.06 |
| Group 2: Raloxifene 60 mg | Changes in Serum Lipid Levels | Baseline: Triglycerides | 113.2 mg/dL | Standard Deviation 48.39 |
| Group 2: Raloxifene 60 mg | Changes in Serum Lipid Levels | Baseline: LDL Cholesterol | 114.7 mg/dL | Standard Deviation 27.53 |
| Group 2: Raloxifene 60 mg | Changes in Serum Lipid Levels | 2 year: HDL Cholestrol | 68.63 mg/dL | Standard Deviation 15.04 |
| Group 2: Raloxifene 60 mg | Changes in Serum Lipid Levels | 1 year: LDL Cholesterol | 106.8 mg/dL | Standard Deviation 25.98 |
| Group 3: Raloxifene 30 mg | Changes in Serum Lipid Levels | 1 year: Triglycerides | 113.7 mg/dL | Standard Deviation 49.76 |
| Group 3: Raloxifene 30 mg | Changes in Serum Lipid Levels | Baseline: Total Cholesterol | 204.3 mg/dL | Standard Deviation 36.29 |
| Group 3: Raloxifene 30 mg | Changes in Serum Lipid Levels | 1 year: Total Cholestrol | 199.6 mg/dL | Standard Deviation 28.43 |
| Group 3: Raloxifene 30 mg | Changes in Serum Lipid Levels | 2 year: Total Cholesterol | 202.3 mg/dL | Standard Deviation 25.58 |
| Group 3: Raloxifene 30 mg | Changes in Serum Lipid Levels | Baseline: LDL Cholesterol | 111.2 mg/dL | Standard Deviation 31.83 |
| Group 3: Raloxifene 30 mg | Changes in Serum Lipid Levels | 1 year: LDL Cholesterol | 106.2 mg/dL | Standard Deviation 24.38 |
| Group 3: Raloxifene 30 mg | Changes in Serum Lipid Levels | 2 year: LDL Cholesterol | 106.1 mg/dL | Standard Deviation 25.4 |
| Group 3: Raloxifene 30 mg | Changes in Serum Lipid Levels | Baseline: HDL Cholesterol | 70.92 mg/dL | Standard Deviation 18.54 |
| Group 3: Raloxifene 30 mg | Changes in Serum Lipid Levels | 1 year: HDL Cholesterol | 70.59 mg/dL | Standard Deviation 16.63 |
| Group 3: Raloxifene 30 mg | Changes in Serum Lipid Levels | 2 year: HDL Cholestrol | 73.17 mg/dL | Standard Deviation 18.01 |
| Group 3: Raloxifene 30 mg | Changes in Serum Lipid Levels | Baseline: Triglycerides | 110.6 mg/dL | Standard Deviation 50.49 |
| Group 3: Raloxifene 30 mg | Changes in Serum Lipid Levels | 2 year: Triglycerides | 115.8 mg/dL | Standard Deviation 58.48 |
| Group 4: Lovaza 4 gm | Changes in Serum Lipid Levels | 2 year: LDL Cholesterol | 110.4 mg/dL | Standard Deviation 29.2 |
| Group 4: Lovaza 4 gm | Changes in Serum Lipid Levels | Baseline: Total Cholesterol | 197.7 mg/dL | Standard Deviation 33.2 |
| Group 4: Lovaza 4 gm | Changes in Serum Lipid Levels | 1 year: HDL Cholesterol | 70.59 mg/dL | Standard Deviation 18.31 |
| Group 4: Lovaza 4 gm | Changes in Serum Lipid Levels | 1 year: LDL Cholesterol | 109.7 mg/dL | Standard Deviation 29.22 |
| Group 4: Lovaza 4 gm | Changes in Serum Lipid Levels | 2 year: HDL Cholestrol | 70.67 mg/dL | Standard Deviation 19.38 |
| Group 4: Lovaza 4 gm | Changes in Serum Lipid Levels | Baseline: LDL Cholesterol | 106.6 mg/dL | Standard Deviation 31.96 |
| Group 4: Lovaza 4 gm | Changes in Serum Lipid Levels | 2 year: Triglycerides | 95.41 mg/dL | Standard Deviation 49.6 |
| Group 4: Lovaza 4 gm | Changes in Serum Lipid Levels | Baseline: Triglycerides | 115.1 mg/dL | Standard Deviation 52.33 |
| Group 4: Lovaza 4 gm | Changes in Serum Lipid Levels | 2 year: Total Cholesterol | 200.2 mg/dL | Standard Deviation 34.55 |
| Group 4: Lovaza 4 gm | Changes in Serum Lipid Levels | 1 year: Total Cholestrol | 199.6 mg/dL | Standard Deviation 30.45 |
| Group 4: Lovaza 4 gm | Changes in Serum Lipid Levels | 1 year: Triglycerides | 96.22 mg/dL | Standard Deviation 42.94 |
| Group 4: Lovaza 4 gm | Changes in Serum Lipid Levels | Baseline: HDL Cholesterol | 68.06 mg/dL | Standard Deviation 16.89 |
| Group 5: Lovaza 4 gm and Raloxifene 30 mg | Changes in Serum Lipid Levels | 2 year: LDL Cholesterol | 99.48 mg/dL | Standard Deviation 25.2 |
| Group 5: Lovaza 4 gm and Raloxifene 30 mg | Changes in Serum Lipid Levels | Baseline: Triglycerides | 103.6 mg/dL | Standard Deviation 38.79 |
| Group 5: Lovaza 4 gm and Raloxifene 30 mg | Changes in Serum Lipid Levels | Baseline: Total Cholesterol | 197.6 mg/dL | Standard Deviation 38.68 |
| Group 5: Lovaza 4 gm and Raloxifene 30 mg | Changes in Serum Lipid Levels | 1 year: HDL Cholesterol | 76.11 mg/dL | Standard Deviation 18.61 |
| Group 5: Lovaza 4 gm and Raloxifene 30 mg | Changes in Serum Lipid Levels | 1 year: Total Cholestrol | 189.4 mg/dL | Standard Deviation 33.45 |
| Group 5: Lovaza 4 gm and Raloxifene 30 mg | Changes in Serum Lipid Levels | Baseline: LDL Cholesterol | 108.1 mg/dL | Standard Deviation 35.87 |
| Group 5: Lovaza 4 gm and Raloxifene 30 mg | Changes in Serum Lipid Levels | 2 year: Triglycerides | 86.43 mg/dL | Standard Deviation 35 |
| Group 5: Lovaza 4 gm and Raloxifene 30 mg | Changes in Serum Lipid Levels | 1 year: LDL Cholesterol | 96.58 mg/dL | Standard Deviation 26.37 |
| Group 5: Lovaza 4 gm and Raloxifene 30 mg | Changes in Serum Lipid Levels | 2 year: HDL Cholestrol | 75.77 mg/dL | Standard Deviation 17.8 |
| Group 5: Lovaza 4 gm and Raloxifene 30 mg | Changes in Serum Lipid Levels | Baseline: HDL Cholesterol | 68.9 mg/dL | Standard Deviation 17.68 |
| Group 5: Lovaza 4 gm and Raloxifene 30 mg | Changes in Serum Lipid Levels | 2 year: Total Cholesterol | 192.6 mg/dL | Standard Deviation 30.02 |
| Group 5: Lovaza 4 gm and Raloxifene 30 mg | Changes in Serum Lipid Levels | 1 year: Triglycerides | 83.71 mg/dL | Standard Deviation 31.08 |