Breast Cancer
Conditions
Brief summary
This research will examine the effectiveness of calcitriol in treating bone loss in women who are about to begin treatment for breast cancer. Twenty-five (25) subjects are expected to take part in this study. The investigators don't know if bone loss in breast cancer survivors should be treated differently than bone loss in other women.
Detailed description
The calcitriol intervention is aimed at reducing fracture risk by maintaining proper bone density. Calcitriol is efficacious in maintaining proper bone health and muscle mass among the general population, but little research has been done on breast cancer patients. In addition, calcitriol may be effective in reducing tumor proliferation and angiogenesis, while increasing tumor apoptosis. Each of those factors could have beneficial effects on breast cancer outcomes.
Interventions
DRUGCalcitriol
In pill form, 45 micrograms once a week for 12 weeks
Sponsors
University of Rochester
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 88 Years
Healthy volunteers
No
Inclusion criteria
* Must be female. * Must have pathologically confirmed incident, primary invasive breast cancer. * Must be awaiting surgical resection. * Women of child-bearing potential (i.e. women who are pre-menopausal or not surgically sterile) must use acceptable contraceptive methods (abstinence, intrauterine device (IUD), or double barrier device) and must have a negative serum or urine pregnancy test within 1 week prior to beginning treatment on this trial. Contraceptive use needs to be continued at least 1 month after the trial has ended. * Must provide informed consent. * Must be willing to discontinue use of calcium and/or vitamin D supplements other than multivitamin supplementation. * Participants must have an ionized serum calcium level within normal limits (1.19-1.29mmol/L) and a total corrected serum calcium of \< 10.2mg/dl.
Exclusion criteria
* Subjects with life-threatening conditions that would preclude them from breast cancer treatment including: chronic cardiac failure, which is unstable despite medication use; uncontrolled hypertension; uncontrolled diabetes mellitus; or unstable coronary artery disease. * Patients with severe metabolic disorders, which includes phenylketonuria (PKU), homocystinuria, and Fabry's disease, that would preclude them from taking calcitriol. * Patients with a previous history of any other cancer except non-melanomous skin cancer within the past 5 years. * Patients with impaired renal function (CRCL \< 60 mL/min) or who had kidney stones (calcium salt) within the past 5 years. * Patients with hypercalcemia (corrected serum CA \> 10.2 mg/dl) or a history of hypercalcemia or vitamin D toxicity. * Patients currently taking calcium supplements or aluminum-based antacids must immediately discontinue their use if they are to enroll in the study. * Patients currently taking vitamin D supplements must immediately discontinue their use if they are to enroll in the study. * Patients with a known sensitivity to calcitriol. * Women who are pregnant or lactating. * Women on antiresorptive drugs (e.g. bisphosphonates) within the past year. * Women currently using oral contraception. * Women with malabsorptive syndromes (i.e. cystic fibrosis, chronic pancreatitis) or taking medications that decrease the absorption of fat soluble vitamins (i.e. Orlistat, Questran). * Participants assigned to calcitriol who are routinely taking a multivitamin supplement may continue the supplement as long as the amount of vitamin D in the supplement is not in excess of the RDA (recommended daily allowance) of 400 IU or 10 μg. If they are not taking a multivitamin supplement, they will be asked to not start supplementation while on study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change in Bone Resorption: NTX (N-terminal Telopeptide) | baseline to 12 weeks | Scale score for NTX (N-terminal telopeptide) minimum value = 4.2 nmol BCE; maximum value = 3688 nmol BCE Higher scale score for NTX indicates worse outcome. |
| Mean Change in Bone Formation: BAP (Bone-specific Alkaline Phosphatase) | baseline to 12 weeks | Scale score for BAP (Bone-specific alkaline phosphatase) minimum value = 7 mcg/L; maximum value = 329 mcg/L Higher scale score for BAP indicates worse outcome. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Calcitriol Calcitriol 45mcg/week
Calcitriol: In pill form, 45 micrograms once a week for 12 weeks | 12 |
| Total | 12 |
Baseline characteristics
| Characteristic | Calcitriol |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 12 Participants |
| Do you know or have you ever smoked 100 cigarettes in your lifetime? No | 9 Participants |
| Do you know or have you ever smoked 100 cigarettes in your lifetime? Yes | 3 Participants |
| During the past 5 years did you regularly take a Calcium Supplement No | 7 Participants |
| During the past 5 years did you regularly take a Calcium Supplement Yes | 5 Participants |
| During the past 5 years did you regularly take a Multivitamin? No | 8 Participants |
| During the past 5 years did you regularly take a Multivitamin? Yes | 4 Participants |
| During the past 5 years did you regularly take Vitamin D? No | 8 Participants |
| During the past 5 years did you regularly take Vitamin D? Yes | 4 Participants |
| Education Level Bachelor's degree or higher | 10 Participants |
| Education Level High school graduate | 0 Participants |
| Education Level Non-high school graduate | 0 Participants |
| Education Level Partial college training (less than 4 years) | 2 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 12 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Marital Status Divorced | 3 Participants |
| Marital Status Married | 7 Participants |
| Marital Status Separated | 1 Participants |
| Marital Status Single | 1 Participants |
| Marital Status Widowed | 0 Participants |
| Present Family Income <$15,000 | 0 Participants |
| Present Family Income $15,000-$29,999 | 2 Participants |
| Present Family Income $30,000-$59,999 | 4 Participants |
| Present Family Income >$60,000 | 5 Participants |
| Present Family Income Unknown | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 11 Participants |
| Sex: Female, Male Female | 12 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 12 |
| other Total, other adverse events | 3 / 12 |
| serious Total, serious adverse events | 0 / 12 |
Outcome results
Primary
Mean Change in Bone Formation: BAP (Bone-specific Alkaline Phosphatase)
Scale score for BAP (Bone-specific alkaline phosphatase) minimum value = 7 mcg/L; maximum value = 329 mcg/L Higher scale score for BAP indicates worse outcome.
Time frame: baseline to 12 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Calcitriol | Mean Change in Bone Formation: BAP (Bone-specific Alkaline Phosphatase) | NA mcg/L |
Primary
Mean Change in Bone Resorption: NTX (N-terminal Telopeptide)
Scale score for NTX (N-terminal telopeptide) minimum value = 4.2 nmol BCE; maximum value = 3688 nmol BCE Higher scale score for NTX indicates worse outcome.
Time frame: baseline to 12 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Calcitriol | Mean Change in Bone Resorption: NTX (N-terminal Telopeptide) | NA nmol |