Robert Carlson
Ph I/II of Vitamin D on Bone Mineral Density & Markers of Bone Resorption
Contact Information
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Brief
Aromatase inhibitors are potent suppressors of breast cancer growth, but side effects include bone loss, fractures, arthralgias and myalgias. We hypothesize vitamin D administration might be beneficial in treating these symptoms and to protect bone.
Recruiting Status:
RecruitingStanford Recruiting Status:
RecruitingCondition(s):
Intervention(s):
- Drug: Vitamin D
Phase:
Phase 1/Phase 2Eligibility
Ages Eligible for Study:
18 years to 85 yearsGenders Eligible for Study:
FemaleHealth of Volunteers:
People with the conditions listed in this trial can participate as controls.Key Inclusion Criteria:
3.1.1 All postmenopausal women with histology-confirmed invasive primary breast cancer, who have completed primary surgical or XRT with or without adjuvant chemotherapy and are candidates to receive adjuvant therapy with aromatase inhibitors will be screened for eligibility. Postmenopausal is defined as satisfying one or more of the following criteria: having had bilateral oophorectomy; aged more than 60 years; or aged 55-59 years with an intact uterus and amenorrheic for at least 12 months; or if amenorrheic for less than 12 months (after receiving hysterectomy, hormone therapy or chemotherapy).
3.1.2 At the time of study enrollment, participants will have completed primary surgical or XRT with or without adjuvant chemotherapy. Chemotherapy will be completed at least 28 days prior to enrollment.
3.1.4 Participants will be women between 18-85 years of age. Women and minorities will be actively recruited. Though breast cancer extremely rarely occurs in children and men, this study will only recruit adult females.
3.1.5 Participants will have a life expectancy of at least 5 years.
3.1.6 Participants will have ECOG (Eastern Clinical Oncology Group) performance status 0-2.
3.1.7 Ability to understand and the willingness to sign a written informed consent document
Key Exclusion Criteria:
3.2.1 Medications affecting bone metabolism (bisphosphonates, anticonvulsants, chronic heparin therapy, chronic glucocorticoid use > 5 mg/day prednisone or equivalent, teriparatide).
3.2.2 Use of any investigational drug within past 90 days.
3.2.3 Metastatic breast cancer. High risk for osteoporosis/fractures (BMD < -2.0, history of non-traumatic fracture). Hyperparathyroidism Hypercalcemia Hypercalciuria (fasting spot urine calcium/creatinine ratio >0.20) History of renal stones Renal failure with creatinine over 2.0
3.2.4 Considering that vitamin D3 is produced by the human body, allergy to vitamin D3 is not expected to develop. Subjects with known history of allergic reaction to compounds used to manufacture capsules (rice powder) will be excluded form this study.
3.2.5 Recent history of excessive alcohol or drug use.
3.2.6 As this study will recruit post-menopausal patients, thus pregnant or nursing patients are not part of this investigation.
3.2.8 This study is designed to study women after completing primary therapy for breast cancer. Survivors of previous cancers and HIV-positive subjects will not be excluded.
Additional Study Details
Official Title:
A Phase I/II randomized, double-blind, controlled study to evaluate efficacy and safety of vitamin D on bone mineral density and markers of bone resorption in aromatase inhibitor-induced bone loss in women with breast cancer.Anticipated start date:
4/17/2009Lead Sponsor:
Stanford UniversityCollaborator(s):
- Department of Defense
Investigator(s):
Study Type:
InterventionalPurpose:
TreatmentAllocation:
RandomizedMasking:
Double BlindControl:
noneAssignment:
Single GroupEndpoints:
Safety/EfficacyPrimary Outcomes:
- Spine bone mineral density T score change over one year
Secondary Outcomes:
- Change in hip BMD T-score
- Bone turnover markers
- Arthralgias and myalgias
- Serum calcium and fasting spot urine calcium/creatinine ratio
Total Number to be Enrolled:
100Total Number to be Enrolled at Stanford:
100More Information
Secondary ID(s):
- BRSADJ0014
- NCT00904423
Locations & Contacts
Stanford Locations & Contacts:
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Non-Stanford Locations:
The Stanford website does not have any locations outside of Stanford listed for this trial. You may want to check clinicaltrials.gov for posible additional locations.
This listing was last updated:
6/10/2009PLEASE NOTE:
Study Coordinators and Research Nurses cannot give medical advice over the phone. Telephone numbers are provided for obtaining additional information on specific clinical research trials only. If you have specific questions which require clinical expertise, please call your primary care physician. If you do not have a primary care physician please feel free to call the SHC Physician Referral Service at (800) 756-9000 or send an email.
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