Status:
TERMINATED
Ph I/II of Vitamin D on Bone Mineral Density & Markers of Bone Resorption
Lead Sponsor:
Mark Pegram
Collaborating Sponsors:
United States Department of Defense
Conditions:
Breast Cancer
Bone Diseases
Eligibility:
FEMALE
18-85 years
Phase:
PHASE1
PHASE2
Brief Summary
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 beneficia...
Eligibility Criteria
Inclusion
- 1.1 All postmenopausal women with histology-confirmed invasive primary breast cancer, who have completed primary surgical or radiotherapy (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).
- 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.
- 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.
- 1.5 Participants will have a life expectancy of at least 5 years.
- 1.6 Participants will have Eastern Clinical Oncology Group (ECOG) performance status 0-2.
- 1.7 Ability to understand and the willingness to sign a written informed consent document
Exclusion
- 2.1 Medications affecting bone metabolism (bisphosphonates, anticonvulsants, chronic heparin therapy, chronic glucocorticoid use \> 5 mg/day prednisone or equivalent, teriparatide).
- 2.2 Use of any investigational drug within past 90 days.
- 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
- 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.
- 2.5 Recent history of excessive alcohol or drug use.
- 2.6 As this study will recruit post-menopausal patients, thus pregnant or nursing patients are not part of this investigation.
- 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.
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2011
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT00904423
Start Date
April 1 2009
End Date
April 1 2011
Last Update
February 14 2017
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Stanford University School of Medicine
Stanford, California, United States, 94305