Ph I/II of Vitamin D on Bone Mineral Density & Markers of Bone Resorption
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| First Received Date ICMJE | May 13, 2009 | ||||||||
| Last Updated Date | October 6, 2011 | ||||||||
| Start Date ICMJE | April 2009 | ||||||||
| Primary Completion Date | April 2011 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Spine bone mineral density T score change over one year [ Time Frame: one year ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE |
Spine bone mineral density T score change over one year | ||||||||
| Change History | Complete list of historical versions of study NCT00904423 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Ph I/II of Vitamin D on Bone Mineral Density & Markers of Bone Resorption | ||||||||
| Official Title ICMJE | 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. | ||||||||
| 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 beneficial in treating these symptoms and to protect bone. |
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 1 Phase 2 |
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| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE | Drug: Vitamin D
up to 2400 mg; oral tablet
Other Name: Vital Nurients |
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| Study Arm (s) | Not Provided | ||||||||
| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Terminated | ||||||||
| Estimated Enrollment ICMJE | 100 | ||||||||
| Completion Date | April 2011 | ||||||||
| Primary Completion Date | April 2011 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | 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 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. |
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| Gender | Female | ||||||||
| Ages | 18 Years to 85 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00904423 | ||||||||
| Other Study ID Numbers ICMJE | BRSADJ0014, SU-09232008-1302 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | Eva Balint, Stanford University | ||||||||
| Study Sponsor ICMJE | Stanford University | ||||||||
| Collaborators ICMJE | Department of Defense | ||||||||
| Investigators ICMJE |
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| Information Provided By | Stanford University | ||||||||
| Verification Date | October 2011 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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