Ph I/II of Vitamin D on Bone Mineral Density & Markers of Bone Resorption

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00904423
Recruitment Status : Terminated (Low accrual)
First Posted : May 19, 2009
Results First Posted : February 14, 2017
Last Update Posted : February 14, 2017
United States Department of Defense
Information provided by (Responsible Party):
Mark Pegram, Stanford University

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Bone Diseases Drug: Vitamin D Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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.
Study Start Date : April 2009
Actual Primary Completion Date : April 2011
Actual Study Completion Date : April 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Vitamin D

Arm Intervention/treatment
Experimental: Vitamin D Drug: Vitamin D
up to 2400 mg; oral tablet
Other Name: Vital nutrients

Primary Outcome Measures :
  1. Spine Bone Mineral Density T Score Change Over One Year [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Change in Hip Bone Mineral Density (BMD) T-score [ Time Frame: one year ]
  2. Bone Turnover Markers [ Time Frame: months 4 and 12 ]
  3. Arthralgias and Myalgias [ Time Frame: every 4 months ]
  4. Serum Calcium and Fasting Spot Urine Calcium/Creatinine Ratio [ Time Frame: every 4 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

3.1.1 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).

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 Eastern Clinical Oncology Group (ECOG) 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00904423

United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Mark Pegram
United States Department of Defense
Principal Investigator: Eva Balint Stanford University
Principal Investigator: Robert W Carlson Stanford University

Responsible Party: Mark Pegram, Susy Yuan-Huey Hung Professor, Stanford University Identifier: NCT00904423     History of Changes
Other Study ID Numbers: IRB-15005
SU-09232008-1302 ( Other Identifier: Stanford University )
BRSADJ0014 ( Other Identifier: OnCore )
First Posted: May 19, 2009    Key Record Dates
Results First Posted: February 14, 2017
Last Update Posted: February 14, 2017
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Breast Neoplasms
Bone Diseases
Bone Resorption
Neoplasms by Site
Breast Diseases
Skin Diseases
Musculoskeletal Diseases
Vitamin D
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents