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

NCT00904423 | Terminated Phase 1 Results DMC

• 3 other identifiers: IRB-15005SU-09232008-1302BRSADJ0014
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer; Bone Diseases

Outcome Measures

Primary Outcomes (1)

• Spine Bone Mineral Density T Score Change Over One Year

  1 year

Secondary Outcomes (4)

• Change in Hip Bone Mineral Density (BMD) T-score

  one year

• Bone Turnover Markers

  months 4 and 12

• Arthralgias and Myalgias

  every 4 months

• Serum Calcium and Fasting Spot Urine Calcium/Creatinine Ratio

  every 4 months

Study Arms (1)

Vitamin D

EXPERIMENTAL

Drug: Vitamin D

Interventions

Vitamin D DRUG

up to 2400 mg; oral tablet

Also known as: Vital nutrients

Vitamin D

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• 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.
• 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.
• Participants will have a life expectancy of at least 5 years.
• Participants will have Eastern Clinical Oncology Group (ECOG) performance status 0-2.
• Ability to understand and the willingness to sign a written informed consent document

You may not qualify if:

• Medications affecting bone metabolism (bisphosphonates, anticonvulsants, chronic heparin therapy, chronic glucocorticoid use \> 5 mg/day prednisone or equivalent, teriparatide).
• Use of any investigational drug within past 90 days.
• 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
• 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.
• Recent history of excessive alcohol or drug use.
• As this study will recruit post-menopausal patients, thus pregnant or nursing patients are not part of this investigation.
• 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.

Sponsors & Collaborators

• Mark Pegram: lead
• United States Department of Defense: collaborator

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Bone Diseases

Interventions

Vitamin D

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Limitations and Caveats

Early termination secondary to low accrual.

Results Point of Contact

• Title: Mark D Pegram, MD
• Organization: Stanford Cancer Institute, Stanford University

mpegram@stanford.edu

650-723-5801

Study Officials

• Eva Balint

  Stanford University

  PRINCIPAL INVESTIGATOR

• Robert W Carlson

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Susy Yuan-Huey Hung Professor

Study Record Dates

• First Submitted: May 13, 2009
• First Posted: May 19, 2009
• Study Start: April 1, 2009
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: February 14, 2017
• Results First Posted: February 14, 2017

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)