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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.


Phase 1/Phase 2
18 Years
85 Years
Not Enrolling
Female
Breast Cancer, Bone Diseases

Thank you

Trial Information

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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Spine bone mineral density T score change over one year

Outcome Time Frame:

one year

Safety Issue:

No

Principal Investigator

Eva Balint

Investigator Role:

Principal Investigator

Investigator Affiliation:

Stanford University

Authority:

United States: Food and Drug Administration

Study ID:

BRSADJ0014

NCT ID:

NCT00904423

Start Date:

April 2009

Completion Date:

April 2011

Related Keywords:

  • Breast Cancer
  • Bone Diseases
  • Bone Diseases
  • Bone Resorption
  • Breast Neoplasms

Name

Location

Stanford University School of MedicineStanford, California  94305-5317