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

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.

Status

Terminated

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00904423

Enrollment

Registered

2009-05-19

Start date

2009-04-30

Completion date

2011-04-30

Last updated

2017-02-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bone Diseases, 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.

Interventions

DRUGVitamin D

up to 2400 mg; oral tablet

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 85 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Spine Bone Mineral Density T Score Change Over One Year	1 year

Secondary

Measure	Time frame
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

Countries

United States

Participant flow

Participants by arm

Arm	Count
Vitamin D	8
Total	8

Baseline characteristics

Characteristic	Vitamin D
Age, Categorical <=18 years	0 Participants
Age, Categorical >=65 years	0 Participants
Age, Categorical Between 18 and 65 years	8 Participants
Gender Female	8 Participants
Gender Male	0 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants
Race (NIH/OMB) Asian	3 Participants
Race (NIH/OMB) Black or African American	0 Participants
Race (NIH/OMB) More than one race	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants
Race (NIH/OMB) White	5 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	— / —
other Total, other adverse events	0 / 8
serious Total, serious adverse events	0 / 8