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

• Sponsor: Mark Pegram (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00904423
• Collaborator: United States Department of Defense (U.S. Fed)
• Enrollment: 8
• Location: 1
• Arm: 1
• Duration (Months): 24
• Patients Per Site Per Month: 0.3

Study Details

Study Description

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 Design

• Study Type: Interventional
• Actual Enrollment: 8 participants
• Allocation: N/A
• 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: Apr 1, 2009
• Actual Primary Completion Date: Apr 1, 2011
• Actual Study Completion Date: Apr 1, 2011

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Spine Bone Mineral Density T Score Change Over One Year [1 year]

Secondary Outcome Measures

1. Change in Hip Bone Mineral Density (BMD) T-score [one year]

2. Bone Turnover Markers [months 4 and 12]

3. Arthralgias and Myalgias [every 4 months]

4. Serum Calcium and Fasting Spot Urine Calcium/Creatinine Ratio [every 4 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 85 Years
• 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Stanford University School of Medicine	Stanford	California	United States	94305

Sponsors and Collaborators

• Mark Pegram
• United States Department of Defense

Investigators

• Principal Investigator: Eva Balint, Stanford University
• Principal Investigator: Robert W Carlson, Stanford University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Mark Pegram, Susy Yuan-Huey Hung Professor, Stanford University
• ClinicalTrials.gov Identifier: NCT00904423
• Other Study ID Numbers: IRB-15005; SU-09232008-1302; BRSADJ0014
• First Posted: May 19, 2009
• Last Update Posted: Feb 14, 2017
• Last Verified: Dec 1, 2016

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Breast Neoplasms; Bone Diseases; Bone Resorption; Vitamin D

Study Results

Participant Flow

Arm/Group Title	Vitamin D
Arm/Group Description
Period Title: Overall Study
STARTED	8
COMPLETED	8
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Vitamin D
Arm/Group Description
Overall Participants	8
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	8 100%
>=65 years	0 0%
Gender (Count of Participants)
Female	8 100%
Male	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	3 37.5%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	0 0%
White	5 62.5%
More than one race	0 0%
Unknown or Not Reported	0 0%

Outcome Measures

1. Primary Outcome

Title	Spine Bone Mineral Density T Score Change Over One Year
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

Data are not accessible.

Arm/Group Title	Vitamin D
Arm/Group Description	Vitamin D: up to 2400 mg; oral tablet
Measure Participants	0

2. Secondary Outcome

Title	Change in Hip Bone Mineral Density (BMD) T-score
Time Frame	one year

Outcome Measure Data

Analysis Population Description

Data are not accessible.

Arm/Group Title	Vitamin D
Arm/Group Description	Vitamin D: up to 2400 mg; oral tablet
Measure Participants	0

3. Secondary Outcome

Title	Bone Turnover Markers
Time Frame	months 4 and 12

Outcome Measure Data

Analysis Population Description

Data are not accessible.

Arm/Group Title	Vitamin D
Arm/Group Description	Vitamin D: up to 2400 mg; oral tablet
Measure Participants	0

4. Secondary Outcome

Title	Arthralgias and Myalgias
Time Frame	every 4 months

Outcome Measure Data

Analysis Population Description

Data are not accessible.

Arm/Group Title	Vitamin D
Arm/Group Description	Vitamin D: up to 2400 mg; oral tablet
Measure Participants	0

5. Secondary Outcome

Title	Serum Calcium and Fasting Spot Urine Calcium/Creatinine Ratio
Time Frame	every 4 months

Outcome Measure Data

Analysis Population Description

Data are not accessible.

Arm/Group Title	Vitamin D
Arm/Group Description	Vitamin D: up to 2400 mg; oral tablet
Measure Participants	0

Adverse Events

Time Frame	1 year
Adverse Event Reporting Description	Adverse event data are not accessible.
Arm/Group Title	Vitamin D
Arm/Group Description	Vitamin D: up to 2400 mg; oral tablet
All Cause Mortality
	Vitamin D
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Vitamin D
	Affected / at Risk (%)	# Events
Total	0/8 (0%)
Other (Not Including Serious) Adverse Events
	Vitamin D
	Affected / at Risk (%)	# Events
Total	0/8 (0%)

Limitations/Caveats

Early termination secondary to low accrual.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.