Trial Outcomes & Findings for Ph I/II of Vitamin D on Bone Mineral Density & Markers of Bone Resorption (NCT NCT00904423)

NCT ID: NCT00904423

Last Updated: 2017-02-14

Results Overview

• Recruitment status: TERMINATED
• Study phase: PHASE1/PHASE2
• Target enrollment: 8 participants
• Primary outcome timeframe: 1 year
• Results posted on: 2017-02-14

Participant Flow

Participant milestones

Measure	Vitamin D
Overall Study STARTED	8
Overall Study COMPLETED	8
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

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

PRIMARY outcome

Timeframe: 1 year

Population: Data are not accessible.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: one year

Population: Data are not accessible.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: months 4 and 12

Population: Data are not accessible.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: every 4 months

Population: Data are not accessible.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: every 4 months

Population: Data are not accessible.

Outcome measures

Outcome data not reported

Adverse Events

Vitamin D

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Mark D Pegram, MD

Stanford Cancer Institute, Stanford University

Phone: 650-723-5801

Email: mpegram@stanford.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place