Trial Outcomes & Findings for Effects of High Dose Calcitriol in Breast Cancer Patients (NCT NCT01293682)

NCT ID: NCT01293682

Last Updated: 2022-04-20

Results Overview

Scale score for NTX (N-terminal telopeptide) minimum value = 4.2 nmol BCE; maximum value = 3688 nmol BCE Higher scale score for NTX indicates worse outcome.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 12 participants
• Primary outcome timeframe: baseline to 12 weeks
• Results posted on: 2022-04-20

Participant Flow

Participant milestones

Measure	Calcitriol Calcitriol 45mcg/week Calcitriol: In pill form, 45 micrograms once a week for 12 weeks
Overall Study STARTED	12
Overall Study COMPLETED	12
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effects of High Dose Calcitriol in Breast Cancer Patients

Baseline characteristics by cohort

Measure	Calcitriol n=12 Participants Calcitriol 45mcg/week Calcitriol: In pill form, 45 micrograms once a week for 12 weeks
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	12 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 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	1 Participants n=5 Participants
Race (NIH/OMB) White	11 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
Marital Status Married	7 Participants n=5 Participants
Marital Status Divorced	3 Participants n=5 Participants
Marital Status Separated	1 Participants n=5 Participants
Marital Status Single	1 Participants n=5 Participants
Marital Status Widowed	0 Participants n=5 Participants
Education Level Bachelor's degree or higher	10 Participants n=5 Participants
Education Level Partial college training (less than 4 years)	2 Participants n=5 Participants
Education Level High school graduate	0 Participants n=5 Participants
Education Level Non-high school graduate	0 Participants n=5 Participants
Present Family Income <$15,000	0 Participants n=5 Participants
Present Family Income $15,000-$29,999	2 Participants n=5 Participants
Present Family Income $30,000-$59,999	4 Participants n=5 Participants
Present Family Income >$60,000	5 Participants n=5 Participants
Present Family Income Unknown	1 Participants n=5 Participants
During the past 5 years did you regularly take a Multivitamin? Yes	4 Participants n=5 Participants
During the past 5 years did you regularly take a Multivitamin? No	8 Participants n=5 Participants
During the past 5 years did you regularly take Vitamin D? Yes	4 Participants n=5 Participants
During the past 5 years did you regularly take Vitamin D? No	8 Participants n=5 Participants
During the past 5 years did you regularly take a Calcium Supplement Yes	5 Participants n=5 Participants
During the past 5 years did you regularly take a Calcium Supplement No	7 Participants n=5 Participants
Do you know or have you ever smoked 100 cigarettes in your lifetime? Yes	3 Participants n=5 Participants
Do you know or have you ever smoked 100 cigarettes in your lifetime? No	9 Participants n=5 Participants

PRIMARY outcome

Timeframe: baseline to 12 weeks

Scale score for NTX (N-terminal telopeptide) minimum value = 4.2 nmol BCE; maximum value = 3688 nmol BCE Higher scale score for NTX indicates worse outcome.

Outcome measures

Measure	Calcitriol n=12 Participants Calcitriol 45mcg/week Calcitriol: In pill form, 45 micrograms once a week for 12 weeks
Mean Change in Bone Resorption: NTX (N-terminal Telopeptide)	NA nmol Standard Deviation NA The values of NTX were so low for all subjects as to be not detectable.

PRIMARY outcome

Timeframe: baseline to 12 weeks

Scale score for BAP (Bone-specific alkaline phosphatase) minimum value = 7 mcg/L; maximum value = 329 mcg/L Higher scale score for BAP indicates worse outcome.

Outcome measures

Measure	Calcitriol n=12 Participants Calcitriol 45mcg/week Calcitriol: In pill form, 45 micrograms once a week for 12 weeks
Mean Change in Bone Formation: BAP (Bone-specific Alkaline Phosphatase)	NA mcg/L Standard Deviation NA The values of BAP were so low for all subjects as to be not detectable.

Adverse Events

Calcitriol

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Calcitriol n=12 participants at risk Calcitriol 45mcg/week Calcitriol: In pill form, 45 micrograms once a week for 12 weeks
Blood and lymphatic system disorders Hypercalcemia	25.0% 3/12 • Number of events 7 • 12 weeks

Additional Information

Luke J Peppone, PhD, MPH

University of Rochester

Phone: 585-275-7827

Email: Luke_Peppone@urmc.rochester.edu

Results disclosure agreements

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