Trial Outcomes & Findings for Vitamin D and Physical Activity on Bone Health (NCT NCT01419730)

NCT ID: NCT01419730

Last Updated: 2026-08-05

Results Overview

To collect preliminary data on the effects of vitamin D therapy and exercise (alone or in combination) on bone mineral density (BMD) as measured by a dual energy X-ray absorptiometry (DXA) in non-metastatic breast cancer patients who began hormonal therapy within the previous 12 months. Amount of bone loss was measured with change in BMD.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE2

Target enrollment

191 participants

Primary outcome timeframe

24 weeks

Results posted on

2026-08-05

Participant Flow

Participant milestones

Participant milestones
Measure	High Dose Vitamin D Patients will be assigned to receive a daily multivitamin, 800mg of calcium, and 50,000 IU/week of vitamin D for a period of 24 weeks.	High Dose Vitamin D + Exercise Patients will be assigned to receive a daily multivitamin, 800mg of calcium, 50,000 IU/week of vitamin D, and a progressive walking and resistance band exercise prescription for a period of 24 weeks.	Control Patients will be assigned to receive a daily multivitamin, 800mg of calcium, and a placebo for a period of 24 weeks
Overall Study STARTED	34	36	35
Overall Study COMPLETED	34	34	35
Overall Study NOT COMPLETED	0	2	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Vitamin D and Physical Activity on Bone Health

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	High Dose Vitamin D n=34 Participants Patients will be assigned to receive a daily multivitamin, 800mg of calcium, and 50,000 IU/week of vitamin D for a period of 24 weeks.	High Dose Vitamin D + Exercise n=36 Participants Patients will be assigned to receive a daily multivitamin, 800mg of calcium, 50,000 IU/week of vitamin D, and a progressive walking and resistance band exercise prescription for a period of 24 weeks.	Control n=35 Participants Patients will be assigned to receive a daily multivitamin, 800mg of calcium, and a placebo for a period of 24 weeks	Total n=105 Participants Total of all reporting groups
Age, Continuous	60.2 Years STANDARD_DEVIATION 9.1 • n=20 Participants	63.1 Years STANDARD_DEVIATION 7.6 • n=20 Participants	59.8 Years STANDARD_DEVIATION 7.5 • n=40 Participants	60.0 Years STANDARD_DEVIATION 7.5 • n=6 Participants
Sex: Female, Male Female	34 Participants n=20 Participants	36 Participants n=20 Participants	35 Participants n=40 Participants	105 Participants n=6 Participants
Sex: Female, Male Male	0 Participants n=20 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants	0 Participants n=6 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=20 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants	0 Participants n=6 Participants
Race (NIH/OMB) Asian	0 Participants n=20 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants	0 Participants n=6 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=20 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants	0 Participants n=6 Participants
Race (NIH/OMB) Black or African American	2 Participants n=20 Participants	4 Participants n=20 Participants	0 Participants n=40 Participants	6 Participants n=6 Participants
Race (NIH/OMB) White	32 Participants n=20 Participants	31 Participants n=20 Participants	32 Participants n=40 Participants	95 Participants n=6 Participants
Race (NIH/OMB) More than one race	0 Participants n=20 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants	0 Participants n=6 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=20 Participants	1 Participants n=20 Participants	3 Participants n=40 Participants	4 Participants n=6 Participants
Stage 0	3 Participants n=20 Participants	2 Participants n=20 Participants	7 Participants n=40 Participants	12 Participants n=6 Participants
Stage 1	22 Participants n=20 Participants	19 Participants n=20 Participants	19 Participants n=40 Participants	60 Participants n=6 Participants
Stage 2	7 Participants n=20 Participants	12 Participants n=20 Participants	9 Participants n=40 Participants	28 Participants n=6 Participants
Stage 3	1 Participants n=20 Participants	2 Participants n=20 Participants	0 Participants n=40 Participants	3 Participants n=6 Participants
Stage Unknown	1 Participants n=20 Participants	1 Participants n=20 Participants	0 Participants n=40 Participants	2 Participants n=6 Participants

PRIMARY outcome

Timeframe: 24 weeks

Outcome measures

Outcome measures
Measure	High Dose Vitamin D n=34 Participants Patients will be assigned to receive a daily multivitamin, 800mg of calcium, and 50,000 IU/week of vitamin D for a period of 24 weeks.	High Dose Vitamin D + Exercise n=34 Participants Patients will be assigned to receive a daily multivitamin, 800mg of calcium, 50,000 IU/week of vitamin D, and a progressive walking and resistance band exercise prescription for a period of 24 weeks.	Control n=35 Participants Patients will be assigned to receive a daily multivitamin, 800mg of calcium, and a placebo for a period of 24 weeks
Measure the Amount of Bone Mineral Density Loss in Non-metastatic Breast Cancer Patients Receiving a High Dose Vitamin D Therapy Along With a Structured Home-based Walking and Progressive Resistance Exercise Program.	-0.0015 Change in Hip BMD g/cm^2 Standard Deviation 0.0045	-0.0013 Change in Hip BMD g/cm^2 Standard Deviation 0.0044	-0.0163 Change in Hip BMD g/cm^2 Standard Deviation 0.0058

SECONDARY outcome

Timeframe: 24 weeks

Population: Participants did not record data properly for Pedometer. For functional outcomes they were unable to perform that day.

Measuring physical fitness for muscle strength using handgrip dynamometer in non-metastatic breast cancer patients who begin hormonal therapy within the previous 12 months.

Outcome measures

Outcome measures
Measure	High Dose Vitamin D n=26 Participants Patients will be assigned to receive a daily multivitamin, 800mg of calcium, and 50,000 IU/week of vitamin D for a period of 24 weeks.	High Dose Vitamin D + Exercise n=28 Participants Patients will be assigned to receive a daily multivitamin, 800mg of calcium, 50,000 IU/week of vitamin D, and a progressive walking and resistance band exercise prescription for a period of 24 weeks.	Control n=28 Participants Patients will be assigned to receive a daily multivitamin, 800mg of calcium, and a placebo for a period of 24 weeks
Measure the Effect of Vitamin D and Muscle Strength in Non-metastatic Breast Cancer Patients	-0.585 Kilograms Standard Error 0.708	0.256 Kilograms Standard Error 0.695	1.344 Kilograms Standard Error 0.695

SECONDARY outcome

Timeframe: 24 Weeks

Pedometer for number of steps for aerobic capacity.

Outcome measures

Outcome measures
Measure	High Dose Vitamin D n=15 Participants Patients will be assigned to receive a daily multivitamin, 800mg of calcium, and 50,000 IU/week of vitamin D for a period of 24 weeks.	High Dose Vitamin D + Exercise n=23 Participants Patients will be assigned to receive a daily multivitamin, 800mg of calcium, 50,000 IU/week of vitamin D, and a progressive walking and resistance band exercise prescription for a period of 24 weeks.	Control n=26 Participants Patients will be assigned to receive a daily multivitamin, 800mg of calcium, and a placebo for a period of 24 weeks
Measure the Effect of Vitamin D and Aerobic Capacity in Non-metastatic Breast Cancer Patients	138.655 Number of Steps Standard Error 949.602	80.048 Number of Steps Standard Error 766.362	938.837 Number of Steps Standard Error 721.220

SECONDARY outcome

Timeframe: 24 weeks

Testing Force Plate Area95 Eyes Closed Open Base for measure of balance

Outcome measures

Outcome measures
Measure	High Dose Vitamin D n=26 Participants Patients will be assigned to receive a daily multivitamin, 800mg of calcium, and 50,000 IU/week of vitamin D for a period of 24 weeks.	High Dose Vitamin D + Exercise n=28 Participants Patients will be assigned to receive a daily multivitamin, 800mg of calcium, 50,000 IU/week of vitamin D, and a progressive walking and resistance band exercise prescription for a period of 24 weeks.	Control n=28 Participants Patients will be assigned to receive a daily multivitamin, 800mg of calcium, and a placebo for a period of 24 weeks
Measure the Effect of Vitamin D and Balance in Non-metastatic Breast Cancer Patients	-0.235 Centimeters Squared Standard Error 0.121	-0.012 Centimeters Squared Standard Error 0.116	-0.079 Centimeters Squared Standard Error 0.116

Adverse Events

High Dose Vitamin D

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

High Dose Vitamin D + Exercise

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	High Dose Vitamin D n=34 participants at risk Patients will be assigned to receive a daily multivitamin, 800mg of calcium, and 50,000 IU/week of vitamin D for a period of 24 weeks.	High Dose Vitamin D + Exercise n=36 participants at risk Patients will be assigned to receive a daily multivitamin, 800mg of calcium, 50,000 IU/week of vitamin D, and a progressive walking and resistance band exercise prescription for a period of 24 weeks.	Control n=35 participants at risk Patients will be assigned to receive a daily multivitamin, 800mg of calcium, and a placebo for a period of 24 weeks
Metabolism and nutrition disorders Hypercalcemia	8.8% 3/34 • from enrollment until end of follow-up, up to 24 weeks	16.7% 6/36 • from enrollment until end of follow-up, up to 24 weeks	8.6% 3/35 • from enrollment until end of follow-up, up to 24 weeks

Additional Information

Dr. Luke J. Peppone

University of Rochester

Phone: 5852757827

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place