Vitamin D + Physical Activity for Osteoporosis

Age: 18+

Sex: Female

Trial Phase: Phase 2

Sponsor: University of Rochester

Must not be taking: Antiresorptives, Fat blockers

Disqualifiers: Unstable cardiac, Uncontrolled diabetes, Renal impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 24 weeks

191 Participants Needed

Trial Summary

What is the purpose of this trial?

This research will examine the effectiveness of vitamin D or placebo (the placebo is a tablet that looks like Vitamin D study drug, but has no Vitamin D study drug in it), with and without physical activity (walking and progressive resistance exercise), in treating bone loss in women who have undergone treatment for breast cancer. The investigators would also like to find out if the physical activity program improves cardiovascular fitness, energy expenditure, muscular strength, muscle mass, and balance. One hundred five (105) subjects are expected to take part in this study. The investigators don't know if bone loss in breast cancer survivors should be treated differently than bone loss in other women.

Research Team

Luke J Peppone, PhD, MPH

Principal Investigator

University of Rochester

Eligibility Criteria

This trial is for postmenopausal women with a history of hormone-receptor positive breast cancer, who are slightly vitamin D deficient and within 5 years of diagnosis. They must be able to perform light physical activity and not currently taking calcium or vitamin D supplements. Women with severe health issues or certain metabolic disorders cannot participate.

Inclusion Criteria

Must provide informed consent

Must be willing to discontinue use of calcium and/or vitamin D supplements

Participants must have an ionized serum calcium level within normal limits (1.19-1.29mmol/L) and a total corrected serum calcium of < 10.6 mg/dl

Exclusion Criteria

You have a known sensitivity or allergy to vitamin D.

Patients currently taking vitamin D supplements must immediately discontinue their use if they are to enroll in the study

Subjects with life-threatening conditions that would preclude them from breast cancer treatment including chronic cardiac failure, which is unstable despite medication use, uncontrolled hypertension, uncontrolled diabetes mellitus, or unstable coronary artery disease

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive vitamin D or placebo, with or without physical activity, for bone health improvement

24 weeks

Regular visits for monitoring and exercise guidance

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Physical Activity
• Vitamin D3

Trial Overview The study tests the impact of Vitamin D (or placebo) combined with walking and resistance exercises on bone health in breast cancer survivors. It aims to improve cardiovascular fitness, energy use, muscle strength, mass, and balance among participants.

Participant Groups

Group I: Vitamin D3 50,000 IU Active Control 1 Intervention

Vitamin D3 50,000 IU: Patients will be assigned to receive a daily multivitamin, calcium supplement and 50,000 IU/week of vitamin D for a period of 24 weeks.

Group II: Vitamin D3 50,000 IU and Physical Activity Active Control 2 Interventions

Vitamin D3 50,000 IU and Physical Activity: Patients will be assigned to receive a daily multivitamin, calcium supplement, 50,000 IU/week of vitamin D, and a progressive walking and resistance band exercise prescription for a period of 24 weeks.

Group III: Control Active Control 1 Intervention

Patients will be assigned to receive a daily multivitamin, calcium supplement, vitamin D placebo, and standard care monitoring.

Who Is Running the Clinical Trial?

University of Rochester

Lead Sponsor

Trials

883

Recruited

555,000+