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Vitamin D + Physical Activity for Osteoporosis

Phase 2
Waitlist Available
Led By Luke J Peppone, PhD, MPH
Research Sponsored by University of Rochester
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 weeks
Awards & highlights
No Placebo-Only Group

Summary

This trial will study whether vitamin D or a placebo, with or without physical activity, can help treat bone loss in breast cancer survivors.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects may include reactions related to Vitamin D supplementation such as high calcium levels in blood or urine which could lead to kidney stones or digestive issues. Exercise might cause muscle soreness or injury if not done properly.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Measure the amount of bone 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.
Secondary study objectives
Breast

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Active Control
Group I: Vitamin D3 50,000 IUActive Control1 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 ActivityActive Control2 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: ControlActive Control1 Intervention
Patients will be assigned to receive a daily multivitamin, calcium supplement, vitamin D placebo, and standard care monitoring.

Find a Location

Who is running the clinical trial?

University of RochesterLead Sponsor
872 Previous Clinical Trials
549,900 Total Patients Enrolled
Luke J Peppone, PhD, MPHPrincipal InvestigatorUniversity of Rochester
1 Previous Clinical Trials
108 Total Patients Enrolled

Media Library

Physical Activity Clinical Trial Eligibility Overview. Trial Name: NCT01419730 — Phase 2
Physical Fitness Research Study Groups: Vitamin D3 50,000 IU, Vitamin D3 50,000 IU and Physical Activity, Control
Physical Fitness Clinical Trial 2023: Physical Activity Highlights & Side Effects. Trial Name: NCT01419730 — Phase 2
Physical Activity 2023 Treatment Timeline for Medical Study. Trial Name: NCT01419730 — Phase 2
~13 spots leftby Dec 2025
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