Vitamin D + Physical Activity for Osteoporosis
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether vitamin D and physical activity can help with bone loss in women treated for breast cancer. Researchers aim to determine if vitamin D supplements, with or without a simple exercise program like walking and using resistance bands, can strengthen bones and improve overall fitness. Women who have had breast cancer, are postmenopausal, and have a slight vitamin D deficiency might be suitable candidates for this trial. The study seeks to discover if these treatments should be managed differently compared to other cases of bone loss. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important findings.
Do I have to stop taking my current medications for the trial?
You will need to stop taking calcium and vitamin D supplements to join the trial. The protocol does not specify other medications, so it's best to discuss with the trial team if you have concerns about other medications you are taking.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that taking a high dose of vitamin D3, such as 50,000 IU per week, is generally safe for adults. Studies have found that vitamin D3 supports bone health and can help prevent osteoporosis, a condition where bones become weak and brittle. However, some research suggests that very high doses of vitamin D might increase the risk of falls, so it's important to adhere to recommended amounts.
When combined with exercise, vitamin D3 remains safe. Exercise and vitamin D3 together are effective and low-risk methods to improve bone health. Activities like walking and resistance exercises strengthen bones and muscles.
Overall, both treatments in this study—vitamin D3 alone or with exercise—are well-tolerated and safe for most people. However, individuals should consult healthcare professionals before starting to ensure it suits their personal health needs.12345Why are researchers excited about this trial's treatments?
Researchers are excited about the Vitamin D3 and Physical Activity approach for osteoporosis because it combines bone-strengthening nutrients with exercise, which is not typically emphasized in standard treatments. While most osteoporosis treatments focus on medications like bisphosphonates or hormone replacement therapy, this method harnesses the power of Vitamin D3, known for its role in calcium absorption, alongside physical activity to potentially enhance bone density and strength. The combination of high-dose Vitamin D3 and progressive physical activities, such as walking and resistance exercises, aims to improve bone health more naturally and holistically.
What evidence suggests that this trial's treatments could be effective for bone loss in breast cancer survivors?
Research has shown that vitamin D3 can help treat osteoporosis by slowing bone loss. One study found that women taking vitamin D3 experienced less bone loss in their spine compared to those taking a placebo. Another study demonstrated that vitamin D3 is effective for both preventing and treating osteoporosis. In this trial, one group of participants will receive vitamin D3 alone, while another group will receive vitamin D3 combined with physical activities like walking and resistance exercises. Evidence suggests that this combination can be more beneficial for bone strength than either vitamin D3 or exercise alone. Thus, vitamin D3, especially when paired with exercise, could effectively treat bone loss.56789
Who Is on the Research Team?
Luke J Peppone, PhD, MPH
Principal Investigator
University of Rochester
Are You a Good Fit for This Trial?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive vitamin D or placebo, with or without physical activity, for bone health improvement
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
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.
How Is the Trial Designed?
3
Treatment groups
Active Control
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.
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.
Patients will be assigned to receive a daily multivitamin, calcium supplement, vitamin D placebo, and standard care monitoring.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Rochester
Lead Sponsor
Citations
Vitamin D and Calcium in Osteoporosis, and the Role of ...
The aim of this narrative review is to summarize the effects of vitamin D and calcium supplementation separately and in combination, on bone density and ...
Effects of Supplemental Vitamin D on Bone Health ...
Vitamin D 3 supplementation versus placebo in women resulted in a trend for smaller decreases in aBMD at the spine.
Effect of High-Dose Vitamin D Supplementation on ...
Vitamin D supplementation has been considered beneficial for prevention and treatment of osteoporosis. Clinical trial data support skeletal ...
Results from a nationwide study with focus in osteoporosis
Treatment with Ca 600 mg/cholecalciferol 2000 IU for at least 24 weeks is effective and safe, especially in osteoporosis. Patients with VDD significantly ...
Supplemental Vitamin D and Incident Fractures in Midlife ...
Vitamin D 3 supplementation did not result in a significantly lower risk of fractures than placebo among generally healthy midlife and older adults.
Cholecalciferol (vitamin D3): efficacy, safety, and ...
High-dose vitamin D3 supplementation (typically 4,000–10,000 IU/day in adults) has been investigated for its potential to promote bone mass accrual and prevent ...
Vitamin D
Generally safe. Without vitamin D, bones can become soft, thin and brittle. Not having enough vitamin D also is linked to the bone-thinning condition ...
Vitamin D - Health Professional Fact Sheet
Together with calcium, vitamin D also helps protect older adults from osteoporosis. Vitamin D has other roles in the body, including ...
Daily or intermittent vitamin D supplementation in patients ...
Other studies suggest that intermittent doses may increase the fall risk (monthly 60,000 IU vitamin D3 versus placebo), or that the risk of falls is higher with ...
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