Exercise + Calcium Supplementation for Osteoporosis

(ESkAPE Trial)

Overseen By Sarah J Wherry, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Must not be taking: Osteoporosis medications, Diuretics, Glucocorticoids

Disqualifiers: Diabetes, Cardiovascular disease, Hypertension, others

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

Compensation: Varies

Number of Visits: 20

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether taking calcium supplements before exercise can improve bone health in people with osteoporosis. It focuses on Veterans at higher risk for hip fractures and aims to find the best combination of exercise and nutrition to strengthen bones and reduce fracture risks. Participants will engage in an endurance exercise intervention (a structured exercise program) to assess its impact on bone strength. Ideal participants are Veterans who are normally active, such as those who enjoy cycling or walking, but do not regularly engage in more intense exercise. As an unphased trial, this study offers Veterans a unique opportunity to contribute to research that could enhance bone health strategies for those at risk.

Do I need to stop my current medications to join the trial?

The trial does not specify if you need to stop your current medications, but you cannot join if you've started or changed the dose of medications affecting bone metabolism in the past 6 months.

What prior data suggests that this exercise intervention is safe for improving bone health?

Research shows that exercise is generally safe for people with osteoporosis. Studies have found that strength training and impact activities can strengthen bones without causing harm. Another review examined the risks of exercise for those with osteoporosis and found no major safety concerns. Regular exercise increases bone density and muscle strength, particularly in older adults with weaker bones. Overall, exercise is considered safe and beneficial for bone health. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using endurance exercise combined with calcium supplementation for osteoporosis because it offers a natural and holistic approach to bone health. Unlike standard treatments like bisphosphonates or hormone therapy, which primarily focus on slowing bone loss, exercise actively promotes bone strength and density by stimulating bone-forming cells. Additionally, this approach enhances overall physical fitness and balance, potentially reducing the risk of falls and fractures. By integrating exercise, this treatment could provide a dual benefit of improving bone health and overall well-being.

What evidence suggests that this exercise intervention could be effective for osteoporosis?

Studies have shown that physical exercise can promote bone growth in individuals with osteoporosis. Research indicates that regular physical activity prevents bone loss and improves bone health in older adults. Various exercises, such as balance and flexibility training, lower the risk of falls and enhance joint mobility. The frequency and duration of exercise can also influence bone strength, particularly in the hip and spine. Overall, exercise is a proven method to maintain strong and healthy bones for those at risk of osteoporosis. Participants in this trial will engage in an endurance exercise intervention to assess its impact on bone health. ^{3 6 7 8 9}

Who Is on the Research Team?

Wendy M Kohrt, PhD

Principal Investigator

Rocky Mountain Regional VA Medical Center, Aurora, CO

Are You a Good Fit for This Trial?

This trial is for male and female Veterans aged 25-45 and 55-75 who are normally active but not in regular intense exercise. Women must be pre or postmenopausal with specific hormonal levels. Exclusions include severe bone density loss, kidney issues, uncontrolled thyroid/blood calcium levels, high blood pressure, type 1 diabetes, recent fractures, obesity, certain heart conditions or anemia.

Inclusion Criteria

I am a woman who is either premenopausal with regular periods or postmenopausal.

Eligible volunteers will be normally active (e.g., recreational cycling or walking) but will not participate in regular moderate-to-vigorous exercise

I am a veteran aged between 25-45 or 55-75.

Exclusion Criteria

Hemoglobin A1c >7%

In the event of abnormal eGFR, alkaline phosphatase, TSH, BP, 25(OH)D, or hemoglobin values, volunteers can be reassessed, including after appropriate follow-up evaluation and treatment by their health care provider

Anemia (hemoglobin <12.1 g/dL for women, <14.3 g/dL for men)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Baseline measurements of VO2peak, HRmax, FFM, FM, and BMD are conducted

1 week

1 visit (in-person)

Exercise Intervention

Participants engage in treadmill exercise at 70% to 80% of maximal heart rate, 60 minutes per day, 4 days per week, for 4 weeks

4 weeks

16 visits (in-person)

Follow-up

Participants are monitored for changes in serum markers of bone formation and resorption after exercise sessions

4 weeks

3 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Endurance exercise intervention

Trial Overview The study tests if taking supplemental calcium before endurance exercises can help maintain blood calcium levels during workouts to improve bone health. It aims to provide better exercise and nutrition guidelines to reduce fracture risk in Veterans.

How Is the Trial Designed?

Group I: Exercise Experimental Treatment 1 Intervention

All participants engage in exercise training

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6323511/

The Effectiveness of Physical Exercise on Bone Density in ... Physical exercise is considered an effective means to stimulate bone osteogenesis in osteoporotic patients.

2. frontiersin.org frontiersin.org/journals/sports-and-active-living/articles/10.3389/fspor.2025.1655404/epub

The effect of physical activity intervention and detraining on ... Conclusion: The results emphasize the importance of long-term physical activity as part of osteoporosis prevention while also highlighting the ...

3. ijbnpa.biomedcentral.com ijbnpa.biomedcentral.com/articles/10.1186/s12966-020-01040-4

Evidence on physical activity and osteoporosis prevention for ... Included studies suggest that physical activity interventions probably improve bone health among older adults and thus prevent osteoporosis ( ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12507884/

Effects of different exercise interventions on bone mineral ... Balance training reduces the risk of falls, and flexibility exercises improve joint mobility and muscle coordination. Together, these components ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S875632822100106X

Effects of exercise frequency and training volume on bone ... This study indicates that exercise frequency and training volume were predictors of the changes in hip and spine BMD following a multi-component exercise ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10345999/

Position Statement: Exercise Guidelines for Osteoporosis ... The 50 RCTs reported that even with osteoporosis and osteopenia, resistance and impact training consistently maximized bone strength, improved body strength and ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7155356/

Adverse events and safety issues associated with physical ... We conducted a systematic review to identify adverse effects of physical activity and/or exercise for adults with osteoporosis/osteopenia.

8. frontiersin.org frontiersin.org/journals/sports-and-active-living/articles/10.3389/fspor.2025.1655404/full

The effect of physical activity intervention and detraining on ... In conclusion, regular exercise significantly improves BMD, muscular strength, and endurance in postmenopausal women with osteopenia and osteoporosis. However, ...

9. bjsm.bmj.com bjsm.bmj.com/content/56/15/837

Strong, steady and straight: UK consensus statement on ... Exercise and physical activity can improve bone strength and the risk of falls, which may offer benefits in the prevention and management of osteoporosis.