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

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

Compensation: Varies

Number of Visits: 20

18 Participants Needed

Trial Summary

What is the purpose of this trial?

Exercise is essential for building and maintaining bone mass and strength, but current exercise recommendations for how to achieve this lack detail on the optimal exercise prescription. Recent studies found that blood calcium level decreases during exercise, and that calcium is mobilized from bone to slow the decline. If this occurs repeatedly during exercise training, it could diminish the potential benefits of exercise to improve bone health. The proposed study will determine whether further research on pre-exercise supplemental calcium to minimize the decline in blood calcium level during exercise is warranted. This research is important for Veterans because they are at increased risk of hip fracture when compared with non-Veterans. Further, because osteoporosis in men is under-recognized and under-treated, providing male (and female) Veterans with more specific exercise and nutrition guidelines has the potential to enhance bone health, reduce fracture risk, and improve quality of life.

Research Team

Wendy M Kohrt, PhD

Principal Investigator

Rocky Mountain Regional VA Medical Center, Aurora, CO

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+