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Exercise + Calcium Supplementation for Osteoporosis (ESkAPE Trial)

N/A

Waitlist Available

Led By Wendy M Kohrt, PhD

Research Sponsored by VA Office of Research and Development

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Women will be premenopausal with regular menstrual cycles or postmenopausal, defined as absence of menses for at least 12 mo or, in those who underwent a hysterectomy, a serum follicle stimulating hormone (FSH) >30 mIU/mL

Female and male Veterans aged 25 to 45 y and 55 to 75 y

Must not have

Impaired renal function, defined as an estimated glomerular filtration rate (eGFR) <60 mL/min/1.73m2

Fracture in the past 6 months

Timeline

Screening 3 weeks

Treatment Varies

Follow Up bmd of the lumbar spine and proximal femur is measured at baseline

Awards & highlights

No Placebo-Only Group

Summary

This trial will test whether pre-exercise supplemental calcium can help improve bone health for veterans by looking at the effects of exercise on blood calcium levels.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While the trial does not mention specific side effects of the interventions (exercise and potential calcium supplements), common concerns may include muscle soreness from exercise or gastrointestinal discomfort from supplements.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My kidney function is reduced, with an eGFR below 60.

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I have had a bone fracture in the last 6 months.

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I have type 2 diabetes and am on insulin or sulfonylurea therapy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ serum po4 is measured before (-15, 0 minutes), during (15, 30, 45, 60 minutes), and after (15, 30, 60, 120, 180, 240 minutes, 24 hours) the 1st, 8th, and 16th exercise sessions

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~serum po4 is measured before (-15, 0 minutes), during (15, 30, 45, 60 minutes), and after (15, 30, 60, 120, 180, 240 minutes, 24 hours) the 1st, 8th, and 16th exercise sessions

This trial's timeline: 3 weeks for screening, Varies for treatment, and serum po4 is measured before (-15, 0 minutes), during (15, 30, 45, 60 minutes), and after (15, 30, 60, 120, 180, 240 minutes, 24 hours) the 1st, 8th, and 16th exercise sessions for reporting.