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Calcium Supplements for Osteoporosis

Phase < 1

Recruiting

Led By Sarah J Wherry, PhD

Research Sponsored by University of Colorado, Denver

Eligibility Criteria Checklist

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

Must have

Currently taking a bisphosphonate medication

Healthy adults aged 60-80 y

Must not have

Moderate or severe renal impairment defined as an estimated glomerular filtration rate of <60 mL/min/1.73m2 based on the Modified Diet in Renal Disease (MDRD) equation

Use of medications (other than bisphosphonates) in the past 6 months known to affect bone metabolism (e.g., thiazide diuretics, oral glucocorticoids)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at baseline, through 60 minutes of exercise, and during 4 hours of recovery

Awards & highlights

Approved for 10 Other Conditions

All Individual Drugs Already Approved

Summary

This trial will test if a "calcium clamp" can prevent bone breakdown during exercise by keeping calcium levels stable.

Who is the study for?

This trial is for healthy adults aged 60-80 who are currently taking bisphosphonates for osteoporosis. It's not suitable for those on other bone-affecting meds, with severe osteoporosis, uncontrolled high blood pressure, liver or kidney issues, diabetes, thyroid dysfunction, asthma or heart disease.

What is being tested?

The study tests if using a 'calcium clamp' to prevent drops in serum calcium during exercise can also stop increases in markers of bone loss. Participants will receive either Calcium Chloride/Calcium Gluconate or a placebo while exercising.

What are the potential side effects?

Potential side effects may include reactions at the infusion site due to calcium administration such as warmth or discomfort and possible changes in blood pressure. Long-term effects on bone health are being studied.

Eligibility Criteria

Inclusion Criteria

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

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I am currently on bisphosphonate medication.

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I am a healthy adult between 60 and 80 years old.

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 a filtration rate below 60 mL/min.

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I haven't taken any medications that affect bone health, except for bisphosphonates, in the last 6 months.

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I have a condition that affects how my intestines absorb nutrients.

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I have asthma.

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I have a history of diabetes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at baseline, through 60 minutes of exercise, and during 4 hours of recovery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at baseline, through 60 minutes of exercise, and during 4 hours of recovery

This trial's timeline: 3 weeks for screening, Varies for treatment, and at baseline, through 60 minutes of exercise, and during 4 hours of recovery for reporting.