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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

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.Check my eligibility

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.See study design

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.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Parathyroid Hormone (PTH)

Secondary outcome measures

Change in C-telopeptide (CTX)

Change in Total Calcium (Ca)

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Calcium InfusionExperimental Treatment1 Intervention

Continuous calcium infusion during exercise

Group II: Saline InfusionPlacebo Group1 Intervention

Continuous saline infusion during exercise

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Center for Advancing Translational Sciences (NCATS)NIH

329 Previous Clinical Trials

402,119 Total Patients Enrolled

1 Trials studying Osteoporosis

48 Patients Enrolled for Osteoporosis

University of Colorado, DenverLead Sponsor

1,758 Previous Clinical Trials

2,166,225 Total Patients Enrolled

11 Trials studying Osteoporosis

1,113 Patients Enrolled for Osteoporosis

Sarah J Wherry, PhDPrincipal InvestigatorUniversity of Colorado, Denver

3 Previous Clinical Trials

192 Total Patients Enrolled

3 Trials studying Osteoporosis

192 Patients Enrolled for Osteoporosis

~4 spots leftby Jul 2025

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