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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at baseline, through 60 minutes of exercise, and during 4 hours of recovery
Awards & highlights
Study 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 belowSelect...
I am currently on bisphosphonate medication.
Select...
I am a healthy adult between 60 and 80 years old.
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
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
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Who is running the clinical trial?
National Center for Advancing Translational Sciences (NCATS)NIH
326 Previous Clinical Trials
401,739 Total Patients Enrolled
1 Trials studying Osteoporosis
48 Patients Enrolled for Osteoporosis
University of Colorado, DenverLead Sponsor
1,755 Previous Clinical Trials
2,166,384 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
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