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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 below
Select...
I am currently on bisphosphonate medication.
Select...
I am a healthy adult between 60 and 80 years old.

Timeline

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

Find a Location

Who is running the clinical trial?

National Center for Advancing Translational Sciences (NCATS)NIH
320 Previous Clinical Trials
401,695 Total Patients Enrolled
1 Trials studying Osteoporosis
48 Patients Enrolled for Osteoporosis
University of Colorado, DenverLead Sponsor
1,732 Previous Clinical Trials
2,143,513 Total Patients Enrolled
11 Trials studying Osteoporosis
1,197 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can individuals aged sixty and over participate in this research?

"Based on the study's inclusion criteria, only patients aged between 60 and 80 can participate."

Answered by AI

What other research has been conducted on the efficacy of Calcium Infusion?

"Right now, 8 clinical trials investigating Calcium Infusion are in progress with 1 of them having reached Phase 3. Primarily conducted within the city limits of Pittsburgh, Pennsylvania, there are 49 medical sites operating studies related to this molecule."

Answered by AI

How is Calcium Infusion commonly employed in clinical practice?

"Calcium Infusion is frequently used to correct fluid imbalances and replenish electrolyte levels. Additionally, it has been utilized in cases of parenteral nutrition or hypovolemic shock."

Answered by AI

Is this research currently enrolling participants?

"Affirmative. The information housed on clinicaltrials.gov confirms that this investigation is currently recruiting participants. It was first posted in November 1, 2015 and the most recent update took place on September 18th 2023. 35 patients will be accepted from one facility for enrollment into the trial."

Answered by AI

What is the size of the cohort being researched in this trial?

"Affirmative. The clinical trial, which was initially posted on November 1st 2015 is currently recruiting participants according to information found on clinicaltrials.gov. 35 patients need to be gathered from a single medical site for the study and its details were last updated September 18th 2023."

Answered by AI

Who is eligible for participation in this medical research?

"Prospective candidates for this medical trial must suffer from osteoporosis, and be within the aged 60 to 80. Currently, 35 participants are needed in total."

Answered by AI
~0 spots leftby Jun 2024