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Bisphosphonate

Cinacalcet for Chronic Kidney Failure

N/A

Waitlist Available

Research Sponsored by Hartmut Malluche, MD

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up one year (at baseline and one year)

Awards & highlights

Study Summary

This trial is testing the concept that CKD osteoporosis can be treated when treatment is individualized by patients' turnover status, in order to improve quality of life.

Eligible Conditions

Chronic Kidney Failure

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year (at baseline and 1 year)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year (at baseline and 1 year)

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year (at baseline and 1 year) 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 Quantitative Computed Tomography (QCT) Bone Mineral Density of the Hip

Secondary outcome measures

Change in Coronary Artery Calcifications by Multiple Detector Computed Tomography (MDCT)

Change in Serum Biochemical Bone Markers of Bone Activity - Bone-specific Alkaline Phosphatase (BSAP)

Change in Serum Biochemical Bone Markers of Bone Activity - Fibroblast Growth Factor 23 (FGF23)

+1 more

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: Treatment, low turnoverExperimental Treatment2 Interventions

Low turnover osteoporosis group treated with teriparatide and cinacalcet.

Group II: Treatment, high turnoverExperimental Treatment1 Intervention

High turnover osteoporosis group treated with alendronate.

Group III: Control, low turnoverActive Control1 Intervention

No intervention in low turnover osteoporosis control group.

Group IV: Control, high turnoverActive Control1 Intervention

No intervention in high turnover osteoporosis control group.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Teriparatide

FDA approved

Cinacalcet

FDA approved

Alendronic acid

FDA approved

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Wright State UniversityOTHER

41 Previous Clinical Trials

54,741 Total Patients Enrolled

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH

2,359 Previous Clinical Trials

4,314,450 Total Patients Enrolled

Hartmut Malluche, MDLead Sponsor

3 Previous Clinical Trials

564 Total Patients Enrolled

Frequently Asked Questions

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

How many participants are engaged in this clinical experiment?

"At this time, no further participants may join this clinical trial. The posting of the study was on July 1st 2015 and it ceased enrolling patients as of July 13th 2021. There are currently 293 trials for chronic kidney failure and 22 studies recruiting cinacalcet users."

Answered by AI

What is the typical purpose of Cinacalcet treatment?

"Cinacalcet is frequently prescribed to treat osteogenesis imperfecta, though it can potentially help patients with parathyroidectomy, parathyroid carcinoma, and even bone density issues."

Answered by AI

Is this research endeavor open to enrollment of participants at the moment?

"The clinical trial that was first posted on July 1st 2015 is no longer seeking patients. For those who are interested in other studies, 293 trials related to kidney failure and 22 involving cinacalcet are actively recruiting candidates."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Renal Osteodystrophy: An Individual Management Approach

Hartmut Malluche, MD 2015. "Renal Osteodystrophy: An Individual Management Approach". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02440581.