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Bisphosphonate

Experimental for Osteopenia

N/A
Waitlist Available
Led By Tamara Vokes, MD
Research Sponsored by University of Chicago
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 baseline to month 24
Awards & highlights

Summary

The purpose of this study is to determine if a new test for osteoporosis can be useful in monitoring treatment. We are studying a new method for examining the quality of bone by an experimental method of computerized analysis of radiographic images (x-ray pictures) of the heel.

Eligible Conditions
  • Osteopenia
  • Osteoporosis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to month 24
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to month 24 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Changes in Lumbar Spine BMD +/- Treatment With Alendronate
Secondary outcome measures
Changes in Femoral Neck BMD +/- Treatment With Alendronate
Changes in Peripheral Heel BMD +/- Treatment With Alendronate
Changes in Radiographic Texture Analysis (RTA) Feature Integrated First Moment of the Power Spectrum (iFMP) From Baseline to Month 24
+6 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: ExperimentalExperimental Treatment3 Interventions
All subjects will receive 600 mg of elemental calcium (as calcium citrate) and 500 mg of Vitamin D with their evening meal. This group will also receive alendronate 70 mg once weekly, according to standard recommendations.
Group II: ControlActive Control2 Interventions
All subjects will receive 600 mg of elemental calcium (as calcium citrate) and 500 mg of Vitamin D with their evening meal.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Alendronic acid
FDA approved
Calcium Citrate
2012
Completed Phase 4
~250
Vitamin D
2013
Completed Phase 4
~3470

Find a Location

Who is running the clinical trial?

University of ChicagoLead Sponsor
1,018 Previous Clinical Trials
734,579 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,736 Previous Clinical Trials
7,507,914 Total Patients Enrolled
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)NIH
488 Previous Clinical Trials
1,088,381 Total Patients Enrolled
~1 spots leftby Aug 2025
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