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Bisphosphonate

Experimental for Osteoporosis

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

All Individual Drugs Already Approved

Approved for 5 Other Conditions

No Placebo-Only Group

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

Osteoporosis
Osteopenia

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to month 24

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Changes in Lumbar Spine BMD +/- Treatment With Alendronate

Secondary study objectives

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

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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