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Bisphosphonate

Zoledronic acid for Osteoporosis (ZEST II Trial)

Phase 4
Waitlist Available
Led By Susan L Greenspan, MD
Research Sponsored by Susan L. Greenspan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights

ZEST II Trial Summary

This study is evaluating whether a drug called zoledronic acid can reduce the risk of fractures in people with dementia.

Eligible Conditions
  • Osteoporosis
  • Osteoporotic Fractures

ZEST II Trial Timeline

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

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Non-traumatic Incidental Fractures (Vertebral and Nonvertebral [Identified by X-ray, CT, MRI, VFA Imaging] Per Person-year)

Side effects data

From 2012 Phase 4 trial • 21 Patients • NCT02042872
100%
Lethargy
100%
Myalgia
75%
Vomiting
75%
Acute Febrile Reaction
38%
General Surgery
13%
Hypocalcemia
13%
Decubitus Ulcer
13%
Spinal headache
13%
Deep Venous Thrombosis
13%
Bowel Impaction
100%
80%
60%
40%
20%
0%
Study treatment Arm
Zoledronic Acid
No Treatment

ZEST II Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Active Medication GroupExperimental Treatment3 Interventions
Annual dose: intravenous zoledronic acid (Reclast) 5.0 mg; vitamin D (800 IU/daily) and calcium (approximately 1200 mg/daily, dietary + supplements)
Group II: Placebo GroupPlacebo Group3 Interventions
Annual dose: intravenous saline; vitamin D (800 IU/daily and calcium (approximately 1200 mg/daily, dietary + supplements)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
calcium
2010
Completed Phase 4
~2060
vitamin D
2013
Completed Phase 3
~2380
Zoledronic acid
2014
Completed Phase 4
~4920

Find a Location

Who is running the clinical trial?

Susan L. GreenspanLead Sponsor
5 Previous Clinical Trials
771 Total Patients Enrolled
5 Trials studying Osteoporosis
771 Patients Enrolled for Osteoporosis
National Institutes of Health (NIH)NIH
2,698 Previous Clinical Trials
7,492,189 Total Patients Enrolled
10 Trials studying Osteoporosis
1,919 Patients Enrolled for Osteoporosis
National Institute on Aging (NIA)NIH
1,672 Previous Clinical Trials
28,018,353 Total Patients Enrolled
22 Trials studying Osteoporosis
11,958 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.
Recent research and studies
clinicaltrials.govStudy
Zoledronic Acid for Osteoporotic Fracture Prevention (ZEST II)
Susan L. Greenspan 2016. "Zoledronic Acid for Osteoporotic Fracture Prevention (ZEST II)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02589600.
~34 spots leftby Apr 2025
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