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Monoclonal Antibodies

denosumab for Osteoporosis (PROUD 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 39 months
Awards & highlights

PROUD Trial Summary

This trial will test if denosumab can treat and prevent bone loss in elderly patients with osteoporosis living in long-term care facilities.

Eligible Conditions
  • Osteoporosis
  • Osteoporotic Fractures

PROUD Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~39 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 39 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Bone density of the spine
Bone density of the total hip
Extension - Zoledronic Acid Infusion Safety Treatment: Bone density of the spine
+1 more

Side effects data

From 2020 Phase 4 trial • 76 Patients • NCT02176382
5%
wrist fracture
5%
breast cancer
3%
clavicle fracture
3%
fibula avulsion fracture
3%
humeral fracture
3%
kidney cancer
3%
pancreatitis
3%
rib fracture
3%
shoulder dislocation
3%
throat cancer
3%
vertebral fracture
100%
80%
60%
40%
20%
0%
Study treatment Arm
Standard Dose Teriparatide
High Dose Teriparatide

PROUD Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Denosumab, then Zoledronic AcidExperimental Treatment3 Interventions
Semi-annual dose: denosumab 60 mg semi-annual injection; Vitamin D 800-1000 IU/daily and Calcium approximately 1200 mg/daily (dietary + supplements); Zoledronic acid will be offered to all study participants upon completing the course of Denosumab.
Group II: Placebo Group, then Zoledronic AcidPlacebo Group3 Interventions
Semi-annual: placebo saline injection; Vitamin D 800-1000 IU/daily and Calcium approximately1200 mg/daily (dietary + supplements); Zoledronic acid will be offered to all study participants upon completing the course of placebo.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Calcium and Vitamin D
2018
Completed Phase 4
~460
Zoledronic Acid
2008
Completed Phase 4
~13830
denosumab
2014
Completed Phase 4
~4450

Find a Location

Who is running the clinical trial?

National Institutes of Health (NIH)NIH
2,696 Previous Clinical Trials
6,952,378 Total Patients Enrolled
10 Trials studying Osteoporosis
2,028 Patients Enrolled for Osteoporosis
National Institute on Aging (NIA)NIH
1,669 Previous Clinical Trials
28,004,913 Total Patients Enrolled
22 Trials studying Osteoporosis
12,067 Patients Enrolled for Osteoporosis
Susan L. GreenspanLead Sponsor
5 Previous Clinical Trials
880 Total Patients Enrolled
5 Trials studying Osteoporosis
880 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.

What conditions are commonly treated by denosumab?

"Denosumab is often prescribed to skeletally mature individuals as a form of treatment, but there are other applications including the management of glucocorticoids, tumors, solids, and androgens."

Answered by AI

Has denosumab acquired clearance from the FDA?

"There is plenty of evidence supporting the safety profile of denosumab, thus it was ranked a 3 on our scale. This treatment has already been approved for general use in many countries."

Answered by AI

What is the participant quota for this experiment?

"This particular trial is no longer seeking patients, as the study was initially advertised on June 1st 2016 and last updated on September 7th 2022. At this time, there are 144 trials recruiting participants with osteoporosis or postmenopausal conditions, in addition to 76 trials actively looking for denosumab candidates."

Answered by AI

Are there still vacancies open to participants in this trial?

"Data on clinicaltrials.gov demonstrates that this particular trial, which was initially posted in June 2016 and modified in September 2022, is not currently recruiting patients. However, there are 220 additional medical studies seeking participants at the moment."

Answered by AI

Who else is applying?

What state do they live in?
Ohio
How old are they?
18 - 65
What site did they apply to?
UPMC Senior Communities
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Preventing Osteoporosis Using Denosumab
Susan L. Greenspan 2016. "Preventing Osteoporosis Using Denosumab". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02753283.
~23 spots leftby Apr 2025
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