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Monoclonal Antibodies

Denosumab for Osteoporosis

Phase 4

Recruiting

Research Sponsored by Susan L. Greenspan

Eligibility Criteria Checklist

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

Must have

Ambulatory male and female residents with osteoporosis or low bone mass (at risk for fracture) age 65 and older will be considered if: 1) they reside in an institution (nursing home, assisted living facility or senior community) and; 2) they have osteoporosis as diagnosed by a) BMD (spine, hip or forearm BMD T-score ≤ -2.5 SD), b) a previous adult fragility spine or hip fracture, or c) have osteopenia but would be treated based on FRAX and the BHOF treatment thresholds of a 10-year major fracture risk of ≥ 20% or ≥ 3% hip fracture risk using femoral neck BMD.

Be older than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

Study Summary

This trial aims to show that a new medication called Denosumab can help older adults who are weak and frail by improving their muscle health, strength, mobility, and overall function.

Who is the study for?

This trial is for ambulatory men and women aged 65 or older living in institutions like nursing homes, who have osteoporosis or low bone mass at risk of fractures. They must have a diagnosis based on bone density scores, history of certain fractures, or high fracture risk as per specific criteria.Check my eligibility

What is being tested?

The study tests the effectiveness of Denosumab in improving muscle health and strength compared to Zoledronic Acid in frail elderly adults with osteoporosis. It aims to see if Denosumab can help maintain mobility and function.See study design

What are the potential side effects?

Potential side effects may include skin infections around the injection site for Denosumab, low calcium levels, joint pain, general weakness, and rarely jawbone problems. Zoledronic Acid might cause flu-like symptoms, kidney issues, muscle pain, and also rare jawbone complications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 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

Knee extension strength change

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: DenosumabExperimental Treatment1 Intervention

Denosumab 60mg SQ with placebo zoledronic acid

Group II: Zoledronic acidActive Control1 Intervention

Zoledronic acid 5mg IV with Denosumab placebo

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Susan L. GreenspanLead Sponsor

5 Previous Clinical Trials

833 Total Patients Enrolled

5 Trials studying Osteoporosis

833 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.

Is the enrollment for this study currently available to prospective participants?

"Indeed, the information available on clinicaltrials.gov indicates that this study is actively seeking eligible participants. The clinical trial was initially posted on January 15, 2024 and has been recently updated on January 24, 2024. The research team aims to enroll a total of 248 patients at a single designated site."

Answered by AI

What is the overall count of individuals participating in this medical study?

"Indeed, the information retrieved from clinicaltrials.gov confirms that this study is currently accepting candidates for enrollment. The initial posting of the trial took place on January 15th, 2024 and it was most recently updated on January 24th, 2024. A total of 248 patients will be enrolled at a single site."

Answered by AI