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Monoclonal Antibodies

Denosumab Switch for Osteoporosis

Phase 4
Waitlist Available
Research Sponsored by University of Alabama at Birmingham
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
≥ 3 months of glucocorticoid use at > 7.5 mg /day (prednisone equivalent dose) and anticipated to remain on glucocorticoids for at least six months
A baseline BMD T-score of ≤ -2.0 at the lumbar spine, total hip, or femoral neck; OR A BMD T-score ≤ -1.0 at the lumbar spine, total hip, or femoral neck and a history of an osteoporotic fracture.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months post randomization
Awards & highlights

Study Summary

This trial is testing whether switching from one medication to another will help people who are taking glucocorticoids and have increased bone turnover markers.

Who is the study for?
This trial is for men and women aged 18 or older who have been using glucocorticoids at a certain dose for over 3 months and will continue for at least another six. They must have osteoporosis as shown by bone density scores, or a history of fractures with less severe bone loss. Exclusions include various other bone diseases, recent cancer, dental issues, malnutrition disorders, pregnancy/breastfeeding without contraception use, and intolerance to study drugs.Check my eligibility
What is being tested?
The study tests if switching from Denosumab (DMAB) to 'late' zoledronic acid (9 months after last DMAB dose) versus 'early' zoledronic acid (6 months after last DMAB dose) or weekly alendronate affects bone turnover markers in patients on long-term steroids differently.See study design
What are the potential side effects?
Potential side effects may include reactions related to the immune system's response to the drug infusion process; changes in blood calcium levels; jawbone problems; unusual thigh bone fractures; gastrointestinal issues due to oral bisphosphonates like alendronate; and general discomfort.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been taking a steroid medication equivalent to more than 7.5 mg of prednisone daily for over 3 months and will continue for at least 6 months.
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My bone density is low, or I've had a fracture due to weak bones.
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I am 18 or older and can give my consent.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months post randomization
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months post randomization for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
CTX absolute difference V1 vs. V3

Trial Design

3Treatment groups
Active Control
Group I: DMAB to "Early" Zoledronic Acid (ZA)Active Control1 Intervention
Switch from Denosumab 60 mg administered subcutaneously (SC) to one "early" zoledronic acid infusion (5 mg; 6 months after last denosumab dose)
Group II: Denosumab (DMAB) to Alendronate (ALN)Active Control1 Intervention
Switch from Denosumab 60 mg administered subcutaneously (SC) to weekly oral alendronate (70 mg; started 6 months after last denosumab dose)
Group III: DMAB to "Late" ZAActive Control1 Intervention
Switch from Denosumab 60 mg administered subcutaneously (SC) to one "late" zoledronic acid infusion (5 mg; 9 months after last denosumab dose)

Find a Location

Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor
1,581 Previous Clinical Trials
2,277,984 Total Patients Enrolled
16 Trials studying Osteoporosis
581,009 Patients Enrolled for Osteoporosis
Vrije Universiteit BrusselOTHER
186 Previous Clinical Trials
259,437 Total Patients Enrolled
Maastricht UniversityOTHER
232 Previous Clinical Trials
13,180,183 Total Patients Enrolled

Media Library

Denosumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04177940 — Phase 4
Osteoporosis Research Study Groups: DMAB to "Early" Zoledronic Acid (ZA), Denosumab (DMAB) to Alendronate (ALN), DMAB to "Late" ZA
Osteoporosis Clinical Trial 2023: Denosumab Highlights & Side Effects. Trial Name: NCT04177940 — Phase 4
Denosumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04177940 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this medical experiment currently assembling new participants?

"This clinical trial, which was first advertised on August 17th 2020, is currently accepting enrolment applications. The listing has been updated as recently as December 3rd 2021 according to the data available online."

Answered by AI

What is the scope of this research endeavor in terms of participant numbers?

"Affirmative. Clinicaltrials.gov records show that this clinical trial is actively searching for participants, with its initial post on August 17th 2020 and a recent edit on December 3rd 2021. 45 patients will be accepted from 1 medical centre."

Answered by AI

Has the FDA approved a comparison between Denosumab and Alendronate?

"Due to this being a phase 4 trial, which implies FDA approval for the treatment, Denosumab (DMAB)'s safety when compared to Alendronate (ALN) has been rated as a 3."

Answered by AI
~7 spots leftby Dec 2024