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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.
Must not have
History of Addison disease
Contraindication to, or poorly tolerant of denosumab therapy (including hypersensitivity to the drug)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months post randomization
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial

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.
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.
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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have been diagnosed with Addison's disease.
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I cannot take denosumab due to bad reactions or allergies.
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I haven't had cancer in the last 5 years, except for certain skin cancers or early-stage cervical cancer.
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I cannot tolerate or am allergic to zoledronic therapy.
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My thyroid is overactive and not controlled by medication.
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My kidney function is severely reduced.
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I have been treated with denosumab for over 24 months.
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I cannot take alendronate due to severe side effects or allergy.
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I have a history of soft bones (osteomalacia).
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I have a history of Paget's disease of bone.
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I have had osteonecrosis of the jaw.
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My thyroid condition is not well-managed.
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I have had an unusual fracture in my thigh bone.
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Less than three of my lower back bones can be checked with a special X-ray.
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I have had a solid organ or bone marrow transplant.
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I have a bone condition that affects how my bones break down and rebuild.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
CTX absolute difference V1 vs. V3

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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
1,646 Previous Clinical Trials
2,342,728 Total Patients Enrolled
17 Trials studying Osteoporosis
593,419 Patients Enrolled for Osteoporosis
Vrije Universiteit BrusselOTHER
202 Previous Clinical Trials
264,021 Total Patients Enrolled
Maastricht UniversityOTHER
244 Previous Clinical Trials
13,191,330 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
~1 spots leftby Dec 2024
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