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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
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 belowSelect...
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:Select...
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.
Select...
My thyroid is overactive and not controlled by medication.
Select...
My kidney function is severely reduced.
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I have been treated with denosumab for over 24 months.
Select...
I cannot take alendronate due to severe side effects or allergy.
Select...
I have a history of soft bones (osteomalacia).
Select...
I have a history of Paget's disease of bone.
Select...
I have had osteonecrosis of the jaw.
Select...
My thyroid condition is not well-managed.
Select...
I have had an unusual fracture in my thigh bone.
Select...
Less than three of my lower back bones can be checked with a special X-ray.
Select...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months post randomization
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months post randomization
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
1,599 Previous Clinical Trials
2,287,875 Total Patients Enrolled
17 Trials studying Osteoporosis
583,643 Patients Enrolled for Osteoporosis
Vrije Universiteit BrusselOTHER
193 Previous Clinical Trials
263,626 Total Patients Enrolled
Maastricht UniversityOTHER
239 Previous Clinical Trials
13,181,111 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with Addison's disease.I cannot take denosumab due to bad reactions or allergies.I haven't had cancer in the last 5 years, except for certain skin cancers or early-stage cervical cancer.I cannot tolerate or am allergic to zoledronic therapy.You have a history of anorexia nervosa, bulimia, or obvious malnutrition.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.Your liver tests show high levels of certain chemicals.Your blood test shows low levels of vitamin D.My thyroid is overactive and not controlled by medication.I plan to have dental surgery or implants within the next 2 years.My kidney function is severely reduced.My bone density is low, or I've had a fracture due to weak bones.I have been treated with denosumab for over 24 months.I am 18 or older and can give my consent.I cannot take alendronate due to severe side effects or allergy.I have a history of soft bones (osteomalacia).I have a history of Paget's disease of bone.I have had osteonecrosis of the jaw.My thyroid condition is not well-managed.Your calcium levels are significantly lower than the normal range.Your calcium levels are more than 10% higher than the normal range.I plan to try for a child within the next year.I have taken bisphosphonates in the last 2 years.I have had an unusual fracture in my thigh bone.You can't take calcium or vitamin D supplements.Less than three of my lower back bones can be checked with a special X-ray.I have had dental surgery, including tooth extraction or implants, in the last 6 months.I have had a solid organ or bone marrow transplant.I have a bone condition that affects how my bones break down and rebuild.
Research Study Groups:
This trial has the following groups:- Group 1: DMAB to "Early" Zoledronic Acid (ZA)
- Group 2: Denosumab (DMAB) to Alendronate (ALN)
- Group 3: DMAB to "Late" ZA
Awards:
This trial has 3 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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