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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 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.
Select...
My bone density is low, or I've had a fracture due to weak bones.
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
1,581 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
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.
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
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