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Osteoporosis Agent
Abaloparatide for Osteoporosis in Knee Replacement
Phase 4
Waitlist Available
Led By Neil Binkley, MD
Research Sponsored by University of Wisconsin, Madison
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Post-menopausal women and men age ≥ 55 years scheduled to undergo primary TKA at the University of Wisconsin Total Joint Program
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 18 months
Awards & highlights
Study Summary
This trial will test if a medication can prevent bone loss in people with osteoporosis who are getting surgery for a knee replacement.
Who is the study for?
This trial is for post-menopausal women and men aged 55 or older with osteoporosis, scheduled for knee replacement surgery at the University of Wisconsin. They must have normal blood tests, take daily calcium and vitamin D3, and not have had certain treatments affecting bone metabolism. People with chronic diseases or a history of cancer (except some skin cancers) in the past five years are excluded.Check my eligibility
What is being tested?
The study is testing whether abaloparatide treatment before and after total knee arthroplasty can reduce bone loss in osteoporotic patients. Participants will receive this medication alongside their surgical care to see if it improves outcomes.See study design
What are the potential side effects?
While specific side effects aren't listed here, common ones associated with similar medications include nausea, dizziness, headache, increased heart rate, fatigue, and injection site reactions such as redness or pain.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a post-menopausal woman or a man aged 55 or older planning to have a knee replacement at the University of Wisconsin.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 18 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~18 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Distal femoral Bone mineral density (BMD) at the 25% regions of interest (ROIs)
Secondary outcome measures
Change in Distal femoral BMD at the 15% and 60 %ROI
Change in Femur cortical thickness at the 15%, 25% and 60% femur ROIs
Change in Veterans RAND 12 (VR-12) Question Health Survey score
+9 moreTrial Design
2Treatment groups
Active Control
Group I: Comparator groupActive Control1 Intervention
Those with clinical osteopenia who receive no treatment.
Group II: Treatment groupActive Control1 Intervention
Those with clinical osteoporosis who elect ABL treatment.
ABL therapy will begin 3 months pre-TKA and continue for a total of 18 months. ABL will be administered by injection pen with dose of 80 mcg SC qDay.
Find a Location
Who is running the clinical trial?
Radius Health, Inc.Industry Sponsor
14 Previous Clinical Trials
21,115 Total Patients Enrolled
11 Trials studying Osteoporosis
20,964 Patients Enrolled for Osteoporosis
University of Wisconsin, MadisonLead Sponsor
1,182 Previous Clinical Trials
3,167,329 Total Patients Enrolled
7 Trials studying Osteoporosis
434 Patients Enrolled for Osteoporosis
Neil Binkley, MDPrincipal InvestigatorUniversity of Wisconsin, Madison
8 Previous Clinical Trials
445 Total Patients Enrolled
1 Trials studying Osteoporosis
26 Patients Enrolled for Osteoporosis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had cancer in the last 5 years, except for skin cancer.I am willing to take daily calcium and vitamin D3 as directed.I haven't had hormone or absorption disorders in the past year.I am not currently taking anabolic steroids or calcineurin inhibitors.I have not taken IV bisphosphonates before or oral bisphosphonates in the last 3 years, except for a short course over 6 months ago.You have been diagnosed with Hepatitis B, Hepatitis C, HIV-1, or HIV-2.I am a post-menopausal woman or a man aged 55 or older planning to have a knee replacement at the University of Wisconsin.I have osteoporosis or osteopenia based on bone density tests or a history of certain fractures.I haven't taken calcitonin in the last 6 months or denosumab in the last 18 months.Your blood tests for calcium, creatinine, and parathyroid levels are all normal, and your vitamin D levels are above 10 ng/mL.I have previously been treated with drugs derived from PTH or PTHrP.You are allergic to any of the test materials or similar substances.I have a bone condition that is not osteoporosis.I have had osteosarcoma in the past.You have a history of ongoing or repeat health problems in your kidneys, liver, lungs, allergies, heart, stomach, hormones, brain, blood, or metabolism, or immune system, emotions, or mental health issues that could affect the study results.My kidney function is not significantly impaired.I haven't taken medications like phenobarbital or heparin in the last 6 months.I have not used fluoride, strontium, or experimental bone treatments in the last 5 years.I have been taking steroids daily for the past year.It's hard to measure the bone density in your lower leg because of metal implants or other things in the way.I have had radiation therapy on my bones, not including radioiodine treatment.I have had kidney or bladder stones in the last 5 years.You drink more than 2 alcoholic drinks every day or use illegal drugs within the last year.
Research Study Groups:
This trial has the following groups:- Group 1: Comparator group
- Group 2: Treatment group
Awards:
This trial has 3 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- 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.
Are there presently any opportunities to enroll in this research project?
"As indicated on clinicaltrials.gov, this medicinal experiment is actively recruiting potential participants. The initial posting was published January 10th of 2020 and the data was most recently updated April 7th 2022."
Answered by AI
Are there any analogous investigations into Treatment group's efficacy?
"Currently, 7 trials are underway to investigate the efficacy of Treatment group. None of these studies have entered Phase 3 yet. Most of them are located in New york City but there 11 sites conducting research on this treatment altogether."
Answered by AI
What level of security does the Treatment group provide to individuals?
"Our safety assessment of the treatment group assigns it a score of 3, indicating that this therapy has already been authorized for release."
Answered by AI
How many individuals are authorized to participate in this research program?
"Affirmative, the information available on clinicaltrials.gov implies that this investigation is presently looking for participants. It was initally advertised on January 10th 2020 and has since been revised on April 7th 2022. 58 individuals need to be recruited from 1 site."
Answered by AI
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