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Osteoporosis Agent
Abaloparatide for Spinal Fusion
Phase 2
Recruiting
Led By Emily Stein, MD
Research Sponsored by Hospital for Special Surgery, New York
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one year
Awards & highlights
Study Summary
This trial is studying whether a medication can improve surgical outcomes, pain, and bone mass in postmenopausal women who need lumbar spinal fusion surgery.
Who is the study for?
This trial is for postmenopausal women over 50 needing lumbar spinal fusion surgery, with low bone mass and specific degenerative conditions. Excluded are those unwilling to take placebo or abaloparatide, unable to consent, with recent kidney stones, prior lumbar surgery revisions, bisphosphonate treatment history, hypersensitivity to abaloparatide, risk of osteosarcoma, smokers, certain medical conditions like hypercalcemia or chronic steroid use.Check my eligibility
What is being tested?
The study tests if abaloparatide can improve surgical outcomes in these women compared to a placebo. Participants will be randomly assigned in a 2:1 ratio to receive either the drug or placebo daily for six months. The main measures are pain relief and bone mass volume at the fusion site after six months and one year.See study design
What are the potential side effects?
Potential side effects of abaloparatide include increased risk of kidney stones; reactions at the injection site; elevated calcium levels leading to muscle weakness or confusion; dizziness; nausea; headache; palpitations due to rapid heart rate.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ one year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Difference in incidence of adverse surgical outcomes
Difference in measure of fusion mass bridging from transverse process to transverse process
Secondary outcome measures
Pain assessed by the Numeric Rating Scale
Pain assessed by the Oswestry Disability Index
Other outcome measures
CT evaluation of Fusion bone mass volume
Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: AbaloparatideActive Control1 Intervention
Abaloparatide 80 mcg dose administered subcutaneously with a pen once daily for 6 months
Group II: PlaceboPlacebo Group1 Intervention
Placebo administered subcutaneously with a pen once daily for 6 months
Find a Location
Who is running the clinical trial?
Hospital for Special Surgery, New YorkLead Sponsor
243 Previous Clinical Trials
59,258 Total Patients Enrolled
Emily Stein, MDPrincipal InvestigatorHospital for Special Surgery, New York
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have high calcium levels or an active parathyroid disorder.My cancer has spread to other parts of my body or I have multiple myeloma.I have had kidney stones multiple times or within the last 2 years.I am willing to take either a placebo or abaloparatide.I have used Forteo or Tymlos for more than a year or within the last 6 months.I need spine surgery for a lower back condition.I have Paget's disease or have had radiation therapy, increasing my risk of bone cancer.I have been taking oral steroids daily for over a month for an inflammatory condition.I am able to understand and sign the informed consent.I have been treated with bisphosphonates for over a year in the last 5 years.I have not had a menstrual cycle for over 12 months.I am 50 years old or older.I am having surgery to correct a previous lower back fusion surgery.
Research Study Groups:
This trial has the following groups:- Group 1: Abaloparatide
- Group 2: Placebo
Awards:
This trial has 0 awards, including: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.
What other research has there been on Abaloparatide?
"At the moment, there are 7 research studies being conducted on Abaloparatide with 0 of them in Phase 3. Although most trials for Abaloparatide take place in Madison, Wisconsin, 11 different locations are running these tests."
Answered by AI
Has the US Food and Drug Administration cleared Abaloparatide for use?
"Abaloparatide's safety is rated at a 2 because, while there is some evidence backing its safety, none of the clinical data collected thus far supports efficacy."
Answered by AI
Are new participants still being welcomed into this research project?
"The study, which is currently recruiting patients, was initially posted on 8/14/2019. The listing was last updated on 3/29/2022 according to data from clinicaltrials.gov"
Answered by AI
How many human test subjects are a part of this clinical trial?
"That is correct, the online information indicates that this trial is still actively looking for subjects. The listing appeared on 8/14/2019 and was edited as recently as 3/29/2022. Currently, 72 individuals are needed to enroll at a single site."
Answered by AI
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