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Osteoporosis Agent
Abaloparatide for Spinal Fusion (FAST-Healing Trial)
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
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.
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.
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Difference in incidence of adverse surgical outcomes
Difference in measure of fusion mass bridging from transverse process to transverse process
Secondary study objectives
Pain assessed by the Numeric Rating Scale
Pain assessed by the Oswestry Disability Index
Other study objectives
CT evaluation of Fusion bone mass volume
Side effects data
From 2021 Phase 3 trial • 228 Patients • NCT0351226213%
Injection site erythema
9%
Nasopharyngitis
9%
Dizziness
7%
Injection site swelling
7%
Arthralgia
6%
Injection site pain
5%
Headache
5%
Back pain
5%
Bronchitis
5%
Upper respiratory tract infection
5%
Hypertension
4%
Sinusitis
1%
Peripheral nerve palsy
1%
Influenza
1%
Chronic obstructive pulmonary disease
1%
Cerebrovascular accident
1%
Supraventricular tachycardia
1%
Lung adenocarcinoma
1%
Angina unstable
1%
Small intestinal obstruction
1%
Toxicity to various agents
1%
Appendicitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Abaloparatide
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Abaloparatide (Men)Experimental Treatment1 Intervention
Open-label treatment with Abaloparatide 80 mcg dose administered subcutaneously with a pen once daily for 6 months
Group II: Abaloparatide (PM Women)Active Control1 Intervention
Abaloparatide 80 mcg dose administered subcutaneously with a pen once daily for 6 months
Group III: Placebo (PM Women)Placebo Group1 Intervention
Placebo administered subcutaneously with a pen once daily for 6 months
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Abaloparatide
2021
Completed Phase 3
~22310
Find a Location
Who is running the clinical trial?
Hospital for Special Surgery, New YorkLead Sponsor
250 Previous Clinical Trials
61,240 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 (PM Women)
- Group 2: Placebo (PM Women)
- Group 3: Abaloparatide (Men)
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.
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