Abaloparatide for Osteoporosis
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a treatment called abaloparatide, a medication for osteoporosis, to determine if it can improve bone density in individuals with osteoporosis who require back surgery for lumbar degenerative disease. Researchers aim to discover whether abaloparatide can strengthen bones and reduce surgery-related issues, such as adjacent segment disease and other complications. Individuals with osteoporosis, who have experienced certain fractures and are scheduled for specific back surgeries, might be suitable candidates for this trial. Participants will receive training to self-administer the treatment and will undergo regular follow-up checks for up to two years post-surgery to monitor progress. As a Phase 2 trial, this research focuses on evaluating the treatment's effectiveness in an initial, smaller group of participants.
Do I need to stop my current medications for the trial?
The trial information does not specify if you need to stop taking your current medications. However, if you are on thyroid hormone replacement, you must have been taking it for at least 6 months before starting the trial.
Is there any evidence suggesting that abaloparatide is likely to be safe for humans?
Research has shown that abaloparatide is generally safe for treating osteoporosis. Studies have found that it can reduce the risk of spine fractures by up to 86% and other bone fractures by 43%. Some patients using abaloparatide have experienced side effects such as severe redness, swelling, and pain at the injection site, occurring in 2.9%, 0.4%, and 0.4% of patients, respectively. There is also a small risk of elevated calcium levels in the blood.
Abaloparatide is similar to another osteoporosis drug, teriparatide, which is already approved. However, a warning exists about a potential increased risk of osteosarcoma, a type of bone cancer, particularly in individuals who have undergone radiation treatment. Despite these risks, many patients tolerate the medication well, and it provides significant benefits in preventing bone fractures.12345Why do researchers think this study treatment might be promising for osteoporosis?
Unlike the standard treatments for osteoporosis, which often include bisphosphonates or hormone-related therapies, abaloparatide offers a unique approach. Abaloparatide is a synthetic peptide that mimics parathyroid hormone-related protein, stimulating new bone formation and increasing bone density. Researchers are excited because it has the potential to rapidly improve bone strength, specifically in patients who are undergoing spinal fusion and decompression. This could lead to better surgical outcomes and quicker recovery times, making it a promising option for those with lumbar degenerative disease.
What evidence suggests that abaloparatide might be an effective treatment for osteoporosis?
Research has shown that abaloparatide effectively treats osteoporosis by lowering fracture risk. One study found that it reduced the risk of new spine fractures by 88% compared to a placebo. It also significantly increased bone mineral density (BMD), a measure of bone strength, more than some other treatments. Abaloparatide protects against both spine and other types of fractures, making it a promising option for osteoporosis. Additionally, it proved more effective than teriparatide in reducing certain types of fractures. These findings suggest that abaloparatide could improve bone health and reduce fracture risks in patients undergoing spinal fusion and decompression.14678
Are You a Good Fit for This Trial?
This trial is for adults with osteoporosis who are scheduled to have spinal fusion and decompression surgery for lumbar degenerative disc disease. Participants should be able to use injectable medication and attend follow-up visits.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Pre-surgical Assessment
Participants undergo baseline assessments including lumbar MRI, DEXA scan, and lumbar CT, and are trained on the subcutaneous application of abaloparatide
Treatment
Participants self-administer abaloparatide for 3-6 months
Follow-up
Participants return to clinic for follow-up assessments including a new MRI, lumbar CT, and DEXA scan
Long-term Follow-up
Participants are monitored for up to 2 years postoperatively to identify complications such as adjacent segment disease, pseudarthrosis, failure of instrumentation, and PJK
What Are the Treatments Tested in This Trial?
Interventions
- Abaloparatide
Trial Overview
The study tests whether the osteoporosis drug abaloparatide, given by injection after spine surgery, improves bone quality and reduces complications compared to standard assessments. Patients receive abaloparatide for 3-6 months and are monitored up to 2 years.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
3-6 months of self-administered abaloparatide in osteoporotic patients will undergo spinal fusion and decompression for lumbar degenerative disease
Find a Clinic Near You
Who Is Running the Clinical Trial?
State University of New York at Buffalo
Lead Sponsor
Citations
The Efficacy and Safety of Abaloparatide in Osteoporosis - PMC
Abaloparatide reduced vertebral fractures (RR 0.13–0.21) and showed moderate reductions in non-vertebral fractures. Lumbar spine BMD increased ...
Comparative Effectiveness of Abaloparatide and ...
There were significantly lower rates of hip and nonvertebral fractures with abaloparatide compared to teriparatide, which were consistent across subgroups.
Effect of abaloparatide on fracture incidence and bone ...
New vertebral fracture risk was reduced in participants receiving abaloparatide (4 [0.72%]) and teriparatide (6 [0.99%]) versus placebo (28 [ ...
Efficacy and Safety of Transdermal Abaloparatide in ...
A recent real‐world study found only 16.8% of patients designated as very high risk for fracture received osteoporosis treatment, and of those who received ...
5.
rheumatologyadvisor.com
rheumatologyadvisor.com/news/abaloparatide-significantly-reduces-fracture-risk-in-women-with-postmenopausal-osteoporosis/Abaloparatide Significantly Reduces Fracture Risk in ...
Treatment with abaloparatide reduces the risk for vertebral, nonvertebral, and wrist fractures in postmenopausal women with osteoporosis ...
TYMLOS (abaloparatide) injection Label - accessdata.fda.gov
Severe redness, severe edema, and severe pain were reported among 2.9%, 0.4%, and 0.4% of the TYMLOS-treated patients. Laboratory Abnormalities. Hypercalcemia.
Abaloparatide - StatPearls - NCBI Bookshelf - NIH
In the ACTIVE trial, 86% relative risk reduction (RRR) in new vertebral fractures and 43% RRR in nonvertebral fractures were observed.[5] The ...
The Safety and Efficacy of Abaloparatide on ...
Abaloparatide has a protective effect on women with postmenopausal osteoporosis. It could reduce their risk for vertebral fracture; increase ...
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