Abaloparatide for Spinal Fusion

(FAST-Healing Trial)

Overseen By Giavanna D'Erasmo

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Hospital for Special Surgery, New York

Must not be taking: Chronic oral steroids, Forteo, Tymlos, Bisphosphonates

Disqualifiers: Hypersensitivity to abaloparatide, Osteosarcoma risk, Hypercalcemia, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

96 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether abaloparatide, a medication, improves outcomes of spinal fusion surgery in postmenopausal women and men with low bone mass. The researchers aim to determine if this treatment enhances bone healing and reduces pain after surgery. For postmenopausal women, the trial compares abaloparatide to a placebo, while men receive the treatment without comparison. It suits individuals needing lumbar spinal fusion surgery for conditions like degenerative disk disease or spinal stenosis and who are under the care of spine surgeons at the Hospital for Special Surgery. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important medical advancements.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are on chronic oral steroids or have used certain bone medications like Forteo or Tymlos recently, you may not be eligible to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

In a previous study, over 11,000 postmenopausal women in the U.S. received abaloparatide. The research showed that this treatment generally increased bone strength and reduced fracture risk. Most participants tolerated it well. Common side effects included dizziness and nausea, but these were usually mild.

Abaloparatide is already approved for treating another condition, indicating its general safety. However, individual responses vary, so discussing any concerns with a healthcare provider before joining a trial is important. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for spinal fusion?

Researchers are excited about abaloparatide for spinal fusion because it offers a potentially new way to enhance bone healing. Unlike traditional treatments that rely mainly on surgical techniques and bone grafts, abaloparatide is a synthetic peptide that mimics a hormone involved in bone growth. It is administered via a daily injection and works to stimulate bone formation, possibly accelerating the fusion process. This could be particularly beneficial for postmenopausal women and men undergoing spinal fusion surgery, offering a more targeted approach to enhance recovery and improve outcomes.

What evidence suggests that abaloparatide might be an effective treatment for spinal fusion?

Research has shown that abaloparatide can greatly benefit bone health, which is important for successful spinal fusion surgeries. In this trial, some participants will receive abaloparatide, which increases bone mass and potentially leads to better surgical outcomes by providing stronger bone for implant attachment. Low bone mass can result in poor surgical outcomes. Previous studies found that patients taking abaloparatide experienced significant improvements in bone density and reduced fracture risk compared to those on a placebo. These findings suggest that abaloparatide may support bone healing and fusion in patients undergoing spinal surgery. ^{3 6 7 8 9}

Who Is on the Research Team?

Emily Stein, MD

Principal Investigator

Hospital for Special Surgery, New York

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I need spine surgery for a lower back condition.

I have not had a menstrual cycle for over 12 months.

I am 50 years old or older.

Exclusion 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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either 80 mcg of abaloparatide or placebo subcutaneously every day for 6 months

6 months

Follow-up

Participants are monitored for surgical outcomes, pain, and fusion bone mass volume at 6 months and 1 year

6 months to 1 year

Open-label extension (Men)

Men receive open-label treatment with abaloparatide for 6 months

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Abaloparatide
• Placebo
• Spinal Fusion Surgery

Trial Overview 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.

How Is the Trial Designed?

Group I: Abaloparatide (Men) Experimental Treatment 1 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 Control 1 Intervention

Abaloparatide 80 mcg dose administered subcutaneously with a pen once daily for 6 months

Group III: Placebo (PM Women) Placebo Group 1 Intervention

Placebo administered subcutaneously with a pen once daily for 6 months

Abaloparatide is already approved in United States, European Union, Japan for the following indications:

Approved in United States as Tymlos for:

• Osteoporosis in postmenopausal women at high risk of fracture
• Osteoporosis in men at high risk of fracture

Approved in European Union as Eladynos for:

• Osteoporosis in postmenopausal women at increased risk of fracture

Approved in Japan as Tymlos for:

• Osteoporosis in patients at high risk of fracture

Who Is Running the Clinical Trial?

Hospital for Special Surgery, New York

Lead Sponsor

Trials

257

Recruited

61,800+

Published Research Related to This Trial

In a phase 3 study involving 511 postmenopausal women with osteoporosis, the transdermal system for abaloparatide showed clinically meaningful increases in lumbar spine and total hip bone mineral density (BMD) after 12 months, but it did not demonstrate noninferiority compared to the subcutaneous (SC) formulation.

Both treatment methods had similar safety profiles, with the most common adverse events being administration site reactions; however, the transdermal system had a higher incidence of these reactions (94.4% vs. 70.5% for SC).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Transdermal Abaloparatide in Postmenopausal Women with Osteoporosis: A Randomized Study. Lewiecki, EM., Czerwinski, E., Recknor, C., et al.[2023]

Abaloparatide (Tymlos™) is a synthetic peptide that effectively treats postmenopausal osteoporosis by activating the parathyroid hormone type 1 receptor, promoting bone formation and reducing fracture risk.

Approved in the USA in April 2017 for women at high risk of fractures, abaloparatide is also undergoing review in Europe and has a transdermal formulation in development for easier administration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Abaloparatide: First Global Approval. Shirley, M.[2018]

In a 12-month study with osteopenic ovariectomized rats, abaloparatide significantly increased bone mass and density without causing bone resorption or hypercalcemia, indicating its safety and efficacy as a bone anabolic agent.

The treatment led to a 25% increase in whole-body bone mineral density and improved trabecular microarchitecture, demonstrating that abaloparatide selectively stimulates bone formation through the parathyroid hormone receptor signaling pathway.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

One Year of Abaloparatide, a Selective Activator of the PTH1 Receptor, Increased Bone Formation and Bone Mass in Osteopenic Ovariectomized Rats Without Increasing Bone Resorption. Varela, A., Chouinard, L., Lesage, E., et al.[2018]

In an 18-month phase 3 study, abaloparatide significantly increased bone mineral density (BMD) in postmenopausal women with osteoporosis, showing greater improvements compared to both placebo and teriparatide.

At 18 months, 44.5% of patients treated with abaloparatide experienced over a 3% increase in BMD, compared to only 1.9% for placebo and 32.0% for teriparatide, indicating its superior efficacy in enhancing bone health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bone mineral density response rates are greater in patients treated with abaloparatide compared with those treated with placebo or teriparatide: Results from the ACTIVE phase 3 trial. Miller, PD., Hattersley, G., Lau, E., et al.[2020]

In the Phase 3 ACTIVE trial, abaloparatide-SC significantly reduced new vertebral fractures by 86% and nonvertebral fractures by 43% in postmenopausal women with osteoporosis, demonstrating its efficacy in fracture prevention.

Abaloparatide-SC also increased bone mineral density at key sites (3.4% at the hip, 2.9% at the femoral neck, and 9.2% at the lumbar spine) after 18 months, and its protective effects against fractures were consistent across various baseline risk factors, making it a suitable treatment for a broad range of patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Abaloparatide-SC on Fractures and Bone Mineral Density in Subgroups of Postmenopausal Women With Osteoporosis and Varying Baseline Risk Factors. Cosman, F., Hattersley, G., Hu, MY., et al.[2018]

In a study involving 32 New Zealand rabbits, a single dose of pamidronate (PA) administered at the time of spinal fusion surgery resulted in a higher spinal fusion rate (50%) compared to the control group (25%), although this difference was not statistically significant (p = 0.137).

The findings suggest that while pamidronate did not negatively impact spinal fusion rates, its effect on enhancing fusion rates remains inconclusive, indicating the need for further research to clarify its role in spinal fusion procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of a single dose of pamidronate administered at the time of surgery in a rabbit posterolateral spinal fusion model. Urrutia, J., Briceno, J., Carmona, M., et al.[2021]

In a study involving 676 patients from eight randomized clinical trials and three prospective studies, teriparatide combined with Denosumab significantly increased the fusion rate in spinal surgery compared to placebo and bisphosphonate treatments.

This network meta-analysis suggests that teriparatide is a promising option for enhancing spinal fusion outcomes, highlighting its potential effectiveness in peri-operative care for patients undergoing thoracic and lumbar spine surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of teriparatide and bisphosphonate on spinal fusion procedure: A systematic review and network meta-analysis. Cheng, SH., Kuo, YJ., Chen, C., et al.[2020]

Abaloparatide, a selective activator of the parathyroid hormone receptor 1, significantly improved bone mass and strength in osteopenic ovariectomized rats over a 12-month treatment period, with dose-dependent effects observed at various skeletal sites.

The study found that increases in bone mass were correlated with enhanced bone strength and quality, indicating that abaloparatide not only increases bone density but also improves the structural integrity of bones.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

One year of abaloparatide, a selective peptide activator of the PTH1 receptor, increased bone mass and strength in ovariectomized rats. Varela, A., Chouinard, L., Lesage, E., et al.[2017]

In the ACTIVE-J trial, daily subcutaneous injections of 80 μg abaloparatide significantly increased bone mineral density and improved hip geometry in Japanese patients with osteoporosis at high fracture risk, with 128 participants receiving abaloparatide and 65 receiving placebo over 78 weeks.

Abaloparatide treatment led to notable improvements in various hip structural analysis parameters, including increased cortical thickness and cross-sectional area, and a decrease in the buckling ratio, indicating enhanced biomechanical properties compared to placebo.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of abaloparatide on hip geometry and biomechanical properties in Japanese osteoporotic patients assessed using DXA-based hip structural analysis: results of the Japanese phase 3 ACTIVE-J trial. Sone, T., Ohnaru, K., Sugai, T., et al.[2023]

In a study involving 67 patients with osteoporosis undergoing spinal fusion, teriparatide (TPTD) therapy significantly improved bone mineral density (BMD) and bone formation markers compared to zoledronic acid (ZOL) after 12 months.

TPTD also demonstrated a higher spinal fusion rate at 12 months (86%) compared to ZOL (70%), indicating its greater efficacy in promoting bone healing in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effect of Daily Teriparatide versus One-Time Annually Zoledronic Acid Administration After Transforaminal Lumbar Interbody Fusion in Osteoporotic Patients. Wang, Z., Zhuang, C., Chen, W., et al.[2022]

In a study of 77 postmenopausal women with osteoporosis undergoing spinal fusion, teriparatide led to a higher rate of bone union at 6 months compared to zoledronate, indicating its potential effectiveness in enhancing early recovery after surgery.

Both teriparatide and zoledronate improved bone mineral density (BMD) over 2 years, but teriparatide showed greater BMD increases at 12 months and resulted in lower disability scores, suggesting it may offer additional benefits in functional recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Teriparatide Versus Zoledronate on Posterior Lumbar Interbody Fusion in Postmenopausal Women with Osteoporosis. Xiong, Y., Li, L., Liu, P., et al.[2023]

Abaloparatide is a synthetic peptide approved for treating postmenopausal women with osteoporosis, showing strong anabolic effects that help increase bone density and reduce fracture risk.

Clinical trials indicate that abaloparatide significantly lowers the risk of both vertebral and nonvertebral fractures while improving bone mineral density in key areas like the femoral neck and lumbar spine.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Abaloparatide for the treatment of postmenopausal osteoporosis. Pietrogrande, L., Raimondo, E.[2018]

Osteoporotic patients treated with teriparatide showed significantly lower rates of reoperation (11.5% vs. 23.1%) and pseudarthrosis (6.4% vs. 21.8%) compared to osteopenic patients after 2 years of spinal fusion surgery, indicating teriparatide's efficacy in improving surgical outcomes.

When compared to patients with normal bone mineral density, those on teriparatide had similar rates of reoperation and pseudarthrosis, suggesting that teriparatide can help osteoporotic patients achieve outcomes comparable to those with healthier bones.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of Teriparatide on Complications and Patient-Reported Outcomes of Patients Undergoing Long Spinal Fusion According to Bone Density. Mohanty, S., Sardar, ZM., Hassan, FM., et al.[2023]

Citations

1. centerwatch.com centerwatch.com/clinical-trials/listings/NCT03841058/abaloparatide-vs-placebo-in-post-menopausal-women-and-abaloparatide-in-men-receiving-initial-spinal-fusion-surgery

Abaloparatide vs. Placebo in Post-Menopausal Women ... This is a prospective randomized, double-blinded, placebo-controlled, phase 2, 12-month pilot to study the efficacy of abaloparatide in postmenopausal women.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7334019/

Abaloparatide and the Spine: A Narrative Review - PMC Osteoporosis plays a significant role in outcomes of spine surgery as successful spinal fusion requires adequate bone stock for implant fixation ...

3. cdek.pharmacy.purdue.edu cdek.pharmacy.purdue.edu/trial/NCT03841058/

Trial | NCT03841058 This is a prospective randomized, double-blinded, placebo-controlled, phase 2, 12-month pilot to study the efficacy of abaloparatide in postmenopausal women ...

4. jamanetwork.com jamanetwork.com/journals/jama/fullarticle/2544640

Effect of Abaloparatide vs Placebo on New Vertebral ... This randomized clinical trial compares the effects of subcutaneous abaloparatide vs placebo on risk of new vertebral and nonvertebral ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7984001/

Effects of systemically administered abaloparatide, an ... These results indicate a substantial effect of abaloparatide on vertebral bone mass that may be relevant to patients undergoing spinal fusion. Abaloparatide‐ ...

6. tymlos.com tymlos.com/hcp/

TYMLOS (abaloparatide) Injection Mechanism of Action TYMLOS is self-administered and requires no refrigeration after first use. · See how TYMLOS performed in clinical trials. Review Efficacy and Safety Data >.

7. ema.europa.eu ema.europa.eu/en/documents/assessment-report/eladynos-epar-refusal-public-assessment-report_en.pdf

Assessment report - Eladynos - European Medicines Agency ... BA058-05-. 003. Data from extension study BA058-05-005 only derives safety data after abaloparatide discontinuation since all patients ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S0014299921005628

Abaloparatide: A review of preclinical and clinical studies Mounting evidence from preclinical and clinical studies has uniformly reported that abaloparatide increases bone mineral density and reduces fracture risk.

9. tga.gov.au tga.gov.au/sites/default/files/2025-03/auspar-eladynos-250218.pdf

Australian public assessment report for Eladynos The retrospective observational study BA058-05-028 provided safety data from 11,027 postmenopausal women exposed to abaloparatide in the US. The ...