Abaloparatide vs. Placebo in Post-Menopausal Women and Abaloparatide in Men Receiving Initial Spinal Fusion Surgery

What this trial studies

This is a prospective randomized, double-blinded, placebo-controlled, phase 2, 12-month pilot to study the efficacy of abaloparatide in postmenopausal women needing lumbar spinal fusion surgery. A total of 72 women with low bone mass who are scheduled to undergo spinal fusion surgery will be randomized 2:1 in a blinded fashion to receive either 80 mcg of abaloparatide subcutaneously (SC) every day or an identical-appearing placebo SC for 6 months. As well as a total of 24 men in an open-label design will be enrolled as an extension to this study. The total anticipated enrollment updated to 97.

Conditions in scope

• Spinal Fusion

Interventions

• Abaloparatide (Drug) — 80 mcg delivered SC by a pen
• Placebo (Drug) — A pen to deliver a SC dose of placebo

Who can join

All sexes · Ages 50 Years and up

Inclusion criteria

• Postmenopausal women (defined as \>12 months since last menstrual cycle) OR men
• Age of 50 years or older
• Requiring posterolateral lumbar spine fusion surgery (L1-2; L2-3; L3-4; L4-5, L5-S1) with single or multi-level fusion for degenerative conditions of the lumbar spine (including lumbar degenerative disk disease, severe instability, high grade spondylolisthesis, deformity, degenerative scoliosis, pseudoarthrosis, and spinal stenosis) under the care of spine surgeons at the Hospital for Special Surgery.

Exclusion criteria

• Hypersensitivity to abaloparatide
• Patients with increased risk of osteosarcoma: Paget's disease, prior radiation therapy
• Patients with active hypercalcemia or current diagnosis of hyperparathyroidism
• History of multiple renal calculi or renal calculus within 2 years
• Unexplained elevations in alkaline phosphatase
• Evidence of metastatic cancer or multiple myeloma.
• Patients unwilling to take placebo or abaloparatide.
• Patients whose surgery is for a revision to a prior lumbar spinal fusion surgery

Eligibility wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.

Where it’s happening

Status & timeline

• Overall status: Active, not recruiting
• Study type: Interventional
• Phase: PHASE2
• Start date: 2019-08-14
• Primary completion: 2027-02
• Last update posted: 2026-04-28
• First posted: 2019-02-15

Sponsor & contact

Lead sponsor: Hospital for Special Surgery, New York (Other)

For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.

Outcome measures

Primary outcomes

• Difference in measure of fusion mass bridging from transverse process to transverse process (one year)
  CT assessment of fusion mass using a qualitative five-point scale to assess fusion quality (1 = unfused, 2 = partial unilateral fusion, 3 = partial bilateral fusion, 4 = complete unilateral fusion, 5 = complete bilateral fusion)
• Difference in incidence of adverse surgical outcomes (one year)
  Adverse outcomes include pedicle screw loosening, adjacent segment fracture and proximal junctional kyphosis will be evaluated on CT images

Related ClearedRx care

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