Effect of Abaloparatide on Lumbar Disc Degeneration

• Status: Withdrawn
• Trial end date: 2024-02-01
• Target enrollment: 0
• Participant gender: All

Summary

Low back pain is a major public health issue as the leading cause of disability globally. Degeneration of intervertebral disc (IVD) disorder is once source of low back pain. Current treatment options for low back pain secondary to degeneration of intervertebral disc include conservative care, steroid injections, prescription pain medications, physical therapy, or surgery, such as discectomy or laminectomy. Treatments focus on addressing manifested symptoms rather than functional causes, and symptomatic treatment of discogenic low back pain is less than ideal. The investigators have recently found that parathyroid hormone (PTH) effectively attenuates disc degeneration in aged mice. This clinical trial will test if 3-months of daily PTH-related protein (PTHrP), abaloparatide will improve pain, function, and disc health in people with low back pain secondary to lumbar disc degeneration.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johns Hopkins University
• Treatments: Abaloparatide

Criteria

Inclusion Criteria:

• Symptomatic moderate to severe discogenic low back pain as defined by centralized chronic low back pain with a discogenic character (i.e. increases with activity, worsened with sitting or standing, or requires frequent change of positions) and has been present for 6+ months

• Identifiable change in disc morphology as defined by MRI consistent with early degenerative disc disease as defined by both Modified Pfirrmann (MRI) score of 2-3 (Graded 1-8, where 1= hydrated healthy disc, 8 = dark, dehydrated disc) and Modic Grade II change or less

• Single- or two-level DDD at lumbar spine

• < 30% vertebral body height loss

• Oswestry disability index score > 30

• Failed > 3 months of appropriate non-operative care (i.e. pain medication, local drug injections, physical therapy)

• Predominant back pain with or without leg pain

• Able and willing to comply with follow-up schedule

• Willing to give written informed consent

Exclusion Criteria:

• Presence of objective motor deficit

• Symptomatic compressive pathology due to stenosis or disc herniation

• Any spondylolisthesis

• Any spondylolysis

• Scoliosis > 20 degrees

• Spinal tumor

• Previous thoracic or lumbar fusion

• Current or prior fracture at T10-S1

• Arachnoiditis

• Current or prior use of PTHrP (abaloparatide) or PTH (teriparatide) analog

• Diagnosis of osteoporosis or osteopenia that is not well controlled on anti-resorptive therapy and anticipated to require use of an anabolic agent, such as abaloparatide or teriparatide.

• Evidence of metabolic bone disease as evidenced by abnormalities in calcium, intact parathyroid hormone, phosphorus or alkaline phosphatase in blood or elevated spot urine calcium to creatinine ratio.

• History of or current osteosarcoma or cancer metastatic to the bone

• History of or current Paget's disease of bone

• History of or current nephrolithiasis

• History of or current multiple myeloma

• History of focal radiation to any bone

• Current Pregnancy or breastfeeding

• Current use of medications that increase risk of hypercalcemia, such as thiazide diuretics

• Diagnosis of psychotic disorder

• Participation in another study on investigational drug

• Inability to provide informed consent