Use of Forteo (Teriparatide) in Posterolateral Lumbar Spine Fusion
Condition: Lumbar Spondylosis; Lumbar Spondylolisthesis; Adult Degenerative Lumbar Scoliosis
MeSH terms: Scoliosis; Spondylolisthesis; Spondylosis
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine the effects of 12 weeks of daily treatment with
      teriparatide on spine fusion in adult patients who are undergoing multi-level posterolateral
      spine fusion surgery for degenerative conditions of the lumbar spine.
    

Detailed description: 
      For patients undergoing spine fusion surgery, non-fusion (or pseudarthrosis) is one of the
      major complications that can lead to poor clinical outcomes. Therefore, treatments that
      promote or augment fusion are highly desirable. Teriparatide (Forteo, recombinant human
      parathyroid hormone [1-34]) is a systemically administered peptide hormone that is
      FDA-approved for the treatment of osteoporosis in postmenopausal women or other populations
      at high risk for fracture. While teriparatide has been shown to enhance spinal fusion in
      several rodent and rabbit studies, no clinical studies to date have examined its effect on
      spinal fusion in humans. While Forteo is FDA approved, and IND is required for this trial to
      study an unapproved indication: Posterolateral Lumbar Spine Fusion.

      This single-site two-year prospective randomized double-blind placebo-controlled study is
      designed to examine the effects of peri-operative teriparatide treatment in older adults
      undergoing multi-level posterolateral lumbar spine fusion. All eligible patients seen at the
      UCSF Spine Center will be invited to enroll in the study. Upon enrollment, patients will have
      screening labs drawn in conjunction with their routine pre-operative work-up, to include
      complete blood count (CBC), chemistry panel including calcium level, liver function tests
      (LFTs) including alkaline phosphatase, parathyroid hormone (PTH) level, and 25-hydroxyvitamin
      D level. If eligible after screening labs are completed, they will be scheduled for bone
      density (DEXA) scan and be randomized in a 2:1 ratio to receive daily subcutaneous injections
      of teriparatide 20 ug/d or placebo. The total duration of treatment will be 12 weeks, with
      two weeks pre-operative and 10 weeks post-operative treatment.

      Patients will be scheduled to attend all standard post-operative follow-up clinic visits,
      which will be at 6 weeks, 3 months, 6 months, and 12 months after surgery. At 3 months post
      operative visit, patients will have lab drawn for calcium. At each follow-up visit, AP and
      lateral x-ray radiographs will be taken of the lumber spine to assess progression of bone
      healing and positioning of any hardware placed. Participants will be asked to complete a pain
      Visual Analog Score (VAS), European Quality of Life-5 Dimensions (EQ-5D), and Oswestry
      Disability Index (ODI) questionnaire at each visit for assessment of clinical outcomes.
      Thin-section helical CT scans of the lumbar spine will be taken at 12 months after surgery
      for definitive assessment of fusion. All radiographs will be evaluated by a blinded panel of
      three reviewers including a radiologist and a spine surgeon to assess primary outcome.
    

Intervention name(s): teriparatide; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): Teriparatide 20 ug subcutaneous injection daily for 12 weeks; Saline solution
Other intervention name(s): Forteo; recombinant human parathyroid hormone (1-34)
Intervention MeSH terms: Teriparatide; Parathyroid Hormone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment