Use of Forteo (Teriparatide) in Posterolateral Lumbar Spine Fusion
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|ClinicalTrials.gov Identifier: NCT01292252|
Recruitment Status : Completed
First Posted : February 9, 2011
Last Update Posted : August 19, 2019
|Condition or disease||Intervention/treatment||Phase|
|Lumbar Spondylosis Lumbar Spondylolisthesis Adult Degenerative Lumbar Scoliosis||Biological: teriparatide Biological: Placebo||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Assessment of the Efficacy of Forteo (Teriparatide) in Patients Undergoing Posterolateral Lumbar Spinal Fusion|
|Study Start Date :||August 2011|
|Actual Primary Completion Date :||December 2015|
|Actual Study Completion Date :||December 2016|
Forteo, Terapeptide 20 ug subcutaneous injection
Teriparatide 20 ug subcutaneous injection daily for 12 weeks
Placebo Comparator: Control
- Quality of spine fusion [ Time Frame: One year ]Quality of spine fusion at one year will be assessed using thin-section helical CT scan of the lumbar spine.
- Time to spine fusion [ Time Frame: One year ]Time to spine fusion will be determined using AP/lateral x-rays of the lumbar spine taken at 6 weeks, 3 months, 6 months, and 1 year after surgery.
- Clinical outcome [ Time Frame: One year ]Clinical outcomes will be assessed using self-reported pain Visual Analog Score (VAS), European Quality of Life - 5 Dimensions (EQ-5D), and Oswestry Disability Index (ODI) scores at the preoperative and postoperative follow-up visits.
- Adverse effects [ Time Frame: One year ]Patient-reported adverse effects of study treatment will be recorded at the time of surgery and at all post-operative follow-up visits.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01292252
|United States, California|
|UCSF Spine Center|
|San Francisco, California, United States, 94143|
|Principal Investigator:||Shane Burch, MD||University of California, San Francisco|
|Study Director:||Carmen Li||University of California, San Francisco|