Lumbar Spondylolisthesis Clinical Trial
Official title:
Assessment of the Efficacy of Forteo (Teriparatide) in Patients Undergoing Posterolateral Lumbar Spinal Fusion
Verified date | April 2021 |
Source | University of California, San Francisco |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 36 |
Est. completion date | December 2016 |
Est. primary completion date | December 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 60 Years to 90 Years |
Eligibility | Inclusion Criteria: - Patients aged 60-90 years with lumbar spondylosis, spondylolithesis, or adult degenerative scoliosis, including disc pathology, stenosis, deformity, instability, or postdecompression revision, who are scheduled to undergo three-level or greater posterolateral lumbar spinal fusion. - Willing and able to use a pen-type delivery system to administer daily subcutaneous injections. Exclusion Criteria: - Use of bone morphogenic protein (BMP) posterolaterally during the fusion procedure. - Previous spinal fusion at the intended fusion levels. - Prior use of Forteo (teriparatide). - Use of digoxin. - Paget's Disease of bone. - History of primary skeletal malignancy, presence of bone metastases, or previous skeletal exposure to therapeutic irradiation. - Elevated serum calcium, serum PTH >70 pg/ml, 25-hydroxyvitamin D <12 ng/mL, or active liver disease. - History of symptomatic nephro- or urolithiasis in the past two years. - History of malignant neoplasm in the past five years, except for superficial basal cell carcinoma or squamous cell carcinoma. - Carcinoma in situ of the uterine cervix treated in the past year. |
Country | Name | City | State |
---|---|---|---|
United States | UCSF Spine Center | San Francisco | California |
Lead Sponsor | Collaborator |
---|---|
Shane Burch | Eli Lilly and Company |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Quality of Spine Fusion, Measured by the Number of Participants With Complete Spine Fusion at 1 Year | Quality of spine fusion, measured by the number of participants with complete spine fusion at 1 year. Spine fusion at one year was assessed using thin-section helical computed tomography (CT) scan of the lumbar spine. | One year | |
Primary | Time to Spine Fusion | One year | ||
Secondary | Patient Reported Outcomes Measured by: Visual Analog Score (VAS), European Quality of Life - 5 Dimensions (EQ-5D) and Oswestry Disability Index (ODI) Scores at 1 Year | The self-reported pain Visual Analog Score (VAS), the score range is 0-100 with higher scores indicating more pain.
European Quality of Life - 5 Dimensions (EQ-5D) is a standardized instrument for measuring generic health status, the scale range is from 0.000 (death) to 1.000 (perfect health). Oswestry Disability Index (ODI) provides information about how back or leg pain is affecting the ability to manage in everyday life, the points range from 0-50, which is doubled and reported as a percentage. Higher scores indicate higher disability. |
One year | |
Secondary | Adverse Effects | Number of participants with serious adverse events and other (not including serious) adverse events at one year are reported. | One year |
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