Use of Forteo (Teriparatide) in Posterolateral Lumbar Spine Fusion (NCT01292252) | Clinical Trial Compass
CompletedPhase 4
Use of Forteo (Teriparatide) in Posterolateral Lumbar Spine Fusion
United States36 participantsStarted 2011-08
Plain-language 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.
Who can participate
Age range60 Years – 90 Years
SexALL
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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.
What they're measuring
1
Quality of Spine Fusion, Measured by the Number of Participants With Complete Spine Fusion at 1 Year