Use of Forteo (Teriparatide) in Posterolateral Lumbar Spine Fusion
Completed · Phase 4 · Has a placebo group
Conditions studied: Lumbar Spondylosis, Lumbar Spondylolisthesis, Adult Degenerative Lumbar Scoliosis
In brief
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.
Key facts
- Study ID
- NCT01292252
- Run by
- Shane Burch
- People needed
- 36
- Starts
- 2011-08-01
- Expected to finish
- 2016-12-01
- Last updated by the study team
- 2021-05-03
Who can join
Age: 60 and older, up to 90. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- UCSF Spine Center — San Francisco, California, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.