Phase 4
N=36
Use of Forteo (Teriparatide) in Posterolateral Lumbar Spine Fusion
Lumbar Spondylosis · Lumbar Spondylolisthesis · Adult Degenerative Lumbar Scoliosis
Bottom Line
View on ClinicalTrials.gov: NCT01292252 ↗Enrolled (actual)
36
Serious AEs
5.6%
Results posted
Feb 2021
Primary outcome: Primary: Quality of Spine Fusion, Measured by the Number of Participants With Complete Spine Fusion at 1 Year — 11; 6 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- teriparatide (Biological); Placebo (Biological)
- Age
- Adult, Older Adult · 60+ yrs
- Sex
- All
- Sponsor
- Shane Burch
- Primary completion
- Dec 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Quality of Spine Fusion, Measured by the Number of Participants With Complete Spine Fusion at 1 Year |
11; 6 | — |
| PRIMARY Time to Spine Fusion |
— | — |
| 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 |
11.67; 9.67; 0.733; 0.708; 32.3; 31.9 | — |
| SECONDARY Adverse Effects |
1; 1; 9; 6 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01292252). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.