Phase 4
Completed N=36
Use of Forteo (Teriparatide) in Posterolateral Lumbar Spine Fusion
Lumbar Spondylosis · Lumbar Spondylolisthesis · Adult Degenerative Lumbar Scoliosis
Source: ClinicalTrials.gov NCT01292252 ↗
Enrolled (actual)
36
Serious AEs
5.6%
Results posted
Feb 2021
Primary outcomePrimary: Quality of Spine Fusion, Measured by the Number of Participants With Complete Spine Fusion at 1 Year — 11; 6 Participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
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 | — |
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. Informational only — not medical advice.