Trial · Interventional

CompletedPhase 4Results postedRegistry data

Use of Forteo (Teriparatide) in Posterolateral Lumbar Spine Fusion

NCTNCT01292252Other idUCSFSpineForteo

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 4
Enrollment: 36 participants (actual)
Sponsor: Shane Burch · Other
Design: Randomized · Double masking
Countries: 1 country
United States
Start: Aug 2011
Primary completion: Dec 2015
Completion: Dec 2016
First posted: 9 Feb 2011 (estimated)
Last update posted: 3 May 2021
Conditions: Lumbar Spondylosis · Lumbar Spondylolisthesis · Adult Degenerative Lumbar Scoliosis

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

2011201220132014201520162017

Ph 4
Use of Forteo (Teriparatide) in Posterolateral Lumbar Spine Fusion
NCT01292252
Aug 2011 to Dec 2016

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

teriparatideBiological
PlaceboBiological

Arms2

Experimental
Treatment
Forteo, Terapeptide 20 ug subcutaneous injection
Placebo comparator
Control
Saline placebo

Primary outcomes2

Outcomes the sponsor listed as primary.

Quality of Spine Fusion, Measured by the Number of Participants With Complete Spine Fusion at 1 Year
Time frame · One year
Registry description
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.
Time to Spine Fusion
Time frame · One year

Secondary outcomes(2)

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
Time frame · One year
Registry description
1. The self-reported pain Visual Analog Score (VAS), the score range is 0-100 with higher scores indicating more pain. 2. 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). 3. 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.
Adverse Effects
Time frame · One year
Registry description
Number of participants with serious adverse events and other (not including serious) adverse events at one year are reported.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeCount of participants· One year

Quality of Spine Fusion, Measured by the Number of Participants With Complete Spine Fusion at 1 Year

Group	Value (Participants)
Treatment: Forteo, Terapeptide 20 ug	11
Control: Saline Placebo	6

Primary outcome· One year

Time to Spine Fusion

Group	Value
Treatment: Forteo, Terapeptide 20 ug	not posted
Control: Saline Placebo	not posted

Secondary and other outcome results(2)

Secondary outcomeMean· One year

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

Group	Value (units on a scale)	Spread
Treatment: Forteo, Terapeptide 20 ug	11.67	13.4
Control: Saline Placebo	9.67	8.0

Secondary outcomeCount of participants· One year

Adverse Effects

Group	Value (Participants)
Treatment: Forteo, Terapeptide 20 ug	1
Control: Saline Placebo	1

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
Treatment: Forteo, Terapeptide 20 ugForteo, Terapeptide 20 ug subcutaneous injection teriparatide: Teriparatide 20 ug subcutaneous injection daily for 12 weeks	0 / 21	1 / 21	9 / 21
Control: Saline PlaceboSaline placebo Placebo: Saline solution	0 / 15	1 / 15	6 / 15

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 60 Years up to 90 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

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.

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