Trial Outcomes & Findings for Use of Forteo (Teriparatide) in Posterolateral Lumbar Spine Fusion (NCT NCT01292252)
NCT ID: NCT01292252
Last Updated: 2021-05-03
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
36 participants
Primary outcome timeframe
One year
Results posted on
2021-05-03
Participant Flow
714 patients were screened for the study between August 2011 and March 2016.
Participant milestones
| Measure |
Treatment: Forteo, Terapeptide 20 ug
Forteo, Terapeptide 20 ug subcutaneous injection
teriparatide: Teriparatide 20 ug subcutaneous injection daily for 12 weeks
|
Control: Saline Placebo
Saline placebo
Placebo: Saline solution
|
|---|---|---|
|
Overall Study
STARTED
|
21
|
15
|
|
Overall Study
COMPLETED
|
21
|
14
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Use of Forteo (Teriparatide) in Posterolateral Lumbar Spine Fusion
Baseline characteristics by cohort
| Measure |
Treatment: Forteo, Terapeptide 20 ug
n=21 Participants
Forteo, Terapeptide 20 ug subcutaneous injection
teriparatide: Teriparatide 20 ug subcutaneous injection daily for 12 weeks
|
Control: Saline Placebo
n=15 Participants
Saline placebo
Placebo: Saline solution
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
70.0 years
STANDARD_DEVIATION 6.1 • n=5 Participants
|
71.3 years
STANDARD_DEVIATION 6.3 • n=7 Participants
|
70.5 years
STANDARD_DEVIATION 6.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
21 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Body mass index (BMI)
|
27.8 kg/m^2
STANDARD_DEVIATION 7.6 • n=5 Participants
|
29.44 kg/m^2
STANDARD_DEVIATION 6.4 • n=7 Participants
|
28.48 kg/m^2
STANDARD_DEVIATION 7.07 • n=5 Participants
|
|
Visual Analog Score (VAS)
|
19.7 units on a scale
STANDARD_DEVIATION 9.6 • n=5 Participants
|
15.2 units on a scale
STANDARD_DEVIATION 9.1 • n=7 Participants
|
17.8 units on a scale
STANDARD_DEVIATION 9.5 • n=5 Participants
|
|
European Quality of Life - 5 Dimensions (EQ-5D)
|
0.57 units on a scale
STANDARD_DEVIATION 0.2 • n=5 Participants
|
0.60 units on a scale
STANDARD_DEVIATION 0.2 • n=7 Participants
|
0.58 units on a scale
STANDARD_DEVIATION 0.2 • n=5 Participants
|
|
Oswestry Disability Index (ODI)
|
52.1 units on a scale
STANDARD_DEVIATION 16.1 • n=5 Participants
|
46.4 units on a scale
STANDARD_DEVIATION 15.3 • n=7 Participants
|
49.7 units on a scale
STANDARD_DEVIATION 15.9 • n=5 Participants
|
PRIMARY outcome
Timeframe: One yearQuality 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.
Outcome measures
| Measure |
Treatment: Forteo, Terapeptide 20 ug
n=21 Participants
Forteo, Terapeptide 20 ug subcutaneous injection
teriparatide: Teriparatide 20 ug subcutaneous injection daily for 12 weeks
|
Control: Saline Placebo
n=15 Participants
Saline placebo
Placebo: Saline solution
|
|---|---|---|
|
Quality of Spine Fusion, Measured by the Number of Participants With Complete Spine Fusion at 1 Year
|
11 Participants
|
6 Participants
|
PRIMARY outcome
Timeframe: One yearPopulation: Data were not collected as intended and are not available to reported.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: One year1. 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.
Outcome measures
| Measure |
Treatment: Forteo, Terapeptide 20 ug
n=21 Participants
Forteo, Terapeptide 20 ug subcutaneous injection
teriparatide: Teriparatide 20 ug subcutaneous injection daily for 12 weeks
|
Control: Saline Placebo
n=15 Participants
Saline placebo
Placebo: Saline solution
|
|---|---|---|
|
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
Visual Analog Score (VAS)
|
11.67 units on a scale
Standard Deviation 13.4
|
9.67 units on a scale
Standard Deviation 8.0
|
|
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
European Quality of Life - 5 Dimensions (EQ-5D)
|
0.733 units on a scale
Standard Deviation 0.19
|
0.708 units on a scale
Standard Deviation 0.17
|
|
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
Oswestry Disability Index (ODI)
|
32.3 units on a scale
Standard Deviation 19.9
|
31.9 units on a scale
Standard Deviation 17.6
|
SECONDARY outcome
Timeframe: One yearNumber of participants with serious adverse events and other (not including serious) adverse events at one year are reported.
Outcome measures
| Measure |
Treatment: Forteo, Terapeptide 20 ug
n=21 Participants
Forteo, Terapeptide 20 ug subcutaneous injection
teriparatide: Teriparatide 20 ug subcutaneous injection daily for 12 weeks
|
Control: Saline Placebo
n=15 Participants
Saline placebo
Placebo: Saline solution
|
|---|---|---|
|
Adverse Effects
Serious Adverse Events
|
1 Participants
|
1 Participants
|
|
Adverse Effects
Other (Not Including Serious) Adverse Events
|
9 Participants
|
6 Participants
|
Adverse Events
Treatment: Forteo, Terapeptide 20 ug
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
Control: Saline Placebo
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment: Forteo, Terapeptide 20 ug
n=21 participants at risk
Forteo, Terapeptide 20 ug subcutaneous injection
teriparatide: Teriparatide 20 ug subcutaneous injection daily for 12 weeks
|
Control: Saline Placebo
n=15 participants at risk
Saline placebo
Placebo: Saline solution
|
|---|---|---|
|
Cardiac disorders
myocardial infarction
|
4.8%
1/21
|
0.00%
0/15
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
lung cancer
|
0.00%
0/21
|
6.7%
1/15
|
Other adverse events
| Measure |
Treatment: Forteo, Terapeptide 20 ug
n=21 participants at risk
Forteo, Terapeptide 20 ug subcutaneous injection
teriparatide: Teriparatide 20 ug subcutaneous injection daily for 12 weeks
|
Control: Saline Placebo
n=15 participants at risk
Saline placebo
Placebo: Saline solution
|
|---|---|---|
|
Gastrointestinal disorders
constipation
|
9.5%
2/21
|
6.7%
1/15
|
|
General disorders
dizziness
|
9.5%
2/21
|
0.00%
0/15
|
|
Gastrointestinal disorders
nausea
|
4.8%
1/21
|
0.00%
0/15
|
|
General disorders
headache
|
4.8%
1/21
|
0.00%
0/15
|
|
Cardiac disorders
rapid heart
|
4.8%
1/21
|
0.00%
0/15
|
|
Skin and subcutaneous tissue disorders
skin rash
|
4.8%
1/21
|
0.00%
0/15
|
|
General disorders
insomnia
|
4.8%
1/21
|
0.00%
0/15
|
|
General disorders
chest pain
|
4.8%
1/21
|
0.00%
0/15
|
|
Infections and infestations
infection of surgical site
|
4.8%
1/21
|
6.7%
1/15
|
|
Respiratory, thoracic and mediastinal disorders
shortness of breath
|
4.8%
1/21
|
0.00%
0/15
|
|
Infections and infestations
shingles
|
0.00%
0/21
|
6.7%
1/15
|
|
Skin and subcutaneous tissue disorders
pain and burning at injection site
|
0.00%
0/21
|
20.0%
3/15
|
|
General disorders
altered mental state
|
0.00%
0/21
|
6.7%
1/15
|
Additional Information
Shane Burch, MD
University of California, San Francisco
Phone: 415-353-4487
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place