Trial Outcomes & Findings for Fracture (FX) Improvement With Teriparatide: FiX-IT Study (NCT NCT01705587)
NCT ID: NCT01705587
Last Updated: 2017-12-12
Results Overview
The radiologic indices of fracture healing included (1) cortical continuity on two of four cortices, (2) persistence of alignment, (3) decreased conspicuity of fracture line, and (4) increased callus formation. For each of these indices, healing was graded on a scale of 1 to 4 with 1 = no change (less than 25%), 2 = minimum healing (25-50%), 3 = moderate healing (50-75%), and 4 = complete healing (greater than 75%). A composite score was calculated by summing the subscale scores for the 4 indices. Composite score scale ranged from 4 to 16 with higher scores indicating more complete healing. The primary grading was performed by a radiologist with expertise in musculoskeletal radiology, then independently repeated by a second radiologist, both of whom were blinded to the study allocation.
COMPLETED
PHASE4
13 participants
6, 12 months of treatment
2017-12-12
Participant Flow
Participant milestones
| Measure |
Immediate Teriparatide
Open label teriparatide given immediately following surgical repair of fracture
teriparatide: 20 microgram once-daily subcutaneous injection
|
Delayed Teriparatide
Open label teriparatide given six months following surgical repair of fracture
teriparatide: 20 microgram once-daily subcutaneous injection
|
|---|---|---|
|
Overall Study
STARTED
|
7
|
6
|
|
Overall Study
COMPLETED
|
7
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Immediate Teriparatide
Open label teriparatide given immediately following surgical repair of fracture
teriparatide: 20 microgram once-daily subcutaneous injection
|
Delayed Teriparatide
Open label teriparatide given six months following surgical repair of fracture
teriparatide: 20 microgram once-daily subcutaneous injection
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Fracture (FX) Improvement With Teriparatide: FiX-IT Study
Baseline characteristics by cohort
| Measure |
Immediate Teriparatide
n=7 Participants
Open label teriparatide given immediately following surgical repair of fracture
teriparatide: 20 microgram once-daily subcutaneous injection
|
Delayed Teriparatide
n=6 Participants
Open label teriparatide given six months following surgical repair of fracture
teriparatide: 20 microgram once-daily subcutaneous injection
|
Total
n=13 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
78.0 years
STANDARD_DEVIATION 8.660 • n=5 Participants
|
69.8 years
STANDARD_DEVIATION 8.085 • n=7 Participants
|
74.2 years
STANDARD_DEVIATION 9.094 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6, 12 months of treatmentThe radiologic indices of fracture healing included (1) cortical continuity on two of four cortices, (2) persistence of alignment, (3) decreased conspicuity of fracture line, and (4) increased callus formation. For each of these indices, healing was graded on a scale of 1 to 4 with 1 = no change (less than 25%), 2 = minimum healing (25-50%), 3 = moderate healing (50-75%), and 4 = complete healing (greater than 75%). A composite score was calculated by summing the subscale scores for the 4 indices. Composite score scale ranged from 4 to 16 with higher scores indicating more complete healing. The primary grading was performed by a radiologist with expertise in musculoskeletal radiology, then independently repeated by a second radiologist, both of whom were blinded to the study allocation.
Outcome measures
| Measure |
Immediate Teriparatide
n=7 Participants
Open label teriparatide given immediately following surgical repair of fracture
teriparatide: 20 microgram once-daily subcutaneous injection
|
Delayed Teriparatide
n=6 Participants
Open label teriparatide given six months following surgical repair of fracture
teriparatide: 20 microgram once-daily subcutaneous injection
|
|---|---|---|
|
Radiologic Evidence of Bone Healing
6 mo
|
12.6 units on a scale
Standard Error 0.6
|
11.2 units on a scale
Standard Error 1.3
|
|
Radiologic Evidence of Bone Healing
12 mo
|
15.4 units on a scale
Standard Error 0.4
|
13.2 units on a scale
Standard Error 1.2
|
PRIMARY outcome
Timeframe: at 10 weeks for immediate teriparatide groupPopulation: Based on orthopedic surgeons' assessment, x-rays were not deemed necessary in over 30% of patients at week 10. Results presented are for those who had x-rays at 10 weeks to assess persistence of alignment for safety purposes.
Number of participants with persistence of alignment as determined by a radiologist.
Outcome measures
| Measure |
Immediate Teriparatide
n=5 Participants
Open label teriparatide given immediately following surgical repair of fracture
teriparatide: 20 microgram once-daily subcutaneous injection
|
Delayed Teriparatide
n=4 Participants
Open label teriparatide given six months following surgical repair of fracture
teriparatide: 20 microgram once-daily subcutaneous injection
|
|---|---|---|
|
Radiologic Evidence of Healing
|
5 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: at 2, 6, 24, and 48 weeksPopulation: Data not collected at 2 and 6 weeks. Twenty-Four week (6 months) data is presented in 6 month outcomes, and 48 week (12 months) data as 12 month outcomes (See primary outcomes section above).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: at 6 and 12 monthsPercent change in Bone Mineral Density (BMD) as assessed by dual x-ray absorptiometry (DXA) at the spine, contralateral hip, distal 1/3 radius, and femoral neck
Outcome measures
| Measure |
Immediate Teriparatide
n=7 Participants
Open label teriparatide given immediately following surgical repair of fracture
teriparatide: 20 microgram once-daily subcutaneous injection
|
Delayed Teriparatide
n=6 Participants
Open label teriparatide given six months following surgical repair of fracture
teriparatide: 20 microgram once-daily subcutaneous injection
|
|---|---|---|
|
Increased Bone Density
Spine-PA (6 months)
|
2.1 percentage change in BMD
Standard Error 1.5
|
-0.6 percentage change in BMD
Standard Error 1.3
|
|
Increased Bone Density
Spine-PA (12 months)
|
2.8 percentage change in BMD
Standard Error 2.0
|
5.4 percentage change in BMD
Standard Error 2.8
|
|
Increased Bone Density
Total Hip (6 months)
|
-1.6 percentage change in BMD
Standard Error 1.5
|
-0.8 percentage change in BMD
Standard Error 0.7
|
|
Increased Bone Density
Total Hip (12 months)
|
-0.3 percentage change in BMD
Standard Error 1.8
|
1.5 percentage change in BMD
Standard Error 2.7
|
|
Increased Bone Density
Femoral Neck (6 months)
|
-1.8 percentage change in BMD
Standard Error 2.1
|
-2.7 percentage change in BMD
Standard Error 1.0
|
|
Increased Bone Density
Femoral Neck (12 months)
|
-2.5 percentage change in BMD
Standard Error 3.0
|
-1.9 percentage change in BMD
Standard Error 3.6
|
|
Increased Bone Density
Distal 1/3 Radius (6 months)
|
-0.6 percentage change in BMD
Standard Error 1.9
|
-0.7 percentage change in BMD
Standard Error 1.1
|
|
Increased Bone Density
Distal 1/3 Radius (12 months)
|
-1.9 percentage change in BMD
Standard Error 1.7
|
-6.1 percentage change in BMD
Standard Error 2.1
|
SECONDARY outcome
Timeframe: at 12 monthsAssessed by quality of life questionnaire (SF-36). There are 8 subscales each ranging from 0-100 with higher scores indicating better quality of life.
Outcome measures
| Measure |
Immediate Teriparatide
n=7 Participants
Open label teriparatide given immediately following surgical repair of fracture
teriparatide: 20 microgram once-daily subcutaneous injection
|
Delayed Teriparatide
n=4 Participants
Open label teriparatide given six months following surgical repair of fracture
teriparatide: 20 microgram once-daily subcutaneous injection
|
|---|---|---|
|
Quality of Life Improvements
Pain
|
72.9 units on a scale
Standard Error 9.7
|
59.4 units on a scale
Standard Error 21.2
|
|
Quality of Life Improvements
Physical functioning
|
49.3 units on a scale
Standard Error 6.5
|
65.0 units on a scale
Standard Error 20.3
|
|
Quality of Life Improvements
Physical health limitations
|
48.2 units on a scale
Standard Error 9.1
|
68.8 units on a scale
Standard Error 21.2
|
|
Quality of Life Improvements
Emotional health limitations
|
75.0 units on a scale
Standard Error 9.1
|
72.9 units on a scale
Standard Error 19.7
|
|
Quality of Life Improvements
Energy/Fatigue
|
54.5 units on a scale
Standard Error 7.4
|
59.4 units on a scale
Standard Error 15.0
|
|
Quality of Life Improvements
Emotional well-being
|
80.7 units on a scale
Standard Error 4.1
|
70.0 units on a scale
Standard Error 9.1
|
|
Quality of Life Improvements
Social functioning
|
92.9 units on a scale
Standard Error 4.6
|
65.6 units on a scale
Standard Error 23.6
|
|
Quality of Life Improvements
General health
|
66.1 units on a scale
Standard Error 6.2
|
67.2 units on a scale
Standard Error 12.1
|
SECONDARY outcome
Timeframe: intervals over 12-18 months depending on treatment groupPopulation: Funding unavailable for sample analysis.
upfront therapy group compared to delayed therapy group and no therapy group
Outcome measures
Outcome data not reported
Adverse Events
Immediate Teriparatide
Delayed Teriparatide
Serious adverse events
| Measure |
Immediate Teriparatide
n=7 participants at risk
Open label teriparatide given immediately following surgical repair of fracture
teriparatide: 20 microgram once-daily subcutaneous injection
|
Delayed Teriparatide
n=6 participants at risk
Open label teriparatide given six months following surgical repair of fracture
teriparatide: 20 microgram once-daily subcutaneous injection
|
|---|---|---|
|
Surgical and medical procedures
elective back surgery
|
0.00%
0/7
|
16.7%
1/6 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ewings Sarcoma
|
0.00%
0/7
|
16.7%
1/6 • Number of events 1
|
|
Infections and infestations
Cellulitis
|
14.3%
1/7 • Number of events 1
|
0.00%
0/6
|
|
Blood and lymphatic system disorders
Abnormal coagulation profile
|
14.3%
1/7 • Number of events 1
|
0.00%
0/6
|
|
General disorders
Hematoma
|
14.3%
1/7 • Number of events 1
|
0.00%
0/6
|
Other adverse events
| Measure |
Immediate Teriparatide
n=7 participants at risk
Open label teriparatide given immediately following surgical repair of fracture
teriparatide: 20 microgram once-daily subcutaneous injection
|
Delayed Teriparatide
n=6 participants at risk
Open label teriparatide given six months following surgical repair of fracture
teriparatide: 20 microgram once-daily subcutaneous injection
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Fall
|
14.3%
1/7 • Number of events 1
|
0.00%
0/6
|
|
Nervous system disorders
aphasia
|
14.3%
1/7 • Number of events 1
|
0.00%
0/6
|
|
Ear and labyrinth disorders
myringotomy
|
14.3%
1/7 • Number of events 1
|
0.00%
0/6
|
|
Musculoskeletal and connective tissue disorders
arthralgias
|
14.3%
1/7 • Number of events 1
|
0.00%
0/6
|
|
Infections and infestations
pneumonia
|
14.3%
1/7 • Number of events 1
|
0.00%
0/6
|
|
Eye disorders
macular degeneration
|
14.3%
1/7 • Number of events 1
|
0.00%
0/6
|
|
Surgical and medical procedures
cataract removal
|
14.3%
1/7 • Number of events 2
|
0.00%
0/6
|
|
Vascular disorders
deep vein thrombosis
|
0.00%
0/7
|
16.7%
1/6 • Number of events 1
|
|
General disorders
gingivitis
|
0.00%
0/7
|
16.7%
1/6 • Number of events 1
|
|
Surgical and medical procedures
periodontal gum surgery
|
0.00%
0/7
|
16.7%
1/6 • Number of events 1
|
|
Immune system disorders
allergic rhinitis
|
0.00%
0/7
|
16.7%
1/6 • Number of events 1
|
|
Vascular disorders
coronary artery disease
|
0.00%
0/7
|
16.7%
1/6 • Number of events 1
|
|
Surgical and medical procedures
cardiac catheterization
|
0.00%
0/7
|
16.7%
1/6 • Number of events 1
|
|
General disorders
dizziness
|
0.00%
0/7
|
16.7%
1/6 • Number of events 1
|
|
Infections and infestations
varicella zoster
|
0.00%
0/7
|
16.7%
1/6 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
thigh pain
|
0.00%
0/7
|
33.3%
2/6 • Number of events 2
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place