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Fracture (FX) Improvement With Teriparatide: FiX-IT Study (FiX-IT)

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ClinicalTrials.gov Identifier: NCT01705587
Recruitment Status : Completed
First Posted : October 12, 2012
Results First Posted : December 12, 2017
Last Update Posted : December 12, 2017
Sponsor:
Collaborators:
University of Pittsburgh
Eli Lilly and Company
Information provided by (Responsible Party):
Susan L. Greenspan, University of Pittsburgh

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Osteoporosis
Atypical Femoral Fracture
Intervention Drug: teriparatide
Enrollment 13
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Immediate Teriparatide Delayed Teriparatide
Hide Arm/Group Description

Open label teriparatide given immediately following surgical repair of fracture

teriparatide: 20 microgram once-daily subcutaneous injection

Open label teriparatide given six months following surgical repair of fracture

teriparatide: 20 microgram once-daily subcutaneous injection

Period Title: Overall Study
Started 7 6
Completed 7 5
Not Completed 0 1
Reason Not Completed
Withdrawal by Subject             0             1
Arm/Group Title Immediate Teriparatide Delayed Teriparatide Total
Hide Arm/Group Description

Open label teriparatide given immediately following surgical repair of fracture

teriparatide: 20 microgram once-daily subcutaneous injection

Open label teriparatide given six months following surgical repair of fracture

teriparatide: 20 microgram once-daily subcutaneous injection

Total of all reporting groups
Overall Number of Baseline Participants 7 6 13
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 7 participants 6 participants 13 participants
78.0  (8.660) 69.8  (8.085) 74.2  (9.094)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 6 participants 13 participants
Female
7
 100.0%
6
 100.0%
13
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 6 participants 13 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
1
  16.7%
1
   7.7%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
1
  16.7%
1
   7.7%
White
7
 100.0%
4
  66.7%
11
  84.6%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Radiologic Evidence of Bone Healing
Hide Description 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.
Time Frame 6, 12 months of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Immediate Teriparatide Delayed Teriparatide
Hide Arm/Group Description:

Open label teriparatide given immediately following surgical repair of fracture

teriparatide: 20 microgram once-daily subcutaneous injection

Open label teriparatide given six months following surgical repair of fracture

teriparatide: 20 microgram once-daily subcutaneous injection

Overall Number of Participants Analyzed 7 6
Mean (Standard Error)
Unit of Measure: units on a scale
6 mo 12.6  (0.6) 11.2  (1.3)
12 mo 15.4  (0.4) 13.2  (1.2)
2.Primary Outcome
Title Radiologic Evidence of Healing
Hide Description Number of participants with persistence of alignment as determined by a radiologist.
Time Frame at 10 weeks for immediate teriparatide group
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Immediate Teriparatide Delayed Teriparatide
Hide Arm/Group Description:

Open label teriparatide given immediately following surgical repair of fracture

teriparatide: 20 microgram once-daily subcutaneous injection

Open label teriparatide given six months following surgical repair of fracture

teriparatide: 20 microgram once-daily subcutaneous injection

Overall Number of Participants Analyzed 5 4
Measure Type: Count of Participants
Unit of Measure: Participants
5
 100.0%
4
 100.0%
3.Secondary Outcome
Title Radiologic Healing
Hide Description [Not Specified]
Time Frame at 2, 6, 24, and 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title Immediate Teriparatide Delayed Teriparatide
Hide Arm/Group Description:

Open label teriparatide given immediately following surgical repair of fracture

teriparatide: 20 microgram once-daily subcutaneous injection

Open label teriparatide given six months following surgical repair of fracture

teriparatide: 20 microgram once-daily subcutaneous injection

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Increased Bone Density
Hide Description Percent 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
Time Frame at 6 and 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Immediate Teriparatide Delayed Teriparatide
Hide Arm/Group Description:

Open label teriparatide given immediately following surgical repair of fracture

teriparatide: 20 microgram once-daily subcutaneous injection

Open label teriparatide given six months following surgical repair of fracture

teriparatide: 20 microgram once-daily subcutaneous injection

Overall Number of Participants Analyzed 7 6
Mean (Standard Error)
Unit of Measure: percentage change in BMD
Spine-PA (6 months) 2.1  (1.5) -0.6  (1.3)
Spine-PA (12 months) 2.8  (2.0) 5.4  (2.8)
Total Hip (6 months) -1.6  (1.5) -0.8  (0.7)
Total Hip (12 months) -0.3  (1.8) 1.5  (2.7)
Femoral Neck (6 months) -1.8  (2.1) -2.7  (1.0)
Femoral Neck (12 months) -2.5  (3.0) -1.9  (3.6)
Distal 1/3 Radius (6 months) -0.6  (1.9) -0.7  (1.1)
Distal 1/3 Radius (12 months) -1.9  (1.7) -6.1  (2.1)
5.Secondary Outcome
Title Quality of Life Improvements
Hide Description Assessed by quality of life questionnaire (SF-36). There are 8 subscales each ranging from 0-100 with higher scores indicating better quality of life.
Time Frame at 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Immediate Teriparatide Delayed Teriparatide
Hide Arm/Group Description:

Open label teriparatide given immediately following surgical repair of fracture

teriparatide: 20 microgram once-daily subcutaneous injection

Open label teriparatide given six months following surgical repair of fracture

teriparatide: 20 microgram once-daily subcutaneous injection

Overall Number of Participants Analyzed 7 4
Mean (Standard Error)
Unit of Measure: units on a scale
Physical functioning 49.3  (6.5) 65.0  (20.3)
Physical health limitations 48.2  (9.1) 68.8  (21.2)
Emotional health limitations 75.0  (9.1) 72.9  (19.7)
Energy/Fatigue 54.5  (7.4) 59.4  (15.0)
Emotional well-being 80.7  (4.1) 70.0  (9.1)
Social functioning 92.9  (4.6) 65.6  (23.6)
Pain 72.9  (9.7) 59.4  (21.2)
General health 66.1  (6.2) 67.2  (12.1)
6.Secondary Outcome
Title Difference in Biochemical Markers of Bone Turnover
Hide Description upfront therapy group compared to delayed therapy group and no therapy group
Time Frame intervals over 12-18 months depending on treatment group
Hide Outcome Measure Data
Hide Analysis Population Description
Funding unavailable for sample analysis.
Arm/Group Title Immediate Teriparatide Delayed Teriparatide
Hide Arm/Group Description:

Open label teriparatide given immediately following surgical repair of fracture

teriparatide: 20 microgram once-daily subcutaneous injection

Open label teriparatide given six months following surgical repair of fracture

teriparatide: 20 microgram once-daily subcutaneous injection

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Immediate Teriparatide Delayed Teriparatide
Hide Arm/Group Description

Open label teriparatide given immediately following surgical repair of fracture

teriparatide: 20 microgram once-daily subcutaneous injection

Open label teriparatide given six months following surgical repair of fracture

teriparatide: 20 microgram once-daily subcutaneous injection

All-Cause Mortality
Immediate Teriparatide Delayed Teriparatide
Affected / at Risk (%) Affected / at Risk (%)
Total   0/7 (0.00%)      0/6 (0.00%)    
Hide Serious Adverse Events
Immediate Teriparatide Delayed Teriparatide
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/7 (42.86%)      2/6 (33.33%)    
Blood and lymphatic system disorders     
Abnormal coagulation profile   1/7 (14.29%)  1 0/6 (0.00%)  0
General disorders     
Hematoma  [1]  1/7 (14.29%)  1 0/6 (0.00%)  0
Infections and infestations     
Cellulitis * [2]  1/7 (14.29%)  1 0/6 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Ewings Sarcoma * [3]  0/7 (0.00%)  0 1/6 (16.67%)  1
Surgical and medical procedures     
elective back surgery   0/7 (0.00%)  0 1/6 (16.67%)  1
Indicates events were collected by systematic assessment
[1]
Hospitalized for incision and drainage of right hip hematoma at femoral surgical site
*
Indicates events were collected by non-systematic assessment
[2]
Developed cellulitis at surgical site following repair of femur fracture
[3]
Discovered prior to initiation of treatment with teritparatide
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Immediate Teriparatide Delayed Teriparatide
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/7 (71.43%)      5/6 (83.33%)    
Ear and labyrinth disorders     
myringotomy   1/7 (14.29%)  1 0/6 (0.00%)  0
Eye disorders     
macular degeneration   1/7 (14.29%)  1 0/6 (0.00%)  0
General disorders     
gingivitis   0/7 (0.00%)  0 1/6 (16.67%)  1
dizziness   0/7 (0.00%)  0 1/6 (16.67%)  1
Immune system disorders     
allergic rhinitis   0/7 (0.00%)  0 1/6 (16.67%)  1
Infections and infestations     
pneumonia   1/7 (14.29%)  1 0/6 (0.00%)  0
varicella zoster   0/7 (0.00%)  0 1/6 (16.67%)  1
Musculoskeletal and connective tissue disorders     
Fall   1/7 (14.29%)  1 0/6 (0.00%)  0
arthralgias   1/7 (14.29%)  1 0/6 (0.00%)  0
thigh pain   0/7 (0.00%)  0 2/6 (33.33%)  2
Nervous system disorders     
aphasia   1/7 (14.29%)  1 0/6 (0.00%)  0
Surgical and medical procedures     
cataract removal   1/7 (14.29%)  2 0/6 (0.00%)  0
periodontal gum surgery   0/7 (0.00%)  0 1/6 (16.67%)  1
cardiac catheterization   0/7 (0.00%)  0 1/6 (16.67%)  1
Vascular disorders     
deep vein thrombosis   0/7 (0.00%)  0 1/6 (16.67%)  1
coronary artery disease   0/7 (0.00%)  0 1/6 (16.67%)  1
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Susan Greenspan, MD
Organization: University of Pittsburgh
Phone: 412-692-2477
EMail: greenspn@pitt.edu
Layout table for additonal information
Responsible Party: Susan L. Greenspan, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01705587    
Other Study ID Numbers: PRO12040560 (FiX-IT)
First Submitted: October 9, 2012
First Posted: October 12, 2012
Results First Submitted: August 30, 2017
Results First Posted: December 12, 2017
Last Update Posted: December 12, 2017