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Effect of Teriparatide on Hip Fracture Healing

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01473589
First received: November 14, 2011
Last updated: April 10, 2015
Last verified: April 2015
Results First Received: November 10, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Condition: Femur Neck Fracture
Interventions: Drug: Teriparatide
Drug: Placebo
Dietary Supplement: Calcium supplementation
Dietary Supplement: Vitamin D supplementation

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Teriparatide Teriparatide 20 micrograms (µg) administered once-daily by subcutaneous (SC) injection for 6 months. Participants received calcium and vitamin D supplements.
Placebo Placebo administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.

Participant Flow:   Overall Study
    Teriparatide   Placebo
STARTED   60   62 
Received at Least 1 Dose of Study Drug   60 [1]   61 [1] 
Completed 6 Months   51   54 
Completed 12 Months   49   48 
COMPLETED   49   46 
NOT COMPLETED   11   16 
Adverse Event                1                1 
Death                2                0 
Lost to Follow-up                2                2 
Protocol Violation                1                0 
Withdrawal by Subject                5                11 
Physician Decision                0                1 
Entry criteria not met                0                1 
[1] Randomized participants who received at least 1 dose of study drug.



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set (FAS): All randomized participants who received at least 1 dose of study drug.

Reporting Groups
  Description
Teriparatide Teriparatide 20 µg administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
Placebo Placebo administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
Total Total of all reporting groups

Baseline Measures
   Teriparatide   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 60   61   121 
Age 
[Units: Years]
Mean (Standard Deviation)
 68.49  (11.321)   70.96  (12.023)   69.73  (11.698) 
Gender 
[Units: Participants]
     
Female   43   44   87 
Male   17   17   34 
Ethnicity (NIH/OMB) 
[Units: Participants]
     
Hispanic or Latino   0   1   1 
Not Hispanic or Latino   26   27   53 
Unknown or Not Reported   34   33   67 
Race (NIH/OMB) 
[Units: Participants]
     
American Indian or Alaska Native   0   0   0 
Asian   35   34   69 
Native Hawaiian or Other Pacific Islander   0   0   0 
Black or African American   0   0   0 
White   25   27   52 
More than one race   0   0   0 
Unknown or Not Reported   0   0   0 
Region of Enrollment 
[Units: Participants]
     
United States   1   1   2 
Spain   7   8   15 
Taiwan   10   9   19 
Lithuania   2   2   4 
Israel   3   4   7 
India   2   1   3 
Canada   3   1   4 
Denmark   1   1   2 
Australia   1   0   1 
Latvia   2   3   5 
Japan   14   15   29 
New Zealand   5   6   11 
Korea, Republic of   9   9   18 
Sweden   0   1   1 
Surgical screw type [1] 
[Units: Participants]
     
Cancellous Screws   54   53   107 
Sliding Hip Screws   6   8   14 
[1] Surgical screws used in initial surgery to repair femur neck hip fracture.


  Outcome Measures
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1.  Primary:   Percentage of Participants With No Revision Surgery at 12 Months After Internal Fixation of a Low-Trauma Femoral Neck Fracture   [ Time Frame: 12 months ]

2.  Secondary:   Percentage of Participants With Radiographic Evidence of Healing   [ Time Frame: Randomization up to 12 months ]

3.  Secondary:   Percentage of Participants With Pain Control During Ambulation   [ Time Frame: Up to 12 months ]

4.  Secondary:   Percentage of Participants Without Severe Fracture-Site Pain During 24 Hours Prior to Visit   [ Time Frame: Up to 12 months ]

5.  Secondary:   Percentage of Participants Without Severe Fracture-Site Pain During Weight Bearing   [ Time Frame: Up to 12 months ]

6.  Secondary:   Percentage of Participants With Functional Evidence of Healing   [ Time Frame: 12 Months ]

7.  Secondary:   Percentage of Participants Able to Ambulate   [ Time Frame: Up to 12 months ]

8.  Secondary:   Percentage of Participants Who Regain Their Prefracture Ambulatory Status   [ Time Frame: Up to 12 months ]

9.  Secondary:   Mean Change From Baseline to 6 Months in Worst Fracture-Site Pain   [ Time Frame: Baseline, 6 Months ]

10.  Secondary:   Mean Change From Baseline to 6 Months in Gait Speed   [ Time Frame: Baseline, up to 6 Months ]

11.  Secondary:   Time to Revision Surgery   [ Time Frame: Baseline to revision surgery (up to 14.14 Months) ]

12.  Secondary:   Mean Change From Baseline to 6 Months on Short Form-12 (SF-12) Physical (PCS) and Mental Component Summary (MCS) Scores   [ Time Frame: Baseline, up to 6 Months ]

13.  Secondary:   Mean Change From Baseline to 6 Months on Western Ontario McMaster Osteoarthritis Index (WOMAC)   [ Time Frame: Baseline, up to 6 Months ]

14.  Secondary:   Mean Change From Baseline to 6 Months on European Quality of Life Questionnaire (EQ-5D) Health State Score   [ Time Frame: Baseline, up to 6 Months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
phone: 800-545-5979



Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01473589     History of Changes
Other Study ID Numbers: 13467
B3D-MC-GHDN ( Other Identifier: Eli Lilly and Company )
Study First Received: November 14, 2011
Results First Received: November 10, 2014
Last Updated: April 10, 2015
Health Authority: United States: Food and Drug Administration
Korea: Institutional Review Board
Sweden: Institutional Review Board
Taiwan: Institutional Review Board
Norway: Ethics Committee
Canada: Ethics Review Committee
Denmark: Ethics Committee
Finland: Ethics Committee
Japan: Institutional Review Board
India: Institutional Review Board
Israel: Ethics Commission
Estonia: Research Ethics Committee
Lithuania: Bioethics Committee
Latvia: Institutional Review Board
Australia: Human Research Ethics Committee
New Zealand: Institutional Review Board
Spain: Ethics Committee