A Study Using Imaging Technology to Measure Changes in Bone Structure After Treatment With Teriparatide

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00557310
First received: November 9, 2007
Last updated: October 7, 2011
Last verified: October 2011
Results First Received: October 7, 2011  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Osteoporosis, Postmenopausal
Intervention: Drug: teriparatide

  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
Participants who completed the 18 month main study had an option to continue treatment for an additional 6 months (Extension Phase).

Reporting Groups
  Description
Teriparatide 20 microgram (mcg) teriparatide subcutaneous injection per day for 18 months, with possibility to continue for 24 months

Participant Flow for 2 periods

Period 1:   Main Study (0 - 18 Months)
    Teriparatide  
STARTED     35  
COMPLETED     30 [1]
NOT COMPLETED     5  
Adverse Event                 4  
Withdrawal by Subject                 1  
[1] One had a metal hip implant, a protocol violation, and was excluded from efficacy analyses.

Period 2:   Extension Phase (18 - 24 Months)
    Teriparatide  
STARTED     30  
COMPLETED     25 [1]
NOT COMPLETED     5  
Adverse Event                 1  
Lost to Follow-up                 1  
Physician Decision                 2  
Protocol Violation                 1  
[1] One had a metal hip implant, a protocol violation, and was excluded from efficacy analyses.



  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.
No text entered.

Reporting Groups
  Description
Teriparatide 20 microgram (mcg) teriparatide subcutaneous injection per day for 18 months, with possibility to continue for 24 months

Baseline Measures
    Teriparatide  
Number of Participants  
[units: participants]
  34  
Age  
[units: years]
Mean ± Standard Deviation
  61.96  ± 8.14  
Gender  
[units: participants]
 
Female     34  
Male     0  
Race/Ethnicity, Customized  
[units: participants]
 
Caucasian     31  
Hispanic     2  
West Asian     1  
Region of Enrollment  
[units: participants]
 
United States     28  
Canada     6  
Dominant Hand  
[units: participants]
 
Left     1  
Right     33  
Prevalent Fractures [1]
[units: participants]
 
None     14  
Any vertebral fracture     4  
Any non-vertebral fracture     17  
Years Postmenopausal  
[units: years]
Mean ± Standard Deviation
  16.97  ± 12.10  
Prior Bisphosphonate Use  
[units: participants]
 
Yes     21  
No     13  
Lumbar Spine T-Score [2]
[units: units on a scale]
Mean ± Standard Deviation
  -2.91  ± 1.04  
Femoral Neck T-Score  
[units: units on a scale]
Mean ± Standard Deviation
  -2.38  ± 0.67  
Total Hip T-Score  
[units: units on a scale]
Mean ± Standard Deviation
  -1.80  ± 0.81  
[1] A prevalent fracture is defined as a fracture that a participant already had at the time of study entry. One participant had both a vertebral and non-vertebral fracture and therefore the total number of participants is higher than the baseline population number.
[2] The T-score is a comparison of a patient's bone mineral density (BMD) to that of the mean BMD for a healthy population of women at peak bone mass (30 years). A normal T-score has a value of -1.0 or higher. Osteoporosis is defined as a T-score of -2.5 or lower, meaning a bone mineral density that is two and a half standard deviations below the mean BMD of a healthy population of women at peak bone mass (30 years).



  Outcome Measures
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1.  Primary:   Percent Change From Baseline in Surface-to-Curve Ratio (SCR) in the Distal Radius at Month 18 Endpoint   [ Time Frame: Baseline, 18 months ]

2.  Secondary:   Percent Change From Baseline in Surface-to-Curve Ratio (SCR) in the Distal Radius at Month 24 Endpoint   [ Time Frame: Baseline, 24 months ]

3.  Secondary:   Percent Change From Baseline in Cortical Thickness (CT) in the Distal Radius at Month 18 and 24 Endpoint   [ Time Frame: Baseline, 18, 24 months ]

4.  Secondary:   Percent Change From Baseline in Topological Erosion Index (TEI) in the Distal Radius at Month 18 and 24 Endpoint   [ Time Frame: Baseline, 18, 24 months ]

5.  Secondary:   Percent Change From Baseline in Bone Volume (BV)/Total Volume (TV) Ratio in the Distal Radius at Month 18 and 24 Endpoint   [ Time Frame: Baseline, 18, 24 months ]

6.  Secondary:   Percent Change From Baseline in Surface-to-Curve Ratio (SCR) at Month 3, 6, 12, 18 and 24 Endpoint   [ Time Frame: Baseline, 3, 6, 12, 18, 24 months ]

7.  Secondary:   Percent Change From Baseline in Volumetric Bone Mineral Density (BMD) of Lumbar Spine at Month 18 Endpoint   [ Time Frame: Baseline, 18 months ]

8.  Secondary:   Percent Change From Baseline in Volumetric Bone Mineral Density (BMD) of Hip at Month 18 Endpoint   [ Time Frame: Baseline, 18 months ]

9.  Secondary:   Percent Change From Baseline in the Estimate of Bone Strength of Lumbar Spine at Month 18 Endpoint   [ Time Frame: Baseline, 18 months ]

10.  Secondary:   Percent Change From Baseline in the Estimate of Bone Strength of Hip at Month 18 Endpoint   [ Time Frame: Baseline, 18 months ]

11.  Secondary:   Percent Change From Baseline in Areal BMD at the Lumbar Spine at Month 18 and 24 Endpoint   [ Time Frame: Baseline, 18, 24 months ]

12.  Secondary:   Percent Change From Baseline in Areal BMD at the Femoral Neck at Month 18 and 24 Endpoint   [ Time Frame: Baseline, 18, 24 months ]

13.  Secondary:   Percent Change From Baseline in Areal BMD Responses at Total Hip at Month 18 and 24 Endpoint   [ Time Frame: Baseline, 18, 24 months ]

14.  Secondary:   Percent Change From Baseline in Areal BMD at ⅓ Distal Radius at Month 18 and 24 Endpoint   [ Time Frame: Baseline, 18, 24 months ]

15.  Secondary:   Percent Change From Baseline in Areal BMD at Ultra-Distal Radius at Month 18 and 24 Endpoint   [ Time Frame: Baseline, 18, 24 months ]

16.  Secondary:   Percent Change From Baseline in Serum Procollagen Type I N-Terminal Propeptide (PINP) at Month 3, 6 and 24 Endpoint   [ Time Frame: Baseline, 3, 6, 24 months ]

17.  Secondary:   Percent Change From Baseline in Serum Carboxyterminal Cross-Linking Telopeptide of Type I Collagen (CTX) at Month 3, 6 and 24 Endpoint   [ Time Frame: Baseline, 3, 6, 24 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


No publications provided


Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT00557310     History of Changes
Other Study ID Numbers: 11996, B3D-US-GHDJ
Study First Received: November 9, 2007
Results First Received: October 7, 2011
Last Updated: October 7, 2011
Health Authority: United States: Institutional Review Board
Canada: Ethics Review Committee