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A Study of LY2541546 in Women With Low Bone Mineral Density

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ClinicalTrials.gov Identifier: NCT01144377
Recruitment Status : Completed
First Posted : June 15, 2010
Results First Posted : December 4, 2017
Last Update Posted : December 4, 2017
Sponsor:
Information provided by (Responsible Party):

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition: Osteoporosis
Interventions: Drug: LY2541546
Drug: Placebo

  Participant Flow

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
After exposure to study medication for the 52 week treatment phase, participants entered a 12 week non-treatment safety follow-up period with the option of staying in the non-treatment safety follow-up period for an additional 40 weeks (for a total of 52 weeks follow-up for the main study participants only).

Reporting Groups
  Description
180 mg LY2541546 Q4W + Placebo LY2541546 + Placebo: 180 milligrams (mg) LY2541546 administered subcutaneously every 4 weeks (Q4W) for 52 weeks with Placebo administered subcutaneously every alternate 2 weeks from the LY2541546 dose for 52 weeks. After exposure to study medication for the 52 week treatment phase, participants entered a 12 week non-treatment safety follow-up period with the option of staying in the non-treatment safety follow-up period for an additional 40 weeks (for a total of 52 weeks follow-up for the main study participants only).
180 mg LY2541546 Q2W LY2541546: 180 mg administered subcutaneously every 2 weeks (Q2W) for 52 weeks. After exposure to study medication for the 52 week treatment phase, participants entered a 12 week non-treatment safety follow-up period with the option of staying in the non-treatment safety follow-up period for an additional 40 weeks (for a total of 52 weeks follow-up for the main study participants only).
270 mg LY2541546 Q2W LY2541546: 270 mg administered subcutaneously every 2 weeks (Q2W) for 52 weeks. After exposure to study medication for the 52 week treatment phase, participants entered a 12 week non-treatment safety follow-up period with the option of staying in the non-treatment safety follow-up period for an additional 40 weeks (for a total of 52 weeks follow-up for the main study participants only).
270 mg LY2541546 Q12W + Placebo LY2541546 + Placebo: 270 mg LY2541546 administered subcutaneously every 12 weeks (Q12W) with Placebo administered subcutaneously every 2 weeks when LY2541546 is not administered for 52 weeks. After exposure to study medication for the 52 week treatment phase, participants entered a 12 week non-treatment safety follow-up period with the option of staying in the non-treatment safety follow-up period for an additional 40 weeks (for a total of 52 weeks follow-up for the main study participants only).
Placebo Q2W Placebo: administered subcutaneously every 2 weeks (Q2W) for 52 weeks. After exposure to study medication for the 52 week treatment phase, participants entered a 12 week non-treatment safety follow-up period with the option of staying in the non-treatment safety follow-up period (for an additional 40 weeks for a total of 52 weeks follow-up for the main study participants only).

Participant Flow for 3 periods

Period 1:   52 Week Treatment Period
    180 mg LY2541546 Q4W + Placebo   180 mg LY2541546 Q2W   270 mg LY2541546 Q2W   270 mg LY2541546 Q12W + Placebo   Placebo Q2W
STARTED   31   30   30   26   37 
Received at Least One Dose of Study Drug   31   30   30   25   37 
COMPLETED   26   29   25   22   34 
NOT COMPLETED   5   1   5   4   3 
Adverse Event                0                0                3                2                1 
Entry Criteria Not Met                0                0                1                1                0 
Protocol Violation                0                0                0                0                1 
Lost to Follow-up                1                0                0                0                0 
Withdrawal by Subject                4                1                1                1                0 
Sponsor Decision                0                0                0                0                1 

Period 2:   12 Week Safety Follow-up Period
    180 mg LY2541546 Q4W + Placebo   180 mg LY2541546 Q2W   270 mg LY2541546 Q2W   270 mg LY2541546 Q12W + Placebo   Placebo Q2W
STARTED   26   29   25   22   34 
COMPLETED   26 [1]   29 [2]   25 [3]   22 [4]   34 [5] 
NOT COMPLETED   0   0   0   0   0 
[1] Of the 26 participants who completed this Period, 22 continued to the Optional 40 Week follow-up.
[2] Of the 29 participants who completed this Period, 25 continued to the Optional 40 Week follow-up.
[3] Of the 25 participants who completed this Period, 23 continued to the Optional 40 Week follow-up.
[4] Of the 22 participants who completed this Period, 3 continued to the Optional 40 Week follow-up.
[5] Of the 34 participants who completed this Period, 23 continued to the Optional 40 Week follow-up.

Period 3:   Optional 40 Week Safety Follow-up Period
    180 mg LY2541546 Q4W + Placebo   180 mg LY2541546 Q2W   270 mg LY2541546 Q2W   270 mg LY2541546 Q12W + Placebo   Placebo Q2W
STARTED   22   25   23   3   23 
COMPLETED   21   24   23   3   21 
NOT COMPLETED   1   1   0   0   2 
Adverse Event                0                1                0                0                1 
Lost to Follow-up                0                0                0                0                1 
Sponsor Decision                1                0                0                0                0 



  Baseline Characteristics

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.
Participants who received at least one dose of study drug.

Reporting Groups
  Description
180 mg LY2541546 Q4W + Placebo LY2541546 + Placebo: 180 milligrams (mg) LY2541546 administered subcutaneously every 4 weeks (Q4W) for 52 weeks with Placebo administered subcutaneously every alternate 2 weeks from the LY2541546 dose for 52 weeks.
180 mg LY2541546 Q2W LY2541546: 180 mg administered subcutaneously every 2 weeks (Q2W) for 52 weeks.
270 mg LY2541546 Q2W LY2541546: 270 mg administered subcutaneously every 2 weeks (Q2W) for 52 weeks.
270 mg LY2541546 Q12W + Placebo LY2541546 + Placebo: 270 mg LY2541546 administered subcutaneously every 12 weeks (Q12W) with Placebo administered subcutaneously every 2 weeks when LY2541546 is not administered for 52 weeks.
Placebo Q2W Placebo: administered subcutaneously every 2 weeks (Q2W) for 52 weeks.
Total Total of all reporting groups

Baseline Measures
   180 mg LY2541546 Q4W + Placebo   180 mg LY2541546 Q2W   270 mg LY2541546 Q2W   270 mg LY2541546 Q12W + Placebo   Placebo Q2W   Total 
Overall Participants Analyzed 
[Units: Participants]
 31   30   30   25   37   153 
Age 
[Units: Years]
Mean (Standard Deviation)
 66.78  (8.98)   64.17  (8.20)   66.12  (7.68)   63.56  (8.02)   65.17  (8.91)   65.22  (8.38) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
           
Female      31 100.0%      30 100.0%      30 100.0%      25 100.0%      37 100.0%      153 100.0% 
Male      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
           
Hispanic or Latino      4  12.9%      4  13.3%      2   6.7%      9  36.0%      8  21.6%      27  17.6% 
Not Hispanic or Latino      23  74.2%      24  80.0%      26  86.7%      16  64.0%      26  70.3%      115  75.2% 
Unknown or Not Reported      4  12.9%      2   6.7%      2   6.7%      0   0.0%      3   8.1%      11   7.2% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
           
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Asian      14  45.2%      13  43.3%      13  43.3%      11  44.0%      14  37.8%      65  42.5% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Black or African American      0   0.0%      0   0.0%      0   0.0%      0   0.0%      1   2.7%      1   0.7% 
White      17  54.8%      17  56.7%      17  56.7%      14  56.0%      22  59.5%      87  56.9% 
More than one race      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Region of Enrollment 
[Units: Participants]
Count of Participants
           
United States   4   6   5   11   10   36 
Estonia   4   3   5   3   4   19 
Lithuania   3   4   4   0   4   15 
Denmark   6   4   3   0   5   18 
Japan   14   13   13   11   14   65 
Lumbar Spine Bone Mineral Density (Baseline) 
[Units: Grams/square centimeter (g/cm^2)]
Mean (Standard Deviation)
 0.78  (0.09)   0.78  (0.07)   0.80  (0.09)   0.77  (0.09)   0.78  (0.09)   0.78  (0.09) 
Femoral Neck Bone Mineral Density (Baseline) 
[Units: G/cm^2]
Mean (Standard Deviation)
 0.66  (0.15)   0.66  (0.15)   0.69  (0.11)   0.63  (0.11)   0.66  (0.17)   0.66  (0.14) 
Total Hip Bone Mineral Density (Baseline) 
[Units: Grams/square centimeter]
Mean (Standard Deviation)
 0.75  (0.11)   0.75  (0.13)   0.77  (0.10)   0.73  (0.11)   0.73  (0.14)   0.75  (0.12) 


  Outcome Measures

1.  Primary:   Change From Baseline to 52 Week Endpoint in Lumbar Spine Bone Mineral Density (BMD)   [ Time Frame: Baseline, 52 weeks ]

2.  Secondary:   Change From Baseline to 12, 24, and 64 Weeks in Lumbar Spine Bone Mineral Density (BMD)   [ Time Frame: Baseline, 12 weeks and 24 weeks and 64 weeks ]

3.  Secondary:   Change From Baseline to 24, 52, and 64 Weeks in Proximal Femur Bone Mineral Density (BMD)   [ Time Frame: Baseline, 24 weeks and 52 weeks and 64 weeks ]

4.  Secondary:   Change From Baseline to 52 Week Endpoint in Wrist Bone Mineral Density (BMD)   [ Time Frame: Baseline, 52 weeks ]

5.  Secondary:   Change From Baseline to 52 Week Endpoint in Bone-specific Alkaline Phosphatase (BSAP)   [ Time Frame: Baseline, 52 weeks ]

6.  Secondary:   Change From Baseline to 52 Week Endpoint in Serum Type I Collagen Fragment (CTx)   [ Time Frame: Baseline, 52 weeks ]

7.  Secondary:   Change From Baseline to 52 Week Endpoint in Osteocalcin   [ Time Frame: Baseline, 52 weeks ]

8.  Secondary:   Change From Baseline to 52 Week Endpoint in Serum N-terminal Extension Propeptide of Type I Collagen (P1NP)   [ Time Frame: Baseline, 52 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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
No text entered.


  More Information

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: NCT01144377     History of Changes
Other Study ID Numbers: 11953
I2M-MC-GSDB ( Other Identifier: Eli Lilly and Company )
First Submitted: June 11, 2010
First Posted: June 15, 2010
Results First Submitted: September 27, 2017
Results First Posted: December 4, 2017
Last Update Posted: December 4, 2017