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Effects of Teriparatide or Zoledronic Acid Treatment on Bone in Postmenopausal Osteoporotic Women

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00927186
First received: June 22, 2009
Last updated: February 21, 2013
Last verified: February 2013
History of Changes
Results First Received: October 7, 2011  
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: Osteoporosis, Post-menopausal
Interventions: Drug: Teriparatide
Drug: Zoledronic Acid

  Participant Flow
  Hide 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
This was a Phase 4, multicenter, randomized, stratified, double-blind, active comparator-controlled study with the primary endpoint at 6 months. Following the bone biopsy visit at 6 months, the study became open label for an additional 6 months. All participants who complete 12 months of treatment are eligible for an additional 12-month extension.

Reporting Groups
  Description
Teriparatide

20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind.

After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
Zoledronic Acid

5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind.

After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.

Participant Flow for 2 periods

 Period 1:   12 Months Primary Study
    Teriparatide     Zoledronic Acid  
STARTED     34     35  
Completed 6 Months Double Blind Phase     28     31  
COMPLETED     27     31  
NOT COMPLETED     7     4  
Adverse Event                 5                 2  
Lost to Follow-up                 1                 0  
Protocol Violation                 0                 1  
Withdrawal by Subject                 1                 1  

Period 2:   12 - 24 Months Extension Treatment
    Teriparatide     Zoledronic Acid  
STARTED     10 [1]   11 [1]
COMPLETED     10     11  
NOT COMPLETED     0     0  
[1] Not all participants who completed 12 months of primary study chose to enter 12-month extension.



  Baseline Characteristics
  Hide Baseline Characteristics

Reporting Groups
  Description
Teriparatide 20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
Zoledronic Acid 5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
Total Total of all reporting groups

Baseline Measures
    Teriparatide     Zoledronic Acid     Total  
Number of Participants  
[units: participants]
 		  34     35     69  
Age  
[units: years]
Mean ± Standard Deviation 		  65.49  ± 6.93     64.20  ± 5.96     64.84  ± 6.44  
Gender  
[units: participants]
 		     
Female     34     35     69  
Male     0     0     0  
Race/Ethnicity, Customized  
[units: participants]
 		     
Black or African American     1     1     2  
White     33     34     67  
Region of Enrollment  
[units: participants]
 		     
United States     21     25     46  
Canada     13     10     23  
Height  
[units: centimeters (cm)]
Mean ± Standard Deviation 		  159.28  ± 5.92     160.00  ± 7.38     159.64  ± 6.66  
Weight  
[units: kilograms (kg)]
Mean ± Standard Deviation 		  61.25  ± 9.21     64.75  ± 11.66     63.03  ± 10.60  
Pulse  
[units: beats per minute (bpm)]
Mean ± Standard Deviation 		  67.41  ± 7.15     70.60  ± 8.79     69.03  ± 8.13  
Blood Pressure - Systolic  
[units: millimeters of mercury (mmHg)]
Mean ± Standard Deviation 		  125.71  ± 16.19     122.49  ± 16.25     124.07  ± 16.18  
Blood Pressure - Diastolic  
[units: mmHg]
Mean ± Standard Deviation 		  74.79  ± 8.24     73.97  ± 10.15     74.38  ± 9.20  
Alcohol Use  
[units: participants]
 		     
Yes     21     17     38  
No     13     18     31  
Tobacco Use  
[units: participants]
 		     
Yes     5     5     10  
No     29     30     59  
Caffeine or Xanthine Use  
[units: participants]
 		     
Yes     29     30     59  
No     5     5     10  
Previous Osteoporosis Therapy  
[units: participants]
 		     
Yes     17     21     38  
No     17     14     31  
Fracture Status [1]
[units: participants]
 		     
Yes     14     17     31  
No     20     18     38  
Lumbar Spine T-Score [2]
[units: T-Score]
Mean ± Standard Deviation 		  -2.79  ± 0.83     -2.93  ± 0.75     -2.86  ± 0.79  
Femoral Neck T-Score [3]
[units: T-Score]
Mean ± Standard Deviation 		  -2.25  ± 0.68     -2.29  ± 0.74     -2.27  ± 0.70  
Total Hip T-Score [4]
[units: T-Score]
Mean ± Standard Deviation 		  -1.78  ± 0.78     -1.88  ± 0.91     -1.83  ± 0.84  
Serum Procollagen Type I N-Terminal Propeptide (PINP) [5]
[units: microgram/Liter (µg/L)]
Mean ± Standard Deviation 		  49.18  ± 18.28     52.88  ± 19.43     51.03  ± 18.81  
Serum Carboxyterminal Cross-Linking Telopeptide of Collagen Type I (CTX) [6]
[units: nanogram/milliliter (ng/mL)]
Mean ± Standard Deviation 		  0.43  ± 0.23     0.42  ± 0.19     0.43  ± 0.21  
Serum Osteocalcin [7]
[units: microgram/Liter (µg/L)]
Mean ± Standard Deviation 		  25.05  ± 8.37     24.92  ± 8.53     24.98  ± 8.39  
[1] Yes means a participant has already had fracture before study entry.
[2] The T-score at lumbar spine is a comparison of a participant'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).
[3] The T-score at femoral neck is a comparison of a participant'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).
[4] The T-score at total hip is a comparison of a participant'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).
[5] A measure of bone formation.
[6] A measure of bone resorption.
[7] A measure of osteoblast function.



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Mineralizing Surface/Bone Surface (MS/BS) in the Cancellous Compartment (CC) of Iliac Crest Bone Biopsies at 6 Months   [ Time Frame: 6 months ]
  Show Outcome Measure 1

2.  Secondary:   Mineralizing Surface/Bone Surface (MS/BS) in the Cancellous Compartment (CC) of Iliac Crest Bone Biopsies at 24 Months   [ Time Frame: 24 months ]
  Show Outcome Measure 2

3.  Secondary:   Mineralizing Surface/Bone Surface(MS/BS) in the Endocortical Compartment (EC) of Iliac Crest Bone Biopsies at 6 and 24 Months   [ Time Frame: 6 and 24 months ]
  Hide Outcome Measure 3

Measure Type Secondary
Measure Title Mineralizing Surface/Bone Surface(MS/BS) in the Endocortical Compartment (EC) of Iliac Crest Bone Biopsies at 6 and 24 Months
Measure Description MS/BS in EC is a measure of the proportion of BS on which new mineralized bone is deposited at the time of tetracycline (T) labeling and is calculated as sum of total extent of double label (DL) plus half the extent of single label (SL) divided by BS. Participants were given T for two 3-day periods, 14 days apart. T fluoresces under certain light and temporarily binds to new bone. New bone in the biopsy is seen as the amount of bone between 2 fluorescently T labeled lines under a microscope. DL indicates active bone formation, SL or no label (NL) suggests suppression of bone formation.
Time Frame 6 and 24 months  
Safety Issue No  

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.
All participants who received at least one dose of study drug with an evaluable bone biopsy and had MS/BS analysis of the EC at 6 and 24 months.

Reporting Groups
  Description
Teriparatide

20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind.

After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
Zoledronic Acid

5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind.

After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.

Measured Values
    Teriparatide     Zoledronic Acid  
Number of Participants Analyzed  
[units: participants]
 		  23     29  
Mineralizing Surface/Bone Surface(MS/BS) in the Endocortical Compartment (EC) of Iliac Crest Bone Biopsies at 6 and 24 Months  
[units: percentage of surface]
Median ( Inter-Quartile Range ) 		   
6 months (n=23, 29)     18.64  
  ( 9.25 to 21.96 )   		  0.30  
  ( 0.00 to 0.84 )  
24 months (n=9, 8)     5.82  
  ( 3.10 to 7.08 )   		  0.00  
  ( 0.00 to 0.91 )  


Statistical Analysis 1 for Mineralizing Surface/Bone Surface(MS/BS) in the Endocortical Compartment (EC) of Iliac Crest Bone Biopsies at 6 and 24 Months
Groups [1] All groups
Method [2] Wilcoxon (Mann-Whitney)
P Value [3] <0.001
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  P-value is for 6 months.

Statistical Analysis 2 for Mineralizing Surface/Bone Surface(MS/BS) in the Endocortical Compartment (EC) of Iliac Crest Bone Biopsies at 6 and 24 Months
Groups [1] All groups
Method [2] Wilcoxon (Mann-Whitney)
P Value [3] 0.002
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  P-value is for 24 months.



4.  Secondary:   Activation Frequency (Ac.f) in the Cancellous Compartment (CC) of Iliac Crest Bone Biopsies at 6 Months   [ Time Frame: 6 months ]
  Show Outcome Measure 4

5.  Secondary:   Activation Frequency (Ac.f) in the Cancellous Compartment (CC) of Iliac Crest Bone Biopsies at 24 Months   [ Time Frame: 24 months ]
  Show Outcome Measure 5

6.  Secondary:   Activation Frequency (Ac.f) in the Endocortical Compartment (EC) of Iliac Crest Bone Biopsies at 6 and 24 Months   [ Time Frame: 6 and 24 months ]
  Show Outcome Measure 6

7.  Secondary:   Bone Formation Rate (BFR) in the Cancellous Compartment (CC) of Iliac Crest Bone Biopsies at 6 Months   [ Time Frame: 6 months ]
  Show Outcome Measure 7

8.  Secondary:   Bone Formation Rate (BFR) in the Cancellous Compartment (CC) of Iliac Crest Bone Biopsies at 24 Months   [ Time Frame: 24 months ]
  Show Outcome Measure 8

9.  Secondary:   Bone Formation Rate (BFR) in the Endocortical Compartment (EC) of Iliac Crest Bone Biopsies at 6 and 24 Months   [ Time Frame: 6 and 24 months ]
  Show Outcome Measure 9

10.  Secondary:   Mineral Apposition Rate (MAR) in the Cancellous Compartment (CC) of Iliac Crest Bone Biopsies at 6 Months   [ Time Frame: 6 months ]
  Show Outcome Measure 10

11.  Secondary:   Mineral Apposition Rate (MAR) in the Cancellous Compartment (CC) of Iliac Crest Bone Biopsies at 24 Months   [ Time Frame: 24 months ]
  Show Outcome Measure 11

12.  Secondary:   Mineral Apposition Rate (MAR) in the Endocortical Compartment (EC) of Iliac Crest Bone Biopsies at 6 and 24 Months   [ Time Frame: 6 and 24 months ]
  Show Outcome Measure 12

13.  Secondary:   Adjusted Apposition Rate (Aj.AR) in the Cancellous Compartment (CC) of Iliac Crest Bone Biopsies at 6 Months   [ Time Frame: 6 months ]
  Show Outcome Measure 13

14.  Secondary:   Adjusted Apposition Rate (Aj.AR) in the Cancellous Compartment (CC) of Iliac Crest Bone Biopsies at 24 Months   [ Time Frame: 24 months ]
  Show Outcome Measure 14

15.  Secondary:   Adjusted Apposition Rate (Aj.AR) in the Endocortical Compartment (EC) of Iliac Crest Bone Biopsies at 6 and 24 Months   [ Time Frame: 6 and 24 months ]
  Show Outcome Measure 15

16.  Secondary:   Mineralization Lag Time (Mlt) in the Cancellous Compartment (CC) of Iliac Crest Bone Biopsies at 6 Months   [ Time Frame: 6 months ]
  Show Outcome Measure 16

17.  Secondary:   Mineralization Lag Time (Mlt) in the Cancellous Compartment (CC) of Iliac Crest Bone Biopsies at 24 Months   [ Time Frame: 24 months ]
  Show Outcome Measure 17

18.  Secondary:   Mineralization Lag Time (Mlt) in the Endocortical Compartment (EC) of Iliac Crest Bone Biopsies at 6 and 24 Months   [ Time Frame: 6 and 24 months ]
  Show Outcome Measure 18

19.  Secondary:   Osteoid Maturation Time (Omt) in the Cancellous Compartment (CC) of Iliac Crest Bone Biopsies at 6 Months   [ Time Frame: 6 months ]
  Show Outcome Measure 19

20.  Secondary:   Osteoid Maturation Time (Omt) in the Cancellous Compartment (CC) of Iliac Crest Bone Biopsies at 24 Months   [ Time Frame: 24 months ]
  Show Outcome Measure 20

21.  Secondary:   Osteoid Maturation Time (Omt) in the Endocortical Compartment (EC) of Iliac Crest Bone Biopsies at 6 and 24 Months   [ Time Frame: 6 and 24 Months ]
  Show Outcome Measure 21

22.  Secondary:   Total Formation Period (Tt.FP) in the Cancellous Compartment (CC) of Iliac Crest Bone Biopsies at 6 Months   [ Time Frame: 6 months ]
  Show Outcome Measure 22

23.  Secondary:   Total Formation Period (Tt.FP) in the Cancellous Compartment (CC) of Iliac Crest Bone Biopsies at 24 Months   [ Time Frame: 24 months ]
  Show Outcome Measure 23

24.  Secondary:   Total Formation Period (Tt.FP) in the Endocortical Compartment (EC) of Iliac Crest Bone Biopsies at 6 and 24 Months   [ Time Frame: 6 and 24 months ]
  Show Outcome Measure 24

25.  Secondary:   Active Formation Period (a.FP) in the Cancellous Compartment (CC) of Iliac Crest Bone Biopsies at 6 Months   [ Time Frame: 6 months ]
  Show Outcome Measure 25

26.  Secondary:   Active Formation Period (a.FP) in the Cancellous Compartment (CC) of Iliac Crest Bone Biopsies at 24 Months   [ Time Frame: 24 months ]
  Show Outcome Measure 26

27.  Secondary:   Active Formation Period (a.FP) in the Endocortical Compartment (EC) of Iliac Crest Bone Biopsies at 6 and 24 Months   [ Time Frame: 6 and 24 months ]
  Show Outcome Measure 27

28.  Secondary:   Percent of Single or Double Tetracycline Labels Per Bone Surface (sLS/BS), (dLS/BS) in the Cancellous Compartment of Iliac Crest Bone Biopsies at 6 Months   [ Time Frame: 6 months ]
  Show Outcome Measure 28

29.  Secondary:   Percent of Single or Double Tetracycline Labels Per Bone Surface (sLS/BS), (dLS/BS) in the Cancellous Compartment of Iliac Crest Bone Biopsies at 24 Months   [ Time Frame: 24 months ]
  Show Outcome Measure 29

30.  Secondary:   Percent of Single or Double Tetracycline Labels Per Bone Surface (sLS/BS), (dLS/BS) in the Endocortical Compartment of Iliac Crest Bone Biopsies at 6 and 24 Months   [ Time Frame: 6 and 24 months ]
  Show Outcome Measure 30

31.  Secondary:   Number of Samples With Single or Double Tetracycline Labels, Single and Double Labels, or No Tetracycline Labels in the Cancellous Compartment of Iliac Crest Bone Biopsies at 6 Months   [ Time Frame: 6 months ]
  Show Outcome Measure 31

32.  Secondary:   Number of Samples With Single or Double Tetracycline Labels, Single and Double Labels, or No Tetracycline Labels in the Cancellous Compartment of Iliac Crest Bone Biopsies at 24 Months   [ Time Frame: 24 months ]
  Show Outcome Measure 32

33.  Secondary:   Number of Samples With Single or Double Tetracycline Labels, Single and Double Labels, or No Tetracycline Labels in the Endocortical Compartment of Iliac Crest Bone Biopsies at 6 and 24 Months   [ Time Frame: 6 and 24 months ]
  Show Outcome Measure 33

34.  Secondary:   Average Length of Tetracycline Double Labels in the Cancellous Compartment of Iliac Crest Bone Biopsies at 6 Months   [ Time Frame: 6 months ]
  Show Outcome Measure 34

35.  Secondary:   Average Length of Tetracycline Double Labels in the Cancellous Compartment of Iliac Crest Bone Biopsies at 24 Months   [ Time Frame: 24 months ]
  Show Outcome Measure 35

36.  Secondary:   Average Length of Tetracycline Double Labels in the Endocortical Compartment of Iliac Crest Bone Biopsies at 6 and 24 Months   [ Time Frame: 6 and 24 months ]
  Show Outcome Measure 36

37.  Secondary:   Percentage of Osteoid Volume (OV)/Bone Volume (BV) in the Cancellous Compartment of Iliac Crest Bone Biopsies at 6 Months   [ Time Frame: 6 months ]
  Show Outcome Measure 37

38.  Secondary:   Percentage of Osteoid Volume (OV)/Bone Volume (BV) in the Cancellous Compartment of Iliac Crest Bone Biopsies at 24 Months   [ Time Frame: 24 months ]
  Show Outcome Measure 38

39.  Secondary:   Percentage of Osteoid Surface (OS)/Bone Surface (BS) in the Cancellous Compartment of Iliac Crest Bone Biopsies at 6 Months   [ Time Frame: 6 months ]
  Show Outcome Measure 39

40.  Secondary:   Percentage of Osteoid Surface (OS)/Bone Surface (BS) in the Cancellous Compartment of Iliac Crest Bone Biopsies at 24 Months   [ Time Frame: 24 months ]
  Show Outcome Measure 40

41.  Secondary:   Percentage of Osteoid Surface (OS)/Bone Surface (BS) in the Endocortical Compartment of Iliac Crest Bone Biopsies at 6 and 24 Months   [ Time Frame: 6 and 24 months ]
  Show Outcome Measure 41

42.  Secondary:   Osteoid Thickness (OTh.) in the Cancellous Compartment of Iliac Crest Bone Biopsies at 6 Months   [ Time Frame: 6 months ]
  Show Outcome Measure 42

43.  Secondary:   Osteoid Thickness (OTh.) in the Cancellous Compartment of Iliac Crest Bone Biopsies at 24 Months   [ Time Frame: 24 months ]
  Show Outcome Measure 43

44.  Secondary:   Osteoid Thickness (OTh.) in the Endocortical Compartment of Iliac Crest Bone Biopsies at 6 and 24 Months   [ Time Frame: 6 and 24 months ]
  Show Outcome Measure 44

45.  Secondary:   Wall Thickness (WTh.) in the Cancellous Compartment of Iliac Crest Bone Biopsies at 6 Months   [ Time Frame: 6 months ]
  Show Outcome Measure 45

46.  Secondary:   Wall Thickness (WTh.) in the Cancellous Compartment of Iliac Crest Bone Biopsies at 24 Months   [ Time Frame: 24 months ]
  Show Outcome Measure 46

47.  Secondary:   Wall Thickness (WTh.) in the Endocortical Compartment of Iliac Crest Bone Biopsies at 6 and 24 Months   [ Time Frame: 6 and 24 months ]
  Show Outcome Measure 47

48.  Secondary:   Percentage of Eroded Surface/Bone Surface (ES/BS) in the Cancellous Compartment of Iliac Crest Bone Biopsies at 6 Months   [ Time Frame: 6 months ]
  Show Outcome Measure 48

49.  Secondary:   Percentage of Eroded Surface/Bone Surface (ES/BS) in the Cancellous Compartment of Iliac Crest Bone Biopsies at 24 Months   [ Time Frame: 24 months ]
  Show Outcome Measure 49

50.  Secondary:   Percentage of Eroded Surface/Bone Surface (ES/BS) in the Endocortical Compartment of Iliac Crest Bone Biopsies at 6 and 24 Months   [ Time Frame: 6 and 24 months ]
  Show Outcome Measure 50

51.  Secondary:   Change From Baseline in Serum Carboxyterminal Cross-Linking Telopeptide of Type I Collagen (CTX) at Month 1, 3 and 6 Endpoint   [ Time Frame: Baseline, 1, 3, 6 months ]
  Show Outcome Measure 51

52.  Secondary:   Change From Baseline in Serum Carboxyterminal Cross-Linking Telopeptide of Type I Collagen (CTX) at Month 12 Endpoint   [ Time Frame: Baseline, 12 months ]
  Show Outcome Measure 52

53.  Secondary:   Change From Baseline in Serum Procollagen Type I N-Terminal Propeptide (PINP) at Month 1, 3 and 6 Endpoint   [ Time Frame: Baseline, 1, 3, 6 months ]
  Show Outcome Measure 53

54.  Secondary:   Change From Baseline in Serum Procollagen Type I N-Terminal Propeptide (PINP) at Month 12 Endpoint   [ Time Frame: Baseline, 12 months ]
  Show Outcome Measure 54

55.  Secondary:   Change From Baseline in Serum Osteocalcin (OC) at Month 1, 3, and 6 Endpoint   [ Time Frame: Baseline, 1, 3, 6 months ]
  Show Outcome Measure 55

56.  Secondary:   Change From Baseline in Serum Osteocalcin (OC) at Month 12 Endpoint   [ Time Frame: Baseline, 12 months ]
  Show Outcome Measure 56


  Serious Adverse Events
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  Other Adverse Events
  Show Other Adverse Events


  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.


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.  


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: NCT00927186     History of Changes
Other Study ID Numbers: 13032, B3D-US-GHDL
Study First Received: June 22, 2009
Results First Received: October 7, 2011
Last Updated: February 21, 2013
Health Authority: United States: Institutional Review Board