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A Study That Will Compare the Effect of Two Drugs on Participants With Low Bone Mass and a Recent Hip Fracture (MOVE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00887354
First received: April 23, 2009
Last updated: January 27, 2017
Last verified: January 2017
Results First Received: July 15, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Participant, Care Provider, Investigator, Outcomes Assessor;   Primary Purpose: Treatment
Condition: Osteoporosis
Interventions: Drug: Teriparatide
Drug: Risedronate
Drug: Placebo
Dietary Supplement: Calcium
Dietary Supplement: Vitamin D

  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
Full Analysis Set (FAS) is defined as all randomized participants receiving at least one dose of study drug with at least one post-baseline efficacy measure.

Reporting Groups
  Description
Teriparatide

20 microgram (mcg) a day by subcutaneous (SC) injection throughout study.

Calcium: Approximately 500 to 1000 milligram per day (mg/day) administered orally throughout study.

Vitamin D: Approximately 800 International Units per day (IU/day) administered orally throughout study.

Risedronate

35 mg risedronate sodium orally once weekly throughout study.

Calcium: Approximately 500 to 1000 mg/day administered orally throughout study.

Vitamin D: Approximately 800 International Units per day (IU/day) administered orally throughout study.


Participant Flow for 2 periods

Period 1:   Treatment Phase (Week 0 to Week 26)
    Teriparatide   Risedronate
STARTED   111   113 
Received at Least 1 Dose of Study Drug   106   110 
Included in Full Analysis Set   86   85 
COMPLETED   60   65 
NOT COMPLETED   51   48 
Death                0                1 
Sponsor Decision                1                1 
Physician Decision                2                1 
Withdrawal by Subject                14                8 
Adverse Event                3                3 
Lost to Follow-up                2                1 
Entry Criteria Not Met                3                3 
Caregiver Decision                1                2 
No efficacy data                20                25 
Not Treated                5                3 

Period 2:   Open Label Phase (Week 26 to Week 78)
    Teriparatide   Risedronate
STARTED   60   65 
COMPLETED   57   59 
NOT COMPLETED   3   6 
Death                0                2 
Physician Decision                0                1 
Withdrawal by Subject                1                2 
Adverse Event                1                0 
Lost to Follow-up                1                1 



  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 one dose of study drug and with at least one post-baseline efficacy measure.

Reporting Groups
  Description
Teriparatide

20 mcg a day by SC injection throughout study.

Calcium: Approximately 500 to 1000 mg/day administered orally throughout study.

Vitamin D: Approximately 800 International Units per day (IU/day) administered orally throughout study.

Risedronate

35 mg risedronate sodium orally once weekly throughout study.

Calcium: Approximately 500 to 1000 mg/day administered orally throughout study.

Vitamin D: Approximately 800 International Units per day (IU/day) administered orally throughout study.

Total Total of all reporting groups

Baseline Measures
   Teriparatide   Risedronate   Total 
Overall Participants Analyzed 
[Units: Participants]
 86   85   171 
Age 
[Units: Years]
Mean (Standard Deviation)
 77.2  (7.96)   76.4  (7.47)   76.8  (7.71) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      66  76.7%      66  77.6%      132  77.2% 
Male      20  23.3%      19  22.4%      39  22.8% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0% 
Asian      0   0.0%      0   0.0%      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      0   0.0%      0   0.0%      0   0.0% 
White      86 100.0%      85 100.0%      171 100.0% 
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% 
Region of Enrollment 
[Units: Participants]
     
Greece   3   4   7 
Canada   0   2   2 
Czech Republic   8   12   20 
United States   1   4   5 
Norway   5   2   7 
Denmark   13   9   22 
Italy   16   10   26 
Mexico   6   12   18 
France   5   8   13 
Germany   2   1   3 
Spain   21   19   40 
United Kingdom   1   0   1 
Austria   1   0   1 
Ireland   1   0   1 
Sweden   3   2   5 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change in Lumbar Spine Areal Bone Mineral Density (BMD)   [ Time Frame: Baseline, Week 78 ]

2.  Secondary:   Change in Lumbar Spine Areal Bone Mineral Density   [ Time Frame: Baseline, Week 26; Baseline, Week 52 ]

3.  Secondary:   Change in Areal Bone Mineral Density Measured at the Femoral Neck and Total Hip of the Non-Fractured Limb   [ Time Frame: Baseline, Week 26; Baseline, Week 52; Baseline, Week 78 ]

4.  Secondary:   Change From Baseline in Physical Component Summary of the Short Form-36 (SF-36) Questionnaire   [ Time Frame: Baseline, Week 6; Baseline, Week 12; Baseline, Week 18; Baseline, Week 26 ]

5.  Secondary:   Percentage of Participants Reporting Hip Pain in Modification of the Charnley's Pain Scale   [ Time Frame: Baseline ]

6.  Secondary:   Visual Analog Scale (VAS)   [ Time Frame: 6, 12, 18, and 26 Weeks ]

7.  Secondary:   Timed "Up and Go" Test   [ Time Frame: 6, 12, 18, and 26 Weeks ]


  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
No text entered.


  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 more than 60 days but less than or equal to 180 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: NCT00887354     History of Changes
Other Study ID Numbers: 12400
B3D-EW-GHDK ( Other Identifier: Eli Lilly and Company )
Study First Received: April 23, 2009
Results First Received: July 15, 2016
Last Updated: January 27, 2017