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A Study to Examine the Effects of an Experimental Drug on Women With Breast Cancer and Metastatic Bone Disease (MBD)(0822-016)(COMPLETED)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00399802
Recruitment Status : Completed
First Posted : November 15, 2006
Results First Posted : February 1, 2018
Last Update Posted : February 1, 2018
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions: Breast Cancer
Metastatic Bone Disease
Interventions: Drug: ZA
Drug: Odanacatib
Drug: Odanacatib matching placebo
Drug: ZA matching 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
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Reporting Groups
  Description
Single Intravenous (IV) Infusion of Zoledronic Acid (ZA) 4 mg Participants received a single IV infusion of ZA 4 mg at the start of treatment and a once-daily odanacatib matching placebo tablet for 4 weeks.
Once-daily Odanacatib 5 mg Participants received a once-daily odanacatib 5 mg tablet for 4 weeks and a single IV infusion of ZA matching placebo at the start of treatment.

Participant Flow:   Overall Study
    Single Intravenous (IV) Infusion of Zoledronic Acid (ZA) 4 mg   Once-daily Odanacatib 5 mg
STARTED   14   29 
COMPLETED   14   26 
NOT COMPLETED   0   3 
Adverse Event                0                2 
Participant discontinued by mistake                0                1 



  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.
No text entered.

Reporting Groups
  Description
Single IV Infusion of ZA 4 mg Participants received a single IV infusion of ZA 4 mg at the start of treatment and a once-daily odanacatib matching placebo tablet for 4 weeks.
Once-daily Odanacatib 5 mg Participants received a once-daily odanacatib 5 mg tablet for 4 weeks and a single IV infusion of ZA matching placebo at the start of treatment.
Total Total of all reporting groups

Baseline Measures
   Single IV Infusion of ZA 4 mg   Once-daily Odanacatib 5 mg   Total 
Overall Participants Analyzed 
[Units: Participants]
 14   29   43 
Age 
[Units: Years]
Mean (Standard Deviation)
 60.3  (8.3)   59.4  (10.2)   59.7  (9.5) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      14 100.0%      29 100.0%      43 100.0% 
Male      0   0.0%      0   0.0%      0   0.0% 


  Outcome Measures

1.  Primary:   Percentage Change From Baseline in Urinary N-telopeptide of Type I Collagen (u-NTx) at Week 4   [ Time Frame: Baseline and Week 4 ]

2.  Primary:   Number of Participants Who Experienced an Adverse Event (AE)   [ Time Frame: Up to 6 weeks ]

3.  Primary:   Number of Participants Who Discontinued Treatment Due to an AE   [ Time Frame: Up to 4 weeks ]

4.  Secondary:   Percentage Change From Baseline in Urinary Deoxypyridinoline (u-DPD) at Week 4   [ Time Frame: Baseline and Week 4 ]


  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
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  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 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.


Results Point of Contact:  
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
phone: 1-800-672-6372
e-mail: ClinicalTrialsDisclosure@merck.com


Publications of Results:

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00399802     History of Changes
Other Study ID Numbers: 0822-016
2006_533 ( Other Identifier: Merck Registration Number )
MK-0822-016 ( Other Identifier: Merck Protocol Number )
First Submitted: November 14, 2006
First Posted: November 15, 2006
Results First Submitted: April 5, 2017
Results First Posted: February 1, 2018
Last Update Posted: February 1, 2018