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A Study to Examine the Effects of an Experimental Drug on Postmenopausal Osteoporosis (0822-004)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00112437
First received: June 2, 2005
Last updated: October 6, 2010
Last verified: October 2010
History of Changes
Results First Received: April 13, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Osteoporosis
Interventions: Drug: MK0822
Dietary Supplement: Vitamin D3
Dietary Supplement: Calcium Carbonate
Drug: Placebo

  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
Approximately 375 patients were recruited from June 2005 to December 2005. Investigators used one or more of the following recruitment methods: Investigator Patient/Subject Database or Medical Records, Investigator's Local Recruitment/Advertising, Other Health Professional and, Physician Referral (Primary/Specialist/Family Doctor).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants entered screening followed by a 3-week placebo run-in. All took vitamin D3, 5600 IU once weekly, those with average daily calcium intakes <1000 mg took calcium 500 mg/day as calcium carbonate. Participants were excluded from the active treatment based on predetermined exclusion criteria (Bone Mineral Density and laboratory results).

Reporting Groups
  Description
Placebo Placebo 1 tablet once a week.
MK0822 3 mg 3 mg MK0822 1 tablet once a week
MK0822 10 mg 10 mg MK0822 1 tablet once a week
MK0822 25 mg 25 mg MK0822 1 tablet once a week
MK0822 50 mg 50 mg MK0822 1 tablet once a week
Placebo / Placebo 12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Before entering this extension patients in this treatment group took one placebo tablet once a week for 2 years. These patients have been on placebo for 3 years.
Placebo / MK0822 50 mg 12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet of MK0822, once a week. Before entering this extension patients in this treatment group took Placebo for 2 years. These patients have been on placebo for 2 years and 50 mg of MK0822 during the 3rd year.
MK0822 3 mg / Placebo 12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Before entering this extension patients in this treatment group took one 3 mg tablet of MK0822 once a week for 2 years. These patients have been on 3 mg of MK0822 for 2 years and placebo during the 3rd year.
MK0822 3 mg / MK0822 50 mg 12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet, of MK0822, once a week. Before entering this extension patients in this treatment group took one 3 mg tablet of MK0822 once a week during 2 years. These patients have been on 3 mg of MK0822 for two years and 50 mg of MK0822 during the 3rd year.
MK0822 10 mg / Placebo 12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Patients in this treatment group took one 10 mg tablet of MK0822 once a week during 2 years and one placebo tablet during the 3rd year.
MK0822 10 mg / MK0822 50 mg 12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet, of MK0822, once a week. Patients in this treatment group took one 10 mg tablet of MK0822 once a week during 2 years and one 50 mg tablet of MK0822 once a week during the 3rd year.
MK0822 25 mg / Placebo 12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Patients in this treatment group took one 25 mg tablet of MK0822 once a week during 2 years and one placebo tablet once a week during the 3rd year.
MK0822 25 mg / MK0822 50 mg 12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet of MK0822 once a week. Patients in this treatment group took one 25 mg tablet of MK0822 once a week during 2 years and one 50 mg tablet of MK0822 once a week during the 3rd year.
MK0822 50 mg / Placebo 12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Patients in this treatment group took one 50 mg tablet of MK0822 once a week during 2 years and one placebo tablet once a week during the 3rd year.
MK0822 50 mg / MK0822 50 mg 12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet, of MK0822, once a week. Patients in this treatment group took one 50 mg table during 3 years.

Participant Flow for 3 periods

 Period 1:   12 Month Base Study
    Placebo     MK0822 3 mg     MK0822 10 mg     MK0822 25 mg     MK0822 50 mg     Placebo / Placebo     Placebo / MK0822 50 mg     MK0822 3 mg / Placebo     MK0822 3 mg / MK0822 50 mg     MK0822 10 mg / Placebo     MK0822 10 mg / MK0822 50 mg     MK0822 25 mg / Placebo     MK0822 25 mg / MK0822 50 mg     MK0822 50 mg / Placebo     MK0822 50 mg / MK0822 50 mg  
STARTED     83     82     77     79     78     0     0     0     0     0     0     0     0     0     0  
COMPLETED     68 [1]   64 [1]   65     71     66 [1]   0     0     0     0     0     0     0     0     0     0  
NOT COMPLETED     15     18     12     8     12     0     0     0     0     0     0     0     0     0     0  
Adverse Event                 9                 10                 6                 4                 3                 0                 0                 0                 0                 0                 0                 0                 0                 0                 0  
Lack of Efficacy                 0                 1                 0                 0                 0                 0                 0                 0                 0                 0                 0                 0                 0                 0                 0  
Lost to Follow-up                 0                 1                 0                 0                 0                 0                 0                 0                 0                 0                 0                 0                 0                 0                 0  
Protocol Violation                 1                 0                 3                 1                 1                 0                 0                 0                 0                 0                 0                 0                 0                 0                 0  
Withdrawal by Subject                 5                 5                 2                 1                 7                 0                 0                 0                 0                 0                 0                 0                 0                 0                 0  
moved                 0                 1                 1                 0                 0                 0                 0                 0                 0                 0                 0                 0                 0                 0                 0  
patient was unsure that they needed drug                 0                 0                 0                 2                 0                 0                 0                 0                 0                 0                 0                 0                 0                 0                 0  
DXA was lower by more than 8%                 0                 0                 0                 0                 1                 0                 0                 0                 0                 0                 0                 0                 0                 0                 0  
[1] 1 patient completed the base study after Demcember 19, 2006 & is not included in the completed total

Period 2:   12 Month Extension
    Placebo     MK0822 3 mg     MK0822 10 mg     MK0822 25 mg     MK0822 50 mg     Placebo / Placebo     Placebo / MK0822 50 mg     MK0822 3 mg / Placebo     MK0822 3 mg / MK0822 50 mg     MK0822 10 mg / Placebo     MK0822 10 mg / MK0822 50 mg     MK0822 25 mg / Placebo     MK0822 25 mg / MK0822 50 mg     MK0822 50 mg / Placebo     MK0822 50 mg / MK0822 50 mg  
STARTED     63     62     63     69     63     0     0     0     0     0     0     0     0     0     0  
COMPLETED     60     53     55     62     50     0     0     0     0     0     0     0     0     0     0  
NOT COMPLETED     3     9     8     7     13     0     0     0     0     0     0     0     0     0     0  
Adverse Event                 1                 2                 6                 1                 7                 0                 0                 0                 0                 0                 0                 0                 0                 0                 0  
Lack of Efficacy                 1                 6                 0                 0                 2                 0                 0                 0                 0                 0                 0                 0                 0                 0                 0  
Lost to Follow-up                 0                 0                 0                 1                 0                 0                 0                 0                 0                 0                 0                 0                 0                 0                 0  
Protocol Violation                 0                 0                 0                 1                 0                 0                 0                 0                 0                 0                 0                 0                 0                 0                 0  
Withdrawal by Subject                 1                 1                 2                 4                 1                 0                 0                 0                 0                 0                 0                 0                 0                 0                 0  
Patient stopped taking medication                 0                 0                 0                 0                 1                 0                 0                 0                 0                 0                 0                 0                 0                 0                 0  
patient was out of windows                 0                 0                 0                 0                 1                 0                 0                 0                 0                 0                 0                 0                 0                 0                 0  
Moved                 0                 0                 0                 0                 1                 0                 0                 0                 0                 0                 0                 0                 0                 0                 0  

Period 3:   12 Month Extension (Year 3)
    Placebo     MK0822 3 mg     MK0822 10 mg     MK0822 25 mg     MK0822 50 mg     Placebo / Placebo     Placebo / MK0822 50 mg     MK0822 3 mg / Placebo     MK0822 3 mg / MK0822 50 mg     MK0822 10 mg / Placebo     MK0822 10 mg / MK0822 50 mg     MK0822 25 mg / Placebo     MK0822 25 mg / MK0822 50 mg     MK0822 50 mg / Placebo     MK0822 50 mg / MK0822 50 mg  
STARTED     0     0     0     0     0     19     22     18     17     18     17     19     21     18     20  
COMPLETED     0     0     0     0     0     17     17     18     16     17     13     16     20     16     19  
NOT COMPLETED     0     0     0     0     0     2     5     0     1     1     4     3     1     2     1  
Adverse Event                 0                 0                 0                 0                 0                 1                 0                 0                 0                 0                 1                 3                 1                 0                 1  
Lack of Efficacy                 0                 0                 0                 0                 0                 0                 1                 0                 1                 0                 1                 0                 0                 2                 0  
Lost to Follow-up                 0                 0                 0                 0                 0                 0                 0                 0                 0                 0                 1                 0                 0                 0                 0  
Protocol Violation                 0                 0                 0                 0                 0                 0                 0                 0                 0                 0                 1                 0                 0                 0                 0  
Withdrawal by Subject                 0                 0                 0                 0                 0                 0                 3                 0                 0                 1                 0                 0                 0                 0                 0  
cortisone therapy, upcoming surgery                 0                 0                 0                 0                 0                 1                 1                 0                 0                 0                 0                 0                 0                 0                 0  



  Baseline Characteristics
  Hide Baseline Characteristics

Reporting Groups
  Description
Placebo Placebo 1 tablet once a week
MK0822 3 mg 3 mg MK0822 1 tablet once a week
MK0822 10 mg 10 mg MK0822 1 tablet once a week
MK0822 25 mg 25 mg MK0822 1 tablet once a week
MK0822 50 mg 50 mg MK0822 1 tablet once a week
Total Total of all reporting groups

Baseline Measures
    Placebo     MK0822 3 mg     MK0822 10 mg     MK0822 25 mg     MK0822 50 mg     Total  
Number of Participants  
[units: participants]
 		  83     82     77     79     78     399  
Age  
[units: years]
Mean ± Standard Deviation 		  65.9  ± 7.8     63.1  ± 7.3     64.5  ± 8.0     62.9  ± 7.4     64.5  ± 8.1     64.2  ± 7.8  
Gender  
[units: participants]
 		           
Female     83     82     77     79     78     399  
Male     0     0     0     0     0     0  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage Change From Baseline in Lumbar Spine Bone Mineral Density at 12 Months   [ Time Frame: Baseline and 12 months ]
  Show Outcome Measure 1

2.  Primary:   Percentage Change From Baseline in Lumbar Spine Bone Mineral Density at 24 Months   [ Time Frame: Baseline and 24 months ]
  Show Outcome Measure 2

3.  Primary:   Percentage Change From Baseline in Lumbar Spine Bone Mineral Density at 36 Months   [ Time Frame: Baseline and 36 months ]
  Show Outcome Measure 3

4.  Secondary:   Percentage Change in Total Hip Bone Mineral Density at 12 Months   [ Time Frame: Baseline and 12 months ]
  Show Outcome Measure 4

5.  Secondary:   Percentage Change in Femoral Neck Bone Mineral Density at 12 Months   [ Time Frame: Baseline and 12 months ]
  Show Outcome Measure 5

6.  Secondary:   Percentage Change in Trochanter Bone Mineral Density at 12 Months   [ Time Frame: Baseline and 12 Months ]
  Show Outcome Measure 6

7.  Secondary:   Percentage Change in Total Body Bone Mineral Density at 12 Months   [ Time Frame: Baseline and 12 Months ]
  Show Outcome Measure 7

8.  Secondary:   Percentage Change in Distal Forearm Bone Mineral Density at 12 Months   [ Time Frame: Baseline and 12 Months ]
  Show Outcome Measure 8

9.  Secondary:   Percentage Change in Biochemical Marker of Bone Turnover (Urinary N-telopeptides of Type I Collagen (u-NTx)) at 12 Months   [ Time Frame: Baseline and 12 Months ]
  Show Outcome Measure 9

10.  Secondary:   Percentage Change in Biochemical Marker of Bone Turnover (Serum C-telopeptides of Type 1 Collagen (s-CTx)) at 12 Months   [ Time Frame: Baseline and 12 Months ]
  Show Outcome Measure 10

11.  Secondary:   Percentage Change in Biochemical Marker of Bone Turnover (Urinary Total Deoxypyridinolines (u-DPyr)) at 12 Months   [ Time Frame: Baseline and 12 months ]
  Show Outcome Measure 11

12.  Secondary:   Percentage Change in Biochemical Marker of Bone Turnover (Serum Bone-specific Alkaline Phosphatase (s-BSAP)) at 12 Months   [ Time Frame: Baseline and 12 months ]
  Show Outcome Measure 12

13.  Secondary:   Percentage Change in Biochemical Marker of Bone Turnover (Serum N-terminal Propeptide of Type 1 Collagen (s-P1NP)) at 12 Months   [ Time Frame: Baseline and 12 months ]
  Show Outcome Measure 13

14.  Secondary:   Percentage Change in Total Hip Bone Mineral Density at 24 Months   [ Time Frame: Baseline and 24 months ]
  Show Outcome Measure 14

15.  Secondary:   Percentage Change in Femoral Neck Bone Mineral Density at 24 Months   [ Time Frame: Baseline and 24 months ]
  Show Outcome Measure 15

16.  Secondary:   Percentage Change in Tronchanter Bone Mineral Density at 24 Months   [ Time Frame: Baseline and 24 months ]
  Show Outcome Measure 16

17.  Secondary:   Percentage Change in Total Body Bone Mineral Density at 24 Months   [ Time Frame: Baseline and 24 months ]
  Show Outcome Measure 17

18.  Secondary:   Percentage Change in Distal Forearm Bone Mineral Density at 24 Months   [ Time Frame: Baseline and 24 months ]
  Show Outcome Measure 18

19.  Secondary:   Percentage Change in Biochemical Marker of Bone Turnover (Urinary N-telopeptides of Type I Collagen (u-NTx)) at 24 Months   [ Time Frame: Baseline and 24 months ]
  Show Outcome Measure 19

20.  Secondary:   Percentage Change in Biochemical Marker of Bone Turnover (Serum C-telopeptides of Type 1 Collagen (s-CTx)) at 24 Months   [ Time Frame: Baseline and 24 months ]
  Show Outcome Measure 20

21.  Secondary:   Percentage Change in Biochemical Marker of Bone Turnover (Urinary Total Deoxypyridinolines (u-DPyr)) at 24 Months   [ Time Frame: Baseline and 24 months ]
  Show Outcome Measure 21

22.  Secondary:   Percentage Change in Biochemical Marker of Bone Turnover (Serum Bone-specific Alkaline Phosphatase (s-BSAP)) at 24 Months   [ Time Frame: Baseline and 24 months ]
  Hide Outcome Measure 22

Measure Type Secondary
Measure Title Percentage Change in Biochemical Marker of Bone Turnover (Serum Bone-specific Alkaline Phosphatase (s-BSAP)) at 24 Months
Measure Description Back-transformation (geometric mean) of the Least Squares Mean of the log-values Percentage change from baseline, in Biochemical Marker of Bone turnover (serum bone-specific alkaline phosphatase (s-BSAP)) (relative to baseline) at 24 Months
Time Frame Baseline 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.
Analysis used geometric mean percent change from baseline (back-transformation of a log-transformed fraction from baseline) at Month 24 using a Per-Protocol approach where patients with important protocol deviations and major protocol violators were excluded from the analyses. The per-protocol approach did not estimate missing data.

Reporting Groups
  Description
Placebo Placebo 1 tablet once a week
MK0822 3 mg 3 mg MK0822 1 tablet once a week
MK0822 10 mg 10 mg MK0822 1 tablet once a week
MK0822 25 mg 25 mg MK0822 1 tablet once a week
MK0822 50 mg 50 mg MK0822 1 tablet once a week

Measured Values
    Placebo     MK0822 3 mg     MK0822 10 mg     MK0822 25 mg     MK0822 50 mg  
Number of Participants Analyzed  
[units: participants]
 		  57     47     42     53     42  
Percentage Change in Biochemical Marker of Bone Turnover (Serum Bone-specific Alkaline Phosphatase (s-BSAP)) at 24 Months  
[units: Geometric LS Mean percent change]
Least Squares Mean ( 95% Confidence Interval ) 		  3.38  
  ( -4.94 to 12.44 )   		  40.17  
  ( 27.80 to 53.73 )   		  2.99  
  ( -6.57 to 13.54 )   		  10.62  
  ( 1.40 to 20.69 )   		  -13.62  
  ( -21.36 to -4.32 )  


Statistical Analysis 1 for Percentage Change in Biochemical Marker of Bone Turnover (Serum Bone-specific Alkaline Phosphatase (s-BSAP)) at 24 Months
Groups [1] Placebo vs. MK0822 50 mg
Method [2] ANCOVA
P Value [3] 0.002
Difference in Least Square Means [4] -16.64
95% Confidence Interval ( -28.84 to -4.44 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  The secondary objective was to assess the effect of MK0822 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone formation (s-BSAP) compared to placebo over 24 months.
[2] Other relevant information, such as adjustments or degrees of freedom:
  Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure
[4] Other relevant estimation information:
  Difference in Least Square Means (back-transformation of difference in log-fractions from baseline)

Statistical Analysis 2 for Percentage Change in Biochemical Marker of Bone Turnover (Serum Bone-specific Alkaline Phosphatase (s-BSAP)) at 24 Months
Groups [1] Placebo vs. MK0822 25 mg
Method [2] ANCOVA
P Value [3] 0.852
Difference in Least Square Means [4] 7.24
95% Confidence Interval ( -5.73 to 20.21 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  The secondary objective was to assess the effect of MK0822 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone formation (s-BSAP) compared to placebo over 24 months.
[2] Other relevant information, such as adjustments or degrees of freedom:
  Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure
[4] Other relevant estimation information:
  Difference in Least Square Means (back-transformation of difference in log-fractions from baseline)

Statistical Analysis 3 for Percentage Change in Biochemical Marker of Bone Turnover (Serum Bone-specific Alkaline Phosphatase (s-BSAP)) at 24 Months
Groups [1] Placebo vs. MK0822 10 mg
Difference in Least Square Means [2] -0.39
95% Confidence Interval ( -13.69 to 12.92 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  The secondary objective was to assess the effect of MK0822 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone formation (s-BSAP) compared to placebo over 24 months.
[2] Other relevant estimation information:
  Difference in Least Square Means (back-transformation of difference in log-fractions from baseline)

Statistical Analysis 4 for Percentage Change in Biochemical Marker of Bone Turnover (Serum Bone-specific Alkaline Phosphatase (s-BSAP)) at 24 Months
Groups [1] Placebo vs. MK0822 3 mg
Difference in Least Square Means [2] 36.79
95% Confidence Interval ( 21.19 to 52.38 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  The secondary objective was to assess the effect of MK0822 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone formation (s-BSAP) compared to placebo over 24 months.
[2] Other relevant estimation information:
  Difference in Least Square Means (back-transformation of difference in log-fractions from baseline)



23.  Secondary:   Percentage Change in Biochemical Marker of Bone Turnover (Serum N-terminal Propeptide of Type 1 Collagen (s-P1NP)) at 24 Months   [ Time Frame: Baseline and 24 months ]
  Show Outcome Measure 23

24.  Secondary:   Percentage Change From Baseline in Total Hip Bone Mineral Density at 36 Months   [ Time Frame: Baseline and 36 months ]
  Show Outcome Measure 24

25.  Secondary:   Percentage Change From Baseline in Femoral Neck Bone Mineral Density at 36 Months   [ Time Frame: Baseline and 36 months ]
  Show Outcome Measure 25

26.  Secondary:   Percentage Change From Baseline in Trochanter Bone Mineral Density at 36 Months   [ Time Frame: Baseline and 36 months ]
  Show Outcome Measure 26

27.  Secondary:   Percentage Change From Baseline in Total Body Bone Mineral Density at 36 Months   [ Time Frame: Baseline and 36 months ]
  Show Outcome Measure 27

28.  Secondary:   Percentage Change From Baseline in Distal Forearm Bone Mineral Density at 36 Months   [ Time Frame: Baseline and 36 months ]
  Show Outcome Measure 28

29.  Secondary:   Geometric Mean Percentage Change From Baseline, in Biochemical Marker of Bone Turnover (Urinary N-telopeptides of Type I Collagen [u-NTx]) at 36 Months   [ Time Frame: Baseline and 36 months ]
  Show Outcome Measure 29

30.  Secondary:   Geometric Mean Percentage Change From Baseline, in Biochemical Marker of Bone Turnover (Serum C-telopeptides of Type 1 Collagen [s-CTx]) at 36 Months   [ Time Frame: Baseline and 36 months ]
  Show Outcome Measure 30

31.  Secondary:   Geometric Mean Percentage Change From Baseline, in Biochemical Marker of Bone Turnover (Urinary Total Deoxypyridinolines [u-DPyr]) at 36 Months   [ Time Frame: Baseline and 36 months ]
  Show Outcome Measure 31

32.  Secondary:   Geometric Mean Percentage Change From Baseline, in Biochemical Marker of Bone Turnover (Serum Bone-specific Alkaline Phosphatase [s-BSAP]) at 36 Months   [ Time Frame: Baseline and 36 months ]
  Show Outcome Measure 32

33.  Secondary:   Percentage Change in Biochemical Marker of Bone Turnover (Serum N-terminal Propeptide of Type 1 Collagen [s-P1NP]) at 36 Months   [ Time Frame: Baseline and 36 months ]
  Show Outcome Measure 33

34.  Secondary:   Geometric Mean Percentage Change From Baseline, in Biochemical Marker of Bone Turnover (Serum Bone Tartrate-resistant Acid Phosphatase Isoform 5b) [TRAP 5-b]) at 36 Months   [ Time Frame: Baseline and 36 months ]
  Show Outcome Measure 34

35.  Secondary:   Geometric Mean Percentage Change From Baseline, in Biochemical Marker of Bone Turnover (Serum Cross-Linked Carboxyterminal Telopeptides of Type I Collagen [1-CTP]) at 36 Months   [ Time Frame: Baseline and 36 months ]
  Show Outcome Measure 35


  Serious Adverse Events
  Show Serious Adverse Events


  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 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.


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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Results Point of Contact:  
Name/Title: Executive Vice President, Clinical and Quantitative Sciences
Organization: Merck Sharp & Dohme Corp
phone: 1-800-672-6372


No publications provided by Merck

Publications automatically indexed to this study:


Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT00112437     History of Changes
Other Study ID Numbers: 2005_023, MK0822-004
Study First Received: June 2, 2005
Results First Received: April 13, 2010
Last Updated: October 6, 2010
Health Authority: United States: Food and Drug Administration