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Efficacy and Safety of Odanacatib in Postmenopausal Women Previously Treated With Oral Bisphosphonate (MK-0822-076)

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ClinicalTrials.gov Identifier: NCT01803607
Recruitment Status : Terminated (Study halted prematurely due to low enrollment.)
First Posted : March 4, 2013
Results First Posted : May 22, 2017
Last Update Posted : September 4, 2019
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
Condition Osteoporosis
Interventions Drug: odanacatib
Other: placebo to odanacatib
Enrollment 135
Recruitment Details Postmenopausal female participants ≥60 years of age with low bone mineral density (BMD) and who had been treated with an oral bisphosphonate for at least 3 years were recruited at 81 sites in the United States.
Pre-assignment Details The Sponsor made a business decision to terminate the trial early due to poor enrollment; the decision was not related to any findings regarding the efficacy or safety profile of odanacatib.
Arm/Group Title Odanacatib 50 mg Placebo
Hide Arm/Group Description Participants received odanacatib 50 mg OW for 24 months. In addition, participants received Vitamin D 5600 IU as well as open-label daily calcium supplement of 500 mg (sourced locally as calcium carbonate or calcium citrate) to ensure a total daily intake (from both dietary and supplemental sources) of approximately 1200 mg of elemental calcium. Participants received dose-matched placebo to odanacatib OW for 24 months. In addition, participants received Vitamin D 5600 IU as well as open-label daily calcium supplement of 500 mg (sourced locally as calcium carbonate or calcium citrate) to ensure a total daily intake (from both dietary and supplemental sources) of approximately 1200 mg of elemental calcium.
Period Title: Overall Study
Started 68 67
Completed 0 0
Not Completed 68 67
Reason Not Completed
Adverse Event             5             3
Lack of Efficacy             0             1
Protocol Violation             3             2
Study terminated by sponsor             54             56
Withdrawal by Subject             6             5
Arm/Group Title Odanacatib 50 mg Placebo Total
Hide Arm/Group Description Participants received odanacatib 50 mg OW for 24 months. In addition, participants received Vitamin D 5600 IU as well as open-label daily calcium supplement of 500 mg (sourced locally as calcium carbonate or calcium citrate) to ensure a total daily intake (from both dietary and supplemental sources) of approximately 1200 mg of elemental calcium. Participants received dose-matched placebo to odanacatib OW for 24 months. In addition, participants received Vitamin D 5600 IU as well as open-label daily calcium supplement of 500 mg (sourced locally as calcium carbonate or calcium citrate) to ensure a total daily intake (from both dietary and supplemental sources) of approximately 1200 mg of elemental calcium. Total of all reporting groups
Overall Number of Baseline Participants 68 67 135
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 68 participants 67 participants 135 participants
71.7  (7.9) 70.7  (7.6) 70.9  (7.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 68 participants 67 participants 135 participants
Female
68
 100.0%
67
 100.0%
135
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Percent Change From Baseline to Month 12 in Femoral BMD
Hide Description Dual-energy X-ray absorptiometry (DXA) was used to determine the change from baseline in femoral neck BMD at Month 12.
Time Frame Baseline and Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis set (FAS) includes all randomized participants who took at least one dose of study medication and had the relevant baseline and follow-up measurements.
Arm/Group Title Odanacatib 50 mg Placebo
Hide Arm/Group Description:
Participants received odanacatib 50 mg OW for 24 months. In addition, participants received Vitamin D 5600 IU as well as open-label daily calcium supplement of 500 mg (sourced locally as calcium carbonate or calcium citrate) to ensure a total daily intake (from both dietary and supplemental sources) of approximately 1200 mg of elemental calcium.
Participants received dose-matched placebo to odanacatib OW for 24 months. In addition, participants received Vitamin D 5600 IU as well as open-label daily calcium supplement of 500 mg (sourced locally as calcium carbonate or calcium citrate) to ensure a total daily intake (from both dietary and supplemental sources) of approximately 1200 mg of elemental calcium.
Overall Number of Participants Analyzed 24 20
Mean (Standard Error)
Unit of Measure: Percent Change from Baseline
0.70  (1.00) -0.20  (1.17)
2.Secondary Outcome
Title Percent Change From Baseline to Month 24 in Femoral Neck BMD: Within-Group Comparison of Odanacatib
Hide Description DXA was used to determine the within-group change from baseline in femoral neck BMD at Month 24.
Time Frame Baseline and Month 24
Hide Outcome Measure Data
Hide Analysis Population Description
The trial was terminated prematurely, thus this analysis was not conducted.
Arm/Group Title Odanacatib 50 mg Placebo
Hide Arm/Group Description:
Participants received odanacatib 50 mg OW for 24 months. In addition, participants received Vitamin D 5600 IU as well as open-label daily calcium supplement of 500 mg (sourced locally as calcium carbonate or calcium citrate) to ensure a total daily intake (from both dietary and supplemental sources) of approximately 1200 mg of elemental calcium.
Participants received dose-matched placebo to odanacatib OW for 24 months. In addition, participants received Vitamin D 5600 IU as well as open-label daily calcium supplement of 500 mg (sourced locally as calcium carbonate or calcium citrate) to ensure a total daily intake (from both dietary and supplemental sources) of approximately 1200 mg of elemental calcium.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Percent Change From Baseline to Month 12 in Trochanter, Total Hip, and Lumbar Spine BMD
Hide Description DXA was used to determine the change from baseline in trochanter, total hip, and lumbar spine BMD at Month 12.
Time Frame Baseline and Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS includes all randomized participants who took at least one dose of study medication and had the relevant baseline and follow-up measurements
Arm/Group Title Odanacatib 50 mg Placebo
Hide Arm/Group Description:
Participants received odanacatib 50 mg OW for 24 months. In addition, participants received Vitamin D 5600 IU as well as open-label daily calcium supplement of 500 mg (sourced locally as calcium carbonate or calcium citrate) to ensure a total daily intake (from both dietary and supplemental sources) of approximately 1200 mg of elemental calcium.
Participants received dose-matched placebo to odanacatib OW for 24 months. In addition, participants received Vitamin D 5600 IU as well as open-label daily calcium supplement of 500 mg (sourced locally as calcium carbonate or calcium citrate) to ensure a total daily intake (from both dietary and supplemental sources) of approximately 1200 mg of elemental calcium.
Overall Number of Participants Analyzed 24 20
Mean (Standard Error)
Unit of Measure: Percentage Change from Baseline
Trochanter 1.85  (1.14) -1.66  (1.13)
Total Hip -0.09  (0.63) -1.67  (0.51)
Lumbar Spine 2.10  (0.99) -1.52  (0.86)
4.Secondary Outcome
Title Change From Baseline in Serum C-telopeptides of Type 1 Collagen (s-CTx)
Hide Description s-CTx is a biochemical marker of bone resorption. At baseline and Month 12, s-CTx was measured and expressed in ng/mL and results are expressed as percentage change from baseline.
Time Frame Baseline and Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
The Per Protocol (PP) population includes all participants who received 1 dose of study drug, had the necessary baseline and post-baseline data, and did not have any protocol violations that may substantially impact results.
Arm/Group Title Odanacatib 50 mg Placebo
Hide Arm/Group Description:
Participants received odanacatib 50 mg OW for 24 months. In addition, participants received Vitamin D 5600 IU as well as open-label daily calcium supplement of 500 mg (sourced locally as calcium carbonate or calcium citrate) to ensure a total daily intake (from both dietary and supplemental sources) of approximately 1200 mg of elemental calcium.
Participants received dose-matched placebo to odanacatib OW for 24 months. In addition, participants received Vitamin D 5600 IU as well as open-label daily calcium supplement of 500 mg (sourced locally as calcium carbonate or calcium citrate) to ensure a total daily intake (from both dietary and supplemental sources) of approximately 1200 mg of elemental calcium.
Overall Number of Participants Analyzed 18 23
Geometric Mean (Standard Error)
Unit of Measure: Percent Change from Baseline
15.37  (20.24) 44.10  (10.19)
5.Secondary Outcome
Title Change From Baseline in Urine C-telopeptides of Type I Collagen (u-CTx)
Hide Description u-CTx is a biochemical marker of bone resorption. At baseline and Month 12, u-CTx was measured and expressed in ug/mL and results are expressed as percentage change from baseline.
Time Frame Baseline and Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
The PP population includes all participants who received 1 dose of study drug, had the necessary baseline and post-baseline data, and did not have any protocol violations that may substantially impact results.
Arm/Group Title Odanacatib 50 mg Placebo
Hide Arm/Group Description:
Participants received odanacatib 50 mg OW for 24 months. In addition, participants received Vitamin D 5600 IU as well as open-label daily calcium supplement of 500 mg (sourced locally as calcium carbonate or calcium citrate) to ensure a total daily intake (from both dietary and supplemental sources) of approximately 1200 mg of elemental calcium.
Participants received dose-matched placebo to odanacatib OW for 24 months. In addition, participants received Vitamin D 5600 IU as well as open-label daily calcium supplement of 500 mg (sourced locally as calcium carbonate or calcium citrate) to ensure a total daily intake (from both dietary and supplemental sources) of approximately 1200 mg of elemental calcium.
Overall Number of Participants Analyzed 17 20
Geometric Mean (Standard Error)
Unit of Measure: Percentage Change from Baseline
-82.39  (22.46) 63.21  (23.08)
6.Secondary Outcome
Title Change From Baseline in Urine N-telopeptides of Type 1 Collagen Corrected for Creatinine (u-NTx/Cr)
Hide Description The u-NTx/Cr ratio is a biochemical marker of bone resorption. u-NTx/Cr was measured at baseline and Month 12 and expressed in nM:mM and results are expressed as percentage change from baseline.
Time Frame Baseline and Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
The PP population includes all participants who received 1 dose of study drug, had the necessary baseline and post-baseline data, and did not have any protocol violations that may substantially impact results.
Arm/Group Title Odanacatib 50 mg Placebo
Hide Arm/Group Description:
Participants received odanacatib 50 mg OW for 24 months. In addition, participants received Vitamin D 5600 IU as well as open-label daily calcium supplement of 500 mg (sourced locally as calcium carbonate or calcium citrate) to ensure a total daily intake (from both dietary and supplemental sources) of approximately 1200 mg of elemental calcium.
Participants received dose-matched placebo to odanacatib OW for 24 months. In addition, participants received Vitamin D 5600 IU as well as open-label daily calcium supplement of 500 mg (sourced locally as calcium carbonate or calcium citrate) to ensure a total daily intake (from both dietary and supplemental sources) of approximately 1200 mg of elemental calcium.
Overall Number of Participants Analyzed 17 22
Geometric Mean (Standard Error)
Unit of Measure: Percentage Change from Baseline
-29.78  (13.46) 37.73  (10.46)
7.Secondary Outcome
Title Change From Baseline in Serum Bone Specific Alkaline Phosphatase (s-BSAP)
Hide Description s-BSAP is a biochemical marker of bone resorption. s-BSAP was measured and expressed in ng/mL at Baseline and Month 12, and results are shown as percentage change from baseline.
Time Frame Baseline and Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
The PP population includes all participants who received 1 dose of study drug, had the necessary baseline and post-baseline data, and did not have any protocol violations that may substantially impact results
Arm/Group Title Odanacatib 50 mg Placebo
Hide Arm/Group Description:
Participants received odanacatib 50 mg OW for 24 months. In addition, participants received Vitamin D 5600 IU as well as open-label daily calcium supplement of 500 mg (sourced locally as calcium carbonate or calcium citrate) to ensure a total daily intake (from both dietary and supplemental sources) of approximately 1200 mg of elemental calcium.
Participants received dose-matched placebo to odanacatib OW for 24 months. In addition, participants received Vitamin D 5600 IU as well as open-label daily calcium supplement of 500 mg (sourced locally as calcium carbonate or calcium citrate) to ensure a total daily intake (from both dietary and supplemental sources) of approximately 1200 mg of elemental calcium.
Overall Number of Participants Analyzed 18 23
Geometric Mean (Standard Error)
Unit of Measure: Percentage Change from Baseline
22.32  (7.91) 17.19  (4.09)
8.Secondary Outcome
Title Change From Baseline in Serum N-terminal Propeptide of Type 1 Collagen (s-P1NP)
Hide Description s-P1NP is a biochemical marker of bone resorption. s-P1NP was measured and expressed as ng/mL at Baseline and Month 12, and results are expressed as percentage change from baseline.
Time Frame Baseline and Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
The PP population includes all participants who received 1 dose of study drug, had the necessary baseline and post-baseline data, and did not have any protocol violations that may substantially impact results
Arm/Group Title Odanacatib 50 mg Placebo
Hide Arm/Group Description:
Participants received odanacatib 50 mg OW for 24 months. In addition, participants received Vitamin D 5600 IU as well as open-label daily calcium supplement of 500 mg (sourced locally as calcium carbonate or calcium citrate) to ensure a total daily intake (from both dietary and supplemental sources) of approximately 1200 mg of elemental calcium.
Participants received dose-matched placebo to odanacatib OW for 24 months. In addition, participants received Vitamin D 5600 IU as well as open-label daily calcium supplement of 500 mg (sourced locally as calcium carbonate or calcium citrate) to ensure a total daily intake (from both dietary and supplemental sources) of approximately 1200 mg of elemental calcium.
Overall Number of Participants Analyzed 18 23
Geometric Mean (Standard Error)
Unit of Measure: Percentage Change from Baseline
53.65  (16.91) 56.15  (8.80)
Time Frame Up to 54 weeks
Adverse Event Reporting Description An AE is any unfavorable and unintended change in the structure (signs), function (symptoms), or chemistry (laboratory data) of the body temporally associated with any use of a Sponsor product, whether or not considered related to the use of the product.
 
Arm/Group Title ODN 50 mg OW Placebo OW
Hide Arm/Group Description Participants received odanacatib 50 mg OW for 24 months. In addition, participants received Vitamin D 5600 IU as well as open-label daily calcium supplement of 500 mg (sourced locally as calcium carbonate or calcium citrate) to ensure a total daily intake (from both dietary and supplemental sources) of approximately 1200 mg of elemental calcium. Participants received dose-matched placebo to odanacatib OW for 24 months. In addition, participants received Vitamin D 5600 IU as well as open-label daily calcium supplement of 500 mg (sourced locally as calcium carbonate or calcium citrate) to ensure a total daily intake (from both dietary and supplemental sources) of approximately 1200 mg of elemental calcium. One participant who was randomized to odanacatib 50 mg OW received placebo during the entire treatment period and was therefore included in the Placebo OW group for safety analyses.
All-Cause Mortality
ODN 50 mg OW Placebo OW
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
ODN 50 mg OW Placebo OW
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/67 (8.96%)      4/68 (5.88%)    
Cardiac disorders     
Sinus bradycardia  1  1/67 (1.49%)  1 0/68 (0.00%)  0
Gastrointestinal disorders     
Small intestinal obstruction  1  0/67 (0.00%)  0 1/68 (1.47%)  1
Infections and infestations     
Diverticulitis  1  1/67 (1.49%)  1 0/68 (0.00%)  0
Injury, poisoning and procedural complications     
Hip fracture  1  0/67 (0.00%)  0 1/68 (1.47%)  1
Humerus fracture  1  1/67 (1.49%)  1 0/68 (0.00%)  0
Pelvic fracture  1  1/67 (1.49%)  1 0/68 (0.00%)  0
Tibia fracture  1  1/67 (1.49%)  1 0/68 (0.00%)  0
Metabolism and nutrition disorders     
Dehydration  1  1/67 (1.49%)  1 0/68 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Breast cancer  1  0/67 (0.00%)  0 1/68 (1.47%)  1
Squamous cell carcinoma  1  1/67 (1.49%)  1 0/68 (0.00%)  0
Nervous system disorders     
Dizziness  1  0/67 (0.00%)  0 1/68 (1.47%)  1
Transient ischaemic attack  1  1/67 (1.49%)  1 0/68 (0.00%)  0
Renal and urinary disorders     
Urinary retention  1  1/67 (1.49%)  1 0/68 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.1
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
ODN 50 mg OW Placebo OW
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   15/67 (22.39%)      9/68 (13.24%)    
Infections and infestations     
Upper respiratory tract infection  1  5/67 (7.46%)  5 4/68 (5.88%)  4
Urinary tract infection  1  6/67 (8.96%)  7 3/68 (4.41%)  5
Injury, poisoning and procedural complications     
Accidental overdose  1  4/67 (5.97%)  4 3/68 (4.41%)  4
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.1
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 Sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
EMail: ClinicalTrialsDisclosure@merck.com
Layout table for additonal information
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01803607    
Other Study ID Numbers: 0822-076
First Submitted: February 28, 2013
First Posted: March 4, 2013
Results First Submitted: February 27, 2017
Results First Posted: May 22, 2017
Last Update Posted: September 4, 2019