Trial Outcomes & Findings for A Study to Assess Safety and Efficacy of Odanacatib (MK-0822) in Men With Osteoporosis (MK-0822-053) (NCT NCT01120600)
NCT ID: NCT01120600
Last Updated: 2018-08-28
Results Overview
Lumbar spine BMD was assessed by dual energy X-ray absorptiometry (DXA) at Baseline and at Month 24.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
294 participants
Primary outcome timeframe
Baseline and Month 24
Results posted on
2018-08-28
Participant Flow
Participant milestones
| Measure |
Odanacatib 50 mg Once Weekly
Participants received one Odanacatib 50 mg tablet once weekly. In addition, they received a weekly dose 5600 IU of open-label Vitamin D3 as well as a sufficient supply of open-label calcium carbonate so that their total daily calcium intake from both dietary and supplemental sources was approximately 1200 mg.
|
Placebo Once Weekly
Participants received one Placebo tablet once weekly. In addition, they received a weekly dose 5600 IU of open-label Vitamin D3 as well as a sufficient supply of open-label calcium carbonate so that their total daily calcium intake from both dietary and supplemental sources was approximately 1200 mg.
|
|---|---|---|
|
Overall Study
STARTED
|
147
|
147
|
|
Overall Study
Treated
|
146
|
146
|
|
Overall Study
COMPLETED
|
128
|
115
|
|
Overall Study
NOT COMPLETED
|
19
|
32
|
Reasons for withdrawal
| Measure |
Odanacatib 50 mg Once Weekly
Participants received one Odanacatib 50 mg tablet once weekly. In addition, they received a weekly dose 5600 IU of open-label Vitamin D3 as well as a sufficient supply of open-label calcium carbonate so that their total daily calcium intake from both dietary and supplemental sources was approximately 1200 mg.
|
Placebo Once Weekly
Participants received one Placebo tablet once weekly. In addition, they received a weekly dose 5600 IU of open-label Vitamin D3 as well as a sufficient supply of open-label calcium carbonate so that their total daily calcium intake from both dietary and supplemental sources was approximately 1200 mg.
|
|---|---|---|
|
Overall Study
Adverse Event
|
7
|
7
|
|
Overall Study
Excessive Bone Loss
|
0
|
4
|
|
Overall Study
Lost to Follow-up
|
1
|
3
|
|
Overall Study
Physician Decision
|
1
|
3
|
|
Overall Study
Protocol Violation
|
0
|
4
|
|
Overall Study
Withdrawal by Subject
|
10
|
11
|
Baseline Characteristics
A Study to Assess Safety and Efficacy of Odanacatib (MK-0822) in Men With Osteoporosis (MK-0822-053)
Baseline characteristics by cohort
| Measure |
Odanacatib 50 mg Once Weekly
n=147 Participants
Participants received one Odanacatib 50 mg tablet once weekly. In addition, they received a weekly dose 5600 IU of open-label Vitamin D3 as well as a sufficient supply of open-label calcium carbonate so that their total daily calcium intake from both dietary and supplemental sources was approximately 1200 mg.
|
Placebo Once Weekly
n=147 Participants
Participants received one Placebo tablet once weekly. In addition, they received a weekly dose 5600 IU of open-label Vitamin D3 as well as a sufficient supply of open-label calcium carbonate so that their total daily calcium intake from both dietary and supplemental sources was approximately 1200 mg.
|
Total
n=294 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
68.9 years
STANDARD_DEVIATION 8.2 • n=5 Participants
|
68.7 years
STANDARD_DEVIATION 7.7 • n=7 Participants
|
68.8 years
STANDARD_DEVIATION 7.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
147 Participants
n=5 Participants
|
147 Participants
n=7 Participants
|
294 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and Month 24Population: All randomized participants who took at least one dose of blinded study treatment and had available lumbar spine BMD data for Baseline and Month 24
Lumbar spine BMD was assessed by dual energy X-ray absorptiometry (DXA) at Baseline and at Month 24.
Outcome measures
| Measure |
Odanacatib 50 mg Once Weekly
n=112 Participants
Participants received one Odanacatib 50 mg tablet once weekly. In addition, they received a weekly dose 5600 IU of open-label Vitamin D3 as well as a sufficient supply of open-label calcium carbonate so that their total daily calcium intake from both dietary and supplemental sources was approximately 1200 mg.
|
Placebo Once Weekly
n=107 Participants
Participants received one Placebo tablet once weekly. In addition, they received a weekly dose 5600 IU of open-label Vitamin D3 as well as a sufficient supply of open-label calcium carbonate so that their total daily calcium intake from both dietary and supplemental sources was approximately 1200 mg.
|
|---|---|---|
|
Percentage Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Month 24
|
6.86 Percentage change
Interval 6.08 to 7.64
|
1.27 Percentage change
Interval 0.48 to 2.06
|
PRIMARY outcome
Timeframe: Up to 24 months (plus 14 days) after first dose of study drugPopulation: All randomized participants who took at least one dose of study drug
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not it is considered related to the study drug.
Outcome measures
| Measure |
Odanacatib 50 mg Once Weekly
n=146 Participants
Participants received one Odanacatib 50 mg tablet once weekly. In addition, they received a weekly dose 5600 IU of open-label Vitamin D3 as well as a sufficient supply of open-label calcium carbonate so that their total daily calcium intake from both dietary and supplemental sources was approximately 1200 mg.
|
Placebo Once Weekly
n=146 Participants
Participants received one Placebo tablet once weekly. In addition, they received a weekly dose 5600 IU of open-label Vitamin D3 as well as a sufficient supply of open-label calcium carbonate so that their total daily calcium intake from both dietary and supplemental sources was approximately 1200 mg.
|
|---|---|---|
|
Number of Participants Who Experienced an Adverse Event (AE)
|
113 Participants
|
114 Participants
|
PRIMARY outcome
Timeframe: Up to 24 months after first dose of study drugPopulation: All randomized participants who took at least one dose of study drug
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not it is considered related to the study drug.
Outcome measures
| Measure |
Odanacatib 50 mg Once Weekly
n=146 Participants
Participants received one Odanacatib 50 mg tablet once weekly. In addition, they received a weekly dose 5600 IU of open-label Vitamin D3 as well as a sufficient supply of open-label calcium carbonate so that their total daily calcium intake from both dietary and supplemental sources was approximately 1200 mg.
|
Placebo Once Weekly
n=146 Participants
Participants received one Placebo tablet once weekly. In addition, they received a weekly dose 5600 IU of open-label Vitamin D3 as well as a sufficient supply of open-label calcium carbonate so that their total daily calcium intake from both dietary and supplemental sources was approximately 1200 mg.
|
|---|---|---|
|
Number of Participants Who Discontinued Treatment Due to an AE
|
5 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Baseline and Month 24Population: All randomized participants who took at least one dose of blinded study treatment and had available total hip BMD data for Baseline and Month 24
Total hip BMD was assessed by DXA at Baseline and at Month 24.
Outcome measures
| Measure |
Odanacatib 50 mg Once Weekly
n=111 Participants
Participants received one Odanacatib 50 mg tablet once weekly. In addition, they received a weekly dose 5600 IU of open-label Vitamin D3 as well as a sufficient supply of open-label calcium carbonate so that their total daily calcium intake from both dietary and supplemental sources was approximately 1200 mg.
|
Placebo Once Weekly
n=105 Participants
Participants received one Placebo tablet once weekly. In addition, they received a weekly dose 5600 IU of open-label Vitamin D3 as well as a sufficient supply of open-label calcium carbonate so that their total daily calcium intake from both dietary and supplemental sources was approximately 1200 mg.
|
|---|---|---|
|
Percentage Change From Baseline in Total Hip BMD at Month 24
|
1.91 Percentage change
Interval 1.38 to 2.43
|
-0.11 Percentage change
Interval -0.65 to 0.42
|
SECONDARY outcome
Timeframe: Baseline and Month 24Population: All randomized participants who took at least one dose of blinded study treatment and had available femoral neck BMD data for Baseline and Month 24
Femoral Neck BMD was assessed by DXA at Baseline and at Month 24.
Outcome measures
| Measure |
Odanacatib 50 mg Once Weekly
n=111 Participants
Participants received one Odanacatib 50 mg tablet once weekly. In addition, they received a weekly dose 5600 IU of open-label Vitamin D3 as well as a sufficient supply of open-label calcium carbonate so that their total daily calcium intake from both dietary and supplemental sources was approximately 1200 mg.
|
Placebo Once Weekly
n=105 Participants
Participants received one Placebo tablet once weekly. In addition, they received a weekly dose 5600 IU of open-label Vitamin D3 as well as a sufficient supply of open-label calcium carbonate so that their total daily calcium intake from both dietary and supplemental sources was approximately 1200 mg.
|
|---|---|---|
|
Percentage Change From Baseline in Femoral Neck BMD at Month 24
|
1.69 Percentage change
Interval 0.82 to 2.55
|
0 Percentage change
Interval -0.89 to 0.88
|
SECONDARY outcome
Timeframe: Baseline and Month 24Population: All randomized participants who took at least one dose of blinded study treatment and had available trochanter BMD data for Baseline and Month 24
Trochanter BMD was assessed by DXA at Baseline and at Month 24.
Outcome measures
| Measure |
Odanacatib 50 mg Once Weekly
n=111 Participants
Participants received one Odanacatib 50 mg tablet once weekly. In addition, they received a weekly dose 5600 IU of open-label Vitamin D3 as well as a sufficient supply of open-label calcium carbonate so that their total daily calcium intake from both dietary and supplemental sources was approximately 1200 mg.
|
Placebo Once Weekly
n=105 Participants
Participants received one Placebo tablet once weekly. In addition, they received a weekly dose 5600 IU of open-label Vitamin D3 as well as a sufficient supply of open-label calcium carbonate so that their total daily calcium intake from both dietary and supplemental sources was approximately 1200 mg.
|
|---|---|---|
|
Percentage Change From Baseline in Trochanter BMD at Month 24
|
2.77 Percentage change
Interval 1.94 to 3.6
|
0.66 Percentage change
Interval -0.18 to 1.5
|
SECONDARY outcome
Timeframe: Baseline and Month 24Population: All randomized participants who had no important deviations from the protocol that may have substantially affected the results, and had available s-CTx data for Baseline and Week 24
Serum samples were collected to evaluate biochemical markers for s-CTx, which were measured at Baseline and at Month 24.
Outcome measures
| Measure |
Odanacatib 50 mg Once Weekly
n=112 Participants
Participants received one Odanacatib 50 mg tablet once weekly. In addition, they received a weekly dose 5600 IU of open-label Vitamin D3 as well as a sufficient supply of open-label calcium carbonate so that their total daily calcium intake from both dietary and supplemental sources was approximately 1200 mg.
|
Placebo Once Weekly
n=102 Participants
Participants received one Placebo tablet once weekly. In addition, they received a weekly dose 5600 IU of open-label Vitamin D3 as well as a sufficient supply of open-label calcium carbonate so that their total daily calcium intake from both dietary and supplemental sources was approximately 1200 mg.
|
|---|---|---|
|
Percentage Change From Baseline in Serum C-Telopeptides of Type 1 Collagen (s-CTx) at Month 24
|
-20.07 Percentage change
Interval -28.36 to -10.82
|
56.51 Percentage change
Interval 40.01 to 74.96
|
SECONDARY outcome
Timeframe: Baseline and Month 24Population: All randomized participants who had no important deviations from the protocol that may have substantially affected the results, and had available U-NTx/Cr data for Baseline and Week 24
Urine samples were collected to evaluate biochemical markers for u-NTx/Cr, which were measured at Baseline and at Month 24.
Outcome measures
| Measure |
Odanacatib 50 mg Once Weekly
n=111 Participants
Participants received one Odanacatib 50 mg tablet once weekly. In addition, they received a weekly dose 5600 IU of open-label Vitamin D3 as well as a sufficient supply of open-label calcium carbonate so that their total daily calcium intake from both dietary and supplemental sources was approximately 1200 mg.
|
Placebo Once Weekly
n=102 Participants
Participants received one Placebo tablet once weekly. In addition, they received a weekly dose 5600 IU of open-label Vitamin D3 as well as a sufficient supply of open-label calcium carbonate so that their total daily calcium intake from both dietary and supplemental sources was approximately 1200 mg.
|
|---|---|---|
|
Percentage Change From Baseline in Urine Collagen N-Telopeptide/Creatinine Ratio (U-NTx/Cr) at Month 24
|
-61.43 Percentage change
Interval -64.71 to -57.85
|
6.65 Percentage change
Interval -2.68 to 16.87
|
SECONDARY outcome
Timeframe: Baseline and Month 24Population: All randomized participants who had no important deviations from the protocol that may have substantially affected the results, and had available s-BSAP data for Baseline and Week 24
Serum samples were collected to evaluate biochemical markers for s-BSAP, which were measured at Baseline and at Month 24.
Outcome measures
| Measure |
Odanacatib 50 mg Once Weekly
n=114 Participants
Participants received one Odanacatib 50 mg tablet once weekly. In addition, they received a weekly dose 5600 IU of open-label Vitamin D3 as well as a sufficient supply of open-label calcium carbonate so that their total daily calcium intake from both dietary and supplemental sources was approximately 1200 mg.
|
Placebo Once Weekly
n=110 Participants
Participants received one Placebo tablet once weekly. In addition, they received a weekly dose 5600 IU of open-label Vitamin D3 as well as a sufficient supply of open-label calcium carbonate so that their total daily calcium intake from both dietary and supplemental sources was approximately 1200 mg.
|
|---|---|---|
|
Percentage Change From Baseline in Serum Bone-Specific Alkaline Phosphatase (s-BSAP) at Month 24
|
-5.28 Percentage change
Interval -9.76 to -0.57
|
2.66 Percentage change
Interval -2.25 to 7.82
|
SECONDARY outcome
Timeframe: Baseline and Month 24Population: All randomized participants who had no important deviations from the protocol that may have substantially affected the results, and had available s-P1NP data for Baseline and Week 24
Serum samples were collected to evaluate biochemical markers for s-P1NP, which were measured at Baseline and at Month 24.
Outcome measures
| Measure |
Odanacatib 50 mg Once Weekly
n=114 Participants
Participants received one Odanacatib 50 mg tablet once weekly. In addition, they received a weekly dose 5600 IU of open-label Vitamin D3 as well as a sufficient supply of open-label calcium carbonate so that their total daily calcium intake from both dietary and supplemental sources was approximately 1200 mg.
|
Placebo Once Weekly
n=100 Participants
Participants received one Placebo tablet once weekly. In addition, they received a weekly dose 5600 IU of open-label Vitamin D3 as well as a sufficient supply of open-label calcium carbonate so that their total daily calcium intake from both dietary and supplemental sources was approximately 1200 mg.
|
|---|---|---|
|
Percentage Change From Baseline in Serum N-Terminal Propeptides of Type I Collagen (s-P1NP) at Month 24
|
-10.94 Percentage change
Interval -17.27 to -4.14
|
5.06 Percentage change
Interval -2.47 to 13.17
|
Adverse Events
Odanacatib 50 mg Once Weekly
Serious events: 24 serious events
Other events: 30 other events
Deaths: 0 deaths
Placebo Once Weekly
Serious events: 24 serious events
Other events: 44 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Odanacatib 50 mg Once Weekly
n=146 participants at risk
Participants received one Odanacatib 50 mg tablet once weekly. In addition, they received a weekly dose 5600 IU of open-label Vitamin D3 as well as a sufficient supply of open-label calcium carbonate so that their total daily calcium intake from both dietary and supplemental sources was approximately 1200 mg.
|
Placebo Once Weekly
n=146 participants at risk
Participants received one Placebo tablet once weekly. In addition, they received a weekly dose 5600 IU of open-label Vitamin D3 as well as a sufficient supply of open-label calcium carbonate so that their total daily calcium intake from both dietary and supplemental sources was approximately 1200 mg.
|
|---|---|---|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/146 • Up to 24 months (plus 14 days) after first dose of study drug
All randomized participants who took at least one dose of study drug
|
0.68%
1/146 • Number of events 1 • Up to 24 months (plus 14 days) after first dose of study drug
All randomized participants who took at least one dose of study drug
|
|
Cardiac disorders
Angina unstable
|
0.68%
1/146 • Number of events 1 • Up to 24 months (plus 14 days) after first dose of study drug
All randomized participants who took at least one dose of study drug
|
0.00%
0/146 • Up to 24 months (plus 14 days) after first dose of study drug
All randomized participants who took at least one dose of study drug
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.68%
1/146 • Number of events 1 • Up to 24 months (plus 14 days) after first dose of study drug
All randomized participants who took at least one dose of study drug
|
0.00%
0/146 • Up to 24 months (plus 14 days) after first dose of study drug
All randomized participants who took at least one dose of study drug
|
|
Cardiac disorders
Cardiac failure congestive
|
0.68%
1/146 • Number of events 1 • Up to 24 months (plus 14 days) after first dose of study drug
All randomized participants who took at least one dose of study drug
|
0.00%
0/146 • Up to 24 months (plus 14 days) after first dose of study drug
All randomized participants who took at least one dose of study drug
|
|
Cardiac disorders
Coronary artery stenosis
|
0.68%
1/146 • Number of events 1 • Up to 24 months (plus 14 days) after first dose of study drug
All randomized participants who took at least one dose of study drug
|
0.00%
0/146 • Up to 24 months (plus 14 days) after first dose of study drug
All randomized participants who took at least one dose of study drug
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/146 • Up to 24 months (plus 14 days) after first dose of study drug
All randomized participants who took at least one dose of study drug
|
1.4%
2/146 • Number of events 2 • Up to 24 months (plus 14 days) after first dose of study drug
All randomized participants who took at least one dose of study drug
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/146 • Up to 24 months (plus 14 days) after first dose of study drug
All randomized participants who took at least one dose of study drug
|
0.68%
1/146 • Number of events 1 • Up to 24 months (plus 14 days) after first dose of study drug
All randomized participants who took at least one dose of study drug
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/146 • Up to 24 months (plus 14 days) after first dose of study drug
All randomized participants who took at least one dose of study drug
|
0.68%
1/146 • Number of events 1 • Up to 24 months (plus 14 days) after first dose of study drug
All randomized participants who took at least one dose of study drug
|
|
Cardiac disorders
Sick sinus syndrome
|
0.68%
1/146 • Number of events 1 • Up to 24 months (plus 14 days) after first dose of study drug
All randomized participants who took at least one dose of study drug
|
0.00%
0/146 • Up to 24 months (plus 14 days) after first dose of study drug
All randomized participants who took at least one dose of study drug
|
|
Congenital, familial and genetic disorders
Hydrocele
|
0.68%
1/146 • Number of events 1 • Up to 24 months (plus 14 days) after first dose of study drug
All randomized participants who took at least one dose of study drug
|
0.00%
0/146 • Up to 24 months (plus 14 days) after first dose of study drug
All randomized participants who took at least one dose of study drug
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/146 • Up to 24 months (plus 14 days) after first dose of study drug
All randomized participants who took at least one dose of study drug
|
0.68%
1/146 • Number of events 1 • Up to 24 months (plus 14 days) after first dose of study drug
All randomized participants who took at least one dose of study drug
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/146 • Up to 24 months (plus 14 days) after first dose of study drug
All randomized participants who took at least one dose of study drug
|
0.68%
1/146 • Number of events 1 • Up to 24 months (plus 14 days) after first dose of study drug
All randomized participants who took at least one dose of study drug
|
|
Hepatobiliary disorders
Alcoholic liver disease
|
0.00%
0/146 • Up to 24 months (plus 14 days) after first dose of study drug
All randomized participants who took at least one dose of study drug
|
0.68%
1/146 • Number of events 1 • Up to 24 months (plus 14 days) after first dose of study drug
All randomized participants who took at least one dose of study drug
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/146 • Up to 24 months (plus 14 days) after first dose of study drug
All randomized participants who took at least one dose of study drug
|
0.68%
1/146 • Number of events 1 • Up to 24 months (plus 14 days) after first dose of study drug
All randomized participants who took at least one dose of study drug
|
|
Hepatobiliary disorders
Cholelithiasis obstructive
|
0.00%
0/146 • Up to 24 months (plus 14 days) after first dose of study drug
All randomized participants who took at least one dose of study drug
|
0.68%
1/146 • Number of events 1 • Up to 24 months (plus 14 days) after first dose of study drug
All randomized participants who took at least one dose of study drug
|
|
Infections and infestations
Appendicitis
|
0.68%
1/146 • Number of events 1 • Up to 24 months (plus 14 days) after first dose of study drug
All randomized participants who took at least one dose of study drug
|
0.00%
0/146 • Up to 24 months (plus 14 days) after first dose of study drug
All randomized participants who took at least one dose of study drug
|
|
Infections and infestations
Arthritis infective
|
0.68%
1/146 • Number of events 1 • Up to 24 months (plus 14 days) after first dose of study drug
All randomized participants who took at least one dose of study drug
|
0.00%
0/146 • Up to 24 months (plus 14 days) after first dose of study drug
All randomized participants who took at least one dose of study drug
|
|
Infections and infestations
Bacteraemia
|
0.68%
1/146 • Number of events 1 • Up to 24 months (plus 14 days) after first dose of study drug
All randomized participants who took at least one dose of study drug
|
0.00%
0/146 • Up to 24 months (plus 14 days) after first dose of study drug
All randomized participants who took at least one dose of study drug
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/146 • Up to 24 months (plus 14 days) after first dose of study drug
All randomized participants who took at least one dose of study drug
|
0.68%
1/146 • Number of events 1 • Up to 24 months (plus 14 days) after first dose of study drug
All randomized participants who took at least one dose of study drug
|
|
Infections and infestations
Erysipelas
|
0.68%
1/146 • Number of events 1 • Up to 24 months (plus 14 days) after first dose of study drug
All randomized participants who took at least one dose of study drug
|
0.00%
0/146 • Up to 24 months (plus 14 days) after first dose of study drug
All randomized participants who took at least one dose of study drug
|
|
Infections and infestations
Peritonitis
|
0.00%
0/146 • Up to 24 months (plus 14 days) after first dose of study drug
All randomized participants who took at least one dose of study drug
|
0.68%
1/146 • Number of events 1 • Up to 24 months (plus 14 days) after first dose of study drug
All randomized participants who took at least one dose of study drug
|
|
Infections and infestations
Retroperitoneal infection
|
0.00%
0/146 • Up to 24 months (plus 14 days) after first dose of study drug
All randomized participants who took at least one dose of study drug
|
0.68%
1/146 • Number of events 1 • Up to 24 months (plus 14 days) after first dose of study drug
All randomized participants who took at least one dose of study drug
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
1.4%
2/146 • Number of events 2 • Up to 24 months (plus 14 days) after first dose of study drug
All randomized participants who took at least one dose of study drug
|
0.68%
1/146 • Number of events 1 • Up to 24 months (plus 14 days) after first dose of study drug
All randomized participants who took at least one dose of study drug
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.68%
1/146 • Number of events 1 • Up to 24 months (plus 14 days) after first dose of study drug
All randomized participants who took at least one dose of study drug
|
0.00%
0/146 • Up to 24 months (plus 14 days) after first dose of study drug
All randomized participants who took at least one dose of study drug
|
|
Injury, poisoning and procedural complications
Fractured sacrum
|
0.68%
1/146 • Number of events 1 • Up to 24 months (plus 14 days) after first dose of study drug
All randomized participants who took at least one dose of study drug
|
0.00%
0/146 • Up to 24 months (plus 14 days) after first dose of study drug
All randomized participants who took at least one dose of study drug
|
|
Injury, poisoning and procedural complications
Heat exhaustion
|
0.68%
1/146 • Number of events 1 • Up to 24 months (plus 14 days) after first dose of study drug
All randomized participants who took at least one dose of study drug
|
0.00%
0/146 • Up to 24 months (plus 14 days) after first dose of study drug
All randomized participants who took at least one dose of study drug
|
|
Injury, poisoning and procedural complications
Ilium fracture
|
0.00%
0/146 • Up to 24 months (plus 14 days) after first dose of study drug
All randomized participants who took at least one dose of study drug
|
0.68%
1/146 • Number of events 1 • Up to 24 months (plus 14 days) after first dose of study drug
All randomized participants who took at least one dose of study drug
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.68%
1/146 • Number of events 1 • Up to 24 months (plus 14 days) after first dose of study drug
All randomized participants who took at least one dose of study drug
|
0.00%
0/146 • Up to 24 months (plus 14 days) after first dose of study drug
All randomized participants who took at least one dose of study drug
|
|
Injury, poisoning and procedural complications
Postoperative hernia
|
0.00%
0/146 • Up to 24 months (plus 14 days) after first dose of study drug
All randomized participants who took at least one dose of study drug
|
0.68%
1/146 • Number of events 1 • Up to 24 months (plus 14 days) after first dose of study drug
All randomized participants who took at least one dose of study drug
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.68%
1/146 • Number of events 1 • Up to 24 months (plus 14 days) after first dose of study drug
All randomized participants who took at least one dose of study drug
|
0.68%
1/146 • Number of events 1 • Up to 24 months (plus 14 days) after first dose of study drug
All randomized participants who took at least one dose of study drug
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.68%
1/146 • Number of events 1 • Up to 24 months (plus 14 days) after first dose of study drug
All randomized participants who took at least one dose of study drug
|
0.00%
0/146 • Up to 24 months (plus 14 days) after first dose of study drug
All randomized participants who took at least one dose of study drug
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.68%
1/146 • Number of events 1 • Up to 24 months (plus 14 days) after first dose of study drug
All randomized participants who took at least one dose of study drug
|
0.00%
0/146 • Up to 24 months (plus 14 days) after first dose of study drug
All randomized participants who took at least one dose of study drug
|
|
Investigations
Weight decreased
|
0.00%
0/146 • Up to 24 months (plus 14 days) after first dose of study drug
All randomized participants who took at least one dose of study drug
|
0.68%
1/146 • Number of events 1 • Up to 24 months (plus 14 days) after first dose of study drug
All randomized participants who took at least one dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.68%
1/146 • Number of events 1 • Up to 24 months (plus 14 days) after first dose of study drug
All randomized participants who took at least one dose of study drug
|
0.00%
0/146 • Up to 24 months (plus 14 days) after first dose of study drug
All randomized participants who took at least one dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Haemarthrosis
|
0.68%
1/146 • Number of events 1 • Up to 24 months (plus 14 days) after first dose of study drug
All randomized participants who took at least one dose of study drug
|
0.00%
0/146 • Up to 24 months (plus 14 days) after first dose of study drug
All randomized participants who took at least one dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
1.4%
2/146 • Number of events 2 • Up to 24 months (plus 14 days) after first dose of study drug
All randomized participants who took at least one dose of study drug
|
0.00%
0/146 • Up to 24 months (plus 14 days) after first dose of study drug
All randomized participants who took at least one dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Myopathy
|
0.68%
1/146 • Number of events 1 • Up to 24 months (plus 14 days) after first dose of study drug
All randomized participants who took at least one dose of study drug
|
0.00%
0/146 • Up to 24 months (plus 14 days) after first dose of study drug
All randomized participants who took at least one dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.68%
1/146 • Number of events 1 • Up to 24 months (plus 14 days) after first dose of study drug
All randomized participants who took at least one dose of study drug
|
0.68%
1/146 • Number of events 2 • Up to 24 months (plus 14 days) after first dose of study drug
All randomized participants who took at least one dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.68%
1/146 • Number of events 1 • Up to 24 months (plus 14 days) after first dose of study drug
All randomized participants who took at least one dose of study drug
|
0.00%
0/146 • Up to 24 months (plus 14 days) after first dose of study drug
All randomized participants who took at least one dose of study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/146 • Up to 24 months (plus 14 days) after first dose of study drug
All randomized participants who took at least one dose of study drug
|
0.68%
1/146 • Number of events 1 • Up to 24 months (plus 14 days) after first dose of study drug
All randomized participants who took at least one dose of study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign gastric neoplasm
|
0.68%
1/146 • Number of events 1 • Up to 24 months (plus 14 days) after first dose of study drug
All randomized participants who took at least one dose of study drug
|
0.00%
0/146 • Up to 24 months (plus 14 days) after first dose of study drug
All randomized participants who took at least one dose of study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma
|
0.00%
0/146 • Up to 24 months (plus 14 days) after first dose of study drug
All randomized participants who took at least one dose of study drug
|
0.68%
1/146 • Number of events 1 • Up to 24 months (plus 14 days) after first dose of study drug
All randomized participants who took at least one dose of study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bronchial carcinoma
|
0.00%
0/146 • Up to 24 months (plus 14 days) after first dose of study drug
All randomized participants who took at least one dose of study drug
|
0.68%
1/146 • Number of events 1 • Up to 24 months (plus 14 days) after first dose of study drug
All randomized participants who took at least one dose of study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic lymphocytic leukaemia
|
0.00%
0/146 • Up to 24 months (plus 14 days) after first dose of study drug
All randomized participants who took at least one dose of study drug
|
0.68%
1/146 • Number of events 1 • Up to 24 months (plus 14 days) after first dose of study drug
All randomized participants who took at least one dose of study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma of bone
|
0.68%
1/146 • Number of events 1 • Up to 24 months (plus 14 days) after first dose of study drug
All randomized participants who took at least one dose of study drug
|
0.00%
0/146 • Up to 24 months (plus 14 days) after first dose of study drug
All randomized participants who took at least one dose of study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.00%
0/146 • Up to 24 months (plus 14 days) after first dose of study drug
All randomized participants who took at least one dose of study drug
|
0.68%
1/146 • Number of events 1 • Up to 24 months (plus 14 days) after first dose of study drug
All randomized participants who took at least one dose of study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.68%
1/146 • Number of events 1 • Up to 24 months (plus 14 days) after first dose of study drug
All randomized participants who took at least one dose of study drug
|
0.00%
0/146 • Up to 24 months (plus 14 days) after first dose of study drug
All randomized participants who took at least one dose of study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/146 • Up to 24 months (plus 14 days) after first dose of study drug
All randomized participants who took at least one dose of study drug
|
1.4%
2/146 • Number of events 2 • Up to 24 months (plus 14 days) after first dose of study drug
All randomized participants who took at least one dose of study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
0.68%
1/146 • Number of events 1 • Up to 24 months (plus 14 days) after first dose of study drug
All randomized participants who took at least one dose of study drug
|
0.00%
0/146 • Up to 24 months (plus 14 days) after first dose of study drug
All randomized participants who took at least one dose of study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer
|
0.68%
1/146 • Number of events 1 • Up to 24 months (plus 14 days) after first dose of study drug
All randomized participants who took at least one dose of study drug
|
0.00%
0/146 • Up to 24 months (plus 14 days) after first dose of study drug
All randomized participants who took at least one dose of study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.68%
1/146 • Number of events 1 • Up to 24 months (plus 14 days) after first dose of study drug
All randomized participants who took at least one dose of study drug
|
0.68%
1/146 • Number of events 4 • Up to 24 months (plus 14 days) after first dose of study drug
All randomized participants who took at least one dose of study drug
|
|
Nervous system disorders
Cerebral ischaemia
|
0.00%
0/146 • Up to 24 months (plus 14 days) after first dose of study drug
All randomized participants who took at least one dose of study drug
|
0.68%
1/146 • Number of events 1 • Up to 24 months (plus 14 days) after first dose of study drug
All randomized participants who took at least one dose of study drug
|
|
Nervous system disorders
Syncope
|
0.68%
1/146 • Number of events 1 • Up to 24 months (plus 14 days) after first dose of study drug
All randomized participants who took at least one dose of study drug
|
0.00%
0/146 • Up to 24 months (plus 14 days) after first dose of study drug
All randomized participants who took at least one dose of study drug
|
|
Renal and urinary disorders
Calculus ureteric
|
0.00%
0/146 • Up to 24 months (plus 14 days) after first dose of study drug
All randomized participants who took at least one dose of study drug
|
0.68%
1/146 • Number of events 1 • Up to 24 months (plus 14 days) after first dose of study drug
All randomized participants who took at least one dose of study drug
|
|
Renal and urinary disorders
Haematuria
|
0.68%
1/146 • Number of events 1 • Up to 24 months (plus 14 days) after first dose of study drug
All randomized participants who took at least one dose of study drug
|
0.00%
0/146 • Up to 24 months (plus 14 days) after first dose of study drug
All randomized participants who took at least one dose of study drug
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
1.4%
2/146 • Number of events 2 • Up to 24 months (plus 14 days) after first dose of study drug
All randomized participants who took at least one dose of study drug
|
0.00%
0/146 • Up to 24 months (plus 14 days) after first dose of study drug
All randomized participants who took at least one dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.68%
1/146 • Number of events 1 • Up to 24 months (plus 14 days) after first dose of study drug
All randomized participants who took at least one dose of study drug
|
0.00%
0/146 • Up to 24 months (plus 14 days) after first dose of study drug
All randomized participants who took at least one dose of study drug
|
|
Vascular disorders
Hypertension
|
0.68%
1/146 • Number of events 1 • Up to 24 months (plus 14 days) after first dose of study drug
All randomized participants who took at least one dose of study drug
|
0.68%
1/146 • Number of events 1 • Up to 24 months (plus 14 days) after first dose of study drug
All randomized participants who took at least one dose of study drug
|
|
Vascular disorders
Hypotension
|
0.68%
1/146 • Number of events 2 • Up to 24 months (plus 14 days) after first dose of study drug
All randomized participants who took at least one dose of study drug
|
0.00%
0/146 • Up to 24 months (plus 14 days) after first dose of study drug
All randomized participants who took at least one dose of study drug
|
Other adverse events
| Measure |
Odanacatib 50 mg Once Weekly
n=146 participants at risk
Participants received one Odanacatib 50 mg tablet once weekly. In addition, they received a weekly dose 5600 IU of open-label Vitamin D3 as well as a sufficient supply of open-label calcium carbonate so that their total daily calcium intake from both dietary and supplemental sources was approximately 1200 mg.
|
Placebo Once Weekly
n=146 participants at risk
Participants received one Placebo tablet once weekly. In addition, they received a weekly dose 5600 IU of open-label Vitamin D3 as well as a sufficient supply of open-label calcium carbonate so that their total daily calcium intake from both dietary and supplemental sources was approximately 1200 mg.
|
|---|---|---|
|
General disorders
Influenza like illness
|
2.7%
4/146 • Number of events 4 • Up to 24 months (plus 14 days) after first dose of study drug
All randomized participants who took at least one dose of study drug
|
6.2%
9/146 • Number of events 11 • Up to 24 months (plus 14 days) after first dose of study drug
All randomized participants who took at least one dose of study drug
|
|
Infections and infestations
Nasopharyngitis
|
9.6%
14/146 • Number of events 18 • Up to 24 months (plus 14 days) after first dose of study drug
All randomized participants who took at least one dose of study drug
|
10.3%
15/146 • Number of events 18 • Up to 24 months (plus 14 days) after first dose of study drug
All randomized participants who took at least one dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.7%
4/146 • Number of events 4 • Up to 24 months (plus 14 days) after first dose of study drug
All randomized participants who took at least one dose of study drug
|
6.8%
10/146 • Number of events 11 • Up to 24 months (plus 14 days) after first dose of study drug
All randomized participants who took at least one dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.2%
9/146 • Number of events 11 • Up to 24 months (plus 14 days) after first dose of study drug
All randomized participants who took at least one dose of study drug
|
8.2%
12/146 • Number of events 15 • Up to 24 months (plus 14 days) after first dose of study drug
All randomized participants who took at least one dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.1%
3/146 • Number of events 3 • Up to 24 months (plus 14 days) after first dose of study drug
All randomized participants who took at least one dose of study drug
|
6.8%
10/146 • Number of events 12 • Up to 24 months (plus 14 days) after first dose of study drug
All randomized participants who took at least one dose of study drug
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee 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. Any information identified by the SPONSOR as confidential must be deleted prior to submission.
- Publication restrictions are in place
Restriction type: OTHER