Trial Outcomes & Findings for Efficacy and Safety of Odanacatib (MK-0822) in Participants With Involutional Osteoporosis (MK-0822-022) (NCT NCT00620113)
NCT ID: NCT00620113
Last Updated: 2018-08-27
Results Overview
BMD (g/cm2) data was measured by dual-energy X-ray absorptiometry (DXA) at lumbar spine vertebrae 1 through 4 (L1-L4) from anterior view at the Observation visit (up to 5 weeks before Treatment Period), Week 0 (start of Treatment Period) and Week 52 (end of Treatment Period) or at discontinuation. Baseline was defined as the average of the 2 values collected at the Observation visit and Week 0 visit. Percent change from baseline in BMD = (\[BMD at Week 52 visit\] - \[baseline BMD\] ÷ baseline BMD) × 100. Measurements were performed using the Hologic Quantitative Digital Radiography (QDR) Series densitometer, and by same machine and under same scan mode throughout the study period. BMD data was centrally judged.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
287 participants
Primary outcome timeframe
Baseline (Observation visit to Wk 0 treatment visit), Week 52
Results posted on
2018-08-27
Participant Flow
Of 403 participants screened, 287 participants were randomized to treatment on study. 286 participants received the correct treatment on study and were used for safety and efficacy analyses. One participant in the odanacatib 25 mg group also received 50 mg odanacatib during study by mistake and was excluded from all analyses.
Participant milestones
| Measure |
Placebo
After an observation period of \~5 weeks, participants receive dose-matched placebo to odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 International Units (IU) vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium \<1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
|
Odanacatib 10 mg
After an observation period of \~5 weeks, participants receive 10 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium \<1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
|
Odanacatib 25 mg
After an observation period of \~5 weeks, participants receive 25 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium \<1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
|
Odanacatib 50 mg
After an observation period of \~5 weeks, participants receive 50 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium \<1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
73
|
74
|
71
|
69
|
|
Overall Study
Efficacy/Safety Population
|
73
|
74
|
70
|
69
|
|
Overall Study
COMPLETED
|
60
|
67
|
66
|
59
|
|
Overall Study
NOT COMPLETED
|
13
|
7
|
5
|
10
|
Reasons for withdrawal
| Measure |
Placebo
After an observation period of \~5 weeks, participants receive dose-matched placebo to odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 International Units (IU) vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium \<1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
|
Odanacatib 10 mg
After an observation period of \~5 weeks, participants receive 10 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium \<1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
|
Odanacatib 25 mg
After an observation period of \~5 weeks, participants receive 25 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium \<1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
|
Odanacatib 50 mg
After an observation period of \~5 weeks, participants receive 50 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium \<1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
3
|
2
|
2
|
1
|
|
Overall Study
Lack of Efficacy
|
2
|
3
|
0
|
2
|
|
Overall Study
Physician Decision
|
1
|
0
|
0
|
2
|
|
Overall Study
Protocol Violation
|
2
|
1
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
5
|
1
|
3
|
5
|
Baseline Characteristics
Efficacy and Safety of Odanacatib (MK-0822) in Participants With Involutional Osteoporosis (MK-0822-022)
Baseline characteristics by cohort
| Measure |
Placebo
n=73 Participants
After an observation period of \~5 weeks, participants receive dose-matched placebo to odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium \<1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
|
Odanacatib 10 mg
n=74 Participants
After an observation period of \~5 weeks, participants receive 10 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium \<1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
|
Odanacatib 25 mg
n=70 Participants
After an observation period of \~5 weeks, participants receive 25 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium \<1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
|
Odanacatib 50 mg
n=69 Participants
After an observation period of \~5 weeks, participants receive 50 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium \<1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
|
Total
n=286 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
67.7 years
STANDARD_DEVIATION 6.8 • n=5 Participants
|
69.1 years
STANDARD_DEVIATION 7.3 • n=7 Participants
|
67.5 years
STANDARD_DEVIATION 7.4 • n=5 Participants
|
68.7 years
STANDARD_DEVIATION 7.0 • n=4 Participants
|
68.2 years
STANDARD_DEVIATION 7.1 • n=21 Participants
|
|
Sex: Female, Male
Female
|
70 Participants
n=5 Participants
|
69 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
67 Participants
n=4 Participants
|
269 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
17 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline (Observation visit to Wk 0 treatment visit), Week 52Population: Full Analysis Set (FAS): All randomized participants receiving at least one dose of study medication and with necessary on-treatment lumbar spine BMD measurements, with data carried forward.
BMD (g/cm2) data was measured by dual-energy X-ray absorptiometry (DXA) at lumbar spine vertebrae 1 through 4 (L1-L4) from anterior view at the Observation visit (up to 5 weeks before Treatment Period), Week 0 (start of Treatment Period) and Week 52 (end of Treatment Period) or at discontinuation. Baseline was defined as the average of the 2 values collected at the Observation visit and Week 0 visit. Percent change from baseline in BMD = (\[BMD at Week 52 visit\] - \[baseline BMD\] ÷ baseline BMD) × 100. Measurements were performed using the Hologic Quantitative Digital Radiography (QDR) Series densitometer, and by same machine and under same scan mode throughout the study period. BMD data was centrally judged.
Outcome measures
| Measure |
Placebo
n=69 Participants
After an observation period of \~5 weeks, participants receive dose-matched placebo to odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium \<1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
|
Odanacatib 10 mg
n=73 Participants
After an observation period of \~5 weeks, participants receive 10 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium \<1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
|
Odanacatib 25 mg
n=70 Participants
After an observation period of \~5 weeks, participants receive 25 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium \<1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
|
Odanacatib 50 mg
n=68 Participants
After an observation period of \~5 weeks, participants receive 50 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium \<1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
|
|---|---|---|---|---|
|
Percent Change From Baseline to Week 52 in Lumbar Spine Bone Mineral Density (BMD) at Lumbar Vertebrae 1 to 4 (L1-L4)
|
0.55 percent change
Interval -0.32 to 1.42
|
4.09 percent change
Interval 3.24 to 4.93
|
5.67 percent change
Interval 4.81 to 6.54
|
5.94 percent change
Interval 5.07 to 6.82
|
PRIMARY outcome
Timeframe: From first dose up to Post-Study (up to 54 weeks)Population: Safety Population: All randomized participants receiving at least one dose of correct study medication. One participant received both 25 mg and 50 mg doses and was excluded from all analyses.
An AE was defined as any unfavorable and unintended change in the structure (sign), function (symptoms), or chemistry of the body (laboratory data) temporally associated with the use of the SPONSOR's products (including placebo), whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR's product was also an AE. The number of participants that experienced at least one AE was reported for each treatment arm.
Outcome measures
| Measure |
Placebo
n=73 Participants
After an observation period of \~5 weeks, participants receive dose-matched placebo to odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium \<1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
|
Odanacatib 10 mg
n=74 Participants
After an observation period of \~5 weeks, participants receive 10 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium \<1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
|
Odanacatib 25 mg
n=70 Participants
After an observation period of \~5 weeks, participants receive 25 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium \<1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
|
Odanacatib 50 mg
n=69 Participants
After an observation period of \~5 weeks, participants receive 50 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium \<1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
|
|---|---|---|---|---|
|
Number of Participants That Experienced an Adverse Event (AE)
|
57 participants
|
63 participants
|
62 participants
|
58 participants
|
PRIMARY outcome
Timeframe: From first dose up to end of treatment (up to 52 weeks)Population: Safety Population: All randomized participants receiving at least one dose of correct study medication. One participant received both 25 mg and 50 mg doses and was excluded from all analyses.
An AE was defined as any unfavorable and unintended change in the structure (sign), function (symptoms), or chemistry of the body (laboratory data) temporally associated with the use of the SPONSOR's products (including placebo), whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR's product was also an AE. The number of participants that discontinued study drug due to an AE was reported for each treatment arm. Participants may have discontinued study drug but continued on the trial.
Outcome measures
| Measure |
Placebo
n=73 Participants
After an observation period of \~5 weeks, participants receive dose-matched placebo to odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium \<1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
|
Odanacatib 10 mg
n=74 Participants
After an observation period of \~5 weeks, participants receive 10 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium \<1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
|
Odanacatib 25 mg
n=70 Participants
After an observation period of \~5 weeks, participants receive 25 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium \<1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
|
Odanacatib 50 mg
n=69 Participants
After an observation period of \~5 weeks, participants receive 50 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium \<1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
|
|---|---|---|---|---|
|
Number of Participants That Discontinued Study Drug Due to an AE
|
3 participants
|
2 participants
|
1 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Baseline (Observation visit to Wk 0 treatment visit), Week 52Population: FAS: All randomized participants receiving at least one dose of study medication and with necessary on-treatment total hip BMD measurements, with data carried forward.
BMD (g/cm2) data was measured by DXA for total hip at the Observation visit (up to 5 weeks before Treatment Period), Week 0 (start of Treatment Period) and Week 52 (end of Treatment Period) or at discontinuation. Baseline was defined as the average of the 2 values collected at the Observation visit and Week 0 visit. Percent change from baseline in BMD = (\[BMD at Week 52 visit\] - \[baseline BMD\] ÷ baseline BMD) × 100. Measurements were performed using the Hologic QDR Series densitometer, and by same machine and under same scan mode throughout the study period. BMD data was centrally judged.
Outcome measures
| Measure |
Placebo
n=71 Participants
After an observation period of \~5 weeks, participants receive dose-matched placebo to odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium \<1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
|
Odanacatib 10 mg
n=74 Participants
After an observation period of \~5 weeks, participants receive 10 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium \<1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
|
Odanacatib 25 mg
n=70 Participants
After an observation period of \~5 weeks, participants receive 25 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium \<1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
|
Odanacatib 50 mg
n=68 Participants
After an observation period of \~5 weeks, participants receive 50 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium \<1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
|
|---|---|---|---|---|
|
Percent Change From Baseline to Week 52 in Total Hip BMD
|
-0.35 percent change
Interval -1.0 to 0.29
|
1.31 percent change
Interval 0.68 to 1.94
|
1.85 percent change
Interval 1.2 to 2.5
|
2.70 percent change
Interval 2.05 to 3.36
|
SECONDARY outcome
Timeframe: Baseline (Observation visit to Wk 0 treatment visit), Week 52Population: FAS: All randomized participants receiving at least one dose of study medication and with necessary on-treatment femoral neck BMD measurements, with data carried forward.
BMD (g/cm2) data was measured by DXA at the femoral neck subregion of the hip at the Observation visit (up to 5 weeks before Treatment Period), Week 0 (start of Treatment Period) and Week 52 (end of Treatment Period) or at discontinuation. Baseline was defined as the average of the 2 values collected at the Observation visit and Week 0 visit. Percent change from baseline in BMD = (\[BMD at Week 52 visit\] - \[baseline BMD\] ÷ baseline BMD) × 100. Measurements were performed using the Hologic QDR Series densitometer, and by same machine and under same scan mode throughout the study period. BMD data was centrally judged.
Outcome measures
| Measure |
Placebo
n=71 Participants
After an observation period of \~5 weeks, participants receive dose-matched placebo to odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium \<1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
|
Odanacatib 10 mg
n=74 Participants
After an observation period of \~5 weeks, participants receive 10 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium \<1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
|
Odanacatib 25 mg
n=70 Participants
After an observation period of \~5 weeks, participants receive 25 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium \<1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
|
Odanacatib 50 mg
n=68 Participants
After an observation period of \~5 weeks, participants receive 50 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium \<1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
|
|---|---|---|---|---|
|
Percent Change From Baseline to Week 52 in Femoral Neck BMD
|
-0.72 percent change
Interval -1.58 to 0.13
|
1.51 percent change
Interval 0.67 to 2.35
|
1.14 percent change
Interval 0.27 to 2.0
|
2.35 percent change
Interval 1.47 to 3.23
|
SECONDARY outcome
Timeframe: Baseline (Observation visit to Wk 0 treatment visit), Week 52Population: FAS: All randomized participants receiving at least one dose of study medication and with necessary on-treatment trochanter BMD measurements, with data carried forward.
BMD (g/cm2) data was measured by DXA at the trochanter subregion of the hip (near bony protrusions along outside edge of femur) at the Observation visit (up to 5 weeks before Treatment Period), Week 0 (start of Treatment Period) and Week 52 (end of Treatment Period) or at discontinuation. Baseline was defined as the average of the 2 values collected at the Observation visit and Week 0 visit. Percent change from baseline in BMD = (\[BMD at Week 52 visit\] - \[baseline BMD\] ÷ baseline BMD) × 100. Measurements were performed using the Hologic QDR Series densitometer, and by same machine and under same scan mode throughout the study period. BMD data was centrally judged.
Outcome measures
| Measure |
Placebo
n=71 Participants
After an observation period of \~5 weeks, participants receive dose-matched placebo to odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium \<1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
|
Odanacatib 10 mg
n=74 Participants
After an observation period of \~5 weeks, participants receive 10 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium \<1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
|
Odanacatib 25 mg
n=70 Participants
After an observation period of \~5 weeks, participants receive 25 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium \<1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
|
Odanacatib 50 mg
n=68 Participants
After an observation period of \~5 weeks, participants receive 50 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium \<1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
|
|---|---|---|---|---|
|
Percent Change From Baseline to Week 52 in Trochanter BMD
|
-0.28 percent change
Interval -1.31 to 0.76
|
2.16 percent change
Interval 1.14 to 3.17
|
3.56 percent change
Interval 2.52 to 4.6
|
4.38 percent change
Interval 3.33 to 5.44
|
SECONDARY outcome
Timeframe: Baseline (Wk 0), Week 52Population: Per Protocol (PP) Population: All randomized participants receiving at least one dose of study medication, who complied with the protocol (excludes participants with major protocol violation), and with available u-NTx/Cre data.
The u-NTx/Cre ratio is a biochemical marker index of bone resorption. Urine samples were collected from second void morning urine specimens to assess the u-NTx/Cre ratio. Percent change from baseline in biomarker = (\[biomarker value at Week 52 visit\] - \[baseline biomarker value\] ÷ baseline biomarker value) × 100. All measurements of bone biochemical markers were centrally performed.
Outcome measures
| Measure |
Placebo
n=50 Participants
After an observation period of \~5 weeks, participants receive dose-matched placebo to odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium \<1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
|
Odanacatib 10 mg
n=57 Participants
After an observation period of \~5 weeks, participants receive 10 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium \<1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
|
Odanacatib 25 mg
n=56 Participants
After an observation period of \~5 weeks, participants receive 25 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium \<1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
|
Odanacatib 50 mg
n=51 Participants
After an observation period of \~5 weeks, participants receive 50 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium \<1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
|
|---|---|---|---|---|
|
Percent Change From Baseline to Week 52 in Urinary N-telopeptides/Creatinine (u-NTx/Cre) Ratio
|
-7.84 percent change
Interval -21.19 to 7.76
|
-43.59 percent change
Interval -51.26 to -34.71
|
-52.16 percent change
Interval -58.73 to -44.54
|
-58.48 percent change
Interval -64.42 to -51.54
|
SECONDARY outcome
Timeframe: Baseline (Wk 0), Week 52Population: PP Population: All randomized participants receiving at least one dose of study medication, who complied with the protocol (excludes participants with major protocol violation), and with available s-CTx data.
s-CTx is a biochemical marker index of bone resorption. Blood samples were collected in the morning and in fasting state for measurement of s-CTx. Percent change from baseline in biomarker = (\[biomarker value at Week 52 visit\] - \[baseline biomarker value\] ÷ baseline biomarker value) × 100. All measurements of bone biochemical markers were centrally performed.
Outcome measures
| Measure |
Placebo
n=50 Participants
After an observation period of \~5 weeks, participants receive dose-matched placebo to odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium \<1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
|
Odanacatib 10 mg
n=57 Participants
After an observation period of \~5 weeks, participants receive 10 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium \<1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
|
Odanacatib 25 mg
n=56 Participants
After an observation period of \~5 weeks, participants receive 25 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium \<1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
|
Odanacatib 50 mg
n=52 Participants
After an observation period of \~5 weeks, participants receive 50 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium \<1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
|
|---|---|---|---|---|
|
Percent Change From Baseline to Week 52 in Serum C-Telopeptides of Type 1 Collagen (s-CTx) Level
|
-10.95 percent change
Interval -32.05 to 16.72
|
-49.68 percent change
Interval -60.92 to -35.2
|
-71.64 percent change
Interval -78.04 to -63.39
|
-71.36 percent change
Interval -78.02 to -62.68
|
SECONDARY outcome
Timeframe: Baseline (Wk 0), Week 52Population: PP Population: All randomized participants receiving at least one dose of study medication, who complied with the protocol (excludes participants with major protocol violation), and with available u-DPD/Cre data.
The u-DPD/Cre ratio is a biochemical marker index of bone resorption. Urine samples were collected from second void morning urine specimens to assess the u-DPD/Cre ratio. Percent change from baseline in biomarker = (\[biomarker value at Week 52 visit\] - \[baseline biomarker value\] ÷ baseline biomarker value) × 100. All measurements of bone biochemical markers were centrally performed.
Outcome measures
| Measure |
Placebo
n=50 Participants
After an observation period of \~5 weeks, participants receive dose-matched placebo to odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium \<1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
|
Odanacatib 10 mg
n=57 Participants
After an observation period of \~5 weeks, participants receive 10 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium \<1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
|
Odanacatib 25 mg
n=56 Participants
After an observation period of \~5 weeks, participants receive 25 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium \<1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
|
Odanacatib 50 mg
n=51 Participants
After an observation period of \~5 weeks, participants receive 50 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium \<1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
|
|---|---|---|---|---|
|
Percent Change From Baseline to Week 52 in Urinary Deoxypyridinoline/Creatinine Ratio (u-DPD/Cre)
|
16.45 percent change
Interval -1.24 to 37.3
|
-10.32 percent change
Interval -23.11 to 4.61
|
-21.00 percent change
Interval -32.39 to -7.69
|
-26.46 percent change
Interval -37.51 to -13.46
|
SECONDARY outcome
Timeframe: Baseline (Wk 0), Week 52Population: PP Population: All randomized participants receiving at least one dose of study medication, who complied with the protocol (excludes participants with major protocol violation), and with available s-BSAP data.
s-BSAP is a biochemical marker index of bone formation. Blood samples were collected in the morning and in fasting state for measurement of s-BSAP. Percent change from baseline in biomarker = (\[biomarker value at Week 52 visit\] - \[baseline biomarker value\] ÷ baseline biomarker value) × 100. All measurements of bone biochemical markers were centrally performed.
Outcome measures
| Measure |
Placebo
n=53 Participants
After an observation period of \~5 weeks, participants receive dose-matched placebo to odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium \<1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
|
Odanacatib 10 mg
n=60 Participants
After an observation period of \~5 weeks, participants receive 10 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium \<1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
|
Odanacatib 25 mg
n=58 Participants
After an observation period of \~5 weeks, participants receive 25 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium \<1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
|
Odanacatib 50 mg
n=54 Participants
After an observation period of \~5 weeks, participants receive 50 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium \<1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
|
|---|---|---|---|---|
|
Percent Change From Baseline to Week 52 in Serum Bone Specific Alkaline Phosphatase (s-BSAP) Level
|
-9.91 percent change
Interval -17.02 to -2.2
|
-7.44 percent change
Interval -14.31 to -0.02
|
-22.47 percent change
Interval -28.32 to -16.14
|
-25.43 percent change
Interval -31.26 to -19.12
|
SECONDARY outcome
Timeframe: Baseline (Wk 0), Week 52Population: PP Population: All randomized participants receiving at least one dose of study medication, who complied with the protocol (excludes participants with major protocol violation), and with available s-P1NP data.
s-P1NP is a biochemical marker index of bone formation. Blood samples were collected in the morning and in fasting state for measurement of s- P1NP. Percent change from baseline in biomarker = (\[biomarker value at Week 52 visit\] - \[baseline biomarker value\] ÷ baseline biomarker value) × 100. All measurements of bone biochemical markers were centrally performed.
Outcome measures
| Measure |
Placebo
n=53 Participants
After an observation period of \~5 weeks, participants receive dose-matched placebo to odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium \<1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
|
Odanacatib 10 mg
n=60 Participants
After an observation period of \~5 weeks, participants receive 10 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium \<1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
|
Odanacatib 25 mg
n=58 Participants
After an observation period of \~5 weeks, participants receive 25 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium \<1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
|
Odanacatib 50 mg
n=54 Participants
After an observation period of \~5 weeks, participants receive 50 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium \<1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
|
|---|---|---|---|---|
|
Percent Change From Baseline to Week 52 in Serum N-Terminal Propeptides of Type 1 Collagen (s-P1NP) Level
|
-20.14 percent change
Interval -32.74 to -5.18
|
-25.75 percent change
Interval -36.81 to -12.76
|
-48.99 percent change
Interval -56.71 to -39.9
|
-47.00 percent change
Interval -55.28 to -37.19
|
Adverse Events
Placebo
Serious events: 5 serious events
Other events: 46 other events
Deaths: 0 deaths
Odanacatib 10 mg
Serious events: 6 serious events
Other events: 46 other events
Deaths: 0 deaths
Odanacatib 25 mg
Serious events: 4 serious events
Other events: 50 other events
Deaths: 0 deaths
Odanacatib 50 mg
Serious events: 4 serious events
Other events: 51 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=73 participants at risk
After an observation period of \~5 weeks, participants receive dose-matched placebo to odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium \<1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
|
Odanacatib 10 mg
n=74 participants at risk
After an observation period of \~5 weeks, participants receive 10 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium \<1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
|
Odanacatib 25 mg
n=70 participants at risk
After an observation period of \~5 weeks, participants receive 25 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium \<1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
|
Odanacatib 50 mg
n=69 participants at risk
After an observation period of \~5 weeks, participants receive 50 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium \<1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
|
|---|---|---|---|---|
|
Cardiac disorders
Angina pectoris
|
1.4%
1/73 • Number of events 1 • From first dose up to Post-Study (up to 54 weeks)
Safety Population: All randomized participants receiving at least one dose of correct study medication. One participant received both 25 mg and 50 mg doses and was excluded from all analyses.
|
0.00%
0/74 • From first dose up to Post-Study (up to 54 weeks)
Safety Population: All randomized participants receiving at least one dose of correct study medication. One participant received both 25 mg and 50 mg doses and was excluded from all analyses.
|
1.4%
1/70 • Number of events 1 • From first dose up to Post-Study (up to 54 weeks)
Safety Population: All randomized participants receiving at least one dose of correct study medication. One participant received both 25 mg and 50 mg doses and was excluded from all analyses.
|
0.00%
0/69 • From first dose up to Post-Study (up to 54 weeks)
Safety Population: All randomized participants receiving at least one dose of correct study medication. One participant received both 25 mg and 50 mg doses and was excluded from all analyses.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/73 • From first dose up to Post-Study (up to 54 weeks)
Safety Population: All randomized participants receiving at least one dose of correct study medication. One participant received both 25 mg and 50 mg doses and was excluded from all analyses.
|
1.4%
1/74 • Number of events 1 • From first dose up to Post-Study (up to 54 weeks)
Safety Population: All randomized participants receiving at least one dose of correct study medication. One participant received both 25 mg and 50 mg doses and was excluded from all analyses.
|
0.00%
0/70 • From first dose up to Post-Study (up to 54 weeks)
Safety Population: All randomized participants receiving at least one dose of correct study medication. One participant received both 25 mg and 50 mg doses and was excluded from all analyses.
|
0.00%
0/69 • From first dose up to Post-Study (up to 54 weeks)
Safety Population: All randomized participants receiving at least one dose of correct study medication. One participant received both 25 mg and 50 mg doses and was excluded from all analyses.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/73 • From first dose up to Post-Study (up to 54 weeks)
Safety Population: All randomized participants receiving at least one dose of correct study medication. One participant received both 25 mg and 50 mg doses and was excluded from all analyses.
|
2.7%
2/74 • Number of events 2 • From first dose up to Post-Study (up to 54 weeks)
Safety Population: All randomized participants receiving at least one dose of correct study medication. One participant received both 25 mg and 50 mg doses and was excluded from all analyses.
|
0.00%
0/70 • From first dose up to Post-Study (up to 54 weeks)
Safety Population: All randomized participants receiving at least one dose of correct study medication. One participant received both 25 mg and 50 mg doses and was excluded from all analyses.
|
0.00%
0/69 • From first dose up to Post-Study (up to 54 weeks)
Safety Population: All randomized participants receiving at least one dose of correct study medication. One participant received both 25 mg and 50 mg doses and was excluded from all analyses.
|
|
Eye disorders
Cataract
|
0.00%
0/73 • From first dose up to Post-Study (up to 54 weeks)
Safety Population: All randomized participants receiving at least one dose of correct study medication. One participant received both 25 mg and 50 mg doses and was excluded from all analyses.
|
0.00%
0/74 • From first dose up to Post-Study (up to 54 weeks)
Safety Population: All randomized participants receiving at least one dose of correct study medication. One participant received both 25 mg and 50 mg doses and was excluded from all analyses.
|
1.4%
1/70 • Number of events 1 • From first dose up to Post-Study (up to 54 weeks)
Safety Population: All randomized participants receiving at least one dose of correct study medication. One participant received both 25 mg and 50 mg doses and was excluded from all analyses.
|
0.00%
0/69 • From first dose up to Post-Study (up to 54 weeks)
Safety Population: All randomized participants receiving at least one dose of correct study medication. One participant received both 25 mg and 50 mg doses and was excluded from all analyses.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/73 • From first dose up to Post-Study (up to 54 weeks)
Safety Population: All randomized participants receiving at least one dose of correct study medication. One participant received both 25 mg and 50 mg doses and was excluded from all analyses.
|
0.00%
0/74 • From first dose up to Post-Study (up to 54 weeks)
Safety Population: All randomized participants receiving at least one dose of correct study medication. One participant received both 25 mg and 50 mg doses and was excluded from all analyses.
|
1.4%
1/70 • Number of events 1 • From first dose up to Post-Study (up to 54 weeks)
Safety Population: All randomized participants receiving at least one dose of correct study medication. One participant received both 25 mg and 50 mg doses and was excluded from all analyses.
|
0.00%
0/69 • From first dose up to Post-Study (up to 54 weeks)
Safety Population: All randomized participants receiving at least one dose of correct study medication. One participant received both 25 mg and 50 mg doses and was excluded from all analyses.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/73 • From first dose up to Post-Study (up to 54 weeks)
Safety Population: All randomized participants receiving at least one dose of correct study medication. One participant received both 25 mg and 50 mg doses and was excluded from all analyses.
|
0.00%
0/74 • From first dose up to Post-Study (up to 54 weeks)
Safety Population: All randomized participants receiving at least one dose of correct study medication. One participant received both 25 mg and 50 mg doses and was excluded from all analyses.
|
0.00%
0/70 • From first dose up to Post-Study (up to 54 weeks)
Safety Population: All randomized participants receiving at least one dose of correct study medication. One participant received both 25 mg and 50 mg doses and was excluded from all analyses.
|
1.4%
1/69 • Number of events 1 • From first dose up to Post-Study (up to 54 weeks)
Safety Population: All randomized participants receiving at least one dose of correct study medication. One participant received both 25 mg and 50 mg doses and was excluded from all analyses.
|
|
Infections and infestations
Cellulitis
|
1.4%
1/73 • Number of events 1 • From first dose up to Post-Study (up to 54 weeks)
Safety Population: All randomized participants receiving at least one dose of correct study medication. One participant received both 25 mg and 50 mg doses and was excluded from all analyses.
|
0.00%
0/74 • From first dose up to Post-Study (up to 54 weeks)
Safety Population: All randomized participants receiving at least one dose of correct study medication. One participant received both 25 mg and 50 mg doses and was excluded from all analyses.
|
0.00%
0/70 • From first dose up to Post-Study (up to 54 weeks)
Safety Population: All randomized participants receiving at least one dose of correct study medication. One participant received both 25 mg and 50 mg doses and was excluded from all analyses.
|
0.00%
0/69 • From first dose up to Post-Study (up to 54 weeks)
Safety Population: All randomized participants receiving at least one dose of correct study medication. One participant received both 25 mg and 50 mg doses and was excluded from all analyses.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/73 • From first dose up to Post-Study (up to 54 weeks)
Safety Population: All randomized participants receiving at least one dose of correct study medication. One participant received both 25 mg and 50 mg doses and was excluded from all analyses.
|
0.00%
0/74 • From first dose up to Post-Study (up to 54 weeks)
Safety Population: All randomized participants receiving at least one dose of correct study medication. One participant received both 25 mg and 50 mg doses and was excluded from all analyses.
|
0.00%
0/70 • From first dose up to Post-Study (up to 54 weeks)
Safety Population: All randomized participants receiving at least one dose of correct study medication. One participant received both 25 mg and 50 mg doses and was excluded from all analyses.
|
1.4%
1/69 • Number of events 1 • From first dose up to Post-Study (up to 54 weeks)
Safety Population: All randomized participants receiving at least one dose of correct study medication. One participant received both 25 mg and 50 mg doses and was excluded from all analyses.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/73 • From first dose up to Post-Study (up to 54 weeks)
Safety Population: All randomized participants receiving at least one dose of correct study medication. One participant received both 25 mg and 50 mg doses and was excluded from all analyses.
|
0.00%
0/74 • From first dose up to Post-Study (up to 54 weeks)
Safety Population: All randomized participants receiving at least one dose of correct study medication. One participant received both 25 mg and 50 mg doses and was excluded from all analyses.
|
0.00%
0/70 • From first dose up to Post-Study (up to 54 weeks)
Safety Population: All randomized participants receiving at least one dose of correct study medication. One participant received both 25 mg and 50 mg doses and was excluded from all analyses.
|
1.4%
1/69 • Number of events 1 • From first dose up to Post-Study (up to 54 weeks)
Safety Population: All randomized participants receiving at least one dose of correct study medication. One participant received both 25 mg and 50 mg doses and was excluded from all analyses.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/73 • From first dose up to Post-Study (up to 54 weeks)
Safety Population: All randomized participants receiving at least one dose of correct study medication. One participant received both 25 mg and 50 mg doses and was excluded from all analyses.
|
2.7%
2/74 • Number of events 2 • From first dose up to Post-Study (up to 54 weeks)
Safety Population: All randomized participants receiving at least one dose of correct study medication. One participant received both 25 mg and 50 mg doses and was excluded from all analyses.
|
0.00%
0/70 • From first dose up to Post-Study (up to 54 weeks)
Safety Population: All randomized participants receiving at least one dose of correct study medication. One participant received both 25 mg and 50 mg doses and was excluded from all analyses.
|
0.00%
0/69 • From first dose up to Post-Study (up to 54 weeks)
Safety Population: All randomized participants receiving at least one dose of correct study medication. One participant received both 25 mg and 50 mg doses and was excluded from all analyses.
|
|
Musculoskeletal and connective tissue disorders
Foot deformity
|
0.00%
0/73 • From first dose up to Post-Study (up to 54 weeks)
Safety Population: All randomized participants receiving at least one dose of correct study medication. One participant received both 25 mg and 50 mg doses and was excluded from all analyses.
|
0.00%
0/74 • From first dose up to Post-Study (up to 54 weeks)
Safety Population: All randomized participants receiving at least one dose of correct study medication. One participant received both 25 mg and 50 mg doses and was excluded from all analyses.
|
0.00%
0/70 • From first dose up to Post-Study (up to 54 weeks)
Safety Population: All randomized participants receiving at least one dose of correct study medication. One participant received both 25 mg and 50 mg doses and was excluded from all analyses.
|
1.4%
1/69 • Number of events 1 • From first dose up to Post-Study (up to 54 weeks)
Safety Population: All randomized participants receiving at least one dose of correct study medication. One participant received both 25 mg and 50 mg doses and was excluded from all analyses.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma
|
0.00%
0/73 • From first dose up to Post-Study (up to 54 weeks)
Safety Population: All randomized participants receiving at least one dose of correct study medication. One participant received both 25 mg and 50 mg doses and was excluded from all analyses.
|
1.4%
1/74 • Number of events 1 • From first dose up to Post-Study (up to 54 weeks)
Safety Population: All randomized participants receiving at least one dose of correct study medication. One participant received both 25 mg and 50 mg doses and was excluded from all analyses.
|
0.00%
0/70 • From first dose up to Post-Study (up to 54 weeks)
Safety Population: All randomized participants receiving at least one dose of correct study medication. One participant received both 25 mg and 50 mg doses and was excluded from all analyses.
|
0.00%
0/69 • From first dose up to Post-Study (up to 54 weeks)
Safety Population: All randomized participants receiving at least one dose of correct study medication. One participant received both 25 mg and 50 mg doses and was excluded from all analyses.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
1.4%
1/73 • Number of events 1 • From first dose up to Post-Study (up to 54 weeks)
Safety Population: All randomized participants receiving at least one dose of correct study medication. One participant received both 25 mg and 50 mg doses and was excluded from all analyses.
|
0.00%
0/74 • From first dose up to Post-Study (up to 54 weeks)
Safety Population: All randomized participants receiving at least one dose of correct study medication. One participant received both 25 mg and 50 mg doses and was excluded from all analyses.
|
0.00%
0/70 • From first dose up to Post-Study (up to 54 weeks)
Safety Population: All randomized participants receiving at least one dose of correct study medication. One participant received both 25 mg and 50 mg doses and was excluded from all analyses.
|
0.00%
0/69 • From first dose up to Post-Study (up to 54 weeks)
Safety Population: All randomized participants receiving at least one dose of correct study medication. One participant received both 25 mg and 50 mg doses and was excluded from all analyses.
|
|
Nervous system disorders
Cerebellar haemorrhage
|
0.00%
0/73 • From first dose up to Post-Study (up to 54 weeks)
Safety Population: All randomized participants receiving at least one dose of correct study medication. One participant received both 25 mg and 50 mg doses and was excluded from all analyses.
|
0.00%
0/74 • From first dose up to Post-Study (up to 54 weeks)
Safety Population: All randomized participants receiving at least one dose of correct study medication. One participant received both 25 mg and 50 mg doses and was excluded from all analyses.
|
1.4%
1/70 • Number of events 1 • From first dose up to Post-Study (up to 54 weeks)
Safety Population: All randomized participants receiving at least one dose of correct study medication. One participant received both 25 mg and 50 mg doses and was excluded from all analyses.
|
0.00%
0/69 • From first dose up to Post-Study (up to 54 weeks)
Safety Population: All randomized participants receiving at least one dose of correct study medication. One participant received both 25 mg and 50 mg doses and was excluded from all analyses.
|
|
Nervous system disorders
Intraneural cyst
|
1.4%
1/73 • Number of events 1 • From first dose up to Post-Study (up to 54 weeks)
Safety Population: All randomized participants receiving at least one dose of correct study medication. One participant received both 25 mg and 50 mg doses and was excluded from all analyses.
|
0.00%
0/74 • From first dose up to Post-Study (up to 54 weeks)
Safety Population: All randomized participants receiving at least one dose of correct study medication. One participant received both 25 mg and 50 mg doses and was excluded from all analyses.
|
0.00%
0/70 • From first dose up to Post-Study (up to 54 weeks)
Safety Population: All randomized participants receiving at least one dose of correct study medication. One participant received both 25 mg and 50 mg doses and was excluded from all analyses.
|
0.00%
0/69 • From first dose up to Post-Study (up to 54 weeks)
Safety Population: All randomized participants receiving at least one dose of correct study medication. One participant received both 25 mg and 50 mg doses and was excluded from all analyses.
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.00%
0/73 • From first dose up to Post-Study (up to 54 weeks)
Safety Population: All randomized participants receiving at least one dose of correct study medication. One participant received both 25 mg and 50 mg doses and was excluded from all analyses.
|
0.00%
0/74 • From first dose up to Post-Study (up to 54 weeks)
Safety Population: All randomized participants receiving at least one dose of correct study medication. One participant received both 25 mg and 50 mg doses and was excluded from all analyses.
|
0.00%
0/70 • From first dose up to Post-Study (up to 54 weeks)
Safety Population: All randomized participants receiving at least one dose of correct study medication. One participant received both 25 mg and 50 mg doses and was excluded from all analyses.
|
1.4%
1/69 • Number of events 1 • From first dose up to Post-Study (up to 54 weeks)
Safety Population: All randomized participants receiving at least one dose of correct study medication. One participant received both 25 mg and 50 mg doses and was excluded from all analyses.
|
|
Nervous system disorders
Transient ischaemic attack
|
1.4%
1/73 • Number of events 1 • From first dose up to Post-Study (up to 54 weeks)
Safety Population: All randomized participants receiving at least one dose of correct study medication. One participant received both 25 mg and 50 mg doses and was excluded from all analyses.
|
0.00%
0/74 • From first dose up to Post-Study (up to 54 weeks)
Safety Population: All randomized participants receiving at least one dose of correct study medication. One participant received both 25 mg and 50 mg doses and was excluded from all analyses.
|
0.00%
0/70 • From first dose up to Post-Study (up to 54 weeks)
Safety Population: All randomized participants receiving at least one dose of correct study medication. One participant received both 25 mg and 50 mg doses and was excluded from all analyses.
|
0.00%
0/69 • From first dose up to Post-Study (up to 54 weeks)
Safety Population: All randomized participants receiving at least one dose of correct study medication. One participant received both 25 mg and 50 mg doses and was excluded from all analyses.
|
|
Psychiatric disorders
Neurosis
|
1.4%
1/73 • Number of events 1 • From first dose up to Post-Study (up to 54 weeks)
Safety Population: All randomized participants receiving at least one dose of correct study medication. One participant received both 25 mg and 50 mg doses and was excluded from all analyses.
|
0.00%
0/74 • From first dose up to Post-Study (up to 54 weeks)
Safety Population: All randomized participants receiving at least one dose of correct study medication. One participant received both 25 mg and 50 mg doses and was excluded from all analyses.
|
0.00%
0/70 • From first dose up to Post-Study (up to 54 weeks)
Safety Population: All randomized participants receiving at least one dose of correct study medication. One participant received both 25 mg and 50 mg doses and was excluded from all analyses.
|
0.00%
0/69 • From first dose up to Post-Study (up to 54 weeks)
Safety Population: All randomized participants receiving at least one dose of correct study medication. One participant received both 25 mg and 50 mg doses and was excluded from all analyses.
|
Other adverse events
| Measure |
Placebo
n=73 participants at risk
After an observation period of \~5 weeks, participants receive dose-matched placebo to odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium \<1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
|
Odanacatib 10 mg
n=74 participants at risk
After an observation period of \~5 weeks, participants receive 10 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium \<1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
|
Odanacatib 25 mg
n=70 participants at risk
After an observation period of \~5 weeks, participants receive 25 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium \<1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
|
Odanacatib 50 mg
n=69 participants at risk
After an observation period of \~5 weeks, participants receive 50 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium \<1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal discomfort
|
2.7%
2/73 • Number of events 3 • From first dose up to Post-Study (up to 54 weeks)
Safety Population: All randomized participants receiving at least one dose of correct study medication. One participant received both 25 mg and 50 mg doses and was excluded from all analyses.
|
0.00%
0/74 • From first dose up to Post-Study (up to 54 weeks)
Safety Population: All randomized participants receiving at least one dose of correct study medication. One participant received both 25 mg and 50 mg doses and was excluded from all analyses.
|
1.4%
1/70 • Number of events 2 • From first dose up to Post-Study (up to 54 weeks)
Safety Population: All randomized participants receiving at least one dose of correct study medication. One participant received both 25 mg and 50 mg doses and was excluded from all analyses.
|
5.8%
4/69 • Number of events 5 • From first dose up to Post-Study (up to 54 weeks)
Safety Population: All randomized participants receiving at least one dose of correct study medication. One participant received both 25 mg and 50 mg doses and was excluded from all analyses.
|
|
Gastrointestinal disorders
Constipation
|
5.5%
4/73 • Number of events 4 • From first dose up to Post-Study (up to 54 weeks)
Safety Population: All randomized participants receiving at least one dose of correct study medication. One participant received both 25 mg and 50 mg doses and was excluded from all analyses.
|
5.4%
4/74 • Number of events 5 • From first dose up to Post-Study (up to 54 weeks)
Safety Population: All randomized participants receiving at least one dose of correct study medication. One participant received both 25 mg and 50 mg doses and was excluded from all analyses.
|
11.4%
8/70 • Number of events 9 • From first dose up to Post-Study (up to 54 weeks)
Safety Population: All randomized participants receiving at least one dose of correct study medication. One participant received both 25 mg and 50 mg doses and was excluded from all analyses.
|
8.7%
6/69 • Number of events 6 • From first dose up to Post-Study (up to 54 weeks)
Safety Population: All randomized participants receiving at least one dose of correct study medication. One participant received both 25 mg and 50 mg doses and was excluded from all analyses.
|
|
Gastrointestinal disorders
Diarrhoea
|
2.7%
2/73 • Number of events 2 • From first dose up to Post-Study (up to 54 weeks)
Safety Population: All randomized participants receiving at least one dose of correct study medication. One participant received both 25 mg and 50 mg doses and was excluded from all analyses.
|
2.7%
2/74 • Number of events 2 • From first dose up to Post-Study (up to 54 weeks)
Safety Population: All randomized participants receiving at least one dose of correct study medication. One participant received both 25 mg and 50 mg doses and was excluded from all analyses.
|
4.3%
3/70 • Number of events 3 • From first dose up to Post-Study (up to 54 weeks)
Safety Population: All randomized participants receiving at least one dose of correct study medication. One participant received both 25 mg and 50 mg doses and was excluded from all analyses.
|
7.2%
5/69 • Number of events 6 • From first dose up to Post-Study (up to 54 weeks)
Safety Population: All randomized participants receiving at least one dose of correct study medication. One participant received both 25 mg and 50 mg doses and was excluded from all analyses.
|
|
Gastrointestinal disorders
Gastritis
|
2.7%
2/73 • Number of events 2 • From first dose up to Post-Study (up to 54 weeks)
Safety Population: All randomized participants receiving at least one dose of correct study medication. One participant received both 25 mg and 50 mg doses and was excluded from all analyses.
|
5.4%
4/74 • Number of events 5 • From first dose up to Post-Study (up to 54 weeks)
Safety Population: All randomized participants receiving at least one dose of correct study medication. One participant received both 25 mg and 50 mg doses and was excluded from all analyses.
|
1.4%
1/70 • Number of events 1 • From first dose up to Post-Study (up to 54 weeks)
Safety Population: All randomized participants receiving at least one dose of correct study medication. One participant received both 25 mg and 50 mg doses and was excluded from all analyses.
|
1.4%
1/69 • Number of events 1 • From first dose up to Post-Study (up to 54 weeks)
Safety Population: All randomized participants receiving at least one dose of correct study medication. One participant received both 25 mg and 50 mg doses and was excluded from all analyses.
|
|
Gastrointestinal disorders
Periodontitis
|
1.4%
1/73 • Number of events 1 • From first dose up to Post-Study (up to 54 weeks)
Safety Population: All randomized participants receiving at least one dose of correct study medication. One participant received both 25 mg and 50 mg doses and was excluded from all analyses.
|
0.00%
0/74 • From first dose up to Post-Study (up to 54 weeks)
Safety Population: All randomized participants receiving at least one dose of correct study medication. One participant received both 25 mg and 50 mg doses and was excluded from all analyses.
|
5.7%
4/70 • Number of events 4 • From first dose up to Post-Study (up to 54 weeks)
Safety Population: All randomized participants receiving at least one dose of correct study medication. One participant received both 25 mg and 50 mg doses and was excluded from all analyses.
|
1.4%
1/69 • Number of events 1 • From first dose up to Post-Study (up to 54 weeks)
Safety Population: All randomized participants receiving at least one dose of correct study medication. One participant received both 25 mg and 50 mg doses and was excluded from all analyses.
|
|
Gastrointestinal disorders
Stomatitis
|
6.8%
5/73 • Number of events 6 • From first dose up to Post-Study (up to 54 weeks)
Safety Population: All randomized participants receiving at least one dose of correct study medication. One participant received both 25 mg and 50 mg doses and was excluded from all analyses.
|
4.1%
3/74 • Number of events 3 • From first dose up to Post-Study (up to 54 weeks)
Safety Population: All randomized participants receiving at least one dose of correct study medication. One participant received both 25 mg and 50 mg doses and was excluded from all analyses.
|
2.9%
2/70 • Number of events 2 • From first dose up to Post-Study (up to 54 weeks)
Safety Population: All randomized participants receiving at least one dose of correct study medication. One participant received both 25 mg and 50 mg doses and was excluded from all analyses.
|
0.00%
0/69 • From first dose up to Post-Study (up to 54 weeks)
Safety Population: All randomized participants receiving at least one dose of correct study medication. One participant received both 25 mg and 50 mg doses and was excluded from all analyses.
|
|
Infections and infestations
Bronchitis
|
5.5%
4/73 • Number of events 4 • From first dose up to Post-Study (up to 54 weeks)
Safety Population: All randomized participants receiving at least one dose of correct study medication. One participant received both 25 mg and 50 mg doses and was excluded from all analyses.
|
1.4%
1/74 • Number of events 1 • From first dose up to Post-Study (up to 54 weeks)
Safety Population: All randomized participants receiving at least one dose of correct study medication. One participant received both 25 mg and 50 mg doses and was excluded from all analyses.
|
2.9%
2/70 • Number of events 3 • From first dose up to Post-Study (up to 54 weeks)
Safety Population: All randomized participants receiving at least one dose of correct study medication. One participant received both 25 mg and 50 mg doses and was excluded from all analyses.
|
2.9%
2/69 • Number of events 2 • From first dose up to Post-Study (up to 54 weeks)
Safety Population: All randomized participants receiving at least one dose of correct study medication. One participant received both 25 mg and 50 mg doses and was excluded from all analyses.
|
|
Infections and infestations
Cystitis
|
4.1%
3/73 • Number of events 3 • From first dose up to Post-Study (up to 54 weeks)
Safety Population: All randomized participants receiving at least one dose of correct study medication. One participant received both 25 mg and 50 mg doses and was excluded from all analyses.
|
1.4%
1/74 • Number of events 1 • From first dose up to Post-Study (up to 54 weeks)
Safety Population: All randomized participants receiving at least one dose of correct study medication. One participant received both 25 mg and 50 mg doses and was excluded from all analyses.
|
7.1%
5/70 • Number of events 5 • From first dose up to Post-Study (up to 54 weeks)
Safety Population: All randomized participants receiving at least one dose of correct study medication. One participant received both 25 mg and 50 mg doses and was excluded from all analyses.
|
10.1%
7/69 • Number of events 11 • From first dose up to Post-Study (up to 54 weeks)
Safety Population: All randomized participants receiving at least one dose of correct study medication. One participant received both 25 mg and 50 mg doses and was excluded from all analyses.
|
|
Infections and infestations
Gastroenteritis
|
5.5%
4/73 • Number of events 4 • From first dose up to Post-Study (up to 54 weeks)
Safety Population: All randomized participants receiving at least one dose of correct study medication. One participant received both 25 mg and 50 mg doses and was excluded from all analyses.
|
0.00%
0/74 • From first dose up to Post-Study (up to 54 weeks)
Safety Population: All randomized participants receiving at least one dose of correct study medication. One participant received both 25 mg and 50 mg doses and was excluded from all analyses.
|
2.9%
2/70 • Number of events 2 • From first dose up to Post-Study (up to 54 weeks)
Safety Population: All randomized participants receiving at least one dose of correct study medication. One participant received both 25 mg and 50 mg doses and was excluded from all analyses.
|
0.00%
0/69 • From first dose up to Post-Study (up to 54 weeks)
Safety Population: All randomized participants receiving at least one dose of correct study medication. One participant received both 25 mg and 50 mg doses and was excluded from all analyses.
|
|
Infections and infestations
Nasopharyngitis
|
30.1%
22/73 • Number of events 33 • From first dose up to Post-Study (up to 54 weeks)
Safety Population: All randomized participants receiving at least one dose of correct study medication. One participant received both 25 mg and 50 mg doses and was excluded from all analyses.
|
33.8%
25/74 • Number of events 36 • From first dose up to Post-Study (up to 54 weeks)
Safety Population: All randomized participants receiving at least one dose of correct study medication. One participant received both 25 mg and 50 mg doses and was excluded from all analyses.
|
37.1%
26/70 • Number of events 36 • From first dose up to Post-Study (up to 54 weeks)
Safety Population: All randomized participants receiving at least one dose of correct study medication. One participant received both 25 mg and 50 mg doses and was excluded from all analyses.
|
36.2%
25/69 • Number of events 39 • From first dose up to Post-Study (up to 54 weeks)
Safety Population: All randomized participants receiving at least one dose of correct study medication. One participant received both 25 mg and 50 mg doses and was excluded from all analyses.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/73 • From first dose up to Post-Study (up to 54 weeks)
Safety Population: All randomized participants receiving at least one dose of correct study medication. One participant received both 25 mg and 50 mg doses and was excluded from all analyses.
|
1.4%
1/74 • Number of events 1 • From first dose up to Post-Study (up to 54 weeks)
Safety Population: All randomized participants receiving at least one dose of correct study medication. One participant received both 25 mg and 50 mg doses and was excluded from all analyses.
|
0.00%
0/70 • From first dose up to Post-Study (up to 54 weeks)
Safety Population: All randomized participants receiving at least one dose of correct study medication. One participant received both 25 mg and 50 mg doses and was excluded from all analyses.
|
7.2%
5/69 • Number of events 7 • From first dose up to Post-Study (up to 54 weeks)
Safety Population: All randomized participants receiving at least one dose of correct study medication. One participant received both 25 mg and 50 mg doses and was excluded from all analyses.
|
|
Injury, poisoning and procedural complications
Contusion
|
2.7%
2/73 • Number of events 2 • From first dose up to Post-Study (up to 54 weeks)
Safety Population: All randomized participants receiving at least one dose of correct study medication. One participant received both 25 mg and 50 mg doses and was excluded from all analyses.
|
5.4%
4/74 • Number of events 4 • From first dose up to Post-Study (up to 54 weeks)
Safety Population: All randomized participants receiving at least one dose of correct study medication. One participant received both 25 mg and 50 mg doses and was excluded from all analyses.
|
5.7%
4/70 • Number of events 4 • From first dose up to Post-Study (up to 54 weeks)
Safety Population: All randomized participants receiving at least one dose of correct study medication. One participant received both 25 mg and 50 mg doses and was excluded from all analyses.
|
2.9%
2/69 • Number of events 4 • From first dose up to Post-Study (up to 54 weeks)
Safety Population: All randomized participants receiving at least one dose of correct study medication. One participant received both 25 mg and 50 mg doses and was excluded from all analyses.
|
|
Injury, poisoning and procedural complications
Joint sprain
|
6.8%
5/73 • Number of events 5 • From first dose up to Post-Study (up to 54 weeks)
Safety Population: All randomized participants receiving at least one dose of correct study medication. One participant received both 25 mg and 50 mg doses and was excluded from all analyses.
|
2.7%
2/74 • Number of events 2 • From first dose up to Post-Study (up to 54 weeks)
Safety Population: All randomized participants receiving at least one dose of correct study medication. One participant received both 25 mg and 50 mg doses and was excluded from all analyses.
|
2.9%
2/70 • Number of events 3 • From first dose up to Post-Study (up to 54 weeks)
Safety Population: All randomized participants receiving at least one dose of correct study medication. One participant received both 25 mg and 50 mg doses and was excluded from all analyses.
|
0.00%
0/69 • From first dose up to Post-Study (up to 54 weeks)
Safety Population: All randomized participants receiving at least one dose of correct study medication. One participant received both 25 mg and 50 mg doses and was excluded from all analyses.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/73 • From first dose up to Post-Study (up to 54 weeks)
Safety Population: All randomized participants receiving at least one dose of correct study medication. One participant received both 25 mg and 50 mg doses and was excluded from all analyses.
|
0.00%
0/74 • From first dose up to Post-Study (up to 54 weeks)
Safety Population: All randomized participants receiving at least one dose of correct study medication. One participant received both 25 mg and 50 mg doses and was excluded from all analyses.
|
0.00%
0/70 • From first dose up to Post-Study (up to 54 weeks)
Safety Population: All randomized participants receiving at least one dose of correct study medication. One participant received both 25 mg and 50 mg doses and was excluded from all analyses.
|
5.8%
4/69 • Number of events 4 • From first dose up to Post-Study (up to 54 weeks)
Safety Population: All randomized participants receiving at least one dose of correct study medication. One participant received both 25 mg and 50 mg doses and was excluded from all analyses.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.5%
4/73 • Number of events 5 • From first dose up to Post-Study (up to 54 weeks)
Safety Population: All randomized participants receiving at least one dose of correct study medication. One participant received both 25 mg and 50 mg doses and was excluded from all analyses.
|
0.00%
0/74 • From first dose up to Post-Study (up to 54 weeks)
Safety Population: All randomized participants receiving at least one dose of correct study medication. One participant received both 25 mg and 50 mg doses and was excluded from all analyses.
|
7.1%
5/70 • Number of events 7 • From first dose up to Post-Study (up to 54 weeks)
Safety Population: All randomized participants receiving at least one dose of correct study medication. One participant received both 25 mg and 50 mg doses and was excluded from all analyses.
|
4.3%
3/69 • Number of events 3 • From first dose up to Post-Study (up to 54 weeks)
Safety Population: All randomized participants receiving at least one dose of correct study medication. One participant received both 25 mg and 50 mg doses and was excluded from all analyses.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
9.6%
7/73 • Number of events 8 • From first dose up to Post-Study (up to 54 weeks)
Safety Population: All randomized participants receiving at least one dose of correct study medication. One participant received both 25 mg and 50 mg doses and was excluded from all analyses.
|
10.8%
8/74 • Number of events 8 • From first dose up to Post-Study (up to 54 weeks)
Safety Population: All randomized participants receiving at least one dose of correct study medication. One participant received both 25 mg and 50 mg doses and was excluded from all analyses.
|
14.3%
10/70 • Number of events 11 • From first dose up to Post-Study (up to 54 weeks)
Safety Population: All randomized participants receiving at least one dose of correct study medication. One participant received both 25 mg and 50 mg doses and was excluded from all analyses.
|
7.2%
5/69 • Number of events 5 • From first dose up to Post-Study (up to 54 weeks)
Safety Population: All randomized participants receiving at least one dose of correct study medication. One participant received both 25 mg and 50 mg doses and was excluded from all analyses.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
5.5%
4/73 • Number of events 5 • From first dose up to Post-Study (up to 54 weeks)
Safety Population: All randomized participants receiving at least one dose of correct study medication. One participant received both 25 mg and 50 mg doses and was excluded from all analyses.
|
8.1%
6/74 • Number of events 6 • From first dose up to Post-Study (up to 54 weeks)
Safety Population: All randomized participants receiving at least one dose of correct study medication. One participant received both 25 mg and 50 mg doses and was excluded from all analyses.
|
14.3%
10/70 • Number of events 11 • From first dose up to Post-Study (up to 54 weeks)
Safety Population: All randomized participants receiving at least one dose of correct study medication. One participant received both 25 mg and 50 mg doses and was excluded from all analyses.
|
7.2%
5/69 • Number of events 5 • From first dose up to Post-Study (up to 54 weeks)
Safety Population: All randomized participants receiving at least one dose of correct study medication. One participant received both 25 mg and 50 mg doses and was excluded from all analyses.
|
|
Musculoskeletal and connective tissue disorders
Periarthritis
|
1.4%
1/73 • Number of events 1 • From first dose up to Post-Study (up to 54 weeks)
Safety Population: All randomized participants receiving at least one dose of correct study medication. One participant received both 25 mg and 50 mg doses and was excluded from all analyses.
|
1.4%
1/74 • Number of events 1 • From first dose up to Post-Study (up to 54 weeks)
Safety Population: All randomized participants receiving at least one dose of correct study medication. One participant received both 25 mg and 50 mg doses and was excluded from all analyses.
|
2.9%
2/70 • Number of events 2 • From first dose up to Post-Study (up to 54 weeks)
Safety Population: All randomized participants receiving at least one dose of correct study medication. One participant received both 25 mg and 50 mg doses and was excluded from all analyses.
|
7.2%
5/69 • Number of events 6 • From first dose up to Post-Study (up to 54 weeks)
Safety Population: All randomized participants receiving at least one dose of correct study medication. One participant received both 25 mg and 50 mg doses and was excluded from all analyses.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
5.5%
4/73 • Number of events 4 • From first dose up to Post-Study (up to 54 weeks)
Safety Population: All randomized participants receiving at least one dose of correct study medication. One participant received both 25 mg and 50 mg doses and was excluded from all analyses.
|
4.1%
3/74 • Number of events 4 • From first dose up to Post-Study (up to 54 weeks)
Safety Population: All randomized participants receiving at least one dose of correct study medication. One participant received both 25 mg and 50 mg doses and was excluded from all analyses.
|
5.7%
4/70 • Number of events 4 • From first dose up to Post-Study (up to 54 weeks)
Safety Population: All randomized participants receiving at least one dose of correct study medication. One participant received both 25 mg and 50 mg doses and was excluded from all analyses.
|
2.9%
2/69 • Number of events 3 • From first dose up to Post-Study (up to 54 weeks)
Safety Population: All randomized participants receiving at least one dose of correct study medication. One participant received both 25 mg and 50 mg doses and was excluded from all analyses.
|
|
Nervous system disorders
Dizziness
|
6.8%
5/73 • Number of events 9 • From first dose up to Post-Study (up to 54 weeks)
Safety Population: All randomized participants receiving at least one dose of correct study medication. One participant received both 25 mg and 50 mg doses and was excluded from all analyses.
|
2.7%
2/74 • Number of events 2 • From first dose up to Post-Study (up to 54 weeks)
Safety Population: All randomized participants receiving at least one dose of correct study medication. One participant received both 25 mg and 50 mg doses and was excluded from all analyses.
|
0.00%
0/70 • From first dose up to Post-Study (up to 54 weeks)
Safety Population: All randomized participants receiving at least one dose of correct study medication. One participant received both 25 mg and 50 mg doses and was excluded from all analyses.
|
1.4%
1/69 • Number of events 1 • From first dose up to Post-Study (up to 54 weeks)
Safety Population: All randomized participants receiving at least one dose of correct study medication. One participant received both 25 mg and 50 mg doses and was excluded from all analyses.
|
|
Nervous system disorders
Headache
|
4.1%
3/73 • Number of events 4 • From first dose up to Post-Study (up to 54 weeks)
Safety Population: All randomized participants receiving at least one dose of correct study medication. One participant received both 25 mg and 50 mg doses and was excluded from all analyses.
|
6.8%
5/74 • Number of events 5 • From first dose up to Post-Study (up to 54 weeks)
Safety Population: All randomized participants receiving at least one dose of correct study medication. One participant received both 25 mg and 50 mg doses and was excluded from all analyses.
|
1.4%
1/70 • Number of events 1 • From first dose up to Post-Study (up to 54 weeks)
Safety Population: All randomized participants receiving at least one dose of correct study medication. One participant received both 25 mg and 50 mg doses and was excluded from all analyses.
|
1.4%
1/69 • Number of events 1 • From first dose up to Post-Study (up to 54 weeks)
Safety Population: All randomized participants receiving at least one dose of correct study medication. One participant received both 25 mg and 50 mg doses and was excluded from all analyses.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
2.7%
2/73 • Number of events 2 • From first dose up to Post-Study (up to 54 weeks)
Safety Population: All randomized participants receiving at least one dose of correct study medication. One participant received both 25 mg and 50 mg doses and was excluded from all analyses.
|
1.4%
1/74 • Number of events 1 • From first dose up to Post-Study (up to 54 weeks)
Safety Population: All randomized participants receiving at least one dose of correct study medication. One participant received both 25 mg and 50 mg doses and was excluded from all analyses.
|
5.7%
4/70 • Number of events 4 • From first dose up to Post-Study (up to 54 weeks)
Safety Population: All randomized participants receiving at least one dose of correct study medication. One participant received both 25 mg and 50 mg doses and was excluded from all analyses.
|
2.9%
2/69 • Number of events 2 • From first dose up to Post-Study (up to 54 weeks)
Safety Population: All randomized participants receiving at least one dose of correct study medication. One participant received both 25 mg and 50 mg doses and was excluded from all analyses.
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.5%
4/73 • Number of events 10 • From first dose up to Post-Study (up to 54 weeks)
Safety Population: All randomized participants receiving at least one dose of correct study medication. One participant received both 25 mg and 50 mg doses and was excluded from all analyses.
|
0.00%
0/74 • From first dose up to Post-Study (up to 54 weeks)
Safety Population: All randomized participants receiving at least one dose of correct study medication. One participant received both 25 mg and 50 mg doses and was excluded from all analyses.
|
1.4%
1/70 • Number of events 1 • From first dose up to Post-Study (up to 54 weeks)
Safety Population: All randomized participants receiving at least one dose of correct study medication. One participant received both 25 mg and 50 mg doses and was excluded from all analyses.
|
1.4%
1/69 • Number of events 1 • From first dose up to Post-Study (up to 54 weeks)
Safety Population: All randomized participants receiving at least one dose of correct study medication. One participant received both 25 mg and 50 mg doses and was excluded from all analyses.
|
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. SPONSOR review can be expedited to meet publication guidelines.
- Publication restrictions are in place
Restriction type: OTHER