Trial Outcomes & Findings for A Study to Evaluate the Safety, Tolerability, and Efficacy of Odanacatib (MK-0822) in Postmenopausal Women Previously Treated With a Bisphosphonate (MK-0822-042) (NCT NCT00885170)
NCT ID: NCT00885170
Last Updated: 2018-08-28
Results Overview
BMD at the femoral neck was assessed by dual-energy X-ray absorptiometry (DXA) at baseline and Month 24.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
246 participants
Primary outcome timeframe
Baseline and Month 24
Results posted on
2018-08-28
Participant Flow
Participants were enrolled and treated in 40 study centers located in the United States, Europe, South Africa, and Asia-Pacific.
Women ≥ 60 years of age who had been on, or were on, an alendronate therapy for postmenopausal osteoporosis were eligible to participate in this trial.
Participant milestones
| Measure |
Odanacatib 50 mg
Odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
|
Placebo
Placebo to odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
|
|---|---|---|
|
Overall Study
STARTED
|
124
|
122
|
|
Overall Study
Treated
|
122
|
121
|
|
Overall Study
COMPLETED
|
86
|
99
|
|
Overall Study
NOT COMPLETED
|
38
|
23
|
Reasons for withdrawal
| Measure |
Odanacatib 50 mg
Odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
|
Placebo
Placebo to odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
|
|---|---|---|
|
Overall Study
Adverse Event
|
12
|
4
|
|
Overall Study
Excessive bone loss
|
6
|
3
|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
|
Overall Study
Physician Decision
|
2
|
1
|
|
Overall Study
Protocol Violation
|
3
|
1
|
|
Overall Study
Withdrawal by Subject
|
13
|
13
|
Baseline Characteristics
A Study to Evaluate the Safety, Tolerability, and Efficacy of Odanacatib (MK-0822) in Postmenopausal Women Previously Treated With a Bisphosphonate (MK-0822-042)
Baseline characteristics by cohort
| Measure |
Odanacatib 50 mg
n=122 Participants
Odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
|
Placebo
n=121 Participants
Placebo to odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
|
Total
n=243 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
71.5 Years
STANDARD_DEVIATION 6.7 • n=5 Participants
|
71.1 Years
STANDARD_DEVIATION 6.8 • n=7 Participants
|
71.3 Years
STANDARD_DEVIATION 6.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
122 Participants
n=5 Participants
|
121 Participants
n=7 Participants
|
243 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Baseline DEXA Areal Bone Mineral Density T-score
Femoral Neck BMD T-score (122, 121, 243)
|
-2.35 T-score
STANDARD_DEVIATION 0.52 • n=5 Participants
|
-2.38 T-score
STANDARD_DEVIATION 0.48 • n=7 Participants
|
-2.36 T-score
STANDARD_DEVIATION 0.50 • n=5 Participants
|
|
Baseline DEXA Areal Bone Mineral Density T-score
Hip Trochanter BMD T-score (122, 121, 243)
|
-1.91 T-score
STANDARD_DEVIATION 0.70 • n=5 Participants
|
-2.10 T-score
STANDARD_DEVIATION 0.79 • n=7 Participants
|
-2.00 T-score
STANDARD_DEVIATION 0.75 • n=5 Participants
|
|
Baseline DEXA Areal Bone Mineral Density T-score
Total Hip BMD T-score (122, 121, 243)
|
-1.91 T-score
STANDARD_DEVIATION 0.62 • n=5 Participants
|
-2.05 T-score
STANDARD_DEVIATION 0.68 • n=7 Participants
|
-1.98 T-score
STANDARD_DEVIATION 0.65 • n=5 Participants
|
|
Baseline DEXA Areal Bone Mineral Density T-score
Lumbar Spine BMD T-score (113, 116, 229)
|
-2.34 T-score
STANDARD_DEVIATION 1.10 • n=5 Participants
|
-2.49 T-score
STANDARD_DEVIATION 1.14 • n=7 Participants
|
-2.41 T-score
STANDARD_DEVIATION 1.12 • n=5 Participants
|
|
Baseline DEXA Areal Bone Mineral Density T-score
1/3 Distal Forearm BMD T-score (114, 113, 227)
|
-2.62 T-score
STANDARD_DEVIATION 1.26 • n=5 Participants
|
-2.69 T-score
STANDARD_DEVIATION 1.10 • n=7 Participants
|
-2.65 T-score
STANDARD_DEVIATION 1.18 • n=5 Participants
|
|
Baseline Biochemical Markers of Bone Resorption and Bone Formation
C-telopeptides of Type 1 collage (116, 117,233)
|
0.19 ng/mL
STANDARD_DEVIATION 0.22 • n=5 Participants
|
0.18 ng/mL
STANDARD_DEVIATION 0.14 • n=7 Participants
|
0.19 ng/mL
STANDARD_DEVIATION 0.19 • n=5 Participants
|
|
Baseline Biochemical Markers of Bone Resorption and Bone Formation
Serum bone specific alk. phosphatase (115,117,232)
|
9.28 ng/mL
STANDARD_DEVIATION 4.63 • n=5 Participants
|
9.41 ng/mL
STANDARD_DEVIATION 4.16 • n=7 Participants
|
9.35 ng/mL
STANDARD_DEVIATION 4.39 • n=5 Participants
|
|
Baseline Biochemical Markers of Bone Resorption and Bone Formation
Serum N-propeptide, T1 collagen (115, 117, 232)
|
29.48 ng/mL
STANDARD_DEVIATION 28.18 • n=5 Participants
|
27.79 ng/mL
STANDARD_DEVIATION 21.58 • n=7 Participants
|
28.63 ng/mL
STANDARD_DEVIATION 25.03 • n=5 Participants
|
|
Urine N-Telopeptides/Creatinine Ratio
|
26.00 nmol/mmol
STANDARD_DEVIATION 23.76 • n=5 Participants
|
26.35 nmol/mmol
STANDARD_DEVIATION 18.08 • n=7 Participants
|
26.17 nmol/mmol
STANDARD_DEVIATION 21.08 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and Month 24Population: The population analyzed included all randomized, treated participants who had femoral neck BMD data at Baseline and Month 24.
BMD at the femoral neck was assessed by dual-energy X-ray absorptiometry (DXA) at baseline and Month 24.
Outcome measures
| Measure |
Odanacatib 50 mg
n=83 Participants
Odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
|
Placebo
n=95 Participants
Placebo to odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
|
|---|---|---|
|
Percent Change From Baseline in Femoral Neck Bone Mineral Density (BMD) at Month 24
|
1.73 Percent Change
Interval 0.61 to 2.85
|
-0.94 Percent Change
Interval -1.98 to 0.1
|
PRIMARY outcome
Timeframe: Up to 25 monthsPopulation: The population analyzed included all participants who took at least one dose of study medication and were counted in the treatment group of the medication they actually took.
An AE was defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it was considered related to the medical treatment or procedure, that occurred during the course of the study.
Outcome measures
| Measure |
Odanacatib 50 mg
n=122 Participants
Odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
|
Placebo
n=121 Participants
Placebo to odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
|
|---|---|---|
|
Percentage of Participants Experiencing One or More Adverse Events (AEs)
|
68.0 Percentage of participants
|
73.6 Percentage of participants
|
PRIMARY outcome
Timeframe: Up to 24 monthsPopulation: The population analyzed included all participants who took at least one dose of study medication and were counted in the treatment group of the medication they actually took.
An AE was defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it was considered related to the medical treatment or procedure, that occurred during the course of the study.
Outcome measures
| Measure |
Odanacatib 50 mg
n=122 Participants
Odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
|
Placebo
n=121 Participants
Placebo to odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
|
|---|---|---|
|
Percentage of Participants Discontinuing Study Drug Due to an AE
|
9.0 Percentage of participants
|
3.3 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and 12 MonthsPopulation: The population analyzed included all randomized, treated participants who had femoral neck BMD data at Baseline and Month 12.
BMD at the femoral neck was assessed by DXA at baseline and Month 12.
Outcome measures
| Measure |
Odanacatib 50 mg
n=98 Participants
Odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
|
Placebo
n=109 Participants
Placebo to odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
|
|---|---|---|
|
Percent Change From Baseline in Femoral Neck BMD at Month 12
|
0.60 Percent Change
Interval -0.32 to 1.53
|
-0.28 Percent Change
Interval -1.16 to 0.59
|
SECONDARY outcome
Timeframe: Baseline and 24 MonthsPopulation: The population analyzed included all randomized, treated participants who had trochanter BMD data at Baseline and Month 24.
BMD at the trochanter was assessed by DXA at baseline and Month 24.
Outcome measures
| Measure |
Odanacatib 50 mg
n=83 Participants
Odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
|
Placebo
n=95 Participants
Placebo to odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
|
|---|---|---|
|
Percent Change From Baseline in Trochanter BMD at Month 24
|
1.83 Percent Change
Interval 0.34 to 3.32
|
-1.35 Percent Change
Interval -2.73 to 0.03
|
SECONDARY outcome
Timeframe: Baseline and 12 MonthsPopulation: The population analyzed included all randomized, treated participants who had trochanter BMD data at Baseline and Month 12.
BMD at the trochanter was assessed by DXA at baseline and Month 12.
Outcome measures
| Measure |
Odanacatib 50 mg
n=98 Participants
Odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
|
Placebo
n=109 Participants
Placebo to odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
|
|---|---|---|
|
Percent Change From Baseline in Trochanter BMD at Month 12
|
0.86 Percent Change
Interval -0.13 to 1.85
|
-0.14 Percent Change
Interval -1.08 to 0.79
|
SECONDARY outcome
Timeframe: Baseline and 24 MonthsPopulation: The population analyzed included all randomized, treated participants who had total hip BMD data at Baseline and Month 24.
BMD at the total hip was assessed by DXA at baseline and Month 24.
Outcome measures
| Measure |
Odanacatib 50 mg
n=83 Participants
Odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
|
Placebo
n=95 Participants
Placebo to odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
|
|---|---|---|
|
Percent Change From Baseline in Total Hip BMD at Month 24
|
0.83 Percent Change
Interval -0.13 to 1.8
|
-1.87 Percent Change
Interval -2.77 to -0.97
|
SECONDARY outcome
Timeframe: Baseline and 12 MonthsPopulation: The population analyzed included all randomized, treated participants who had total hip BMD data at Baseline and Month 12.
BMD at the total hip was assessed by DXA at baseline and Month 12.
Outcome measures
| Measure |
Odanacatib 50 mg
n=98 Participants
Odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
|
Placebo
n=109 Participants
Placebo to odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
|
|---|---|---|
|
Percent Change From Baseline in Total Hip BMD at Month 12
|
0.26 Percent Change
Interval -0.41 to 0.94
|
-0.80 Percent Change
Interval -1.44 to -0.16
|
SECONDARY outcome
Timeframe: Baseline and 24 MonthsPopulation: The population analyzed included all randomized, treated participants who had lumbar spine BMD data at Baseline and Month 24.
BMD at the lumbar spine was assessed by DXA at baseline and Month 24.
Outcome measures
| Measure |
Odanacatib 50 mg
n=80 Participants
Odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
|
Placebo
n=89 Participants
Placebo to odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
|
|---|---|---|
|
Percent Change From Baseline in Lumbar Spine BMD at Month 24
|
2.28 Percent Change
Interval 1.3 to 3.25
|
-0.30 Percent Change
Interval -1.21 to 0.62
|
SECONDARY outcome
Timeframe: Baseline and 12 MonthsPopulation: The population analyzed included all randomized, treated participants who had lumbar spine BMD data at Baseline and Month 12.
BMD at the lumbar spine was assessed by DXA at baseline and Month 12.
Outcome measures
| Measure |
Odanacatib 50 mg
n=91 Participants
Odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
|
Placebo
n=103 Participants
Placebo to odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
|
|---|---|---|
|
Percent Change From Baseline in Lumbar Spine BMD at Month 12
|
0.69 Percent Change
Interval -0.03 to 1.4
|
-0.12 Percent Change
Interval -0.79 to 0.56
|
SECONDARY outcome
Timeframe: Baseline and 24 MonthsPopulation: The population analyzed included all randomized, treated participants who had 1/3 distal forearm BMD data at Baseline and Month 24.
BMD at the 1/3 distal forearm was assessed by DXA at baseline and Month 24.
Outcome measures
| Measure |
Odanacatib 50 mg
n=80 Participants
Odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
|
Placebo
n=86 Participants
Placebo to odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
|
|---|---|---|
|
Percent Change From Baseline in 1/3 Distal Forearm BMD at Month 24
|
-0.92 Percent Change
Interval -1.99 to 0.15
|
-1.14 Percent Change
Interval -2.16 to -0.13
|
SECONDARY outcome
Timeframe: Baseline and 12 MonthsPopulation: The population analyzed included all randomized, treated participants who had 1/3 distal forearm BMD data at Baseline and Month 12.
BMD at the 1/3 distal forearm was assessed by DXA at baseline and Month 12.
Outcome measures
| Measure |
Odanacatib 50 mg
n=93 Participants
Odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
|
Placebo
n=100 Participants
Placebo to odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
|
|---|---|---|
|
Percent Change From Baseline in 1/3 Distal Forearm BMD at Month 12
|
-0.11 Percent Change
Interval -1.11 to 0.89
|
-0.49 Percent Change
Interval -1.44 to 0.47
|
SECONDARY outcome
Timeframe: Baseline and Month 24Population: The population analyzed included all randomized, treated participants who had s-CTx data at Baseline and Month 24 but excluded participants due to important protocol deviations that may have substantially affected the results such as use of concomitant medication, lack of study medication compliance, and medical history.
s-CTx is a biochemical marker of bone resorption.
Outcome measures
| Measure |
Odanacatib 50 mg
n=80 Participants
Odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
|
Placebo
n=79 Participants
Placebo to odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
|
|---|---|---|
|
Percent Change From Baseline in Log-Transformed Serum C-Telopeptides of Type I Collagen (s-CTx) at Month 24
|
93.86 Percent change
Interval 69.42 to 121.82
|
83.70 Percent change
Interval 61.06 to 109.52
|
SECONDARY outcome
Timeframe: Baseline and Month 12Population: The population analyzed included all randomized, treated participants who had s-CTx data at Baseline and Month 12 but excluded participants due to important protocol deviations that may have substantially affected the results such as use of concomitant medication, lack of study medication compliance, and medical history.
s-CTx is a biochemical marker of bone resorption.
Outcome measures
| Measure |
Odanacatib 50 mg
n=91 Participants
Odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
|
Placebo
n=100 Participants
Placebo to odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
|
|---|---|---|
|
Percent Change From Baseline in Log-Transformed s-CTx at Month 12
|
62.27 Percent change
Interval 39.76 to 88.42
|
68.09 Percent change
Interval 45.58 to 94.08
|
SECONDARY outcome
Timeframe: Baseline and Month 24Population: The population analyzed included all randomized, treated participants who had u-NTx/Cr data at Baseline and Month 24 but excluded participants due to important protocol deviations that may have substantially affected the results such as use of concomitant medication, lack of study medication compliance, and medical history.
N-Telopeptides of Type 1 Collagen to Urine Creatinine Ratio (u-NTx/Cr) is a biochemical marker of bone resorption.
Outcome measures
| Measure |
Odanacatib 50 mg
n=80 Participants
Odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
|
Placebo
n=77 Participants
Placebo to odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
|
|---|---|---|
|
Percent Change From Baseline in Log-Transformed Urine N-Telopeptides/Creatinine Ratio at Month 24
|
-15.55 Percent change
Interval -24.57 to -5.47
|
31.48 Percent change
Interval 17.6 to 47.01
|
SECONDARY outcome
Timeframe: Baseline and Month 12Population: The population analyzed included all randomized, treated participants who had u-NTx/Cr data at Baseline and Month 12 but excluded participants due to important protocol deviations that may have substantially affected the results such as use of concomitant medication, lack of study medication compliance, and medical history.
u-NTx/Cr is a biochemical marker of bone resorption.
Outcome measures
| Measure |
Odanacatib 50 mg
n=91 Participants
Odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
|
Placebo
n=96 Participants
Placebo to odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
|
|---|---|---|
|
Percent Change From Baseline in Log-Transformed u-NTx/Cr at Month 12
|
-17.23 Percent change
Interval -26.02 to -7.4
|
29.06 Percent change
Interval 15.94 to 43.66
|
SECONDARY outcome
Timeframe: Baseline and Month 24Population: The population analyzed included all randomized, treated participants who had BSAP data at Baseline and Month 24 but excluded participants due to important protocol deviations that may have substantially affected the results such as use of concomitant medication, lack of study medication compliance, and medical history.
Bone-Specific Alkaline Phosphatase (BSAP) is a biochemical marker of bone formation.
Outcome measures
| Measure |
Odanacatib 50 mg
n=82 Participants
Odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
|
Placebo
n=84 Participants
Placebo to odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
|
|---|---|---|
|
Percent Change From Baseline in Log-Transformed Serum Bone-Specific Alkaline Phosphatase at Month 24
|
51.62 Percent change
Interval 39.49 to 64.79
|
40.65 Percent change
Interval 29.82 to 52.39
|
SECONDARY outcome
Timeframe: Baseline and Month 12Population: The population analyzed included all randomized, treated participants who had BSAP data at Baseline and Month 12 but excluded participants due to important protocol deviations that may have substantially affected the results such as use of concomitant medication, lack of study medication compliance, and medical history.
BSAP is a biochemical marker of bone formation.
Outcome measures
| Measure |
Odanacatib 50 mg
n=94 Participants
Odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
|
Placebo
n=101 Participants
Placebo to odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
|
|---|---|---|
|
Percent Change From Baseline in Log-Transformed Serum BSAP at Month 12
|
30.91 Percent change
Interval 23.06 to 39.27
|
18.10 Percent change
Interval 11.29 to 25.32
|
SECONDARY outcome
Timeframe: Baseline and Month 24Population: The population analyzed included all randomized, treated participants who had S-P1NP data at Baseline and Month 24 but excluded participants due to important protocol deviations that may have substantially affected the results such as use of concomitant medication, lack of study medication compliance, and medical history.
Serum N-terminal propeptide of Type I collagen (s-P1NP) is a biochemical marker of bone formation.
Outcome measures
| Measure |
Odanacatib 50 mg
n=82 Participants
Odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
|
Placebo
n=85 Participants
Placebo to odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
|
|---|---|---|
|
Percent Change From Baseline in Log-Transformed Serum N-Terminal Propeptide of Type I Collagen at Month 24
|
90.70 Percent change
Interval 70.43 to 113.38
|
59.53 Percent change
Interval 43.1 to 77.84
|
SECONDARY outcome
Timeframe: Baseline and Month 12Population: The population analyzed included all randomized, treated participants who had S-P1NP data at Baseline and Month 12 but excluded participants due to important protocol deviations that may have substantially affected the results such as use of concomitant medication, lack of study medication compliance, and medical history.
s-P1NP is a biochemical marker of bone formation.
Outcome measures
| Measure |
Odanacatib 50 mg
n=94 Participants
Odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
|
Placebo
n=101 Participants
Placebo to odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
|
|---|---|---|
|
Percent Change From Baseline in Log-Transformed Serum N-terminal Propeptide of Type I Collagen at Month 12
|
80.37 Percent change
Interval 60.72 to 102.43
|
56.37 Percent change
Interval 39.86 to 74.82
|
SECONDARY outcome
Timeframe: Baseline and Month 24Population: The population analyzed included all randomized, treated participants who had serum calcium data at Baseline and Month 24 but excluded participants due to important protocol deviations that may have substantially affected the results such as use of concomitant medication, lack of study medication compliance, and medical history.
Serum calcium is an index of calcium homeostasis.
Outcome measures
| Measure |
Odanacatib 50 mg
n=83 Participants
Odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
|
Placebo
n=87 Participants
Placebo to odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
|
|---|---|---|
|
Percent Change From Baseline in Log-Transformed Serum Calcium at Month 24
|
-2.40 Percent Change
Interval -3.23 to -1.56
|
-2.51 Percent Change
Interval -3.31 to -1.7
|
SECONDARY outcome
Timeframe: Baseline and Month 24Population: The population analyzed included all randomized, treated participants who had serum phosphate data at Baseline and Month 24 but excluded participants due to important protocol deviations that may have substantially affected the results such as use of concomitant medication, lack of study medication compliance, and medical history.
Serum phosphate is an index of mineral homeostasis.
Outcome measures
| Measure |
Odanacatib 50 mg
n=83 Participants
Odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
|
Placebo
n=86 Participants
Placebo to odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
|
|---|---|---|
|
Percent Change From Baseline in Log-Transformed Serum Phosphate at Month 24
|
2.37 Percent Change
Interval -0.21 to 5.02
|
0.99 Percent Change
Interval -1.47 to 3.52
|
SECONDARY outcome
Timeframe: Baseline and Month 24Population: The population analyzed included all randomized, treated participants who had SPH data at Baseline and Month 24 but excluded participants due to important protocol deviations that may have substantially affected the results such as use of concomitant medication, lack of study medication compliance, and medical history.
Serum parathyroid hormone (SPH) regulates calcium, phosphorus, and vitamin D levels in the blood.
Outcome measures
| Measure |
Odanacatib 50 mg
n=81 Participants
Odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
|
Placebo
n=85 Participants
Placebo to odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
|
|---|---|---|
|
Percent Change From Baseline in Log-Transformed Serum Parathyroid Hormone at Month 24
|
4.38 Percent Change
Interval -4.08 to 13.58
|
10.28 Percent Change
Interval 1.68 to 19.61
|
SECONDARY outcome
Timeframe: Baseline and Month 24Population: The population analyzed included all randomized, treated participants who had 1,25(OH)2 D data at Baseline and Month 24 but excluded participants due to important protocol deviations that may have substantially affected the results such as use of concomitant medication, lack of study medication compliance, and medical history.
1,25 dihydroxyvitamin D \[1,25(OH)2 D\] is the active vitamin D metabolite and stimulates calcium absorption in the intestine.
Outcome measures
| Measure |
Odanacatib 50 mg
n=80 Participants
Odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
|
Placebo
n=84 Participants
Placebo to odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
|
|---|---|---|
|
Percent Change From Baseline in Log-Transformed Serum 1,25 Dihydroxyvitamin D at Month 24
|
-5.23 Percent Change
Interval -15.32 to 6.05
|
-6.71 Percent Change
Interval -16.25 to 3.93
|
SECONDARY outcome
Timeframe: Baseline and Month 24Population: The population analyzed included all randomized, treated participants who had 25(OH)D data at Baseline and Month 24 but excluded participants due to important protocol deviations that may have substantially affected the results such as use of concomitant medication, lack of study medication compliance, and medical history.
The 25-hydroxy vitamin D \[25(OH)D\] test is the most accurate way to measure vitamin D. In the kidney, 25-hydroxy vitamin D is converted into 1,25 di-hydroxyvitamin D, the active vitamin D metabolite.
Outcome measures
| Measure |
Odanacatib 50 mg
n=81 Participants
Odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
|
Placebo
n=86 Participants
Placebo to odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
|
|---|---|---|
|
Percent Change From Baseline in Log-Transformed Serum 25-Hydroxyvitamin D at Month 24
|
-2.57 Percent Change
Interval -8.16 to 3.37
|
0.57 Percent Change
Interval -5.01 to 6.47
|
Adverse Events
Odanacatib 50 mg
Serious events: 20 serious events
Other events: 40 other events
Deaths: 0 deaths
Placebo
Serious events: 20 serious events
Other events: 48 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Odanacatib 50 mg
n=122 participants at risk
Odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
|
Placebo
n=121 participants at risk
Placebo to odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
|
|---|---|---|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.82%
1/122 • Number of events 1 • Up to 25 months
The APaT population included all participants who took at least one dose of study medication and were counted in the treatment group of the medication they actually took.
|
0.00%
0/121 • Up to 25 months
The APaT population included all participants who took at least one dose of study medication and were counted in the treatment group of the medication they actually took.
|
|
Cardiac disorders
Aortic valve stenosis
|
0.00%
0/122 • Up to 25 months
The APaT population included all participants who took at least one dose of study medication and were counted in the treatment group of the medication they actually took.
|
0.83%
1/121 • Number of events 1 • Up to 25 months
The APaT population included all participants who took at least one dose of study medication and were counted in the treatment group of the medication they actually took.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/122 • Up to 25 months
The APaT population included all participants who took at least one dose of study medication and were counted in the treatment group of the medication they actually took.
|
1.7%
2/121 • Number of events 2 • Up to 25 months
The APaT population included all participants who took at least one dose of study medication and were counted in the treatment group of the medication they actually took.
|
|
Cardiac disorders
Cardiac failure
|
0.82%
1/122 • Number of events 1 • Up to 25 months
The APaT population included all participants who took at least one dose of study medication and were counted in the treatment group of the medication they actually took.
|
0.00%
0/121 • Up to 25 months
The APaT population included all participants who took at least one dose of study medication and were counted in the treatment group of the medication they actually took.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/122 • Up to 25 months
The APaT population included all participants who took at least one dose of study medication and were counted in the treatment group of the medication they actually took.
|
0.83%
1/121 • Number of events 1 • Up to 25 months
The APaT population included all participants who took at least one dose of study medication and were counted in the treatment group of the medication they actually took.
|
|
Cardiac disorders
Mitral valve disease
|
0.00%
0/122 • Up to 25 months
The APaT population included all participants who took at least one dose of study medication and were counted in the treatment group of the medication they actually took.
|
0.83%
1/121 • Number of events 1 • Up to 25 months
The APaT population included all participants who took at least one dose of study medication and were counted in the treatment group of the medication they actually took.
|
|
Cardiac disorders
Nodal rhythm
|
0.00%
0/122 • Up to 25 months
The APaT population included all participants who took at least one dose of study medication and were counted in the treatment group of the medication they actually took.
|
0.83%
1/121 • Number of events 1 • Up to 25 months
The APaT population included all participants who took at least one dose of study medication and were counted in the treatment group of the medication they actually took.
|
|
Eye disorders
Pterygium
|
0.00%
0/122 • Up to 25 months
The APaT population included all participants who took at least one dose of study medication and were counted in the treatment group of the medication they actually took.
|
0.83%
1/121 • Number of events 1 • Up to 25 months
The APaT population included all participants who took at least one dose of study medication and were counted in the treatment group of the medication they actually took.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/122 • Up to 25 months
The APaT population included all participants who took at least one dose of study medication and were counted in the treatment group of the medication they actually took.
|
0.83%
1/121 • Number of events 1 • Up to 25 months
The APaT population included all participants who took at least one dose of study medication and were counted in the treatment group of the medication they actually took.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/122 • Up to 25 months
The APaT population included all participants who took at least one dose of study medication and were counted in the treatment group of the medication they actually took.
|
0.83%
1/121 • Number of events 1 • Up to 25 months
The APaT population included all participants who took at least one dose of study medication and were counted in the treatment group of the medication they actually took.
|
|
Gastrointestinal disorders
Gastritis
|
0.82%
1/122 • Number of events 1 • Up to 25 months
The APaT population included all participants who took at least one dose of study medication and were counted in the treatment group of the medication they actually took.
|
0.00%
0/121 • Up to 25 months
The APaT population included all participants who took at least one dose of study medication and were counted in the treatment group of the medication they actually took.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.82%
1/122 • Number of events 1 • Up to 25 months
The APaT population included all participants who took at least one dose of study medication and were counted in the treatment group of the medication they actually took.
|
0.00%
0/121 • Up to 25 months
The APaT population included all participants who took at least one dose of study medication and were counted in the treatment group of the medication they actually took.
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/122 • Up to 25 months
The APaT population included all participants who took at least one dose of study medication and were counted in the treatment group of the medication they actually took.
|
0.83%
1/121 • Number of events 1 • Up to 25 months
The APaT population included all participants who took at least one dose of study medication and were counted in the treatment group of the medication they actually took.
|
|
General disorders
Chest pain
|
1.6%
2/122 • Number of events 2 • Up to 25 months
The APaT population included all participants who took at least one dose of study medication and were counted in the treatment group of the medication they actually took.
|
0.83%
1/121 • Number of events 1 • Up to 25 months
The APaT population included all participants who took at least one dose of study medication and were counted in the treatment group of the medication they actually took.
|
|
General disorders
Death
|
0.00%
0/122 • Up to 25 months
The APaT population included all participants who took at least one dose of study medication and were counted in the treatment group of the medication they actually took.
|
0.83%
1/121 • Number of events 1 • Up to 25 months
The APaT population included all participants who took at least one dose of study medication and were counted in the treatment group of the medication they actually took.
|
|
Infections and infestations
Erysipelas
|
0.00%
0/122 • Up to 25 months
The APaT population included all participants who took at least one dose of study medication and were counted in the treatment group of the medication they actually took.
|
0.83%
1/121 • Number of events 1 • Up to 25 months
The APaT population included all participants who took at least one dose of study medication and were counted in the treatment group of the medication they actually took.
|
|
Infections and infestations
Herpes zoster infection neurological
|
0.82%
1/122 • Number of events 1 • Up to 25 months
The APaT population included all participants who took at least one dose of study medication and were counted in the treatment group of the medication they actually took.
|
0.00%
0/121 • Up to 25 months
The APaT population included all participants who took at least one dose of study medication and were counted in the treatment group of the medication they actually took.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/122 • Up to 25 months
The APaT population included all participants who took at least one dose of study medication and were counted in the treatment group of the medication they actually took.
|
0.83%
1/121 • Number of events 1 • Up to 25 months
The APaT population included all participants who took at least one dose of study medication and were counted in the treatment group of the medication they actually took.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.82%
1/122 • Number of events 1 • Up to 25 months
The APaT population included all participants who took at least one dose of study medication and were counted in the treatment group of the medication they actually took.
|
0.00%
0/121 • Up to 25 months
The APaT population included all participants who took at least one dose of study medication and were counted in the treatment group of the medication they actually took.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
3.3%
4/122 • Number of events 4 • Up to 25 months
The APaT population included all participants who took at least one dose of study medication and were counted in the treatment group of the medication they actually took.
|
0.83%
1/121 • Number of events 1 • Up to 25 months
The APaT population included all participants who took at least one dose of study medication and were counted in the treatment group of the medication they actually took.
|
|
Injury, poisoning and procedural complications
Fractured sacrum
|
0.00%
0/122 • Up to 25 months
The APaT population included all participants who took at least one dose of study medication and were counted in the treatment group of the medication they actually took.
|
0.83%
1/121 • Number of events 1 • Up to 25 months
The APaT population included all participants who took at least one dose of study medication and were counted in the treatment group of the medication they actually took.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/122 • Up to 25 months
The APaT population included all participants who took at least one dose of study medication and were counted in the treatment group of the medication they actually took.
|
1.7%
2/121 • Number of events 2 • Up to 25 months
The APaT population included all participants who took at least one dose of study medication and were counted in the treatment group of the medication they actually took.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/122 • Up to 25 months
The APaT population included all participants who took at least one dose of study medication and were counted in the treatment group of the medication they actually took.
|
0.83%
1/121 • Number of events 1 • Up to 25 months
The APaT population included all participants who took at least one dose of study medication and were counted in the treatment group of the medication they actually took.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/122 • Up to 25 months
The APaT population included all participants who took at least one dose of study medication and were counted in the treatment group of the medication they actually took.
|
0.83%
1/121 • Number of events 1 • Up to 25 months
The APaT population included all participants who took at least one dose of study medication and were counted in the treatment group of the medication they actually took.
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.82%
1/122 • Number of events 1 • Up to 25 months
The APaT population included all participants who took at least one dose of study medication and were counted in the treatment group of the medication they actually took.
|
0.83%
1/121 • Number of events 1 • Up to 25 months
The APaT population included all participants who took at least one dose of study medication and were counted in the treatment group of the medication they actually took.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.82%
1/122 • Number of events 1 • Up to 25 months
The APaT population included all participants who took at least one dose of study medication and were counted in the treatment group of the medication they actually took.
|
0.83%
1/121 • Number of events 2 • Up to 25 months
The APaT population included all participants who took at least one dose of study medication and were counted in the treatment group of the medication they actually took.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.82%
1/122 • Number of events 1 • Up to 25 months
The APaT population included all participants who took at least one dose of study medication and were counted in the treatment group of the medication they actually took.
|
0.00%
0/121 • Up to 25 months
The APaT population included all participants who took at least one dose of study medication and were counted in the treatment group of the medication they actually took.
|
|
Injury, poisoning and procedural complications
Sternal fracture
|
0.82%
1/122 • Number of events 1 • Up to 25 months
The APaT population included all participants who took at least one dose of study medication and were counted in the treatment group of the medication they actually took.
|
0.00%
0/121 • Up to 25 months
The APaT population included all participants who took at least one dose of study medication and were counted in the treatment group of the medication they actually took.
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/122 • Up to 25 months
The APaT population included all participants who took at least one dose of study medication and were counted in the treatment group of the medication they actually took.
|
0.83%
1/121 • Number of events 1 • Up to 25 months
The APaT population included all participants who took at least one dose of study medication and were counted in the treatment group of the medication they actually took.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/122 • Up to 25 months
The APaT population included all participants who took at least one dose of study medication and were counted in the treatment group of the medication they actually took.
|
0.83%
1/121 • Number of events 1 • Up to 25 months
The APaT population included all participants who took at least one dose of study medication and were counted in the treatment group of the medication they actually took.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.82%
1/122 • Number of events 1 • Up to 25 months
The APaT population included all participants who took at least one dose of study medication and were counted in the treatment group of the medication they actually took.
|
0.00%
0/121 • Up to 25 months
The APaT population included all participants who took at least one dose of study medication and were counted in the treatment group of the medication they actually took.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/122 • Up to 25 months
The APaT population included all participants who took at least one dose of study medication and were counted in the treatment group of the medication they actually took.
|
0.83%
1/121 • Number of events 1 • Up to 25 months
The APaT population included all participants who took at least one dose of study medication and were counted in the treatment group of the medication they actually took.
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis
|
0.82%
1/122 • Number of events 1 • Up to 25 months
The APaT population included all participants who took at least one dose of study medication and were counted in the treatment group of the medication they actually took.
|
0.00%
0/121 • Up to 25 months
The APaT population included all participants who took at least one dose of study medication and were counted in the treatment group of the medication they actually took.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma
|
0.82%
1/122 • Number of events 1 • Up to 25 months
The APaT population included all participants who took at least one dose of study medication and were counted in the treatment group of the medication they actually took.
|
0.00%
0/121 • Up to 25 months
The APaT population included all participants who took at least one dose of study medication and were counted in the treatment group of the medication they actually took.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.82%
1/122 • Number of events 1 • Up to 25 months
The APaT population included all participants who took at least one dose of study medication and were counted in the treatment group of the medication they actually took.
|
0.83%
1/121 • Number of events 1 • Up to 25 months
The APaT population included all participants who took at least one dose of study medication and were counted in the treatment group of the medication they actually took.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast fibroma
|
0.00%
0/122 • Up to 25 months
The APaT population included all participants who took at least one dose of study medication and were counted in the treatment group of the medication they actually took.
|
0.83%
1/121 • Number of events 1 • Up to 25 months
The APaT population included all participants who took at least one dose of study medication and were counted in the treatment group of the medication they actually took.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Glioblastoma
|
0.82%
1/122 • Number of events 1 • Up to 25 months
The APaT population included all participants who took at least one dose of study medication and were counted in the treatment group of the medication they actually took.
|
0.00%
0/121 • Up to 25 months
The APaT population included all participants who took at least one dose of study medication and were counted in the treatment group of the medication they actually took.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to liver
|
0.82%
1/122 • Number of events 1 • Up to 25 months
The APaT population included all participants who took at least one dose of study medication and were counted in the treatment group of the medication they actually took.
|
0.00%
0/121 • Up to 25 months
The APaT population included all participants who took at least one dose of study medication and were counted in the treatment group of the medication they actually took.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic neoplasm
|
0.82%
1/122 • Number of events 1 • Up to 25 months
The APaT population included all participants who took at least one dose of study medication and were counted in the treatment group of the medication they actually took.
|
0.00%
0/121 • Up to 25 months
The APaT population included all participants who took at least one dose of study medication and were counted in the treatment group of the medication they actually took.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/122 • Up to 25 months
The APaT population included all participants who took at least one dose of study medication and were counted in the treatment group of the medication they actually took.
|
0.83%
1/121 • Number of events 1 • Up to 25 months
The APaT population included all participants who took at least one dose of study medication and were counted in the treatment group of the medication they actually took.
|
|
Nervous system disorders
Dementia
|
0.00%
0/122 • Up to 25 months
The APaT population included all participants who took at least one dose of study medication and were counted in the treatment group of the medication they actually took.
|
0.83%
1/121 • Number of events 1 • Up to 25 months
The APaT population included all participants who took at least one dose of study medication and were counted in the treatment group of the medication they actually took.
|
|
Nervous system disorders
Lacunar infarction
|
0.82%
1/122 • Number of events 1 • Up to 25 months
The APaT population included all participants who took at least one dose of study medication and were counted in the treatment group of the medication they actually took.
|
0.00%
0/121 • Up to 25 months
The APaT population included all participants who took at least one dose of study medication and were counted in the treatment group of the medication they actually took.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/122 • Up to 25 months
The APaT population included all participants who took at least one dose of study medication and were counted in the treatment group of the medication they actually took.
|
0.83%
1/121 • Number of events 1 • Up to 25 months
The APaT population included all participants who took at least one dose of study medication and were counted in the treatment group of the medication they actually took.
|
|
Nervous system disorders
Sciatica
|
0.82%
1/122 • Number of events 1 • Up to 25 months
The APaT population included all participants who took at least one dose of study medication and were counted in the treatment group of the medication they actually took.
|
0.00%
0/121 • Up to 25 months
The APaT population included all participants who took at least one dose of study medication and were counted in the treatment group of the medication they actually took.
|
|
Psychiatric disorders
Depression
|
0.00%
0/122 • Up to 25 months
The APaT population included all participants who took at least one dose of study medication and were counted in the treatment group of the medication they actually took.
|
0.83%
1/121 • Number of events 1 • Up to 25 months
The APaT population included all participants who took at least one dose of study medication and were counted in the treatment group of the medication they actually took.
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/122 • Up to 25 months
The APaT population included all participants who took at least one dose of study medication and were counted in the treatment group of the medication they actually took.
|
0.83%
1/121 • Number of events 1 • Up to 25 months
The APaT population included all participants who took at least one dose of study medication and were counted in the treatment group of the medication they actually took.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/122 • Up to 25 months
The APaT population included all participants who took at least one dose of study medication and were counted in the treatment group of the medication they actually took.
|
0.83%
1/121 • Number of events 1 • Up to 25 months
The APaT population included all participants who took at least one dose of study medication and were counted in the treatment group of the medication they actually took.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/122 • Up to 25 months
The APaT population included all participants who took at least one dose of study medication and were counted in the treatment group of the medication they actually took.
|
0.83%
1/121 • Number of events 1 • Up to 25 months
The APaT population included all participants who took at least one dose of study medication and were counted in the treatment group of the medication they actually took.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/122 • Up to 25 months
The APaT population included all participants who took at least one dose of study medication and were counted in the treatment group of the medication they actually took.
|
0.83%
1/121 • Number of events 1 • Up to 25 months
The APaT population included all participants who took at least one dose of study medication and were counted in the treatment group of the medication they actually took.
|
|
Vascular disorders
Hypertension
|
0.00%
0/122 • Up to 25 months
The APaT population included all participants who took at least one dose of study medication and were counted in the treatment group of the medication they actually took.
|
1.7%
2/121 • Number of events 2 • Up to 25 months
The APaT population included all participants who took at least one dose of study medication and were counted in the treatment group of the medication they actually took.
|
Other adverse events
| Measure |
Odanacatib 50 mg
n=122 participants at risk
Odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
|
Placebo
n=121 participants at risk
Placebo to odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
|
|---|---|---|
|
Infections and infestations
Bronchitis
|
5.7%
7/122 • Number of events 9 • Up to 25 months
The APaT population included all participants who took at least one dose of study medication and were counted in the treatment group of the medication they actually took.
|
4.1%
5/121 • Number of events 5 • Up to 25 months
The APaT population included all participants who took at least one dose of study medication and were counted in the treatment group of the medication they actually took.
|
|
Infections and infestations
Nasopharyngitis
|
3.3%
4/122 • Number of events 4 • Up to 25 months
The APaT population included all participants who took at least one dose of study medication and were counted in the treatment group of the medication they actually took.
|
6.6%
8/121 • Number of events 9 • Up to 25 months
The APaT population included all participants who took at least one dose of study medication and were counted in the treatment group of the medication they actually took.
|
|
Infections and infestations
Urinary tract infection
|
12.3%
15/122 • Number of events 18 • Up to 25 months
The APaT population included all participants who took at least one dose of study medication and were counted in the treatment group of the medication they actually took.
|
16.5%
20/121 • Number of events 28 • Up to 25 months
The APaT population included all participants who took at least one dose of study medication and were counted in the treatment group of the medication they actually took.
|
|
Injury, poisoning and procedural complications
Fall
|
1.6%
2/122 • Number of events 4 • Up to 25 months
The APaT population included all participants who took at least one dose of study medication and were counted in the treatment group of the medication they actually took.
|
5.8%
7/121 • Number of events 8 • Up to 25 months
The APaT population included all participants who took at least one dose of study medication and were counted in the treatment group of the medication they actually took.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
9.0%
11/122 • Number of events 13 • Up to 25 months
The APaT population included all participants who took at least one dose of study medication and were counted in the treatment group of the medication they actually took.
|
11.6%
14/121 • Number of events 14 • Up to 25 months
The APaT population included all participants who took at least one dose of study medication and were counted in the treatment group of the medication they actually took.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
11.5%
14/122 • Number of events 15 • Up to 25 months
The APaT population included all participants who took at least one dose of study medication and were counted in the treatment group of the medication they actually took.
|
10.7%
13/121 • Number of events 16 • Up to 25 months
The APaT population included all participants who took at least one dose of study medication and were counted in the treatment group of the medication they actually took.
|
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