Trial Outcomes & Findings for Effect of Dexlansoprazole on Bone Homeostasis (NCT NCT01216293)
NCT ID: NCT01216293
Last Updated: 2024-03-18
Results Overview
The percent change in bone formation marker P1NP measured at week 26 from P1NP measured at baseline. Serum samples for P1NP were analyzed at a central laboratory for bone biomarker P1NP using an electrochemiluminescence immunoassay measured in nanograms per milliliter (ng/mL).
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
115 participants
Primary outcome timeframe
Baseline and Week 26
Results posted on
2024-03-18
Participant Flow
Participants took part in the study at 10 investigative sites in the United States from 01 November 2010 (first subject signed informed consent form) to 1 February 2015.
Healthy post-menopausal women were enrolled equally in 1 of 3 treatment groups, once a day, placebo, 60 mg dexlansoprazole delayed-release capsules or 40 mg esomeprazole delayed-release capsules.
Participant milestones
| Measure |
Placebo
Placebo-matching capsules, orally, once daily for up to 26 weeks. Participants had the option to participate in the calcium absorption sub study to receive calcium isotope 42 calcium (42 Ca) 3 milligram (mg), intravenously and 44 calcium (44 Ca) 8 mg, orally, once on Day-1 and Week 26.
|
Dexlansoprazole 60 mg
Dexlansoprazole 60 mg, capsules, orally, once daily for up to 26 weeks. Participants had the option to participate in the calcium absorption sub study to receive calcium isotope 42 Ca 3 mg, intravenously and 44 Ca 8 mg, orally, once on Day-1 and Week 26.
|
Esomeprazole 40 mg
Esomeprazole 40 mg, capsules, orally, once daily for up to 26 weeks. Participants had the option to participate in the calcium absorption sub study to receive calcium isotope 42 Ca 3 mg, intravenously and 44 Ca 8 mg, orally, once on Day-1 and Week 26.
|
|---|---|---|---|
|
Main Study
STARTED
|
42
|
38
|
35
|
|
Main Study
Safety Set: Received Study Drug
|
41
|
38
|
35
|
|
Main Study
Randomized, Not Treated
|
1
|
0
|
0
|
|
Main Study
COMPLETED
|
34
|
30
|
29
|
|
Main Study
NOT COMPLETED
|
8
|
8
|
6
|
|
Calcium Absorption Substudy
STARTED
|
14
|
10
|
10
|
|
Calcium Absorption Substudy
Safety Set: Received Study Drug
|
14
|
10
|
10
|
|
Calcium Absorption Substudy
COMPLETED
|
12
|
8
|
10
|
|
Calcium Absorption Substudy
NOT COMPLETED
|
2
|
2
|
0
|
Reasons for withdrawal
| Measure |
Placebo
Placebo-matching capsules, orally, once daily for up to 26 weeks. Participants had the option to participate in the calcium absorption sub study to receive calcium isotope 42 calcium (42 Ca) 3 milligram (mg), intravenously and 44 calcium (44 Ca) 8 mg, orally, once on Day-1 and Week 26.
|
Dexlansoprazole 60 mg
Dexlansoprazole 60 mg, capsules, orally, once daily for up to 26 weeks. Participants had the option to participate in the calcium absorption sub study to receive calcium isotope 42 Ca 3 mg, intravenously and 44 Ca 8 mg, orally, once on Day-1 and Week 26.
|
Esomeprazole 40 mg
Esomeprazole 40 mg, capsules, orally, once daily for up to 26 weeks. Participants had the option to participate in the calcium absorption sub study to receive calcium isotope 42 Ca 3 mg, intravenously and 44 Ca 8 mg, orally, once on Day-1 and Week 26.
|
|---|---|---|---|
|
Main Study
Adverse Event
|
1
|
4
|
2
|
|
Main Study
Major Protocol Deviation
|
1
|
0
|
1
|
|
Main Study
Lost to Follow-up
|
3
|
1
|
0
|
|
Main Study
Voluntary Withdrawal
|
2
|
2
|
2
|
|
Main Study
Other Reason Not Specified
|
0
|
1
|
1
|
|
Main Study
Randomized, Not Treated
|
1
|
0
|
0
|
|
Calcium Absorption Substudy
Adverse Event
|
0
|
2
|
0
|
|
Calcium Absorption Substudy
Major Protocol Deviation
|
1
|
0
|
0
|
|
Calcium Absorption Substudy
Voluntary Withdrawal
|
1
|
0
|
0
|
Baseline Characteristics
Number analyzed are the participants with data available for Age
Baseline characteristics by cohort
| Measure |
Placebo
n=41 Participants
Placebo-matching capsules, orally, once daily for up to 26 weeks. Participants had the option to participate in the calcium absorption sub study to receive calcium isotope 42 calcium (42 Ca) 3 milligram (mg), intravenously and 44 calcium (44 Ca) 8 mg, orally, once on Day-1 and Week 26.
|
Dexlansoprazole 60 mg
n=38 Participants
Dexlansoprazole 60 mg, capsules, orally, once daily for up to 26 weeks. Participants had the option to participate in the calcium absorption sub study to receive calcium isotope 42 Ca 3 mg, intravenously and 44 Ca 8 mg, orally, once on Day-1 and Week 26.
|
Esomeprazole 40 mg
n=35 Participants
Esomeprazole 40 mg, capsules, orally, once daily for up to 26 weeks. Participants had the option to participate in the calcium absorption sub study to receive calcium isotope 42 Ca 3 mg, intravenously and 44 Ca 8 mg, orally, once on Day-1 and Week 26.
|
Total
n=114 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
61.2 years
n=40 Participants • Number analyzed are the participants with data available for Age
|
62.4 years
n=37 Participants • Number analyzed are the participants with data available for Age
|
63.2 years
n=35 Participants • Number analyzed are the participants with data available for Age
|
62.2 years
n=112 Participants • Number analyzed are the participants with data available for Age
|
|
Sex: Female, Male
Female
|
41 Participants
n=41 Participants
|
38 Participants
n=38 Participants
|
35 Participants
n=35 Participants
|
114 Participants
n=114 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=41 Participants
|
0 Participants
n=38 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=114 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=41 Participants
|
5 Participants
n=38 Participants
|
3 Participants
n=35 Participants
|
11 Participants
n=114 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
38 Participants
n=41 Participants
|
33 Participants
n=38 Participants
|
32 Participants
n=35 Participants
|
103 Participants
n=114 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=41 Participants
|
0 Participants
n=38 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=114 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=41 Participants
|
0 Participants
n=38 Participants
|
0 Participants
n=35 Participants
|
1 Participants
n=114 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=41 Participants
|
2 Participants
n=38 Participants
|
0 Participants
n=35 Participants
|
2 Participants
n=114 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=41 Participants
|
0 Participants
n=38 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=114 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=41 Participants
|
2 Participants
n=38 Participants
|
2 Participants
n=35 Participants
|
6 Participants
n=114 Participants
|
|
Race (NIH/OMB)
White
|
37 Participants
n=41 Participants
|
34 Participants
n=38 Participants
|
33 Participants
n=35 Participants
|
104 Participants
n=114 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=41 Participants
|
0 Participants
n=38 Participants
|
0 Participants
n=35 Participants
|
1 Participants
n=114 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=41 Participants
|
0 Participants
n=38 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=114 Participants
|
|
Region of Enrollment
United States
|
41 Participants
n=41 Participants
|
38 Participants
n=38 Participants
|
35 Participants
n=35 Participants
|
114 Participants
n=114 Participants
|
|
Height
|
164.4 cm
n=41 Participants
|
164.9 cm
n=38 Participants
|
164.6 cm
n=35 Participants
|
164.6 cm
n=114 Participants
|
|
Weight
|
69.25 kg
n=41 Participants
|
66.54 kg
n=38 Participants
|
69.47 kg
n=35 Participants
|
68.1 kg
n=114 Participants
|
|
Body Mass Index (BMI)
|
25.61 kg/m^2
n=41 Participants
|
24.46 kg/m^2
n=38 Participants
|
25.65 kg/m^2
n=35 Participants
|
25.24 kg/m^2
n=114 Participants
|
|
Smoking Classification
Never smoked
|
30 Participants
n=41 Participants
|
23 Participants
n=38 Participants
|
27 Participants
n=35 Participants
|
80 Participants
n=114 Participants
|
|
Smoking Classification
Current smoker
|
0 Participants
n=41 Participants
|
0 Participants
n=38 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=114 Participants
|
|
Smoking Classification
Ex-smoker
|
11 Participants
n=41 Participants
|
15 Participants
n=38 Participants
|
8 Participants
n=35 Participants
|
34 Participants
n=114 Participants
|
|
Alcohol Classification
Never drank
|
6 Participants
n=41 Participants
|
6 Participants
n=38 Participants
|
6 Participants
n=35 Participants
|
18 Participants
n=114 Participants
|
|
Alcohol Classification
Current drinker
|
30 Participants
n=41 Participants
|
31 Participants
n=38 Participants
|
27 Participants
n=35 Participants
|
88 Participants
n=114 Participants
|
|
Alcohol Classification
Ex-drinker
|
5 Participants
n=41 Participants
|
1 Participants
n=38 Participants
|
2 Participants
n=35 Participants
|
8 Participants
n=114 Participants
|
|
Caffeine Consumption
Had caffeine consumption
|
37 Participants
n=41 Participants
|
34 Participants
n=38 Participants
|
29 Participants
n=35 Participants
|
100 Participants
n=114 Participants
|
|
Caffeine Consumption
Not had caffeine consumption
|
4 Participants
n=41 Participants
|
4 Participants
n=38 Participants
|
6 Participants
n=35 Participants
|
14 Participants
n=114 Participants
|
|
Calcium at Screening Visit
|
9.93 mg/dL
n=41 Participants
|
9.87 mg/dL
n=38 Participants
|
9.97 mg/dL
n=35 Participants
|
9.92 mg/dL
n=114 Participants
|
|
Vitamin D at Screening Visit
|
35.5 ng/mL
n=41 Participants
|
33.2 ng/mL
n=38 Participants
|
33.4 ng/mL
n=35 Participants
|
34.1 ng/mL
n=114 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 26Population: Participants from the Pharmacodynamic Set, all randomized participants who received study drug with evaluable calcium absorption data at Day 1 and Week 26, with data available for this outcome measure.
The percent change in bone formation marker P1NP measured at week 26 from P1NP measured at baseline. Serum samples for P1NP were analyzed at a central laboratory for bone biomarker P1NP using an electrochemiluminescence immunoassay measured in nanograms per milliliter (ng/mL).
Outcome measures
| Measure |
Placebo
n=32 Participants
Placebo-matching capsules, orally, once daily for up to 26 weeks. Participants had the option to participate in the calcium absorption sub study to receive calcium isotope 42 calcium (42 Ca) 3 milligram (mg), intravenously and 44 calcium (44 Ca) 8 mg, orally, once on Day-1 and Week 26.
|
Dexlansoprazole 60 mg
n=31 Participants
Dexlansoprazole 60 mg, capsules, orally, once daily for up to 26 weeks. Participants had the option to participate in the calcium absorption sub study to receive calcium isotope 42 Ca 3 mg, intravenously and 44 Ca 8 mg, orally, once on Day-1 and Week 26.
|
Esomeprazole 40 mg
n=26 Participants
Esomeprazole 40 mg, capsules, orally, once daily for up to 26 weeks. Participants had the option to participate in the calcium absorption sub study to receive calcium isotope 42 Ca 3 mg, intravenously and 44 Ca 8 mg, orally, once on Day-1 and Week 26.
|
|---|---|---|---|
|
Percent Change From Baseline to Week 26 in Bone Formation Marker Aminoterminal Propeptide of Type 1 Collagen (P1NP)
|
-0.4 percent change
Interval -35.0 to 75.0
|
19.3 percent change
Interval -33.0 to 82.0
|
16.9 percent change
Interval -8.0 to 73.0
|
PRIMARY outcome
Timeframe: Baseline and Week 26Population: Participants from the Pharmacodynamic Set, all randomized participants who received study drug with evaluable calcium absorption data at Day 1 and Week 26, with data available for this outcome measure.
The percent change in bone resorption marker CTX measured at week 26 from CTX measured at baseline. Plasma samples were analyzed at a central laboratory for bone biomarker CTX using an electrochemiluminescence immunoassay measured in ng/mL.
Outcome measures
| Measure |
Placebo
n=32 Participants
Placebo-matching capsules, orally, once daily for up to 26 weeks. Participants had the option to participate in the calcium absorption sub study to receive calcium isotope 42 calcium (42 Ca) 3 milligram (mg), intravenously and 44 calcium (44 Ca) 8 mg, orally, once on Day-1 and Week 26.
|
Dexlansoprazole 60 mg
n=31 Participants
Dexlansoprazole 60 mg, capsules, orally, once daily for up to 26 weeks. Participants had the option to participate in the calcium absorption sub study to receive calcium isotope 42 Ca 3 mg, intravenously and 44 Ca 8 mg, orally, once on Day-1 and Week 26.
|
Esomeprazole 40 mg
n=26 Participants
Esomeprazole 40 mg, capsules, orally, once daily for up to 26 weeks. Participants had the option to participate in the calcium absorption sub study to receive calcium isotope 42 Ca 3 mg, intravenously and 44 Ca 8 mg, orally, once on Day-1 and Week 26.
|
|---|---|---|---|
|
Percent Change From Baseline to Week 26 in Bone Resorption Marker C-telopeptide of Collagen Cross-links (CTX)
|
2.441 percent change
Interval -65.59 to 54.55
|
29.524 percent change
Interval -28.81 to 171.74
|
23.897 percent change
Interval -21.9 to 110.53
|
SECONDARY outcome
Timeframe: Baseline and Week 26Population: Participants from the Pharmacodynamic Set, all randomized participants who received study drug with evaluable calcium absorption data at Day 1 and Week 26, with data available for this outcome measure.
The percent change in bone resorption marker NTx measured at week 26 from NTx measured at baseline. Urine samples were analyzed at a central laboratory for NTx using an enzyme-linked immunosorbent assay calculated as (nmol BCE/mmol creatinine). BCE=bone collagen equivalent
Outcome measures
| Measure |
Placebo
n=32 Participants
Placebo-matching capsules, orally, once daily for up to 26 weeks. Participants had the option to participate in the calcium absorption sub study to receive calcium isotope 42 calcium (42 Ca) 3 milligram (mg), intravenously and 44 calcium (44 Ca) 8 mg, orally, once on Day-1 and Week 26.
|
Dexlansoprazole 60 mg
n=31 Participants
Dexlansoprazole 60 mg, capsules, orally, once daily for up to 26 weeks. Participants had the option to participate in the calcium absorption sub study to receive calcium isotope 42 Ca 3 mg, intravenously and 44 Ca 8 mg, orally, once on Day-1 and Week 26.
|
Esomeprazole 40 mg
n=26 Participants
Esomeprazole 40 mg, capsules, orally, once daily for up to 26 weeks. Participants had the option to participate in the calcium absorption sub study to receive calcium isotope 42 Ca 3 mg, intravenously and 44 Ca 8 mg, orally, once on Day-1 and Week 26.
|
|---|---|---|---|
|
Percent Change From Baseline to Week 26 in Urine N-telopeptide of Collagen Cross-links (NTx) Calculated
|
-6.1 percent change
Interval -53.0 to 86.0
|
16.9 percent change
Interval -45.0 to 100.0
|
6.2 percent change
Interval -45.0 to 67.0
|
SECONDARY outcome
Timeframe: Baseline and Week 26Population: Participants from the Pharmacodynamic Set, all randomized participants who received study drug with evaluable calcium absorption data at Day 1 and Week 26, with data available for this outcome measure.
The percent change in bone formation marker BsAP measured at week 26 from BsAP measured at baseline. Serum samples were analyzed at a central laboratory for bone biomarker BsAP using an enzyme immunoassay measured in units per liter (U/L).
Outcome measures
| Measure |
Placebo
n=32 Participants
Placebo-matching capsules, orally, once daily for up to 26 weeks. Participants had the option to participate in the calcium absorption sub study to receive calcium isotope 42 calcium (42 Ca) 3 milligram (mg), intravenously and 44 calcium (44 Ca) 8 mg, orally, once on Day-1 and Week 26.
|
Dexlansoprazole 60 mg
n=31 Participants
Dexlansoprazole 60 mg, capsules, orally, once daily for up to 26 weeks. Participants had the option to participate in the calcium absorption sub study to receive calcium isotope 42 Ca 3 mg, intravenously and 44 Ca 8 mg, orally, once on Day-1 and Week 26.
|
Esomeprazole 40 mg
n=26 Participants
Esomeprazole 40 mg, capsules, orally, once daily for up to 26 weeks. Participants had the option to participate in the calcium absorption sub study to receive calcium isotope 42 Ca 3 mg, intravenously and 44 Ca 8 mg, orally, once on Day-1 and Week 26.
|
|---|---|---|---|
|
Percent Change From Baseline to Week 26 in Bone-specific Alkaline Phosphatase (BsAP)
|
0.50 percent change
Interval -22.7 to 27.2
|
8.68 percent change
Interval -14.6 to 36.2
|
6.23 percent change
Interval -13.5 to 48.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and Week 13Population: The pharmacodynamic set included participants from the safety set who had baseline and postbaseline values for any of the primary or secondary endpoints. The pharmacodynamic set where data for baseline and post-baseline assessments was available.
Serum samples for P1NP were analyzed using an electrochemiluminescence immunoassay measured in ng/mL.
Outcome measures
| Measure |
Placebo
n=35 Participants
Placebo-matching capsules, orally, once daily for up to 26 weeks. Participants had the option to participate in the calcium absorption sub study to receive calcium isotope 42 calcium (42 Ca) 3 milligram (mg), intravenously and 44 calcium (44 Ca) 8 mg, orally, once on Day-1 and Week 26.
|
Dexlansoprazole 60 mg
n=31 Participants
Dexlansoprazole 60 mg, capsules, orally, once daily for up to 26 weeks. Participants had the option to participate in the calcium absorption sub study to receive calcium isotope 42 Ca 3 mg, intravenously and 44 Ca 8 mg, orally, once on Day-1 and Week 26.
|
Esomeprazole 40 mg
n=31 Participants
Esomeprazole 40 mg, capsules, orally, once daily for up to 26 weeks. Participants had the option to participate in the calcium absorption sub study to receive calcium isotope 42 Ca 3 mg, intravenously and 44 Ca 8 mg, orally, once on Day-1 and Week 26.
|
|---|---|---|---|
|
Percent Change From Baseline in P1NP at Week 13
|
6.7 percent change
Standard Deviation 18.27
|
19.1 percent change
Standard Deviation 25.02
|
11.6 percent change
Standard Deviation 18.23
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and Week 13Population: The pharmacodynamic set included participants from the safety set who had baseline and postbaseline values for any of the primary or secondary endpoints. The pharmacodynamic set where data for baseline and post-baseline assessments was available.
Plasma samples were analyzed for bone biomarker CTX using an electrochemiluminescence immunoassay measured in ng/mL.
Outcome measures
| Measure |
Placebo
n=36 Participants
Placebo-matching capsules, orally, once daily for up to 26 weeks. Participants had the option to participate in the calcium absorption sub study to receive calcium isotope 42 calcium (42 Ca) 3 milligram (mg), intravenously and 44 calcium (44 Ca) 8 mg, orally, once on Day-1 and Week 26.
|
Dexlansoprazole 60 mg
n=31 Participants
Dexlansoprazole 60 mg, capsules, orally, once daily for up to 26 weeks. Participants had the option to participate in the calcium absorption sub study to receive calcium isotope 42 Ca 3 mg, intravenously and 44 Ca 8 mg, orally, once on Day-1 and Week 26.
|
Esomeprazole 40 mg
n=30 Participants
Esomeprazole 40 mg, capsules, orally, once daily for up to 26 weeks. Participants had the option to participate in the calcium absorption sub study to receive calcium isotope 42 Ca 3 mg, intravenously and 44 Ca 8 mg, orally, once on Day-1 and Week 26.
|
|---|---|---|---|
|
Percent Change From Baseline in CTX at Week 13
|
7.510 percent change
Standard Deviation 29.9739
|
32.069 percent change
Standard Deviation 45.6413
|
23.212 percent change
Standard Deviation 23.8900
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and Week 26Population: The pharmacodynamic set included participants from the safety set who had baseline and postbaseline values for any of the primary or secondary endpoints. The pharmacodynamic set where data for baseline and post-baseline assessments was available.
DXA is a means of measuring BMD through x-ray.
Outcome measures
| Measure |
Placebo
n=26 Participants
Placebo-matching capsules, orally, once daily for up to 26 weeks. Participants had the option to participate in the calcium absorption sub study to receive calcium isotope 42 calcium (42 Ca) 3 milligram (mg), intravenously and 44 calcium (44 Ca) 8 mg, orally, once on Day-1 and Week 26.
|
Dexlansoprazole 60 mg
n=27 Participants
Dexlansoprazole 60 mg, capsules, orally, once daily for up to 26 weeks. Participants had the option to participate in the calcium absorption sub study to receive calcium isotope 42 Ca 3 mg, intravenously and 44 Ca 8 mg, orally, once on Day-1 and Week 26.
|
Esomeprazole 40 mg
n=24 Participants
Esomeprazole 40 mg, capsules, orally, once daily for up to 26 weeks. Participants had the option to participate in the calcium absorption sub study to receive calcium isotope 42 Ca 3 mg, intravenously and 44 Ca 8 mg, orally, once on Day-1 and Week 26.
|
|---|---|---|---|
|
Percent Change From Baseline in Femoral Neck Bone Mineral Density (BMD) Measured by Dual Energy X-ray Absorptiometry (DXA) at Week 26
|
-0.6632 percent change
Standard Deviation 2.48314
|
-1.6039 percent change
Standard Deviation 2.58207
|
-1.0596 percent change
Standard Deviation 2.41731
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and Week 26Population: The pharmacodynamic set included participants from the safety set who had baseline and postbaseline values for any of the primary or secondary endpoints. The pharmacodynamic set where data for baseline and post-baseline assessments was available.
DXA is a means of measuring BMD through x-ray.
Outcome measures
| Measure |
Placebo
n=26 Participants
Placebo-matching capsules, orally, once daily for up to 26 weeks. Participants had the option to participate in the calcium absorption sub study to receive calcium isotope 42 calcium (42 Ca) 3 milligram (mg), intravenously and 44 calcium (44 Ca) 8 mg, orally, once on Day-1 and Week 26.
|
Dexlansoprazole 60 mg
n=27 Participants
Dexlansoprazole 60 mg, capsules, orally, once daily for up to 26 weeks. Participants had the option to participate in the calcium absorption sub study to receive calcium isotope 42 Ca 3 mg, intravenously and 44 Ca 8 mg, orally, once on Day-1 and Week 26.
|
Esomeprazole 40 mg
n=24 Participants
Esomeprazole 40 mg, capsules, orally, once daily for up to 26 weeks. Participants had the option to participate in the calcium absorption sub study to receive calcium isotope 42 Ca 3 mg, intravenously and 44 Ca 8 mg, orally, once on Day-1 and Week 26.
|
|---|---|---|---|
|
Percent Change From Baseline in Total Hip BMD Measured by DXA at Week 26
|
-0.1928 percent change
Standard Deviation 1.42242
|
-0.7190 percent change
Standard Deviation 1.78479
|
-0.5330 percent change
Standard Deviation 1.50491
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and Week 26Population: The pharmacodynamic set included participants from the safety set who had baseline and postbaseline values for any of the primary or secondary endpoints. The pharmacodynamic set where data for baseline and post-baseline assessments was available.
DXA is a means of measuring BMD through x-ray.
Outcome measures
| Measure |
Placebo
n=19 Participants
Placebo-matching capsules, orally, once daily for up to 26 weeks. Participants had the option to participate in the calcium absorption sub study to receive calcium isotope 42 calcium (42 Ca) 3 milligram (mg), intravenously and 44 calcium (44 Ca) 8 mg, orally, once on Day-1 and Week 26.
|
Dexlansoprazole 60 mg
n=19 Participants
Dexlansoprazole 60 mg, capsules, orally, once daily for up to 26 weeks. Participants had the option to participate in the calcium absorption sub study to receive calcium isotope 42 Ca 3 mg, intravenously and 44 Ca 8 mg, orally, once on Day-1 and Week 26.
|
Esomeprazole 40 mg
n=20 Participants
Esomeprazole 40 mg, capsules, orally, once daily for up to 26 weeks. Participants had the option to participate in the calcium absorption sub study to receive calcium isotope 42 Ca 3 mg, intravenously and 44 Ca 8 mg, orally, once on Day-1 and Week 26.
|
|---|---|---|---|
|
Percent Change From Baseline in Lumbar Spine BMD Measured by DXA at Week 26
|
-0.2486 percent change
Standard Deviation 3.29581
|
-1.0753 percent change
Standard Deviation 3.46909
|
-1.2873 percent change
Standard Deviation 2.06722
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 26 and Week 52Population: The pharmacodynamic set included participants from the safety set who had baseline and postbaseline values for any of the primary or secondary endpoints. The pharmacodynamic set where data for baseline and post-baseline assessments was available.
DXA is a means of measuring BMD through x-ray.
Outcome measures
| Measure |
Placebo
n=23 Participants
Placebo-matching capsules, orally, once daily for up to 26 weeks. Participants had the option to participate in the calcium absorption sub study to receive calcium isotope 42 calcium (42 Ca) 3 milligram (mg), intravenously and 44 calcium (44 Ca) 8 mg, orally, once on Day-1 and Week 26.
|
Dexlansoprazole 60 mg
n=25 Participants
Dexlansoprazole 60 mg, capsules, orally, once daily for up to 26 weeks. Participants had the option to participate in the calcium absorption sub study to receive calcium isotope 42 Ca 3 mg, intravenously and 44 Ca 8 mg, orally, once on Day-1 and Week 26.
|
Esomeprazole 40 mg
n=23 Participants
Esomeprazole 40 mg, capsules, orally, once daily for up to 26 weeks. Participants had the option to participate in the calcium absorption sub study to receive calcium isotope 42 Ca 3 mg, intravenously and 44 Ca 8 mg, orally, once on Day-1 and Week 26.
|
|---|---|---|---|
|
Percent Change From Week 26 in Femoral Neck BMD Measured by DXA at Week 52
|
-0.0063 percent change
Standard Deviation 2.57407
|
-0.3439 percent change
Standard Deviation 2.39680
|
0.2689 percent change
Standard Deviation 2.67283
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 26 and Week 52Population: The pharmacodynamic set included participants from the safety set who had baseline and postbaseline values for any of the primary or secondary endpoints. The pharmacodynamic set where data for baseline and post-baseline assessments was available.
DXA is a means of measuring BMD through x-ray.
Outcome measures
| Measure |
Placebo
n=23 Participants
Placebo-matching capsules, orally, once daily for up to 26 weeks. Participants had the option to participate in the calcium absorption sub study to receive calcium isotope 42 calcium (42 Ca) 3 milligram (mg), intravenously and 44 calcium (44 Ca) 8 mg, orally, once on Day-1 and Week 26.
|
Dexlansoprazole 60 mg
n=25 Participants
Dexlansoprazole 60 mg, capsules, orally, once daily for up to 26 weeks. Participants had the option to participate in the calcium absorption sub study to receive calcium isotope 42 Ca 3 mg, intravenously and 44 Ca 8 mg, orally, once on Day-1 and Week 26.
|
Esomeprazole 40 mg
n=23 Participants
Esomeprazole 40 mg, capsules, orally, once daily for up to 26 weeks. Participants had the option to participate in the calcium absorption sub study to receive calcium isotope 42 Ca 3 mg, intravenously and 44 Ca 8 mg, orally, once on Day-1 and Week 26.
|
|---|---|---|---|
|
Percent Change From Weeks 26 in Total Hip BMD Measured by DXA at Week 52
|
-0.0201 percent change
Standard Deviation 1.28096
|
-0.3324 percent change
Standard Deviation 1.58091
|
-0.0799 percent change
Standard Deviation 1.81755
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 26 and Week 52Population: The pharmacodynamic set included participants from the safety set who had baseline and postbaseline values for any of the primary or secondary endpoints. The pharmacodynamic set where data for baseline and post-baseline assessments was available.
Outcome measures
| Measure |
Placebo
n=17 Participants
Placebo-matching capsules, orally, once daily for up to 26 weeks. Participants had the option to participate in the calcium absorption sub study to receive calcium isotope 42 calcium (42 Ca) 3 milligram (mg), intravenously and 44 calcium (44 Ca) 8 mg, orally, once on Day-1 and Week 26.
|
Dexlansoprazole 60 mg
n=18 Participants
Dexlansoprazole 60 mg, capsules, orally, once daily for up to 26 weeks. Participants had the option to participate in the calcium absorption sub study to receive calcium isotope 42 Ca 3 mg, intravenously and 44 Ca 8 mg, orally, once on Day-1 and Week 26.
|
Esomeprazole 40 mg
n=18 Participants
Esomeprazole 40 mg, capsules, orally, once daily for up to 26 weeks. Participants had the option to participate in the calcium absorption sub study to receive calcium isotope 42 Ca 3 mg, intravenously and 44 Ca 8 mg, orally, once on Day-1 and Week 26.
|
|---|---|---|---|
|
Percent Change From Weeks 26 in Lumbar Spine BMD Measured by DXA at Week 52
|
-0.4913 percent change
Standard Deviation 3.01161
|
-0.3561 percent change
Standard Deviation 2.42934
|
0.8565 percent change
Standard Deviation 2.46230
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline up to Week 26Population: The pharmacodynamic set included participants from the safety set who had baseline and postbaseline values for any of the primary or secondary endpoints.
Outcome measures
| Measure |
Placebo
n=38 Participants
Placebo-matching capsules, orally, once daily for up to 26 weeks. Participants had the option to participate in the calcium absorption sub study to receive calcium isotope 42 calcium (42 Ca) 3 milligram (mg), intravenously and 44 calcium (44 Ca) 8 mg, orally, once on Day-1 and Week 26.
|
Dexlansoprazole 60 mg
n=36 Participants
Dexlansoprazole 60 mg, capsules, orally, once daily for up to 26 weeks. Participants had the option to participate in the calcium absorption sub study to receive calcium isotope 42 Ca 3 mg, intravenously and 44 Ca 8 mg, orally, once on Day-1 and Week 26.
|
Esomeprazole 40 mg
n=34 Participants
Esomeprazole 40 mg, capsules, orally, once daily for up to 26 weeks. Participants had the option to participate in the calcium absorption sub study to receive calcium isotope 42 Ca 3 mg, intravenously and 44 Ca 8 mg, orally, once on Day-1 and Week 26.
|
|---|---|---|---|
|
Number of Participants With Fracture Including Vertebral Fracture During Study Treatment
|
0 participants
|
0 participants
|
0 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and Week 26Population: The pharmacodynamic set included participants from the safety set who had baseline and postbaseline values for any of the primary or secondary endpoints. The pharmacodynamic set where data for baseline and post-baseline assessments was available.
Outcome measures
| Measure |
Placebo
n=29 Participants
Placebo-matching capsules, orally, once daily for up to 26 weeks. Participants had the option to participate in the calcium absorption sub study to receive calcium isotope 42 calcium (42 Ca) 3 milligram (mg), intravenously and 44 calcium (44 Ca) 8 mg, orally, once on Day-1 and Week 26.
|
Dexlansoprazole 60 mg
n=29 Participants
Dexlansoprazole 60 mg, capsules, orally, once daily for up to 26 weeks. Participants had the option to participate in the calcium absorption sub study to receive calcium isotope 42 Ca 3 mg, intravenously and 44 Ca 8 mg, orally, once on Day-1 and Week 26.
|
Esomeprazole 40 mg
n=24 Participants
Esomeprazole 40 mg, capsules, orally, once daily for up to 26 weeks. Participants had the option to participate in the calcium absorption sub study to receive calcium isotope 42 Ca 3 mg, intravenously and 44 Ca 8 mg, orally, once on Day-1 and Week 26.
|
|---|---|---|---|
|
Change From Baseline in 24-hour Urinary Calcium Excretion at Week 26
Baseline
|
160.3 milligram per day (mg/d)
Standard Deviation 76.16
|
184.8 milligram per day (mg/d)
Standard Deviation 79.52
|
153.7 milligram per day (mg/d)
Standard Deviation 90.09
|
|
Change From Baseline in 24-hour Urinary Calcium Excretion at Week 26
Change at Week 26
|
-24.4 milligram per day (mg/d)
Standard Deviation 87.16
|
-50.6 milligram per day (mg/d)
Standard Deviation 84.95
|
-49.7 milligram per day (mg/d)
Standard Deviation 94.38
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and Week 26Population: The pharmacodynamic set included participants from the safety set who had baseline and postbaseline values for any of the primary or secondary endpoints. The pharmacodynamic set where data for baseline and post-baseline assessments was available.
Outcome measures
| Measure |
Placebo
n=36 Participants
Placebo-matching capsules, orally, once daily for up to 26 weeks. Participants had the option to participate in the calcium absorption sub study to receive calcium isotope 42 calcium (42 Ca) 3 milligram (mg), intravenously and 44 calcium (44 Ca) 8 mg, orally, once on Day-1 and Week 26.
|
Dexlansoprazole 60 mg
n=30 Participants
Dexlansoprazole 60 mg, capsules, orally, once daily for up to 26 weeks. Participants had the option to participate in the calcium absorption sub study to receive calcium isotope 42 Ca 3 mg, intravenously and 44 Ca 8 mg, orally, once on Day-1 and Week 26.
|
Esomeprazole 40 mg
n=31 Participants
Esomeprazole 40 mg, capsules, orally, once daily for up to 26 weeks. Participants had the option to participate in the calcium absorption sub study to receive calcium isotope 42 Ca 3 mg, intravenously and 44 Ca 8 mg, orally, once on Day-1 and Week 26.
|
|---|---|---|---|
|
Change From Baseline in Parathyroid Hormone (PTH) at Week 26
Baseline
|
30.67 picogram per milliliter (pg/mL)
Standard Deviation 10.068
|
30.68 picogram per milliliter (pg/mL)
Standard Deviation 11.917
|
31.10 picogram per milliliter (pg/mL)
Standard Deviation 8.254
|
|
Change From Baseline in Parathyroid Hormone (PTH) at Week 26
Change at Week 26
|
2.16 picogram per milliliter (pg/mL)
Standard Deviation 7.793
|
2.08 picogram per milliliter (pg/mL)
Standard Deviation 7.765
|
3.37 picogram per milliliter (pg/mL)
Standard Deviation 9.525
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and Week 26Population: The pharmacodynamic set included participants from the safety set who had baseline and postbaseline values for any of the primary or secondary endpoints. The pharmacodynamic set where data for baseline and post-baseline assessments was available.
Outcome measures
| Measure |
Placebo
n=36 Participants
Placebo-matching capsules, orally, once daily for up to 26 weeks. Participants had the option to participate in the calcium absorption sub study to receive calcium isotope 42 calcium (42 Ca) 3 milligram (mg), intravenously and 44 calcium (44 Ca) 8 mg, orally, once on Day-1 and Week 26.
|
Dexlansoprazole 60 mg
n=32 Participants
Dexlansoprazole 60 mg, capsules, orally, once daily for up to 26 weeks. Participants had the option to participate in the calcium absorption sub study to receive calcium isotope 42 Ca 3 mg, intravenously and 44 Ca 8 mg, orally, once on Day-1 and Week 26.
|
Esomeprazole 40 mg
n=30 Participants
Esomeprazole 40 mg, capsules, orally, once daily for up to 26 weeks. Participants had the option to participate in the calcium absorption sub study to receive calcium isotope 42 Ca 3 mg, intravenously and 44 Ca 8 mg, orally, once on Day-1 and Week 26.
|
|---|---|---|---|
|
Change From Baseline in Serum Calcium at Week 26
Baseline
|
9.48 milligram per deciliter (mg/dL)
Standard Deviation 0.347
|
9.47 milligram per deciliter (mg/dL)
Standard Deviation 0.291
|
9.58 milligram per deciliter (mg/dL)
Standard Deviation 0.308
|
|
Change From Baseline in Serum Calcium at Week 26
Change at Week 26
|
-0.03 milligram per deciliter (mg/dL)
Standard Deviation 0.440
|
-0.03 milligram per deciliter (mg/dL)
Standard Deviation 0.333
|
-0.07 milligram per deciliter (mg/dL)
Standard Deviation 0.331
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and Week 26Population: The pharmacodynamic set included participants from the safety set who had baseline and postbaseline values for any of the primary or secondary endpoints. The pharmacodynamic set where data for baseline and post-baseline assessments was available.
Outcome measures
| Measure |
Placebo
n=36 Participants
Placebo-matching capsules, orally, once daily for up to 26 weeks. Participants had the option to participate in the calcium absorption sub study to receive calcium isotope 42 calcium (42 Ca) 3 milligram (mg), intravenously and 44 calcium (44 Ca) 8 mg, orally, once on Day-1 and Week 26.
|
Dexlansoprazole 60 mg
n=32 Participants
Dexlansoprazole 60 mg, capsules, orally, once daily for up to 26 weeks. Participants had the option to participate in the calcium absorption sub study to receive calcium isotope 42 Ca 3 mg, intravenously and 44 Ca 8 mg, orally, once on Day-1 and Week 26.
|
Esomeprazole 40 mg
n=30 Participants
Esomeprazole 40 mg, capsules, orally, once daily for up to 26 weeks. Participants had the option to participate in the calcium absorption sub study to receive calcium isotope 42 Ca 3 mg, intravenously and 44 Ca 8 mg, orally, once on Day-1 and Week 26.
|
|---|---|---|---|
|
Change From Baseline in Serum Phosphorus at Week 26
Baseline
|
3.73 mg/dL
Standard Deviation 0.377
|
3.92 mg/dL
Standard Deviation 0.422
|
3.89 mg/dL
Standard Deviation 0.335
|
|
Change From Baseline in Serum Phosphorus at Week 26
Change at Week 26
|
0.08 mg/dL
Standard Deviation 0.445
|
0.07 mg/dL
Standard Deviation 0.271
|
0.03 mg/dL
Standard Deviation 0.393
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and Week 26Population: The pharmacodynamic set included participants from the safety set who had baseline and postbaseline values for any of the primary or secondary endpoints. The pharmacodynamic set where data for baseline and post-baseline assessments was available.
Outcome measures
| Measure |
Placebo
n=36 Participants
Placebo-matching capsules, orally, once daily for up to 26 weeks. Participants had the option to participate in the calcium absorption sub study to receive calcium isotope 42 calcium (42 Ca) 3 milligram (mg), intravenously and 44 calcium (44 Ca) 8 mg, orally, once on Day-1 and Week 26.
|
Dexlansoprazole 60 mg
n=32 Participants
Dexlansoprazole 60 mg, capsules, orally, once daily for up to 26 weeks. Participants had the option to participate in the calcium absorption sub study to receive calcium isotope 42 Ca 3 mg, intravenously and 44 Ca 8 mg, orally, once on Day-1 and Week 26.
|
Esomeprazole 40 mg
n=30 Participants
Esomeprazole 40 mg, capsules, orally, once daily for up to 26 weeks. Participants had the option to participate in the calcium absorption sub study to receive calcium isotope 42 Ca 3 mg, intravenously and 44 Ca 8 mg, orally, once on Day-1 and Week 26.
|
|---|---|---|---|
|
Change From Baseline in Serum Magnesium at Week 26
Baseline
|
1.72 milliequivalent per liter (meq/L)
Standard Deviation 0.124
|
1.72 milliequivalent per liter (meq/L)
Standard Deviation 0.145
|
1.77 milliequivalent per liter (meq/L)
Standard Deviation 0.127
|
|
Change From Baseline in Serum Magnesium at Week 26
Change at Week 26
|
-0.01 milliequivalent per liter (meq/L)
Standard Deviation 0.118
|
-0.02 milliequivalent per liter (meq/L)
Standard Deviation 0.109
|
-0.03 milliequivalent per liter (meq/L)
Standard Deviation 0.096
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and Week 26Population: The pharmacodynamic set included participants from the safety set who had baseline and postbaseline values for any of the primary or secondary endpoints. The pharmacodynamic set where data for baseline and post-baseline assessments was available.
Outcome measures
| Measure |
Placebo
n=35 Participants
Placebo-matching capsules, orally, once daily for up to 26 weeks. Participants had the option to participate in the calcium absorption sub study to receive calcium isotope 42 calcium (42 Ca) 3 milligram (mg), intravenously and 44 calcium (44 Ca) 8 mg, orally, once on Day-1 and Week 26.
|
Dexlansoprazole 60 mg
n=32 Participants
Dexlansoprazole 60 mg, capsules, orally, once daily for up to 26 weeks. Participants had the option to participate in the calcium absorption sub study to receive calcium isotope 42 Ca 3 mg, intravenously and 44 Ca 8 mg, orally, once on Day-1 and Week 26.
|
Esomeprazole 40 mg
n=31 Participants
Esomeprazole 40 mg, capsules, orally, once daily for up to 26 weeks. Participants had the option to participate in the calcium absorption sub study to receive calcium isotope 42 Ca 3 mg, intravenously and 44 Ca 8 mg, orally, once on Day-1 and Week 26.
|
|---|---|---|---|
|
Change From Baseline in Urine Magnesium at Week 26
Baseline
|
3.8 meq/L
Standard Deviation 2.11
|
4.6 meq/L
Standard Deviation 3.46
|
4.1 meq/L
Standard Deviation 2.85
|
|
Change From Baseline in Urine Magnesium at Week 26
Change at Week 26
|
-0.1 meq/L
Standard Deviation 2.41
|
-0.8 meq/L
Standard Deviation 2.83
|
-0.5 meq/L
Standard Deviation 2.80
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and Week 26Population: The pharmacodynamic set included participants from the safety set who had baseline and postbaseline values for any of the primary or secondary endpoints. The pharmacodynamic set where data for baseline and post-baseline assessments was available.
Outcome measures
| Measure |
Placebo
n=36 Participants
Placebo-matching capsules, orally, once daily for up to 26 weeks. Participants had the option to participate in the calcium absorption sub study to receive calcium isotope 42 calcium (42 Ca) 3 milligram (mg), intravenously and 44 calcium (44 Ca) 8 mg, orally, once on Day-1 and Week 26.
|
Dexlansoprazole 60 mg
n=32 Participants
Dexlansoprazole 60 mg, capsules, orally, once daily for up to 26 weeks. Participants had the option to participate in the calcium absorption sub study to receive calcium isotope 42 Ca 3 mg, intravenously and 44 Ca 8 mg, orally, once on Day-1 and Week 26.
|
Esomeprazole 40 mg
n=31 Participants
Esomeprazole 40 mg, capsules, orally, once daily for up to 26 weeks. Participants had the option to participate in the calcium absorption sub study to receive calcium isotope 42 Ca 3 mg, intravenously and 44 Ca 8 mg, orally, once on Day-1 and Week 26.
|
|---|---|---|---|
|
Change From Baseline to Week 26 in Vitamin D3 (25-OH-D) Level
Baseline
|
41.3 ng/mL
Standard Deviation 9.96
|
39.4 ng/mL
Standard Deviation 11.64
|
36.4 ng/mL
Standard Deviation 8.48
|
|
Change From Baseline to Week 26 in Vitamin D3 (25-OH-D) Level
Change at Week 26
|
-2.7 ng/mL
Standard Deviation 10.20
|
-0.6 ng/mL
Standard Deviation 12.07
|
1.1 ng/mL
Standard Deviation 9.75
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and Week 26Population: The PD set included participants from the safety set who had baseline and postbaseline values for any of the primary or secondary endpoints. The PD set included participants with evaluable calcium absorption data on Day-1 and Week 26.
Outcome measures
| Measure |
Placebo
n=12 Participants
Placebo-matching capsules, orally, once daily for up to 26 weeks. Participants had the option to participate in the calcium absorption sub study to receive calcium isotope 42 calcium (42 Ca) 3 milligram (mg), intravenously and 44 calcium (44 Ca) 8 mg, orally, once on Day-1 and Week 26.
|
Dexlansoprazole 60 mg
n=9 Participants
Dexlansoprazole 60 mg, capsules, orally, once daily for up to 26 weeks. Participants had the option to participate in the calcium absorption sub study to receive calcium isotope 42 Ca 3 mg, intravenously and 44 Ca 8 mg, orally, once on Day-1 and Week 26.
|
Esomeprazole 40 mg
n=10 Participants
Esomeprazole 40 mg, capsules, orally, once daily for up to 26 weeks. Participants had the option to participate in the calcium absorption sub study to receive calcium isotope 42 Ca 3 mg, intravenously and 44 Ca 8 mg, orally, once on Day-1 and Week 26.
|
|---|---|---|---|
|
Change From Baseline in Intestinal Calcium Absorption by True Fractional Calcium Absorption (TFCA) in a Subset of Participants at Week 26
Baseline
|
0.18 mg/d
Standard Deviation 0.064
|
0.18 mg/d
Standard Deviation 0.043
|
0.17 mg/d
Standard Deviation 0.049
|
|
Change From Baseline in Intestinal Calcium Absorption by True Fractional Calcium Absorption (TFCA) in a Subset of Participants at Week 26
Change at week 26
|
-0.01 mg/d
Standard Deviation 0.049
|
0.02 mg/d
Standard Deviation 0.042
|
0.05 mg/d
Standard Deviation 0.050
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Dexlansoprazole 60 mg
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
Esomeprazole 40mg
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Calcium Absorption Sub Study: Placebo
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Calcium Absorption Sub Study: Dexlansoprazole 60 mg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Calcium Absorption Sub Study: Esomeprazole 40 mg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=41 participants at risk
Placebo-matching capsules, orally, once daily for up to 26 weeks.
|
Dexlansoprazole 60 mg
n=38 participants at risk
Dexlansoprazole 60 mg, capsules, orally, once daily for up to 26 weeks.
|
Esomeprazole 40mg
n=35 participants at risk
Esomeprazole 40 mg, capsules, orally, once daily for up to 26 weeks.
|
Calcium Absorption Sub Study: Placebo
n=14 participants at risk
Following the main study participants had the option to participate in the calcium absorption sub study to receive calcium isotope 42 calcium (42 Ca) 3 milligram (mg), intravenously and 44 calcium (44 Ca) 8 mg, orally, once on Day-1 and Week 26.
|
Calcium Absorption Sub Study: Dexlansoprazole 60 mg
n=10 participants at risk
Following the main study Participants had the option to participate in the calcium absorption sub study to receive calcium isotope 42 Ca 3 mg, intravenously and 44 Ca 8 mg, orally, once on Day-1 and Week 26.
|
Calcium Absorption Sub Study: Esomeprazole 40 mg
n=10 participants at risk
Following the main study participants had the option to participate in the calcium absorption sub study to receive calcium isotope 42 Ca 3 mg, intravenously and 44 Ca 8 mg, orally, once on Day-1 and Week 26.
|
|---|---|---|---|---|---|---|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/41 • First dose of study drug and within 30 days of the last dose of study drug (Up to 30 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
2.6%
1/38 • First dose of study drug and within 30 days of the last dose of study drug (Up to 30 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/35 • First dose of study drug and within 30 days of the last dose of study drug (Up to 30 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/14 • First dose of study drug and within 30 days of the last dose of study drug (Up to 30 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • First dose of study drug and within 30 days of the last dose of study drug (Up to 30 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • First dose of study drug and within 30 days of the last dose of study drug (Up to 30 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
Other adverse events
| Measure |
Placebo
n=41 participants at risk
Placebo-matching capsules, orally, once daily for up to 26 weeks.
|
Dexlansoprazole 60 mg
n=38 participants at risk
Dexlansoprazole 60 mg, capsules, orally, once daily for up to 26 weeks.
|
Esomeprazole 40mg
n=35 participants at risk
Esomeprazole 40 mg, capsules, orally, once daily for up to 26 weeks.
|
Calcium Absorption Sub Study: Placebo
n=14 participants at risk
Following the main study participants had the option to participate in the calcium absorption sub study to receive calcium isotope 42 calcium (42 Ca) 3 milligram (mg), intravenously and 44 calcium (44 Ca) 8 mg, orally, once on Day-1 and Week 26.
|
Calcium Absorption Sub Study: Dexlansoprazole 60 mg
n=10 participants at risk
Following the main study Participants had the option to participate in the calcium absorption sub study to receive calcium isotope 42 Ca 3 mg, intravenously and 44 Ca 8 mg, orally, once on Day-1 and Week 26.
|
Calcium Absorption Sub Study: Esomeprazole 40 mg
n=10 participants at risk
Following the main study participants had the option to participate in the calcium absorption sub study to receive calcium isotope 42 Ca 3 mg, intravenously and 44 Ca 8 mg, orally, once on Day-1 and Week 26.
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
7.3%
3/41 • First dose of study drug and within 30 days of the last dose of study drug (Up to 30 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
15.8%
6/38 • First dose of study drug and within 30 days of the last dose of study drug (Up to 30 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
2.9%
1/35 • First dose of study drug and within 30 days of the last dose of study drug (Up to 30 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
7.1%
1/14 • First dose of study drug and within 30 days of the last dose of study drug (Up to 30 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
30.0%
3/10 • First dose of study drug and within 30 days of the last dose of study drug (Up to 30 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • First dose of study drug and within 30 days of the last dose of study drug (Up to 30 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/41 • First dose of study drug and within 30 days of the last dose of study drug (Up to 30 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/38 • First dose of study drug and within 30 days of the last dose of study drug (Up to 30 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
5/35 • First dose of study drug and within 30 days of the last dose of study drug (Up to 30 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/14 • First dose of study drug and within 30 days of the last dose of study drug (Up to 30 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • First dose of study drug and within 30 days of the last dose of study drug (Up to 30 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
20.0%
2/10 • First dose of study drug and within 30 days of the last dose of study drug (Up to 30 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Upper respiratory tract infection
|
7.3%
3/41 • First dose of study drug and within 30 days of the last dose of study drug (Up to 30 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
2.6%
1/38 • First dose of study drug and within 30 days of the last dose of study drug (Up to 30 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.7%
2/35 • First dose of study drug and within 30 days of the last dose of study drug (Up to 30 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
2/14 • First dose of study drug and within 30 days of the last dose of study drug (Up to 30 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
10.0%
1/10 • First dose of study drug and within 30 days of the last dose of study drug (Up to 30 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
20.0%
2/10 • First dose of study drug and within 30 days of the last dose of study drug (Up to 30 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/41 • First dose of study drug and within 30 days of the last dose of study drug (Up to 30 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
2.6%
1/38 • First dose of study drug and within 30 days of the last dose of study drug (Up to 30 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
8.6%
3/35 • First dose of study drug and within 30 days of the last dose of study drug (Up to 30 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/14 • First dose of study drug and within 30 days of the last dose of study drug (Up to 30 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • First dose of study drug and within 30 days of the last dose of study drug (Up to 30 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
30.0%
3/10 • First dose of study drug and within 30 days of the last dose of study drug (Up to 30 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Research Organization shall not publish any articles or papers nor make any presentations, nor assist any other person in publishing any articles or papers or in making any presentations relating or referring to the Study or any results, data or insights from or any data, information or materials obtained or generated in the performance of its obligations without the prior written consent of Takeda, which consent may be granted or withheld in Takeda's sole discretion.
- Publication restrictions are in place
Restriction type: OTHER