Postmenopausal Women
Conditions
Brief summary
To compare the efficacy 50 mg delayed-release risedronate tablet, dosed immediately after breakfast, to a 35 mg immediate-release tablet, administered according to labeling instructions.
Detailed description
To compare the efficacy, based on the bone turnover marker (BTM) serum Type I collagen C-telopeptide (CTx), of a 50 mg delayed-release risedronate tablet, administered immediately after a typical breakfast, to that of a 35 mg immediate-release tablet, administered according to labeling instructions (ie, at least 30 minutes prior to breakfast) in postmenopausal women after 13 weeks of treatment.
Interventions
DRUGrisedronate
35mg immediate release risedronate tablet before breakfast, once a week for 13 weeks
Sponsors
Warner Chilcott
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
45 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* In generally good health, as determined by medical history, physical examination, and laboratory test results * Postmenopausal greater than 2 years, naturally or surgically based on medical history.
Exclusion criteria
* Used any of the following medications within 3 months prior to dosing or used any of the following medications for more than 1 month at any time within 6 months prior to dosing: * oral or parenteral glucocorticoids (5 mg prednisone or equivalent/day) * anabolic steroids * estrogens (oral, skin patch, or gel), except for low dose vaginal products or insertable estrogen ring, selective estrogen-receptor modulators, or estrogen-related drugs * progestins * calcitonin * vitamin D supplements * calcitriol, calcidiol, or alfacalcidol at any dose * any bisphosphonate * fluoride * strontium * parathyroid hormone, including teriparatide
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent Change in Serum CTX (Type I Collagen C-telopeptide), ITT (Intent to Treat) Population | Baseline and Week 13 |
Secondary
| Measure | Time frame |
|---|---|
| Percent Change in Urine NTX/Cr (Urine Type I Collagen Cross-linked N-telopeptide Corrected for Creatinine Clearance), ITT Population | Baseline and Week 13 |
| Percent Change in Serum BAP (Bone-specific Alkaline Phosphatase), ITT Population | Baseline and Week 13 |
Countries
United States
Participant flow
Recruitment details
Screening began 14-Jul-2006
Participants by arm
| Arm | Count |
|---|---|
| 35 mg IRBB (Immediate Release Before Breakfast) 35 mg immediate release risedronate tablet, 30 minutes prior to breakfast, once a week for 13 weeks | 37 |
| 35 mg DRFB (Delayed Release Following Breakfast) 35 mg delayed release risedronate tablet, immediately following breakfast, once a week for 13 weeks | 36 |
| 50 mg DRFB 50 mg delayed release risedronate tablet, immediately following breakfast, once a week for 13 weeks | 36 |
| 50 mg DRBB (Delayed Release Before Breakfast) 50 mg delayed release risedronate tablet, 30 minutes prior to breakfast, once a week for 13 weeks | 72 |
| Total | 181 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 2 | 1 | 0 | 4 |
| Overall Study | Lost to Follow-up | 0 | 0 | 1 | 0 |
| Overall Study | Protocol Violation | 0 | 0 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 2 | 0 | 0 | 2 |
Baseline characteristics
| Characteristic | 35 mg IRBB (Immediate Release Before Breakfast) | 35 mg DRFB (Delayed Release Following Breakfast) | 50 mg DRFB | 50 mg DRBB (Delayed Release Before Breakfast) | Total |
|---|---|---|---|---|---|
| Age Continuous | 61.1 years STANDARD_DEVIATION 6.2 | 58.9 years STANDARD_DEVIATION 6.7 | 60.0 years STANDARD_DEVIATION 6.1 | 59.7 years STANDARD_DEVIATION 7.8 | 59.9 years STANDARD_DEVIATION 7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 13 Participants | 9 Participants | 14 Participants | 23 Participants | 59 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 24 Participants | 27 Participants | 22 Participants | 49 Participants | 122 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian (Oriental) | 6 Participants | 6 Participants | 3 Participants | 10 Participants | 25 Participants |
| Race/Ethnicity, Customized Black | 0 Participants | 1 Participants | 3 Participants | 2 Participants | 6 Participants |
| Race/Ethnicity, Customized Caucasian | 30 Participants | 29 Participants | 26 Participants | 56 Participants | 141 Participants |
| Race/Ethnicity, Customized Hawaiian/Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Multi-Racial | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Other | 1 Participants | 0 Participants | 4 Participants | 2 Participants | 7 Participants |
| Region of Enrollment United States | 37 participants | 36 participants | 36 participants | 72 participants | 181 participants |
| Sex: Female, Male Female | 37 Participants | 36 Participants | 36 Participants | 72 Participants | 181 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 27 / 37 | 19 / 36 | 24 / 36 | 51 / 72 |
| serious Total, serious adverse events | 0 / 37 | 1 / 36 | 0 / 36 | 1 / 72 |
Outcome results
Primary
Percent Change in Serum CTX (Type I Collagen C-telopeptide), ITT (Intent to Treat) Population
Time frame: Baseline and Week 13
Population: ITT Population
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| 35 mg IRBB (Immediate Release Before Breakfast) | Percent Change in Serum CTX (Type I Collagen C-telopeptide), ITT (Intent to Treat) Population | -43.20 Percent Change |
| 35 mg DRFB (Delayed Release Following Breakfast) | Percent Change in Serum CTX (Type I Collagen C-telopeptide), ITT (Intent to Treat) Population | -62.08 Percent Change |
| 50 mg DRFB | Percent Change in Serum CTX (Type I Collagen C-telopeptide), ITT (Intent to Treat) Population | -65.11 Percent Change |
| 50 mg DRBB (Delayed Release Before Breakfast) | Percent Change in Serum CTX (Type I Collagen C-telopeptide), ITT (Intent to Treat) Population | -66.30 Percent Change |
Comparison: For power calculations, assumed that variability in test treatment groups is no more than 50% higher than reference group. If true ratio of CTX is 0.65, the power to detect this departure from a ratio of 1.0 in the primary analysis is 0.88.90% CI: [1.091, 1.964]
Comparison: For power calculations, assumed that variability in test treatment groups is no more than 50% higher than reference group. If true ratio of CTX is 0.65, the power to detect this departure from a ratio of 1.0 in the primary analysis is 0.88.90% CI: [1.139, 2.066]
Comparison: For power calculations, assumed that variability in test treatment groups is no more than 50% higher than reference group. If true ratio of CTX is 0.65, the power to detect this departure from a ratio of 1.0 in the primary analysis is 0.88.90% CI: [1.177, 2.086]
Comparison: For power calculations, assumed that variability in test treatment groups is no more than 50% higher than reference group. If true ratio of CTX is 0.65, the power to detect this departure from a ratio of 1.0 in the primary analysis is 0.88.90% CI: [0.867, 1.321]
Comparison: For power calculations, assumed that variability in test treatment groups is no more than 50% higher than reference group. If true ratio of CTX is 0.65, the power to detect this departure from a ratio of 1.0 in the primary analysis is 0.88.90% CI: [0.824, 1.267]
Secondary
Percent Change in Serum BAP (Bone-specific Alkaline Phosphatase), ITT Population
Time frame: Baseline and Week 13
Population: ITT Population
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| 35 mg IRBB (Immediate Release Before Breakfast) | Percent Change in Serum BAP (Bone-specific Alkaline Phosphatase), ITT Population | -10.99 Percent Change |
| 35 mg DRFB (Delayed Release Following Breakfast) | Percent Change in Serum BAP (Bone-specific Alkaline Phosphatase), ITT Population | -10.41 Percent Change |
| 50 mg DRFB | Percent Change in Serum BAP (Bone-specific Alkaline Phosphatase), ITT Population | -20.00 Percent Change |
| 50 mg DRBB (Delayed Release Before Breakfast) | Percent Change in Serum BAP (Bone-specific Alkaline Phosphatase), ITT Population | -17.36 Percent Change |
Comparison: The target numbers of subjects assessable for the primary analysis are 70 in the 50 mg DRFB group and 35 in the 35 mg IRBB group. Sample sizes are determined to provide adequate power for the primary comparison (ie, serum CTX for 50 mg DRFB vs. 35 mg IRBB).90% CI: [0.316, 2.993]
Comparison: The target numbers of subjects assessable for the primary analysis are 70 in the 50 mg DRFB group and 35 in the 35 mg IRBB group. Sample sizes are determined to provide adequate power for the primary comparison (ie, serum CTX for 50 mg DRFB vs. 35 mg IRBB).90% CI: [0.929, 5.429]
Comparison: The target numbers of subjects assessable for the primary analysis are 70 in the 50 mg DRFB group and 35 in the 35 mg IRBB group. Sample sizes are determined to provide adequate power for the primary comparison (ie, serum CTX for 50 mg DRFB vs. 35 mg IRBB).90% CI: [0.801, 4.718]
Comparison: The target numbers of subjects assessable for the primary analysis are 70 in the 50 mg DRFB group and 35 in the 35 mg IRBB group. Sample sizes are determined to provide adequate power for the primary comparison (ie, serum CTX for 50 mg DRFB vs. 35 mg IRBB).90% CI: [0.856, 4.668]
Comparison: The target numbers of subjects assessable for the primary analysis are 70 in the 50 mg DRFB group and 35 in the 35 mg IRBB group. Sample sizes are determined to provide adequate power for the primary comparison (ie, serum CTX for 50 mg DRFB vs. 35 mg IRBB).90% CI: [0.504, 1.488]
Secondary
Percent Change in Urine NTX/Cr (Urine Type I Collagen Cross-linked N-telopeptide Corrected for Creatinine Clearance), ITT Population
Time frame: Baseline and Week 13
Population: ITT Population
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| 35 mg IRBB (Immediate Release Before Breakfast) | Percent Change in Urine NTX/Cr (Urine Type I Collagen Cross-linked N-telopeptide Corrected for Creatinine Clearance), ITT Population | -38.57 Percent Change |
| 35 mg DRFB (Delayed Release Following Breakfast) | Percent Change in Urine NTX/Cr (Urine Type I Collagen Cross-linked N-telopeptide Corrected for Creatinine Clearance), ITT Population | -46.60 Percent Change |
| 50 mg DRFB | Percent Change in Urine NTX/Cr (Urine Type I Collagen Cross-linked N-telopeptide Corrected for Creatinine Clearance), ITT Population | -43.65 Percent Change |
| 50 mg DRBB (Delayed Release Before Breakfast) | Percent Change in Urine NTX/Cr (Urine Type I Collagen Cross-linked N-telopeptide Corrected for Creatinine Clearance), ITT Population | -54.27 Percent Change |
Comparison: The target numbers of subjects assessable for the primary analysis are 70 in the 50 mg DRFB group and 35 in the 35 mg IRBB group. Sample sizes are determined to provide adequate power for the primary comparison (ie, serum CTX for 50 mg DRFB vs. 35 mg IRBB).90% CI: [0.749, 2.099]
Comparison: The target numbers of subjects assessable for the primary analysis are 70 in the 50 mg DRFB group and 35 in the 35 mg IRBB group. Sample sizes are determined to provide adequate power for the primary comparison (ie, serum CTX for 50 mg DRFB vs. 35 mg IRBB).90% CI: [0.665, 2.003]
Comparison: The target numbers of subjects assessable for the primary analysis are 70 in the 50 mg DRFB group and 35 in the 35 mg IRBB group. Sample sizes are determined to provide adequate power for the primary comparison (ie, serum CTX for 50 mg DRFB vs. 35 mg IRBB).90% CI: [0.913, 2.404]
Comparison: The target numbers of subjects assessable for the primary analysis are 70 in the 50 mg DRFB group and 35 in the 35 mg IRBB group. Sample sizes are determined to provide adequate power for the primary comparison (ie, serum CTX for 50 mg DRFB vs. 35 mg IRBB).90% CI: [0.797, 1.752]
Comparison: The target numbers of subjects assessable for the primary analysis are 70 in the 50 mg DRFB group and 35 in the 35 mg IRBB group. Sample sizes are determined to provide adequate power for the primary comparison (ie, serum CTX for 50 mg DRFB vs. 35 mg IRBB).90% CI: [0.828, 1.99]