Trial Outcomes & Findings for A Study of Bone Turnover Markers in Post-Menopausal Women With Osteoporosis Treated With Monthly Boniva (Ibandronate) (NCT NCT00303485)
NCT ID: NCT00303485
Last Updated: 2016-05-02
Results Overview
Serum C-terminal Telopeptide of Type 1 Collagen (sCTX) is a biochemical marker for bone turnover that has been shown to detect increased bone resorption, a process by which bone is broken down within the body. It is measured in units of nanograms (ng) per milliliter (mL). The relative change in sCTX was defined as the relative difference between the value at each time point and the value at Baseline, using the following formula: Relative change = (sCTX time point- sCTX Baseline) / (sCTX Baseline) \* 100. The sCTX value used for Baseline was the average of the results from the 2 blood samples taken at screening. If 1 of these 2 samples was nonquantifiable or missing, then the Baseline sCTX was the result from the non-missing sample. Baseline visit was defined as Visit 1.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
67 participants
Primary outcome timeframe
Baseline (Visit 1) and Day 3
Results posted on
2016-05-02
Participant Flow
A total of 67 participants were enrolled across 9 study centers in the United States. This study was conducted between 06 February 2006 and 21 June 2007. Out of 67 participants enrolled, 66 participants received at least 1 dose of trial medication (49 participants received Ibandronate and 17 participants received placebo).
Participant milestones
| Measure |
Ibandronate
Participants received Ibandronate 150 mg tablet once-monthly along with a combination dietary supplement containing vitamin D 200 international units (IU) and elemental calcium 500 mg twice daily with meals for 6 months.
|
Placebo
Participants received a matching placebo tablet to Ibandronate once-monthly along with a combination dietary supplement containing vitamin D 200 IU and elemental calcium 500 mg twice daily with meals for 6 months.
|
|---|---|---|
|
Overall Study
STARTED
|
49
|
17
|
|
Overall Study
COMPLETED
|
48
|
15
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
| Measure |
Ibandronate
Participants received Ibandronate 150 mg tablet once-monthly along with a combination dietary supplement containing vitamin D 200 international units (IU) and elemental calcium 500 mg twice daily with meals for 6 months.
|
Placebo
Participants received a matching placebo tablet to Ibandronate once-monthly along with a combination dietary supplement containing vitamin D 200 IU and elemental calcium 500 mg twice daily with meals for 6 months.
|
|---|---|---|
|
Overall Study
Adverse Event/Intercurrent Illness
|
0
|
1
|
|
Overall Study
Failure to return
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
A Study of Bone Turnover Markers in Post-Menopausal Women With Osteoporosis Treated With Monthly Boniva (Ibandronate)
Baseline characteristics by cohort
| Measure |
Ibandronate
n=49 Participants
Participants received Ibandronate 150 mg tablet once-monthly along with a combination dietary supplement containing vitamin D 200 international units (IU) and elemental calcium 500 mg twice daily with meals for 6 months.
|
Placebo
n=17 Participants
Participants received a matching placebo tablet to Ibandronate once-monthly along with a combination dietary supplement containing vitamin D 200 IU and elemental calcium 500 mg twice daily with meals for 6 months.
|
Total
n=66 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64.3 Years
STANDARD_DEVIATION 8.64 • n=5 Participants
|
63.0 Years
STANDARD_DEVIATION 8.41 • n=7 Participants
|
64.0 Years
STANDARD_DEVIATION 8.54 • n=5 Participants
|
|
Sex: Female, Male
Female
|
49 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline (Visit 1) and Day 3Population: This analysis was performed on the ITT Population. The ITT Population included all randomized participants who received at least 1 dose of study medication.
Serum C-terminal Telopeptide of Type 1 Collagen (sCTX) is a biochemical marker for bone turnover that has been shown to detect increased bone resorption, a process by which bone is broken down within the body. It is measured in units of nanograms (ng) per milliliter (mL). The relative change in sCTX was defined as the relative difference between the value at each time point and the value at Baseline, using the following formula: Relative change = (sCTX time point- sCTX Baseline) / (sCTX Baseline) \* 100. The sCTX value used for Baseline was the average of the results from the 2 blood samples taken at screening. If 1 of these 2 samples was nonquantifiable or missing, then the Baseline sCTX was the result from the non-missing sample. Baseline visit was defined as Visit 1.
Outcome measures
| Measure |
Ibandronate
n=46 Participants
Participants received Ibandronate 150 mg tablet once-monthly along with a combination dietary supplement containing vitamin D 200 international units (IU) and elemental calcium 500 mg twice daily with meals for 6 months.
|
Placebo
n=16 Participants
Participants received a matching placebo tablet to Ibandronate once-monthly along with a combination dietary supplement containing vitamin D 200 IU and elemental calcium 500 mg twice daily with meals for 6 months.
|
|---|---|---|
|
Relative Percent Change in Serum C-terminal Telopeptide of Type 1 Collagen Concentration (sCTX) From Baseline to Day 3
|
-70.16 Percent change
Interval -80.34 to -57.64
|
-5.96 Percent change
Interval -20.79 to 6.03
|
SECONDARY outcome
Timeframe: Baseline (Visit 1), Day (D) 3, D7, D14, D21, D28 of Month (M)1, M2, M3, M4, M5, M6Population: This analysis was performed on the ITT Population. The ITT Population included all randomized participants who received at least 1 dose of study medication. "n" denotes number of participants who received the indicated study drug for each arm.
sCTX is a biochemical marker for bone turnover that has been shown to detect increased bone resorption, a process by which bone is broken down within the body. The relative change in sCTX was defined as the relative difference between the value at each time point and the value at Baseline, using the following formula: Relative change = (sCTX Time point- sCTX Baseline) / (sCTX Baseline) \* 100. The sCTX value used for Baseline was the average of the results from the 2 blood samples taken at screening. If 1 of these 2 samples was nonquantifiable or missing, then the Baseline sCTX was the result from the non-missing sample. Baseline visit was defined as Visit 1.
Outcome measures
| Measure |
Ibandronate
n=47 Participants
Participants received Ibandronate 150 mg tablet once-monthly along with a combination dietary supplement containing vitamin D 200 international units (IU) and elemental calcium 500 mg twice daily with meals for 6 months.
|
Placebo
n=16 Participants
Participants received a matching placebo tablet to Ibandronate once-monthly along with a combination dietary supplement containing vitamin D 200 IU and elemental calcium 500 mg twice daily with meals for 6 months.
|
|---|---|---|
|
Relative Percent Change in Serum C-terminal Telopeptide of Type 1 Collagen (sCTX) Concentration From Baseline Over Time
M1D1, (n = 46, 16)
|
-70.16 Percent change
Interval -80.34 to -57.64
|
-5.96 Percent change
Interval -20.79 to 6.03
|
|
Relative Percent Change in Serum C-terminal Telopeptide of Type 1 Collagen (sCTX) Concentration From Baseline Over Time
M1D7, (n = 47, 16)
|
-73.62 Percent change
Interval -78.89 to -61.56
|
-12.69 Percent change
Interval -26.02 to -0.68
|
|
Relative Percent Change in Serum C-terminal Telopeptide of Type 1 Collagen (sCTX) Concentration From Baseline Over Time
M1D14, (n = 47, 15)
|
-61.19 Percent change
Interval -74.42 to -51.22
|
-21.99 Percent change
Interval -28.69 to -8.24
|
|
Relative Percent Change in Serum C-terminal Telopeptide of Type 1 Collagen (sCTX) Concentration From Baseline Over Time
M1D21, (n = 46, 16)
|
-50.98 Percent change
Interval -61.39 to -35.94
|
-4.46 Percent change
Interval -18.73 to 17.69
|
|
Relative Percent Change in Serum C-terminal Telopeptide of Type 1 Collagen (sCTX) Concentration From Baseline Over Time
M1D28, (n = 46, 15)
|
-43.53 Percent change
Interval -56.4 to -29.74
|
-6.29 Percent change
Interval -18.08 to 4.65
|
|
Relative Percent Change in Serum C-terminal Telopeptide of Type 1 Collagen (sCTX) Concentration From Baseline Over Time
M2D7, (n = 46, 15)
|
-75.57 Percent change
Interval -80.41 to -66.09
|
-7.42 Percent change
Interval -19.25 to 14.34
|
|
Relative Percent Change in Serum C-terminal Telopeptide of Type 1 Collagen (sCTX) Concentration From Baseline Over Time
M2D14, (n = 45, 16)
|
-68.51 Percent change
Interval -75.19 to -54.2
|
-5.01 Percent change
Interval -10.92 to 12.12
|
|
Relative Percent Change in Serum C-terminal Telopeptide of Type 1 Collagen (sCTX) Concentration From Baseline Over Time
M2D21, (n = 44, 15)
|
-53.68 Percent change
Interval -65.53 to -41.52
|
-7.64 Percent change
Interval -28.01 to 23.0
|
|
Relative Percent Change in Serum C-terminal Telopeptide of Type 1 Collagen (sCTX) Concentration From Baseline Over Time
M2D28, (n = 45, 15)
|
-50.32 Percent change
Interval -60.7 to -44.15
|
-14.33 Percent change
Interval -25.27 to 14.69
|
|
Relative Percent Change in Serum C-terminal Telopeptide of Type 1 Collagen (sCTX) Concentration From Baseline Over Time
M3D7, (n = 44, 15)
|
-76.58 Percent change
Interval -80.25 to -69.94
|
-13.84 Percent change
Interval -38.85 to 8.88
|
|
Relative Percent Change in Serum C-terminal Telopeptide of Type 1 Collagen (sCTX) Concentration From Baseline Over Time
M3D14, (n = 44, 15)
|
-66.28 Percent change
Interval -75.01 to -53.71
|
-17.10 Percent change
Interval -31.66 to 11.78
|
|
Relative Percent Change in Serum C-terminal Telopeptide of Type 1 Collagen (sCTX) Concentration From Baseline Over Time
M3D21, (n = 45, 14)
|
-59.77 Percent change
Interval -65.43 to -39.3
|
-21.69 Percent change
Interval -38.65 to -0.46
|
|
Relative Percent Change in Serum C-terminal Telopeptide of Type 1 Collagen (sCTX) Concentration From Baseline Over Time
M3D28, (n = 46, 16)
|
-54.49 Percent change
Interval -64.04 to -35.16
|
-17.13 Percent change
Interval -34.36 to 7.12
|
|
Relative Percent Change in Serum C-terminal Telopeptide of Type 1 Collagen (sCTX) Concentration From Baseline Over Time
M4D7, (n = 45, 16)
|
-76.98 Percent change
Interval -80.9 to -63.65
|
-21.37 Percent change
Interval -36.64 to 10.82
|
|
Relative Percent Change in Serum C-terminal Telopeptide of Type 1 Collagen (sCTX) Concentration From Baseline Over Time
M4D14, (n = 47, 16)
|
-69.50 Percent change
Interval -76.37 to -57.86
|
-6.82 Percent change
Interval -26.1 to 11.16
|
|
Relative Percent Change in Serum C-terminal Telopeptide of Type 1 Collagen (sCTX) Concentration From Baseline Over Time
M4D21, (n = 45, 15)
|
-62.80 Percent change
Interval -70.48 to -50.71
|
-9.97 Percent change
Interval -28.34 to 10.49
|
|
Relative Percent Change in Serum C-terminal Telopeptide of Type 1 Collagen (sCTX) Concentration From Baseline Over Time
M4D28, (n = 46, 13)
|
-59.40 Percent change
Interval -64.52 to -43.44
|
-2.10 Percent change
Interval -34.04 to 10.45
|
|
Relative Percent Change in Serum C-terminal Telopeptide of Type 1 Collagen (sCTX) Concentration From Baseline Over Time
M5D7, (n = 46, 14)
|
-75.40 Percent change
Interval -80.5 to -67.63
|
-2.86 Percent change
Interval -41.48 to 10.82
|
|
Relative Percent Change in Serum C-terminal Telopeptide of Type 1 Collagen (sCTX) Concentration From Baseline Over Time
M5D14, (n = 44, 14)
|
-66.08 Percent change
Interval -74.65 to -56.06
|
-16.42 Percent change
Interval -38.26 to 9.82
|
|
Relative Percent Change in Serum C-terminal Telopeptide of Type 1 Collagen (sCTX) Concentration From Baseline Over Time
M5D21, (n = 47, 13)
|
-58.52 Percent change
Interval -69.7 to -44.78
|
-4.60 Percent change
Interval -25.57 to 9.16
|
|
Relative Percent Change in Serum C-terminal Telopeptide of Type 1 Collagen (sCTX) Concentration From Baseline Over Time
M5D28, (n = 43, 12)
|
-54.00 Percent change
Interval -63.79 to -43.42
|
-31.85 Percent change
Interval -42.51 to 3.93
|
|
Relative Percent Change in Serum C-terminal Telopeptide of Type 1 Collagen (sCTX) Concentration From Baseline Over Time
M6D7, (n = 45, 12)
|
-78.09 Percent change
Interval -83.84 to -67.97
|
-14.59 Percent change
Interval -33.11 to 10.87
|
|
Relative Percent Change in Serum C-terminal Telopeptide of Type 1 Collagen (sCTX) Concentration From Baseline Over Time
M6D14, (n = 44, 14)
|
-71.41 Percent change
Interval -78.35 to -62.57
|
-18.49 Percent change
Interval -38.6 to 11.5
|
|
Relative Percent Change in Serum C-terminal Telopeptide of Type 1 Collagen (sCTX) Concentration From Baseline Over Time
M6D21, (n = 47, 15)
|
-67.52 Percent change
Interval -72.57 to -58.09
|
-15.97 Percent change
Interval -49.9 to 19.54
|
|
Relative Percent Change in Serum C-terminal Telopeptide of Type 1 Collagen (sCTX) Concentration From Baseline Over Time
M6D28, (n = 46, 15)
|
-57.97 Percent change
Interval -71.74 to -46.84
|
-14.92 Percent change
Interval -42.56 to 8.47
|
SECONDARY outcome
Timeframe: Baseline (Visit 1), Day (D) 7 and D 28 of Month (M)1, M2, M3, M4, M5, M6Population: This analysis was performed on the ITT Population. The ITT Population included all randomized participants who received at least 1 dose of study medication. 'n' denotes number of participants who received the indicated study drug for each arm.
BSAP is a biochemical marker of bone formation and measured in units per litre (U/L). The relative percent change in BSAP was defined as the relative difference between the value at each time point and the value at Baseline, using the following formula: Relative change = (BSAP time point- BSAP Baseline) / (BSAP Baseline) \* 100. The greater the percent decrease from Baseline, the greater the response to therapy. Baseline visit was defined as Visit 1.
Outcome measures
| Measure |
Ibandronate
n=47 Participants
Participants received Ibandronate 150 mg tablet once-monthly along with a combination dietary supplement containing vitamin D 200 international units (IU) and elemental calcium 500 mg twice daily with meals for 6 months.
|
Placebo
n=16 Participants
Participants received a matching placebo tablet to Ibandronate once-monthly along with a combination dietary supplement containing vitamin D 200 IU and elemental calcium 500 mg twice daily with meals for 6 months.
|
|---|---|---|
|
Relative Percent Change in Bone Specific Alkaline Phosphatase (BSAP) Concentration From Baseline Over Time
M1D7, (n = 47, 16)
|
1.30 Percent change
Interval -5.92 to 6.64
|
-2.42 Percent change
Interval -8.14 to 1.6
|
|
Relative Percent Change in Bone Specific Alkaline Phosphatase (BSAP) Concentration From Baseline Over Time
M1D28, (n = 46,15)
|
-12.24 Percent change
Interval -14.45 to -3.19
|
-9.78 Percent change
Interval -15.85 to -3.38
|
|
Relative Percent Change in Bone Specific Alkaline Phosphatase (BSAP) Concentration From Baseline Over Time
M2D7, (n = 46, 15)
|
-16.41 Percent change
Interval -18.13 to -8.66
|
-12.30 Percent change
Interval -19.15 to -3.11
|
|
Relative Percent Change in Bone Specific Alkaline Phosphatase (BSAP) Concentration From Baseline Over Time
M2D28, (n = 46,15)
|
-23.84 Percent change
Interval -26.06 to -17.77
|
-11.04 Percent change
Interval -22.54 to -3.38
|
|
Relative Percent Change in Bone Specific Alkaline Phosphatase (BSAP) Concentration From Baseline Over Time
M3D7, (n = 45, 15)
|
-22.61 Percent change
Interval -30.58 to -21.05
|
-12.84 Percent change
Interval -25.35 to -6.1
|
|
Relative Percent Change in Bone Specific Alkaline Phosphatase (BSAP) Concentration From Baseline Over Time
M3D28, (n = 45,16)
|
-29.82 Percent change
Interval -34.3 to -26.67
|
-13.24 Percent change
Interval -26.78 to -1.47
|
|
Relative Percent Change in Bone Specific Alkaline Phosphatase (BSAP) Concentration From Baseline Over Time
M4D7, (n = 44, 16)
|
-30.26 Percent change
Interval -38.05 to -25.15
|
-15.64 Percent change
Interval -28.44 to -4.89
|
|
Relative Percent Change in Bone Specific Alkaline Phosphatase (BSAP) Concentration From Baseline Over Time
M4D28, (n = 46,14)
|
-36.88 Percent change
Interval -44.16 to -27.78
|
-19.71 Percent change
Interval -33.17 to -5.74
|
|
Relative Percent Change in Bone Specific Alkaline Phosphatase (BSAP) Concentration From Baseline Over Time
M5D7, (n = 46, 14)
|
-39.30 Percent change
Interval -42.6 to -30.77
|
-21.16 Percent change
Interval -34.63 to 5.43
|
|
Relative Percent Change in Bone Specific Alkaline Phosphatase (BSAP) Concentration From Baseline Over Time
M5D28, (n = 43,11)
|
-38.28 Percent change
Interval -45.33 to -32.14
|
-20.39 Percent change
Interval -43.45 to -3.66
|
|
Relative Percent Change in Bone Specific Alkaline Phosphatase (BSAP) Concentration From Baseline Over Time
M6D7, (n = 46, 12)
|
-38.54 Percent change
Interval -44.05 to -33.18
|
-13.86 Percent change
Interval -42.79 to -8.15
|
|
Relative Percent Change in Bone Specific Alkaline Phosphatase (BSAP) Concentration From Baseline Over Time
M6D28, (n = 47,15)
|
-40.26 Percent change
Interval -45.87 to -25.61
|
-19.24 Percent change
Interval -37.59 to -5.26
|
SECONDARY outcome
Timeframe: Baseline (Visit 1), Month (M)1 Day (D)7, and M6D7Population: This analysis was performed on the ITT Population. The ITT Population included all randomized participants who received at least 1 dose of study medication.
Parathyroid hormone (PTH) regulates calcium and phosphate metabolism in bone and kidney, and is measured in picogram/milliliter (pg/mL). The relative percent change in PTH was defined as the relative difference between the value at each time point and the value at Baseline, using the following formula: Relative change = (PTH time point- PTH Baseline) / (PTH Baseline) \* 100. Post treatment assessments were done at Baseline, Month (M)1 Day (D)7, and M6D7
Outcome measures
| Measure |
Ibandronate
n=49 Participants
Participants received Ibandronate 150 mg tablet once-monthly along with a combination dietary supplement containing vitamin D 200 international units (IU) and elemental calcium 500 mg twice daily with meals for 6 months.
|
Placebo
n=17 Participants
Participants received a matching placebo tablet to Ibandronate once-monthly along with a combination dietary supplement containing vitamin D 200 IU and elemental calcium 500 mg twice daily with meals for 6 months.
|
|---|---|---|
|
Relative Percent Change in Parathyroid Hormone (PTH) From Baseline to Post Treatment Assessments
Month 1 Day 7
|
37.74 Percent change
Interval 25.0 to 81.58
|
-1.72 Percent change
Interval -10.0 to 33.33
|
|
Relative Percent Change in Parathyroid Hormone (PTH) From Baseline to Post Treatment Assessments
Month 6 Day 7
|
29.63 Percent change
Interval -5.56 to 59.38
|
4.81 Percent change
Interval -13.83 to 45.09
|
SECONDARY outcome
Timeframe: Baseline (Visit 1) and Day (D)3 of Month (M)1 and; D7, D14, D21, D28 of each M1, M2, M3, M4, M5, and M6Population: This analysis was performed on the ITT Population. The ITT Population included all randomized participants who received at least 1 dose of study medication. 'n' denotes number of participants who received the indicated study drug for each arm.
The Cochran-Mantel Haenszel test stratified by Baseline sCTX category was used to compare the 2 treatment groups for proportion of participants whose sCTX concentration was between 0.011 and 0.631 ng/mL (premenopausal normal range mean +/- 2 SD) who achieved a decrease in sCTX of at least 8% from Baseline. Mean and SD are based on the normal range for premenopausal women: Mean = 0.321 ng/mL, SD=0.155 ng/mL. Baseline visit was defined as Visit 1.
Outcome measures
| Measure |
Ibandronate
n=49 Participants
Participants received Ibandronate 150 mg tablet once-monthly along with a combination dietary supplement containing vitamin D 200 international units (IU) and elemental calcium 500 mg twice daily with meals for 6 months.
|
Placebo
n=17 Participants
Participants received a matching placebo tablet to Ibandronate once-monthly along with a combination dietary supplement containing vitamin D 200 IU and elemental calcium 500 mg twice daily with meals for 6 months.
|
|---|---|---|
|
Percentage of Participants With a Serum C-terminal Telopeptide of Type1 Collagen (sCTX) Concentration Between 0.011 and 0.631 ng/mL and Who Have Achieved a Decrease in sCTX Concentration of at Least 8 Percent
Baseline, (n = 49, 17)
|
59.2 Percentage of participants
|
58.8 Percentage of participants
|
|
Percentage of Participants With a Serum C-terminal Telopeptide of Type1 Collagen (sCTX) Concentration Between 0.011 and 0.631 ng/mL and Who Have Achieved a Decrease in sCTX Concentration of at Least 8 Percent
M1D3, (n = 46,16)
|
87.8 Percentage of participants
|
58.8 Percentage of participants
|
|
Percentage of Participants With a Serum C-terminal Telopeptide of Type1 Collagen (sCTX) Concentration Between 0.011 and 0.631 ng/mL and Who Have Achieved a Decrease in sCTX Concentration of at Least 8 Percent
M1D7, (n = 47,16)
|
87.8 Percentage of participants
|
76.5 Percentage of participants
|
|
Percentage of Participants With a Serum C-terminal Telopeptide of Type1 Collagen (sCTX) Concentration Between 0.011 and 0.631 ng/mL and Who Have Achieved a Decrease in sCTX Concentration of at Least 8 Percent
M1D14, (n = 47, 15)
|
87.8 Percentage of participants
|
64.7 Percentage of participants
|
|
Percentage of Participants With a Serum C-terminal Telopeptide of Type1 Collagen (sCTX) Concentration Between 0.011 and 0.631 ng/mL and Who Have Achieved a Decrease in sCTX Concentration of at Least 8 Percent
M1D21, (n = 46, 16)
|
83.7 Percentage of participants
|
58.8 Percentage of participants
|
|
Percentage of Participants With a Serum C-terminal Telopeptide of Type1 Collagen (sCTX) Concentration Between 0.011 and 0.631 ng/mL and Who Have Achieved a Decrease in sCTX Concentration of at Least 8 Percent
M1D28, (n = 46, 15)
|
85.7 Percentage of participants
|
64.7 Percentage of participants
|
|
Percentage of Participants With a Serum C-terminal Telopeptide of Type1 Collagen (sCTX) Concentration Between 0.011 and 0.631 ng/mL and Who Have Achieved a Decrease in sCTX Concentration of at Least 8 Percent
M2D7, (n = 46, 15)
|
89.8 Percentage of participants
|
64.7 Percentage of participants
|
|
Percentage of Participants With a Serum C-terminal Telopeptide of Type1 Collagen (sCTX) Concentration Between 0.011 and 0.631 ng/mL and Who Have Achieved a Decrease in sCTX Concentration of at Least 8 Percent
M2D14, (n = 45, 16)
|
83.7 Percentage of participants
|
58.8 Percentage of participants
|
|
Percentage of Participants With a Serum C-terminal Telopeptide of Type1 Collagen (sCTX) Concentration Between 0.011 and 0.631 ng/mL and Who Have Achieved a Decrease in sCTX Concentration of at Least 8 Percent
M2D21, (n = 44, 15)
|
81.6 Percentage of participants
|
64.7 Percentage of participants
|
|
Percentage of Participants With a Serum C-terminal Telopeptide of Type1 Collagen (sCTX) Concentration Between 0.011 and 0.631 ng/mL and Who Have Achieved a Decrease in sCTX Concentration of at Least 8 Percent
M2D28, (n = 45, 15)
|
83.7 Percentage of participants
|
64.7 Percentage of participants
|
|
Percentage of Participants With a Serum C-terminal Telopeptide of Type1 Collagen (sCTX) Concentration Between 0.011 and 0.631 ng/mL and Who Have Achieved a Decrease in sCTX Concentration of at Least 8 Percent
M3D7, (n = 44, 15)
|
83.7 Percentage of participants
|
64.7 Percentage of participants
|
|
Percentage of Participants With a Serum C-terminal Telopeptide of Type1 Collagen (sCTX) Concentration Between 0.011 and 0.631 ng/mL and Who Have Achieved a Decrease in sCTX Concentration of at Least 8 Percent
M3D14, (n = 44, 15)
|
85.7 Percentage of participants
|
70.6 Percentage of participants
|
|
Percentage of Participants With a Serum C-terminal Telopeptide of Type1 Collagen (sCTX) Concentration Between 0.011 and 0.631 ng/mL and Who Have Achieved a Decrease in sCTX Concentration of at Least 8 Percent
M3D21, (n = 45, 14)
|
81.6 Percentage of participants
|
52.9 Percentage of participants
|
|
Percentage of Participants With a Serum C-terminal Telopeptide of Type1 Collagen (sCTX) Concentration Between 0.011 and 0.631 ng/mL and Who Have Achieved a Decrease in sCTX Concentration of at Least 8 Percent
M3D28, (n = 46, 16)
|
83.7 Percentage of participants
|
76.5 Percentage of participants
|
|
Percentage of Participants With a Serum C-terminal Telopeptide of Type1 Collagen (sCTX) Concentration Between 0.011 and 0.631 ng/mL and Who Have Achieved a Decrease in sCTX Concentration of at Least 8 Percent
M4D7, (n = 45, 16)
|
91.8 Percentage of participants
|
76.5 Percentage of participants
|
|
Percentage of Participants With a Serum C-terminal Telopeptide of Type1 Collagen (sCTX) Concentration Between 0.011 and 0.631 ng/mL and Who Have Achieved a Decrease in sCTX Concentration of at Least 8 Percent
M4D14, (n = 47, 16)
|
89.8 Percentage of participants
|
64.7 Percentage of participants
|
|
Percentage of Participants With a Serum C-terminal Telopeptide of Type1 Collagen (sCTX) Concentration Between 0.011 and 0.631 ng/mL and Who Have Achieved a Decrease in sCTX Concentration of at Least 8 Percent
M4D21, (n = 45, 15)
|
83.7 Percentage of participants
|
64.7 Percentage of participants
|
|
Percentage of Participants With a Serum C-terminal Telopeptide of Type1 Collagen (sCTX) Concentration Between 0.011 and 0.631 ng/mL and Who Have Achieved a Decrease in sCTX Concentration of at Least 8 Percent
M4D28, (n = 46, 13)
|
85.7 Percentage of participants
|
58.8 Percentage of participants
|
|
Percentage of Participants With a Serum C-terminal Telopeptide of Type1 Collagen (sCTX) Concentration Between 0.011 and 0.631 ng/mL and Who Have Achieved a Decrease in sCTX Concentration of at Least 8 Percent
M5D7, (n = 46, 14)
|
91.8 Percentage of participants
|
64.7 Percentage of participants
|
|
Percentage of Participants With a Serum C-terminal Telopeptide of Type1 Collagen (sCTX) Concentration Between 0.011 and 0.631 ng/mL and Who Have Achieved a Decrease in sCTX Concentration of at Least 8 Percent
M5D14, (n = 44, 14)
|
87.8 Percentage of participants
|
64.7 Percentage of participants
|
|
Percentage of Participants With a Serum C-terminal Telopeptide of Type1 Collagen (sCTX) Concentration Between 0.011 and 0.631 ng/mL and Who Have Achieved a Decrease in sCTX Concentration of at Least 8 Percent
M5D21, (n = 47, 13)
|
89.8 Percentage of participants
|
58.8 Percentage of participants
|
|
Percentage of Participants With a Serum C-terminal Telopeptide of Type1 Collagen (sCTX) Concentration Between 0.011 and 0.631 ng/mL and Who Have Achieved a Decrease in sCTX Concentration of at Least 8 Percent
M5D28, (n = 43, 12)
|
81.6 Percentage of participants
|
64.7 Percentage of participants
|
|
Percentage of Participants With a Serum C-terminal Telopeptide of Type1 Collagen (sCTX) Concentration Between 0.011 and 0.631 ng/mL and Who Have Achieved a Decrease in sCTX Concentration of at Least 8 Percent
M6D7, (n = 45, 12)
|
89.8 Percentage of participants
|
52.9 Percentage of participants
|
|
Percentage of Participants With a Serum C-terminal Telopeptide of Type1 Collagen (sCTX) Concentration Between 0.011 and 0.631 ng/mL and Who Have Achieved a Decrease in sCTX Concentration of at Least 8 Percent
M6D14, (n = 44, 14)
|
85.7 Percentage of participants
|
64.7 Percentage of participants
|
|
Percentage of Participants With a Serum C-terminal Telopeptide of Type1 Collagen (sCTX) Concentration Between 0.011 and 0.631 ng/mL and Who Have Achieved a Decrease in sCTX Concentration of at Least 8 Percent
M6D21, (n=47, 15)
|
91.8 Percentage of participants
|
64.7 Percentage of participants
|
|
Percentage of Participants With a Serum C-terminal Telopeptide of Type1 Collagen (sCTX) Concentration Between 0.011 and 0.631 ng/mL and Who Have Achieved a Decrease in sCTX Concentration of at Least 8 Percent
M6D28, (n = 46,15)
|
87.8 Percentage of participants
|
64.7 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline (Visit 1) and Day (D)3 of M1 and D7, D14, D21, D28 of each M1, M2, M3, M4, M5, M6Population: This analysis was performed on the ITT Population. The ITT Population included all randomized participants who received at least 1 dose of study medication. 'n' denotes number of participants who received the indicated study drug for each arm.
Percentage of participants whose sCTX concentration was between 0.011 and 0.476 ng/mL (Mean -2 to + 1 SD) were analyzed at particular time points. Mean and SD are based on the normal range for premenopausal women: Mean = 0.321 ng/mL, SD = 0.155 ng/mL. Baseline visit was defined as Visit 1.
Outcome measures
| Measure |
Ibandronate
n=49 Participants
Participants received Ibandronate 150 mg tablet once-monthly along with a combination dietary supplement containing vitamin D 200 international units (IU) and elemental calcium 500 mg twice daily with meals for 6 months.
|
Placebo
n=17 Participants
Participants received a matching placebo tablet to Ibandronate once-monthly along with a combination dietary supplement containing vitamin D 200 IU and elemental calcium 500 mg twice daily with meals for 6 months.
|
|---|---|---|
|
Percentage of Participants With a Serum C-terminal Telopeptide of Type 1 Collagen (sCTX) Concentration Between 0.011 and 0.476 ng/mL
M5D28, (n = 43, 12)
|
20.4 Percentage of participants
|
41.2 Percentage of participants
|
|
Percentage of Participants With a Serum C-terminal Telopeptide of Type 1 Collagen (sCTX) Concentration Between 0.011 and 0.476 ng/mL
M6D7, (n = 45, 12)
|
8.2 Percentage of participants
|
29.4 Percentage of participants
|
|
Percentage of Participants With a Serum C-terminal Telopeptide of Type 1 Collagen (sCTX) Concentration Between 0.011 and 0.476 ng/mL
M6D14, (n = 44, 14)
|
12.2 Percentage of participants
|
47.1 Percentage of participants
|
|
Percentage of Participants With a Serum C-terminal Telopeptide of Type 1 Collagen (sCTX) Concentration Between 0.011 and 0.476 ng/mL
M6D21, (n=47, 15)
|
22.4 Percentage of participants
|
35.3 Percentage of participants
|
|
Percentage of Participants With a Serum C-terminal Telopeptide of Type 1 Collagen (sCTX) Concentration Between 0.011 and 0.476 ng/mL
M6D28, (n = 46, 15)
|
18.4 Percentage of participants
|
47.1 Percentage of participants
|
|
Percentage of Participants With a Serum C-terminal Telopeptide of Type 1 Collagen (sCTX) Concentration Between 0.011 and 0.476 ng/mL
M5D14, (n = 44, 14)
|
18.4 Percentage of participants
|
47.1 Percentage of participants
|
|
Percentage of Participants With a Serum C-terminal Telopeptide of Type 1 Collagen (sCTX) Concentration Between 0.011 and 0.476 ng/mL
M5D21, (n = 47, 13)
|
20.4 Percentage of participants
|
41.2 Percentage of participants
|
|
Percentage of Participants With a Serum C-terminal Telopeptide of Type 1 Collagen (sCTX) Concentration Between 0.011 and 0.476 ng/mL
M5D7, (n = 46, 14)
|
10.2 Percentage of participants
|
41.2 Percentage of participants
|
|
Percentage of Participants With a Serum C-terminal Telopeptide of Type 1 Collagen (sCTX) Concentration Between 0.011 and 0.476 ng/mL
Baseline, (n = 49, 17)
|
46.9 Percentage of participants
|
41.2 Percentage of participants
|
|
Percentage of Participants With a Serum C-terminal Telopeptide of Type 1 Collagen (sCTX) Concentration Between 0.011 and 0.476 ng/mL
M1D3, (n = 46,16)
|
18.4 Percentage of participants
|
47.1 Percentage of participants
|
|
Percentage of Participants With a Serum C-terminal Telopeptide of Type 1 Collagen (sCTX) Concentration Between 0.011 and 0.476 ng/mL
M1D7, (n = 47,16)
|
10.2 Percentage of participants
|
58.8 Percentage of participants
|
|
Percentage of Participants With a Serum C-terminal Telopeptide of Type 1 Collagen (sCTX) Concentration Between 0.011 and 0.476 ng/mL
M1D14, (n = 47, 15)
|
24.5 Percentage of participants
|
47.1 Percentage of participants
|
|
Percentage of Participants With a Serum C-terminal Telopeptide of Type 1 Collagen (sCTX) Concentration Between 0.011 and 0.476 ng/mL
M1D21, (n = 46, 16)
|
22.4 Percentage of participants
|
47.1 Percentage of participants
|
|
Percentage of Participants With a Serum C-terminal Telopeptide of Type 1 Collagen (sCTX) Concentration Between 0.011 and 0.476 ng/mL
M1D28, (n = 46, 15)
|
32.7 Percentage of participants
|
52.9 Percentage of participants
|
|
Percentage of Participants With a Serum C-terminal Telopeptide of Type 1 Collagen (sCTX) Concentration Between 0.011 and 0.476 ng/mL
M2D7, (n = 46, 15)
|
8.2 Percentage of participants
|
52.9 Percentage of participants
|
|
Percentage of Participants With a Serum C-terminal Telopeptide of Type 1 Collagen (sCTX) Concentration Between 0.011 and 0.476 ng/mL
M2D14, (n = 45, 16)
|
14.3 Percentage of participants
|
52.9 Percentage of participants
|
|
Percentage of Participants With a Serum C-terminal Telopeptide of Type 1 Collagen (sCTX) Concentration Between 0.011 and 0.476 ng/mL
M2D21, (n = 44, 15)
|
24.5 Percentage of participants
|
58.8 Percentage of participants
|
|
Percentage of Participants With a Serum C-terminal Telopeptide of Type 1 Collagen (sCTX) Concentration Between 0.011 and 0.476 ng/mL
M2D28, (n = 45, 15)
|
30.6 Percentage of participants
|
64.7 Percentage of participants
|
|
Percentage of Participants With a Serum C-terminal Telopeptide of Type 1 Collagen (sCTX) Concentration Between 0.011 and 0.476 ng/mL
M3D7, (n = 44, 15)
|
14.3 Percentage of participants
|
52.9 Percentage of participants
|
|
Percentage of Participants With a Serum C-terminal Telopeptide of Type 1 Collagen (sCTX) Concentration Between 0.011 and 0.476 ng/mL
M3D14, (n = 44, 15)
|
16.3 Percentage of participants
|
47.1 Percentage of participants
|
|
Percentage of Participants With a Serum C-terminal Telopeptide of Type 1 Collagen (sCTX) Concentration Between 0.011 and 0.476 ng/mL
M3D21, (n = 45, 14)
|
20.4 Percentage of participants
|
35.3 Percentage of participants
|
|
Percentage of Participants With a Serum C-terminal Telopeptide of Type 1 Collagen (sCTX) Concentration Between 0.011 and 0.476 ng/mL
M3D28, (n = 46, 16)
|
26.5 Percentage of participants
|
52.9 Percentage of participants
|
|
Percentage of Participants With a Serum C-terminal Telopeptide of Type 1 Collagen (sCTX) Concentration Between 0.011 and 0.476 ng/mL
M4D7, (n = 45, 16)
|
14.3 Percentage of participants
|
64.7 Percentage of participants
|
|
Percentage of Participants With a Serum C-terminal Telopeptide of Type 1 Collagen (sCTX) Concentration Between 0.011 and 0.476 ng/mL
M4D14, (n = 47, 16)
|
14.3 Percentage of participants
|
47.1 Percentage of participants
|
|
Percentage of Participants With a Serum C-terminal Telopeptide of Type 1 Collagen (sCTX) Concentration Between 0.011 and 0.476 ng/mL
M4D21, (n = 45, 15)
|
18.4 Percentage of participants
|
41.2 Percentage of participants
|
|
Percentage of Participants With a Serum C-terminal Telopeptide of Type 1 Collagen (sCTX) Concentration Between 0.011 and 0.476 ng/mL
M4D28, (n = 46, 13)
|
22.4 Percentage of participants
|
41.2 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline (Visit 1), Day (D)3 of M1, and D7, D14, D21, D28 of each M1, M2, M3, M4, M5, M6Population: This analysis was performed on the ITT Population. The ITT Population included all randomized participants who received at least 1 dose of study medication. 'n' denotes number of participants who received the indicated study drug for each arm.
Percentage of participants whose sCTX concentration was between 0.011 and 0.321 ng/mL (Mean -2 to + 0 SD) were analyzed at particular time points. Mean and SD are based on the normal range for premenopausal women: Mean = 0.321 ng/mL, SD = 0.155 ng/mL.
Outcome measures
| Measure |
Ibandronate
n=49 Participants
Participants received Ibandronate 150 mg tablet once-monthly along with a combination dietary supplement containing vitamin D 200 international units (IU) and elemental calcium 500 mg twice daily with meals for 6 months.
|
Placebo
n=17 Participants
Participants received a matching placebo tablet to Ibandronate once-monthly along with a combination dietary supplement containing vitamin D 200 IU and elemental calcium 500 mg twice daily with meals for 6 months.
|
|---|---|---|
|
Percentage of Participants With a Serum C-terminal Telopeptide of Type 1 Collagen (sCTX) Concentration Between 0.011 and 0.321 ng/mL
M1D7, (n = 47,16)
|
2.0 Percentage of participants
|
35.3 Percentage of participants
|
|
Percentage of Participants With a Serum C-terminal Telopeptide of Type 1 Collagen (sCTX) Concentration Between 0.011 and 0.321 ng/mL
M1D14, (n = 47, 15)
|
8.2 Percentage of participants
|
11.8 Percentage of participants
|
|
Percentage of Participants With a Serum C-terminal Telopeptide of Type 1 Collagen (sCTX) Concentration Between 0.011 and 0.321 ng/mL
Baseline, (n = 49, 17)
|
16.3 Percentage of participants
|
23.5 Percentage of participants
|
|
Percentage of Participants With a Serum C-terminal Telopeptide of Type 1 Collagen (sCTX) Concentration Between 0.011 and 0.321 ng/mL
M1D3, (n = 46,16)
|
6.1 Percentage of participants
|
29.4 Percentage of participants
|
|
Percentage of Participants With a Serum C-terminal Telopeptide of Type 1 Collagen (sCTX) Concentration Between 0.011 and 0.321 ng/mL
M1D21, (n = 46, 16)
|
10.2 Percentage of participants
|
17.6 Percentage of participants
|
|
Percentage of Participants With a Serum C-terminal Telopeptide of Type 1 Collagen (sCTX) Concentration Between 0.011 and 0.321 ng/mL
M1D28, (n = 46, 15)
|
18.4 Percentage of participants
|
23.5 Percentage of participants
|
|
Percentage of Participants With a Serum C-terminal Telopeptide of Type 1 Collagen (sCTX) Concentration Between 0.011 and 0.321 ng/mL
M2D7, (n = 46, 15)
|
6.1 Percentage of participants
|
23.5 Percentage of participants
|
|
Percentage of Participants With a Serum C-terminal Telopeptide of Type 1 Collagen (sCTX) Concentration Between 0.011 and 0.321 ng/mL
M2D14, (n = 45, 16)
|
6.1 Percentage of participants
|
29.4 Percentage of participants
|
|
Percentage of Participants With a Serum C-terminal Telopeptide of Type 1 Collagen (sCTX) Concentration Between 0.011 and 0.321 ng/mL
M2D21, (n = 44, 15)
|
8.2 Percentage of participants
|
35.3 Percentage of participants
|
|
Percentage of Participants With a Serum C-terminal Telopeptide of Type 1 Collagen (sCTX) Concentration Between 0.011 and 0.321 ng/mL
M2D28, (n = 45, 15)
|
6.1 Percentage of participants
|
29.4 Percentage of participants
|
|
Percentage of Participants With a Serum C-terminal Telopeptide of Type 1 Collagen (sCTX) Concentration Between 0.011 and 0.321 ng/mL
M3D7, (n = 44, 15)
|
4.1 Percentage of participants
|
23.5 Percentage of participants
|
|
Percentage of Participants With a Serum C-terminal Telopeptide of Type 1 Collagen (sCTX) Concentration Between 0.011 and 0.321 ng/mL
M3D14, (n = 44, 15)
|
4.1 Percentage of participants
|
35.3 Percentage of participants
|
|
Percentage of Participants With a Serum C-terminal Telopeptide of Type 1 Collagen (sCTX) Concentration Between 0.011 and 0.321 ng/mL
M3D21, (n = 45, 14)
|
8.2 Percentage of participants
|
17.6 Percentage of participants
|
|
Percentage of Participants With a Serum C-terminal Telopeptide of Type 1 Collagen (sCTX) Concentration Between 0.011 and 0.321 ng/mL
M3D28, (n = 46, 16)
|
4.1 Percentage of participants
|
23.5 Percentage of participants
|
|
Percentage of Participants With a Serum C-terminal Telopeptide of Type 1 Collagen (sCTX) Concentration Between 0.011 and 0.321 ng/mL
M4D7, (n = 45, 16)
|
4.1 Percentage of participants
|
29.4 Percentage of participants
|
|
Percentage of Participants With a Serum C-terminal Telopeptide of Type 1 Collagen (sCTX) Concentration Between 0.011 and 0.321 ng/mL
M4D14, (n = 47, 16)
|
2.0 Percentage of participants
|
17.6 Percentage of participants
|
|
Percentage of Participants With a Serum C-terminal Telopeptide of Type 1 Collagen (sCTX) Concentration Between 0.011 and 0.321 ng/mL
M4D21, (n = 45, 15)
|
0.0 Percentage of participants
|
17.6 Percentage of participants
|
|
Percentage of Participants With a Serum C-terminal Telopeptide of Type 1 Collagen (sCTX) Concentration Between 0.011 and 0.321 ng/mL
M4D28, (n = 46, 13)
|
6.1 Percentage of participants
|
11.8 Percentage of participants
|
|
Percentage of Participants With a Serum C-terminal Telopeptide of Type 1 Collagen (sCTX) Concentration Between 0.011 and 0.321 ng/mL
M5D7, (n = 46, 14)
|
2.0 Percentage of participants
|
11.8 Percentage of participants
|
|
Percentage of Participants With a Serum C-terminal Telopeptide of Type 1 Collagen (sCTX) Concentration Between 0.011 and 0.321 ng/mL
M5D14, (n = 44, 14)
|
4.1 Percentage of participants
|
23.5 Percentage of participants
|
|
Percentage of Participants With a Serum C-terminal Telopeptide of Type 1 Collagen (sCTX) Concentration Between 0.011 and 0.321 ng/mL
M5D21, (n = 47, 13)
|
6.1 Percentage of participants
|
17.6 Percentage of participants
|
|
Percentage of Participants With a Serum C-terminal Telopeptide of Type 1 Collagen (sCTX) Concentration Between 0.011 and 0.321 ng/mL
M6D7, (n = 45, 12)
|
4.1 Percentage of participants
|
17.6 Percentage of participants
|
|
Percentage of Participants With a Serum C-terminal Telopeptide of Type 1 Collagen (sCTX) Concentration Between 0.011 and 0.321 ng/mL
M5D28, (n = 43, 12)
|
8.2 Percentage of participants
|
17.6 Percentage of participants
|
|
Percentage of Participants With a Serum C-terminal Telopeptide of Type 1 Collagen (sCTX) Concentration Between 0.011 and 0.321 ng/mL
M6D14, (n = 44, 14)
|
4.1 Percentage of participants
|
23.5 Percentage of participants
|
|
Percentage of Participants With a Serum C-terminal Telopeptide of Type 1 Collagen (sCTX) Concentration Between 0.011 and 0.321 ng/mL
M6D21, (n= 47, 15)
|
10.2 Percentage of participants
|
23.5 Percentage of participants
|
|
Percentage of Participants With a Serum C-terminal Telopeptide of Type 1 Collagen (sCTX) Concentration Between 0.011 and 0.321 ng/mL
M6D28, (n = 46,15)
|
6.1 Percentage of participants
|
29.4 Percentage of participants
|
SECONDARY outcome
Timeframe: Day (D)7, D14, D21 and D28 of Month 6Population: This analysis was performed on the ITT Population. The ITT Population included all randomized participants who received at least 1 dose of study medication.
Overall minimum and maximum relative percent change in sCTX concentrations from Baseline were calculated for all participants over D7, D14, D21 and D28 of Month 6 and the difference between it was analyzed.
Outcome measures
| Measure |
Ibandronate
n=48 Participants
Participants received Ibandronate 150 mg tablet once-monthly along with a combination dietary supplement containing vitamin D 200 international units (IU) and elemental calcium 500 mg twice daily with meals for 6 months.
|
Placebo
n=15 Participants
Participants received a matching placebo tablet to Ibandronate once-monthly along with a combination dietary supplement containing vitamin D 200 IU and elemental calcium 500 mg twice daily with meals for 6 months.
|
|---|---|---|
|
Difference Between the Minimum and Maximum Relative Percent Change in Serum C-terminal Telopeptide of Type 1 Collagen (sCTX) Concentrations
|
17.23 Percent change
Interval 1.7 to 55.9
|
22.89 Percent change
Interval 11.3 to 44.1
|
SECONDARY outcome
Timeframe: Up to 7 monthsPopulation: The Safety analysis Population was a subset of the ITT Population consisting of participants with at least 1 post-baseline safety assessment. 'n' denotes the number of participants who received the indicated study drug for each arm.
Marked laboratory abnormalities are those which exceed the marked abnormality range (i.e., greater or less than the Roche defined marked abnormality range; i.e Low or High) and which also represents a clinically relevant change from Baseline of at least a designated amount. The indicated abnormal laboratory parameters (along with their marked reference range) are as follows : Hematocrit (0.31- 0.56 fraction), hemoglobin (110 - 200 g/L), platelets (100 - 550 \*10\^9/L), white blood cell (WBC) (3.0 - 18.0 \*10\^9/L), alanine aminotransferase (ALT) (0 - 110 U/L), creatinine (0 - 154 µmol/L), chloride (95 - 115 mmol/L), phosphate (0.75 - 1.60 mmol/L ). Creatinine clearance was calculated using the Cockroft-Gault formula.
Outcome measures
| Measure |
Ibandronate
n=48 Participants
Participants received Ibandronate 150 mg tablet once-monthly along with a combination dietary supplement containing vitamin D 200 international units (IU) and elemental calcium 500 mg twice daily with meals for 6 months.
|
Placebo
n=16 Participants
Participants received a matching placebo tablet to Ibandronate once-monthly along with a combination dietary supplement containing vitamin D 200 IU and elemental calcium 500 mg twice daily with meals for 6 months.
|
|---|---|---|
|
Number of Participants With Any Marked Abnormality in Laboratory Parameters
Hematocrit-Low, (n = 46,16)
|
1 Participants
|
0 Participants
|
|
Number of Participants With Any Marked Abnormality in Laboratory Parameters
Hemoglobin-Low, (n = 46, 16)
|
1 Participants
|
0 Participants
|
|
Number of Participants With Any Marked Abnormality in Laboratory Parameters
Platelets-High, (n = 46, 15)
|
0 Participants
|
1 Participants
|
|
Number of Participants With Any Marked Abnormality in Laboratory Parameters
White blood cells-Low, (n = 46, 16)
|
2 Participants
|
0 Participants
|
|
Number of Participants With Any Marked Abnormality in Laboratory Parameters
ALT- High, (n = 48, 16)
|
1 Participants
|
0 Participants
|
|
Number of Participants With Any Marked Abnormality in Laboratory Parameters
Creatinine-High, (n = 48, 16)
|
1 Participants
|
0 Participants
|
|
Number of Participants With Any Marked Abnormality in Laboratory Parameters
Chloride-Low, (n = 48, 16)
|
0 Participants
|
1 Participants
|
|
Number of Participants With Any Marked Abnormality in Laboratory Parameters
Potassium-High, (n = 48, 16)
|
0 Participants
|
1 Participants
|
|
Number of Participants With Any Marked Abnormality in Laboratory Parameters
Phosphate-High, (n = 48, 16)
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 7 monthsPopulation: The Safety Analysis Population was a subset of the ITT Population consisting of participants with at least 1 post-baseline safety assessment.
An Adverse Event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered to be related to the medicinal product. A Serious Adverse Event (SAE) is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or results in a congenital anomaly/birth defect.
Outcome measures
| Measure |
Ibandronate
n=49 Participants
Participants received Ibandronate 150 mg tablet once-monthly along with a combination dietary supplement containing vitamin D 200 international units (IU) and elemental calcium 500 mg twice daily with meals for 6 months.
|
Placebo
n=17 Participants
Participants received a matching placebo tablet to Ibandronate once-monthly along with a combination dietary supplement containing vitamin D 200 IU and elemental calcium 500 mg twice daily with meals for 6 months.
|
|---|---|---|
|
Number of Participants With Any Adverse Event or Serious Adverse Event
Any AEs
|
40 Participants
|
12 Participants
|
|
Number of Participants With Any Adverse Event or Serious Adverse Event
Any SAEs
|
1 Participants
|
2 Participants
|
Adverse Events
Ibandronate
Serious events: 1 serious events
Other events: 28 other events
Deaths: 0 deaths
Placebo
Serious events: 2 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ibandronate
n=49 participants at risk
Participants received Ibandronate 150 mg tablet once-monthly along with a combination dietary supplement containing vitamin D 200 international units (IU) and elemental calcium 500 mg twice daily with meals for 6 months.
|
Placebo
n=17 participants at risk
Participants received a matching placebo tablet to Ibandronate once-monthly along with a combination dietary supplement containing vitamin D 200 IU and elemental calcium 500 mg twice daily with meals for 6 months.
|
|---|---|---|
|
Cardiac disorders
Angina Unstable
|
0.00%
0/49 • Up to 7 months
Serious adverse events (SAEs) and non-serious AEs were reported for members of the safety population which included all enrolled participants who had received at least one dose of study medication and who had at least one post-baseline safety follow-up assessment.
|
5.9%
1/17 • Up to 7 months
Serious adverse events (SAEs) and non-serious AEs were reported for members of the safety population which included all enrolled participants who had received at least one dose of study medication and who had at least one post-baseline safety follow-up assessment.
|
|
Nervous system disorders
Dizziness
|
2.0%
1/49 • Up to 7 months
Serious adverse events (SAEs) and non-serious AEs were reported for members of the safety population which included all enrolled participants who had received at least one dose of study medication and who had at least one post-baseline safety follow-up assessment.
|
0.00%
0/17 • Up to 7 months
Serious adverse events (SAEs) and non-serious AEs were reported for members of the safety population which included all enrolled participants who had received at least one dose of study medication and who had at least one post-baseline safety follow-up assessment.
|
|
Vascular disorders
Hypertension
|
0.00%
0/49 • Up to 7 months
Serious adverse events (SAEs) and non-serious AEs were reported for members of the safety population which included all enrolled participants who had received at least one dose of study medication and who had at least one post-baseline safety follow-up assessment.
|
5.9%
1/17 • Up to 7 months
Serious adverse events (SAEs) and non-serious AEs were reported for members of the safety population which included all enrolled participants who had received at least one dose of study medication and who had at least one post-baseline safety follow-up assessment.
|
Other adverse events
| Measure |
Ibandronate
n=49 participants at risk
Participants received Ibandronate 150 mg tablet once-monthly along with a combination dietary supplement containing vitamin D 200 international units (IU) and elemental calcium 500 mg twice daily with meals for 6 months.
|
Placebo
n=17 participants at risk
Participants received a matching placebo tablet to Ibandronate once-monthly along with a combination dietary supplement containing vitamin D 200 IU and elemental calcium 500 mg twice daily with meals for 6 months.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.2%
5/49 • Up to 7 months
Serious adverse events (SAEs) and non-serious AEs were reported for members of the safety population which included all enrolled participants who had received at least one dose of study medication and who had at least one post-baseline safety follow-up assessment.
|
5.9%
1/17 • Up to 7 months
Serious adverse events (SAEs) and non-serious AEs were reported for members of the safety population which included all enrolled participants who had received at least one dose of study medication and who had at least one post-baseline safety follow-up assessment.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
8.2%
4/49 • Up to 7 months
Serious adverse events (SAEs) and non-serious AEs were reported for members of the safety population which included all enrolled participants who had received at least one dose of study medication and who had at least one post-baseline safety follow-up assessment.
|
11.8%
2/17 • Up to 7 months
Serious adverse events (SAEs) and non-serious AEs were reported for members of the safety population which included all enrolled participants who had received at least one dose of study medication and who had at least one post-baseline safety follow-up assessment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
8.2%
4/49 • Up to 7 months
Serious adverse events (SAEs) and non-serious AEs were reported for members of the safety population which included all enrolled participants who had received at least one dose of study medication and who had at least one post-baseline safety follow-up assessment.
|
5.9%
1/17 • Up to 7 months
Serious adverse events (SAEs) and non-serious AEs were reported for members of the safety population which included all enrolled participants who had received at least one dose of study medication and who had at least one post-baseline safety follow-up assessment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
4.1%
2/49 • Up to 7 months
Serious adverse events (SAEs) and non-serious AEs were reported for members of the safety population which included all enrolled participants who had received at least one dose of study medication and who had at least one post-baseline safety follow-up assessment.
|
11.8%
2/17 • Up to 7 months
Serious adverse events (SAEs) and non-serious AEs were reported for members of the safety population which included all enrolled participants who had received at least one dose of study medication and who had at least one post-baseline safety follow-up assessment.
|
|
Infections and infestations
Nasopharyngitis
|
16.3%
8/49 • Up to 7 months
Serious adverse events (SAEs) and non-serious AEs were reported for members of the safety population which included all enrolled participants who had received at least one dose of study medication and who had at least one post-baseline safety follow-up assessment.
|
29.4%
5/17 • Up to 7 months
Serious adverse events (SAEs) and non-serious AEs were reported for members of the safety population which included all enrolled participants who had received at least one dose of study medication and who had at least one post-baseline safety follow-up assessment.
|
|
Gastrointestinal disorders
Diarrhoea
|
14.3%
7/49 • Up to 7 months
Serious adverse events (SAEs) and non-serious AEs were reported for members of the safety population which included all enrolled participants who had received at least one dose of study medication and who had at least one post-baseline safety follow-up assessment.
|
0.00%
0/17 • Up to 7 months
Serious adverse events (SAEs) and non-serious AEs were reported for members of the safety population which included all enrolled participants who had received at least one dose of study medication and who had at least one post-baseline safety follow-up assessment.
|
|
Gastrointestinal disorders
Dyspepsia
|
8.2%
4/49 • Up to 7 months
Serious adverse events (SAEs) and non-serious AEs were reported for members of the safety population which included all enrolled participants who had received at least one dose of study medication and who had at least one post-baseline safety follow-up assessment.
|
0.00%
0/17 • Up to 7 months
Serious adverse events (SAEs) and non-serious AEs were reported for members of the safety population which included all enrolled participants who had received at least one dose of study medication and who had at least one post-baseline safety follow-up assessment.
|
|
Nervous system disorders
Headache
|
6.1%
3/49 • Up to 7 months
Serious adverse events (SAEs) and non-serious AEs were reported for members of the safety population which included all enrolled participants who had received at least one dose of study medication and who had at least one post-baseline safety follow-up assessment.
|
11.8%
2/17 • Up to 7 months
Serious adverse events (SAEs) and non-serious AEs were reported for members of the safety population which included all enrolled participants who had received at least one dose of study medication and who had at least one post-baseline safety follow-up assessment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
4.1%
2/49 • Up to 7 months
Serious adverse events (SAEs) and non-serious AEs were reported for members of the safety population which included all enrolled participants who had received at least one dose of study medication and who had at least one post-baseline safety follow-up assessment.
|
17.6%
3/17 • Up to 7 months
Serious adverse events (SAEs) and non-serious AEs were reported for members of the safety population which included all enrolled participants who had received at least one dose of study medication and who had at least one post-baseline safety follow-up assessment.
|
Additional Information
Roche Trial Information Hotline
F. Hoffmann-La Roche AG
Phone: +41 616878333
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER