Post-Menopausal Osteoporosis
Conditions
Brief summary
This 2 arm study will assess the long-term efficacy and safety of oral treatment with 100mg or 150mg Bonviva in women with post-menopausal osteoporosis who have previously completed Bonviva study BM16549 (MOBILE study). Patients will receive Bonviva either 100mg po monthly, or 150mg po monthly. Patients will also receive daily supplementation with vitamin D and calcium. The anticipated time of study treatment is 2+ years, and the target sample size is 500+ individuals.
Interventions
150mg po monthly for 3 years
Sponsors
Hoffmann-La Roche
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
Inclusion criteria
* successful completion of Bonviva study BM16549, with at least 75% compliance; * ambulatory.
Exclusion criteria
* malignant disease diagnosed within the previous 12 years (except basal cell cancer that has been successfully removed); * breast cancer diagnosed within the previous 22 years.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Absolute Change From Baseline in Mean Lumbar Spine (L2 - L4) BMD | Baseline and Months 12, 24 and 36 | Absolute change from Baseline in mean BMD of the lumbar spine (L2 - L4) measured as grams per square centimeter (g/cm\^2). This was baseline of Study MA17903 after two years of treatment in the core study (BM16549 \[NCT00081653\]). |
| Relative Percent (%) Change From Baseline in Mean Lumbar Spine (L2 - L4) Bone Mineral Density (BMD) | Baseline and Months 12, 24 and 36 | BMD was measured by a single dual-energy X-ray absorptiometry (DXA) scan of the lumbar spine (BMD of at least 2 vertebrae \[L2-L4\] that were not fractured and not affected by osteoarthritis to such a degree that BMD measurement would be compromised) at the time of enrollment and at Months 12, 24 and 36. This was baseline of Study MA17903 after two years of treatment in the core study (BM16549 \[NCT00081653\]). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Absolute Change From Baseline in Mean Total Hip BMD | Baseline and 12, 24 and 36 months | BMD was measured by a single DXA scan of the hip. Scores between -1 and -2.5 indicate Osteopenia (thin bones). Less than -2.5 indicate Osteoporosis (porous bones). |
| Relative Percent Change From Baseline in Mean Total Hip BMD | Baseline, 12, 24 and 36 months | BMD was measured by a single DXA scan of the hip. Scores between -1 and -2.5 indicate Osteopenia (thin bones). Less than -2.5 indicate Osteoporosis (porous bones). |
| Absolute Change From Baseline of Trough Serum CTX | Baseline, 6, 12, 24 and 36 months | CTX is a measure of bone resorption and is measured as ng/mL. Blood samples for the Month 6 values were collected 6 days after the 6-month dose; therefore, the Month 6 values are not true 'trough' values. |
| Relative Percent Change From Baseline of Trough Serum CTX | Baseline, 6,12, 24 and 36 months | CTX is a measure of bone resorption and is measured as nanograms per milliliter (ng/mL). Blood samples for the Month 6 values were collected 6 days after the 6-month dose; therefore, the Month 6 values are not true 'trough' values. |
Countries
Belgium, Brazil, Czechia, Denmark, France, Germany, Hungary, Italy, Mexico, Norway, Poland, Spain, United Kingdom, United States
Participant flow
Recruitment details
Patients were recruited from 31 centers over the period of 18 May 2004 to 28 November 2007.
Pre-assignment details
Eligible for the study were patients having completed Study BM16549 (NCT00081653) and who had complied with the monthly regimen for 75 percent (%) or more.
Participants by arm
| Arm | Count |
|---|---|
| Ibandronate 100 mg 100 mg ibandronate PO monthly and monthly oral placebo (corresponding to the 150 mg tablet) | 358 |
| Ibandronate 150 mg 150 mg ibandronate PO monthly and monthly oral placebo (corresponding to the 100 mg tablet) | 361 |
| Total | 719 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 23 | 17 |
| Overall Study | Bone loss | 2 | 0 |
| Overall Study | Loss of bone mass | 0 | 2 |
| Overall Study | Lost to Follow-up | 2 | 4 |
| Overall Study | Low bone mineral density | 1 | 0 |
| Overall Study | Participant leaving country | 1 | 0 |
| Overall Study | Refused Treatment | 18 | 14 |
Baseline characteristics
| Characteristic | Ibandronate 100 mg | Ibandronate 150 mg | Total |
|---|---|---|---|
| Age, Continuous | 67.8 years STANDARD_DEVIATION 6.55 | 67.7 years STANDARD_DEVIATION 6.8 | 67.7 years STANDARD_DEVIATION 6.7 |
| BMI (kg/m^2) | 25.87 kg/m^2 STANDARD_DEVIATION 4.957 | 26.04 kg/m^2 STANDARD_DEVIATION 3.976 | 25.96 kg/m^2 STANDARD_DEVIATION 4.489 |
| Race, Customized Black | 0 participants | 1 participants | 1 participants |
| Race, Customized Caucasian/White | 341 participants | 338 participants | 679 participants |
| Race, Customized Hispanic | 17 participants | 20 participants | 37 participants |
| Race, Customized Oriental | 0 participants | 1 participants | 1 participants |
| Race, Customized Other | 0 participants | 1 participants | 1 participants |
| Sex: Female, Male Female | 358 Participants | 361 Participants | 719 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 187 / 358 | 185 / 361 |
| serious Total, serious adverse events | 68 / 358 | 70 / 361 |
Outcome results
Primary
Absolute Change From Baseline in Mean Lumbar Spine (L2 - L4) BMD
Absolute change from Baseline in mean BMD of the lumbar spine (L2 - L4) measured as grams per square centimeter (g/cm\^2). This was baseline of Study MA17903 after two years of treatment in the core study (BM16549 \[NCT00081653\]).
Time frame: Baseline and Months 12, 24 and 36
Population: ITT population; number (n) equals (=) number of participants analyzed at the specified visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ibandronate 100 mg | Absolute Change From Baseline in Mean Lumbar Spine (L2 - L4) BMD | Baseline (n=347,346) | 0.7916 g/cm^2 | Standard Deviation 0.0814 |
| Ibandronate 100 mg | Absolute Change From Baseline in Mean Lumbar Spine (L2 - L4) BMD | Month 12 (n=347,346) | 0.7977 g/cm^2 | Standard Deviation 0.0831 |
| Ibandronate 100 mg | Absolute Change From Baseline in Mean Lumbar Spine (L2 - L4) BMD | Change from Baseline at Month 12 (n=346,343) | 0.0061 g/cm^2 | Standard Deviation 0.0293 |
| Ibandronate 100 mg | Absolute Change From Baseline in Mean Lumbar Spine (L2 - L4) BMD | Month 24 (n=323,336) | 0.8048 g/cm^2 | Standard Deviation 0.0861 |
| Ibandronate 100 mg | Absolute Change From Baseline in Mean Lumbar Spine (L2 - L4) BMD | Change from Baseline at Month 24 (n=322,333) | 0.0131 g/cm^2 | Standard Deviation 0.0332 |
| Ibandronate 100 mg | Absolute Change From Baseline in Mean Lumbar Spine (L2 - L4) BMD | Month 36 (n=308,320) | 0.8090 g/cm^2 | Standard Deviation 0.0916 |
| Ibandronate 100 mg | Absolute Change From Baseline in Mean Lumbar Spine (L2 - L4) BMD | Change from Baseline at Month 36 (n=307, 318) | 0.0172 g/cm^2 | Standard Deviation 0.0382 |
| Ibandronate 150 mg | Absolute Change From Baseline in Mean Lumbar Spine (L2 - L4) BMD | Change from Baseline at Month 24 (n=322,333) | 0.0140 g/cm^2 | Standard Deviation 0.0356 |
| Ibandronate 150 mg | Absolute Change From Baseline in Mean Lumbar Spine (L2 - L4) BMD | Baseline (n=347,346) | 0.7977 g/cm^2 | Standard Deviation 0.0791 |
| Ibandronate 150 mg | Absolute Change From Baseline in Mean Lumbar Spine (L2 - L4) BMD | Month 36 (n=308,320) | 0.8155 g/cm^2 | Standard Deviation 0.0892 |
| Ibandronate 150 mg | Absolute Change From Baseline in Mean Lumbar Spine (L2 - L4) BMD | Month 24 (n=323,336) | 0.8111 g/cm^2 | Standard Deviation 0.0852 |
| Ibandronate 150 mg | Absolute Change From Baseline in Mean Lumbar Spine (L2 - L4) BMD | Month 12 (n=347,346) | 0.8069 g/cm^2 | Standard Deviation 0.0819 |
| Ibandronate 150 mg | Absolute Change From Baseline in Mean Lumbar Spine (L2 - L4) BMD | Change from Baseline at Month 36 (n=307, 318) | 0.0194 g/cm^2 | Standard Deviation 0.0383 |
| Ibandronate 150 mg | Absolute Change From Baseline in Mean Lumbar Spine (L2 - L4) BMD | Change from Baseline at Month 12 (n=346,343) | 0.0097 g/cm^2 | Standard Deviation 0.0289 |
Primary
Relative Percent (%) Change From Baseline in Mean Lumbar Spine (L2 - L4) Bone Mineral Density (BMD)
BMD was measured by a single dual-energy X-ray absorptiometry (DXA) scan of the lumbar spine (BMD of at least 2 vertebrae \[L2-L4\] that were not fractured and not affected by osteoarthritis to such a degree that BMD measurement would be compromised) at the time of enrollment and at Months 12, 24 and 36. This was baseline of Study MA17903 after two years of treatment in the core study (BM16549 \[NCT00081653\]).
Time frame: Baseline and Months 12, 24 and 36
Population: ITT population: n = number of participants analyzed for the given parameter at the specified visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ibandronate 100 mg | Relative Percent (%) Change From Baseline in Mean Lumbar Spine (L2 - L4) Bone Mineral Density (BMD) | Change from Baseline at Month 12 (n=346,343) | 0.8348 percent change | Standard Deviation 3.8118 |
| Ibandronate 100 mg | Relative Percent (%) Change From Baseline in Mean Lumbar Spine (L2 - L4) Bone Mineral Density (BMD) | Change from Baseline at Month 24 (n=322,333) | 1.6921 percent change | Standard Deviation 4.2385 |
| Ibandronate 100 mg | Relative Percent (%) Change From Baseline in Mean Lumbar Spine (L2 - L4) Bone Mineral Density (BMD) | Change from Baseline at Month 36 (n=307,318) | 2.1794 percent change | Standard Deviation 4.9176 |
| Ibandronate 150 mg | Relative Percent (%) Change From Baseline in Mean Lumbar Spine (L2 - L4) Bone Mineral Density (BMD) | Change from Baseline at Month 12 (n=346,343) | 1.2550 percent change | Standard Deviation 3.6402 |
| Ibandronate 150 mg | Relative Percent (%) Change From Baseline in Mean Lumbar Spine (L2 - L4) Bone Mineral Density (BMD) | Change from Baseline at Month 24 (n=322,333) | 1.7865 percent change | Standard Deviation 4.5058 |
| Ibandronate 150 mg | Relative Percent (%) Change From Baseline in Mean Lumbar Spine (L2 - L4) Bone Mineral Density (BMD) | Change from Baseline at Month 36 (n=307,318) | 2.4322 percent change | Standard Deviation 4.8146 |
Secondary
Absolute Change From Baseline in Mean Total Hip BMD
BMD was measured by a single DXA scan of the hip. Scores between -1 and -2.5 indicate Osteopenia (thin bones). Less than -2.5 indicate Osteoporosis (porous bones).
Time frame: Baseline and 12, 24 and 36 months
Population: ITT Population; n = number of participants analyzed for the given parameter at the specified visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ibandronate 100 mg | Absolute Change From Baseline in Mean Total Hip BMD | Month 24 (n=322,336) | 0.7686 g/cm^2 | Standard Deviation 0.1104 |
| Ibandronate 100 mg | Absolute Change From Baseline in Mean Total Hip BMD | Month 12 (n=347,346) | 0.7669 g/cm^2 | Standard Deviation 0.1097 |
| Ibandronate 100 mg | Absolute Change From Baseline in Mean Total Hip BMD | Change from Baseline at Month 24 (n=319,335) | -0.0010 g/cm^2 | Standard Deviation 0.0227 |
| Ibandronate 100 mg | Absolute Change From Baseline in Mean Total Hip BMD | Baseline (n=345,348) | 0.7680 g/cm^2 | Standard Deviation 0.1093 |
| Ibandronate 100 mg | Absolute Change From Baseline in Mean Total Hip BMD | Month 36 (n=301,321) | 0.7663 g/cm^2 | Standard Deviation 0.1133 |
| Ibandronate 100 mg | Absolute Change From Baseline in Mean Total Hip BMD | Change from Baseline at Month 36 (n=298,320) | -0.0061 g/cm^2 | Standard Deviation 0.0254 |
| Ibandronate 100 mg | Absolute Change From Baseline in Mean Total Hip BMD | Change from Baseline at Month 12 (n=344,345) | -0.0004 g/cm^2 | Standard Deviation 0.0204 |
| Ibandronate 150 mg | Absolute Change From Baseline in Mean Total Hip BMD | Change from Baseline at Month 36 (n=298,320) | -0.0030 g/cm^2 | Standard Deviation 0.0252 |
| Ibandronate 150 mg | Absolute Change From Baseline in Mean Total Hip BMD | Change from Baseline at Month 12 (n=344,345) | 0.0025 g/cm^2 | Standard Deviation 0.02 |
| Ibandronate 150 mg | Absolute Change From Baseline in Mean Total Hip BMD | Baseline (n=345,348) | 0.7862 g/cm^2 | Standard Deviation 0.1112 |
| Ibandronate 150 mg | Absolute Change From Baseline in Mean Total Hip BMD | Month 12 (n=347,346) | 0.7888 g/cm^2 | Standard Deviation 0.1116 |
| Ibandronate 150 mg | Absolute Change From Baseline in Mean Total Hip BMD | Month 24 (n=322,336) | 0.7882 g/cm^2 | Standard Deviation 0.1124 |
| Ibandronate 150 mg | Absolute Change From Baseline in Mean Total Hip BMD | Change from Baseline at Month 24 (n=319,335) | 0.0031 g/cm^2 | Standard Deviation 0.0214 |
| Ibandronate 150 mg | Absolute Change From Baseline in Mean Total Hip BMD | Month 36 (n=301,321) | 0.7834 g/cm^2 | Standard Deviation 0.1128 |
Secondary
Absolute Change From Baseline of Trough Serum CTX
CTX is a measure of bone resorption and is measured as ng/mL. Blood samples for the Month 6 values were collected 6 days after the 6-month dose; therefore, the Month 6 values are not true 'trough' values.
Time frame: Baseline, 6, 12, 24 and 36 months
Population: ITT population; n = number of participants analyzed for the given parameter at the specified visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ibandronate 100 mg | Absolute Change From Baseline of Trough Serum CTX | Change from Baseline at Month 6 Postdose (n=55,67) | -0.055 ng/mL | Standard Deviation 0.1307 |
| Ibandronate 100 mg | Absolute Change From Baseline of Trough Serum CTX | Month 24 (n=54,65) | 0.309 ng/mL | Standard Deviation 0.1406 |
| Ibandronate 100 mg | Absolute Change From Baseline of Trough Serum CTX | Baseline (n= 56,68) | 0.232 ng/mL | Standard Deviation 0.152 |
| Ibandronate 100 mg | Absolute Change From Baseline of Trough Serum CTX | Change from Baseline at Month 24 (n=53,65) | 0.088 ng/mL | Standard Deviation 0.1203 |
| Ibandronate 100 mg | Absolute Change From Baseline of Trough Serum CTX | Month 12 (n=57,67) | 0.279 ng/mL | Standard Deviation 0.1617 |
| Ibandronate 100 mg | Absolute Change From Baseline of Trough Serum CTX | Month 36 (n=51,60) | 0.410 ng/mL | Standard Deviation 0.1805 |
| Ibandronate 100 mg | Absolute Change From Baseline of Trough Serum CTX | Month 6 Postdose (n=56,68) | 0.176 ng/mL | Standard Deviation 0.1826 |
| Ibandronate 100 mg | Absolute Change From Baseline of Trough Serum CTX | Change from Baseline at Month 12 (n=50,60) | 0.205 ng/mL | Standard Deviation 0.1396 |
| Ibandronate 100 mg | Absolute Change From Baseline of Trough Serum CTX | Change from Baseline at Month 12 (n=56,67) | 0.048 ng/mL | Standard Deviation 0.1303 |
| Ibandronate 150 mg | Absolute Change From Baseline of Trough Serum CTX | Change from Baseline at Month 12 (n=50,60) | 0.174 ng/mL | Standard Deviation 0.1549 |
| Ibandronate 150 mg | Absolute Change From Baseline of Trough Serum CTX | Baseline (n= 56,68) | 0.219 ng/mL | Standard Deviation 0.1799 |
| Ibandronate 150 mg | Absolute Change From Baseline of Trough Serum CTX | Change from Baseline at Month 6 Postdose (n=55,67) | -0.093 ng/mL | Standard Deviation 0.151 |
| Ibandronate 150 mg | Absolute Change From Baseline of Trough Serum CTX | Month 12 (n=57,67) | 0.208 ng/mL | Standard Deviation 0.1073 |
| Ibandronate 150 mg | Absolute Change From Baseline of Trough Serum CTX | Change from Baseline at Month 12 (n=56,67) | -0.011 ng/mL | Standard Deviation 0.1406 |
| Ibandronate 150 mg | Absolute Change From Baseline of Trough Serum CTX | Month 24 (n=54,65) | 0.266 ng/mL | Standard Deviation 0.1548 |
| Ibandronate 150 mg | Absolute Change From Baseline of Trough Serum CTX | Change from Baseline at Month 24 (n=53,65) | 0.048 ng/mL | Standard Deviation 0.1607 |
| Ibandronate 150 mg | Absolute Change From Baseline of Trough Serum CTX | Month 36 (n=51,60) | 0.380 ng/mL | Standard Deviation 0.2036 |
| Ibandronate 150 mg | Absolute Change From Baseline of Trough Serum CTX | Month 6 Postdose (n=56,68) | 0.126 ng/mL | Standard Deviation 0.1222 |
Secondary
Relative Percent Change From Baseline in Mean Total Hip BMD
BMD was measured by a single DXA scan of the hip. Scores between -1 and -2.5 indicate Osteopenia (thin bones). Less than -2.5 indicate Osteoporosis (porous bones).
Time frame: Baseline, 12, 24 and 36 months
Population: ITT Population; n = number of participants analyzed for the given parameter at the specified visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ibandronate 100 mg | Relative Percent Change From Baseline in Mean Total Hip BMD | Change from Baseline at Month 36 (n=298,320) | -0.8045 percent change in BMD | Standard Deviation 3.3448 |
| Ibandronate 100 mg | Relative Percent Change From Baseline in Mean Total Hip BMD | Change from Baseline at Month 12 (n=344,345) | -0.0169 percent change in BMD | Standard Deviation 2.8582 |
| Ibandronate 100 mg | Relative Percent Change From Baseline in Mean Total Hip BMD | Change from Baseline at Month 24 (n=319,335) | -0.1092 percent change in BMD | Standard Deviation 3.104 |
| Ibandronate 150 mg | Relative Percent Change From Baseline in Mean Total Hip BMD | Change from Baseline at Month 24 (n=319,335) | 0.4378 percent change in BMD | Standard Deviation 2.8062 |
| Ibandronate 150 mg | Relative Percent Change From Baseline in Mean Total Hip BMD | Change from Baseline at Month 36 (n=298,320) | -0.3496 percent change in BMD | Standard Deviation 3.3254 |
| Ibandronate 150 mg | Relative Percent Change From Baseline in Mean Total Hip BMD | Change from Baseline at Month 12 (n=344,345) | 0.3459 percent change in BMD | Standard Deviation 2.5849 |
Secondary
Relative Percent Change From Baseline of Trough Serum CTX
CTX is a measure of bone resorption and is measured as nanograms per milliliter (ng/mL). Blood samples for the Month 6 values were collected 6 days after the 6-month dose; therefore, the Month 6 values are not true 'trough' values.
Time frame: Baseline, 6,12, 24 and 36 months
Population: ITT population; n = number of participants analyzed for the given parameter at the specified visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ibandronate 100 mg | Relative Percent Change From Baseline of Trough Serum CTX | Month 6 Postdose (n=56, 67) | 0.176 percent change | Standard Deviation 0.1826 |
| Ibandronate 100 mg | Relative Percent Change From Baseline of Trough Serum CTX | Month 24 (n=54,65) | 0.309 percent change | Standard Deviation 0.1406 |
| Ibandronate 100 mg | Relative Percent Change From Baseline of Trough Serum CTX | Month 12 (n=57,67) | 0.279 percent change | Standard Deviation 0.1617 |
| Ibandronate 100 mg | Relative Percent Change From Baseline of Trough Serum CTX | Change from Baseline at Month 24 (n=53,65) | 58.657 percent change | Standard Deviation 65.3128 |
| Ibandronate 100 mg | Relative Percent Change From Baseline of Trough Serum CTX | Change from Baseline at Month 6 Postdose (n=55,67) | -24.622 percent change | Standard Deviation 43.4212 |
| Ibandronate 100 mg | Relative Percent Change From Baseline of Trough Serum CTX | Month 36 (51,60) | 0.410 percent change | Standard Deviation 0.1805 |
| Ibandronate 100 mg | Relative Percent Change From Baseline of Trough Serum CTX | Change from Baseline at Month 12 (n=56,67) | 31.121 percent change | Standard Deviation 58.9832 |
| Ibandronate 100 mg | Relative Percent Change From Baseline of Trough Serum CTX | Change from Baseline at Month 36 (n=50,60) | 121.106 percent change | Standard Deviation 97.9878 |
| Ibandronate 100 mg | Relative Percent Change From Baseline of Trough Serum CTX | Baseline (n=56,68) | 0.232 percent change | Standard Deviation 0.152 |
| Ibandronate 150 mg | Relative Percent Change From Baseline of Trough Serum CTX | Change from Baseline at Month 36 (n=50,60) | 138.502 percent change | Standard Deviation 125.759 |
| Ibandronate 150 mg | Relative Percent Change From Baseline of Trough Serum CTX | Baseline (n=56,68) | 0.219 percent change | Standard Deviation 0.1799 |
| Ibandronate 150 mg | Relative Percent Change From Baseline of Trough Serum CTX | Month 6 Postdose (n=56, 67) | 33.109 percent change | Standard Deviation 40.3544 |
| Ibandronate 150 mg | Relative Percent Change From Baseline of Trough Serum CTX | Change from Baseline at Month 6 Postdose (n=55,67) | -33.109 percent change | Standard Deviation 40.3544 |
| Ibandronate 150 mg | Relative Percent Change From Baseline of Trough Serum CTX | Month 12 (n=57,67) | 0.208 percent change | Standard Deviation 0.1073 |
| Ibandronate 150 mg | Relative Percent Change From Baseline of Trough Serum CTX | Change from Baseline at Month 12 (n=56,67) | 25.125 percent change | Standard Deviation 86.5607 |
| Ibandronate 150 mg | Relative Percent Change From Baseline of Trough Serum CTX | Month 24 (n=54,65) | 0.266 percent change | Standard Deviation 0.1548 |
| Ibandronate 150 mg | Relative Percent Change From Baseline of Trough Serum CTX | Change from Baseline at Month 24 (n=53,65) | 53.704 percent change | Standard Deviation 74.981 |
| Ibandronate 150 mg | Relative Percent Change From Baseline of Trough Serum CTX | Month 36 (51,60) | 0.380 percent change | Standard Deviation 0.2036 |