Osteogenesis Imperfecta
Conditions
Keywords
Primary disease: Osteogenesis Imperfecta
Brief summary
Children with Osteogenesis Imperfecta (OI) have bone pain, low bone mass and fractures. There are no approved drugs for the treatment of OI in children, even though some intravenous (IV) bisphosphonates are used off-label in some countries. In a single dose, pharmacokinetic study, data showed that risedronate was well tolerated in 28 children with OI. This three year study will test the safety and efficacy of risedronate in the treatment of children with OI. For the first year, patients will be randomized to the risedronate and placebo groups in a 2:1 ratio. For the second and third years of the study, all patients will receive risedronate.
Interventions
risedronate tablet once a day for one year followed by risedronate once a day for two years
DRUGPlacebo
placebo tablet once a day for one year followed by risedronate once a day for two years
Sponsors
Warner Chilcott
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
4 Years to 15 Years
Healthy volunteers
No
Inclusion criteria
* OI diagnosis * increased risk of fracture: either has a history of at least 1 radiographically confirmed, non-traumatic or low impact fracture plus low bone mineral density (BMD) or has very low BMD with or without a history of fractures.
Exclusion criteria
* Any bisphosphonate use within one year of enrollment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change From Baseline Lumbar Spine Bone Mineral Density (BMD) at Month 12, ITT Population | Baseline and Month 12 | Lumbar Spine Bone Mineral Density (BMD) measured by dual-energy x-ray absorptiometry (DXA)and read by central reader. Duplicate scans obtained at screening and Month 12. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change From Baseline Lumbar Spine Bone Mineral Density (BMD) at Month 36, ITT Population | Baseline and Month 36 | Lumbar Spine Bone Mineral Density (BMD) measured by dual-energy x-ray absorptiometry (DXA)and read by central reader. |
| Percent Change From Baseline in Total Body BMD at Month 12, ITT Population | Baseline and Month 12 | Percent Change from baseline in Total Body Bone Mineral Density (BMD) measured by DXA. |
| Percent Change From Baseline in Total Body BMD at Month 24, ITT Population | Baseline and Month 24 | Percent Change from baseline in Total Body Bone Mineral Density (BMD) measured by DXA. |
| Percent Change From Baseline in Total Body BMD at Month 36, ITT Population | Baseline and Month 36 | Percent Change from baseline in Total Body Bone Mineral Density (BMD) measured by DXA. |
| Percent Change From Baseline in Lumbar Spine BMC (Bone Mineral Content) at Month 12, ITT Population | Baseline and Month 12 | — |
| Percent Change From Baseline in Lumbar Spine BMC (Bone Mineral Content) at Month 24, ITT Population | Baseline and Month 24 | — |
| Percent Change From Baseline in Lumbar Spine BMC (Bone Mineral Content) at Month 36, ITT Population | Baseline and Month 36 | — |
| Percent Change From Baseline in Total Body BMC at Month 12, ITT Population | Baseline and Month 12 | — |
| Percent Change From Baseline in Total Body BMC at Month 24, ITT Population | Baseline and Month 24 | — |
| Percent Change From Baseline in Total Body BMC at Month 36, ITT Population | Baseline and Month 36 | — |
| Lumbar Spine Z-score - Percent Change From Baseline to Month 12, ITT Population | Baseline and Month 12 | Lumbar Spine Z-score - number of standard deviations a patient's BMD differs from the average BMD of their age, sex, and ethnicity. Positive scores indicate BMD above the mean; Positive values are best values and negative values are worst values. |
| Lumbar Spine Z-score - Percent Change From Baseline to Month 24, ITT Population | Baseline and Month 24 | Lumbar Spine Z-score - number of standard deviations a patient's BMD differs from the average BMD of their age, sex, and ethnicity. Positive scores indicate BMD above the mean; Positive values are best values and negative values are worst values. |
| Lumbar Spine Z-score - Percent Change From Baseline to Month 36, ITT Population | Baseline and Month 36 | Lumbar Spine Z-score - number of standard deviations a patient's BMD differs from the average BMD of their age, sex, and ethnicity. Positive scores indicate BMD above the mean; Positive values are best values and negative values are worst values. |
| Total Body Z-score- Percent Change From Baseline to Month 12, ITT Population | Baseline and Month 12 | Total Body Z-score - number of standard deviations a patient's BMD differs from the average BMD of their age, sex, and ethnicity. Positive scores indicate BMD above the mean; Positive values are best values and negative values are worst values. |
| Total Body Z-score- Percent Change From Baseline to Month 24, ITT Population | Baseline and Month 24 | Total Body Z-score - number of standard deviations a patient's BMD differs from the average BMD of their age, sex, and ethnicity. Positive scores indicate BMD above the mean; Positive values are best values and negative values are worst values. |
| Total Body Z-score- Percent Change From Baseline to Month 36, ITT Population | Baseline and Month 36 | Total Body Z-score - number of standard deviations a patient's BMD differs from the average BMD of their age, sex, and ethnicity. Positive scores indicate BMD above the mean; Positive values are best values and negative values are worst values. |
| Percent Change From Baseline in Lumbar Spine Bone Area at Month 12, ITT Population | Baseline and Month 12 | Measured by DXA. |
| Percent Change From Baseline in Lumbar Spine Bone Area at Month 24, ITT Population | Baseline and Month 24 | Measured by DXA. |
| Percent Change From Baseline in Lumbar Spine Bone Area at Month 36, ITT Population | Baseline and Month 36 | Measured by DXA. |
| Percent Change From Baseline in Total Body Bone Area Month 12, ITT Population | Baseline and Month 12 | — |
| Percent Change From Baseline in Total Body Bone Area Month 24, ITT Population | Baseline and Month 24 | — |
| Percent Change From Baseline in Total Body Bone Area Month 36, ITT Population | Baseline and Month 36 | — |
| New Morphometric Vertebral Fracture at Month 12, ITT Population | Baseline and Month 12 | Morphometric Vertebral Fracture measured by semi-quantitative (SQ) analysis of x-rays using the Genant scoring system at endpoint. (Ref: Genant 1993). SQ-Scores range from 0 (no fracture) to 3 (severe fracture). New fracture = SQ score is 0 at baseline and \>0 at the specified end visit. |
| New Morphometric Vertebral Fracture at Month 36, ITT Population | Baseline and Month 36 | Morphometric Vertebral Fracture measured by SQ analysis of x-rays using the Genant scoring system. (Ref: Genant 1993). SQ-Scores range from 0 (no fracture) to 3 (severe fracture). New fracture = SQ score is 0 at baseline and \>0 at the specified end visit. |
| Categorization by Number of New Morphometric Vertebral Fracture at Month 12, ITT | Baseline and Month 12 | Patients with 1 or more New Morphometric Vertebral Fracture as measured by SQ analysis of x-rays using the Genant scoring system (Ref: Genant 1993). SQ-Scores range from 0 (no fracture) to 3 (severe fracture). Incidence = SQ score is 0 at baseline and \>0 at post-baseline. |
| Categorization by Number of New Morphometric Vertebral Fracture at Month 36, ITT | Baseline and Month 36 | Patients with 1 or more New Morphometric Vertebral Fracture as measured by SQ analysis of x-rays using the Genant scoring system (Ref: Genant 1993). SQ-Scores range from 0 (no fracture) to 3 (severe fracture). Incidence = SQ score is 0 at baseline and \>0 at post-baseline. |
| Incidence New Vertebral Fractures by SQ (Semi-Quantitative) Score, Patients Aged 4-9 Years, Month 12, ITT Population | Month 12 | Patients aged 4-9 years with new morphometric vertebral fractures as measured by SQ analysis of x-rays using the Genant scoring system at Month 12 +/- 14 days. (Ref: Genant 1993). SQ Score mild - 0/no fracture to Grade 1, Moderate to Severe - change from 0/no fracture to Grade 2-3. |
| Incidence New Vertebral Fractures by SQ Score, Patients Aged 10-15 Years, Month 12, ITT Population | Month 12 | Patients aged 10-15 years with new morphometric vertebral fractures as measured by SQ analysis of x-rays using the Genant scoring system at Month 12 +/- 14 days. (Ref: Genant 1993). SQ Score mild - 0/no fracture to Grade 1, Moderate to Severe - change from 0/no fracture to Grade 2-3. |
| Probability of Fracture in 12 Months (Kaplan-Meier Cumulative Incidence), ITT Population | Time to First Event (days) up to 12 Months | Long bones include radius, ulna, humerus, tibia, fibula, femur, upper limb and lower limb fracture. |
| Number of Clinical Fractures, Month 12, ITT Population | 12 Months | Long bones include radius, ulna, humerus, tibia, fibula, femur, upper limb and lower limb fracture. |
| Serum BAP - Percent Change From Baseline to Month 12, ITT Population | Baseline and 12 Months | Serum Bone Alkaline Phosphatase (BAP - bone formation marker). Negative percent changes indicate response to treatment. |
| Serum BAP - Percent Change From Baseline to Month 24, ITT Population | Baseline and 24 Months | Serum Bone Alkaline Phosphatase (BAP - bone formation marker). Negative percent changes indicate response to treatment. |
| Serum BAP - Percent Change From Baseline to Month 36, ITT Population | Baseline and 36 Months | Serum Bone Alkaline Phosphatase (BAP - bone formation marker). Negative percent changes indicate response to treatment. |
| Urine NTX/Cr - Percent Change From Baseline at Month 12, ITT Population | Baseline and Endpoint / Month 12 | Urine type-I collagen N-telopeptide/creatinine (NTX/Cr; bone resorption marker). Negative percent changes indicate response to treatment. |
| Urine NTX/Cr - Percent Change From Baseline at Month 24, ITT Population | Baseline and Month 24 | Urine type-I collagen N-telopeptide/creatinine (NTX/Cr; bone resorption marker). Negative percent changes indicate response to treatment. |
| Urine NTX/Cr - Percent Change From Baseline at Month 36, ITT Population | Baseline and Month 36 | Urine type-I collagen N-telopeptide/creatinine (NTX/Cr; bone resorption marker). Negative percent changes indicate response to treatment. |
| Wong-Baker FACES Pain Rating Scale - Change From Baseline to Month 12, ITT Population | Baseline and Month 12 | Wong-Baker FACES Pain Rating Scale (pain assessment scale using facial expressions, translated into a range from 0= no pain \[smiling face\] to 10= worst pain possible \[distorted face with tears\]; negative values indicate decrease in pain). Reference: Wong DL et al. |
| Percent Change From Baseline Lumbar Spine Bone Mineral Density (BMD) at Month 24, ITT Population | Baseline and Month 24 | Lumbar Spine Bone Mineral Density (BMD) measured by dual-energy x-ray absorptiometry (DXA)and read by central reader. |
| Bone Age (Years), Change From Baseline to Month 24, ITT Population | Baseline and Month 24 | Bone Age determined by visual assessment of hand / wrist radiographs. |
| Bone Age (Years), Change From Baseline to Month 36, ITT Population | Baseline and Month 36 | Bone Age determined by visual assessment of hand / wrist radiographs. |
| Annualized Growth Velocity - Change From Baseline to Month 12, ITT Population | Baseline and Month 12 | Annualized Growth Velocity \[= bone age change from baseline x (365.25/time in days between baseline and the bone age measurement)\] |
| Annualized Growth Velocity - Change From Baseline to Month 36, ITT Population | Baseline and Month 36 | Annualized Growth Velocity \[= bone age change from baseline x (365.25/time in days between baseline and the bone age measurement)\] |
| Bone Age (Years), Change From Baseline to Month 12, ITT Population | Baseline and Month 12 | Bone Age determined by visual assessment of hand / wrist radiographs. |
Countries
Australia, Belgium, Chile, Czechia, Finland, Germany, Hungary, Italy, Poland, South Africa, Spain, United Kingdom, United States
Participant flow
Recruitment details
147 children \> or = 4 and \< 16 years of age with Osteogenesis Imperfecta (OI) enrolled at 20 North American and international study centers starting 16NOV2004. Patients weighing 10-30 kg received risedronate 2.5 mg or placebo daily and patients weighing more than 30 kg received risedronate 5 mg or placebo daily.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Daily placebo tablet, once a day for one year then for two years open label risedronate | 49 |
| Risedronate Daily risedronate tablet, once a day for one year then for two years open label risedronate once a day | 94 |
| Total | 143 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 3 | 2 |
| Overall Study | Lost to Follow-up | 0 | 1 |
| Overall Study | Protocol Violation | 1 | 1 |
| Overall Study | Withdrawal by Subject | 2 | 8 |
Baseline characteristics
| Characteristic | Placebo Daily | Risedronate Daily | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 49 Participants | 94 Participants | 143.0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0.0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0.0 Participants |
| Age Continuous | 8.6 years STANDARD_DEVIATION 3.1 | 8.9 years STANDARD_DEVIATION 3.4 | 8.825 years STANDARD_DEVIATION 3.313 |
| Region of Enrollment Australia | 8 participants | 16 participants | 24.0 participants |
| Region of Enrollment Belgium | 1 participants | 1 participants | 2.0 participants |
| Region of Enrollment Chile | 4 participants | 9 participants | 13.0 participants |
| Region of Enrollment Czech Republic | 1 participants | 4 participants | 5.0 participants |
| Region of Enrollment Finland | 5 participants | 7 participants | 12.0 participants |
| Region of Enrollment Germany | 5 participants | 8 participants | 13.0 participants |
| Region of Enrollment Hungary | 2 participants | 2 participants | 4.0 participants |
| Region of Enrollment Italy | 1 participants | 2 participants | 3.0 participants |
| Region of Enrollment Poland | 5 participants | 9 participants | 14.0 participants |
| Region of Enrollment South Africa | 0 participants | 1 participants | 1.0 participants |
| Region of Enrollment Spain | 1 participants | 1 participants | 2.0 participants |
| Region of Enrollment United Kingdom | 9 participants | 21 participants | 30.0 participants |
| Region of Enrollment United States | 7 participants | 13 participants | 20.0 participants |
| Sex: Female, Male Female | 22 Participants | 49 Participants | 71.0 Participants |
| Sex: Female, Male Male | 27 Participants | 45 Participants | 72.0 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 | 47 / 49 | 86 / 94 | 46 / 49 | 79 / 87 |
| serious Total, serious adverse events | 8 / 49 | 11 / 94 | 13 / 49 | 16 / 87 |
Outcome results
Primary
Percent Change From Baseline Lumbar Spine Bone Mineral Density (BMD) at Month 12, ITT Population
Lumbar Spine Bone Mineral Density (BMD) measured by dual-energy x-ray absorptiometry (DXA)and read by central reader. Duplicate scans obtained at screening and Month 12.
Time frame: Baseline and Month 12
Population: ITT Population
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo Daily | Percent Change From Baseline Lumbar Spine Bone Mineral Density (BMD) at Month 12, ITT Population | 7.592 Percent Change |
| Risedronate Daily | Percent Change From Baseline Lumbar Spine Bone Mineral Density (BMD) at Month 12, ITT Population | 16.159 Percent Change |
Comparison: A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.p-value: <0.000195% CI: [5.59, 11.545]ANCOVA
Secondary
Annualized Growth Velocity - Change From Baseline to Month 12, ITT Population
Annualized Growth Velocity \[= bone age change from baseline x (365.25/time in days between baseline and the bone age measurement)\]
Time frame: Baseline and Month 12
Population: ITT Population, Number of Participants Analyzed = Number of participants at baseline and Month 12 data
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo Daily | Annualized Growth Velocity - Change From Baseline to Month 12, ITT Population | 0.895 Change in Annualized Growth Velocity |
| Risedronate Daily | Annualized Growth Velocity - Change From Baseline to Month 12, ITT Population | 1.002 Change in Annualized Growth Velocity |
Comparison: A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.p-value: 0.3495% CI: [-0.114, 0.328]ANOVA
Secondary
Annualized Growth Velocity - Change From Baseline to Month 36, ITT Population
Annualized Growth Velocity \[= bone age change from baseline x (365.25/time in days between baseline and the bone age measurement)\]
Time frame: Baseline and Month 36
Population: ITT Population, Number of Participants Analyzed = Number of participants at baseline and Month 12 data
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo Daily | Annualized Growth Velocity - Change From Baseline to Month 36, ITT Population | 0.982 Change in Annualized Growth Velocity |
| Risedronate Daily | Annualized Growth Velocity - Change From Baseline to Month 36, ITT Population | 1.011 Change in Annualized Growth Velocity |
Comparison: A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.p-value: 0.621895% CI: [-0.084, 0.142]ANOVA
Secondary
Bone Age (Years), Change From Baseline to Month 12, ITT Population
Bone Age determined by visual assessment of hand / wrist radiographs.
Time frame: Baseline and Month 12
Population: ITT Population
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo Daily | Bone Age (Years), Change From Baseline to Month 12, ITT Population | 0.956 Years |
| Risedronate Daily | Bone Age (Years), Change From Baseline to Month 12, ITT Population | 1.083 Years |
Comparison: A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.p-value: 0.291795% CI: [-0.111, 0.365]ANOVA
Secondary
Bone Age (Years), Change From Baseline to Month 24, ITT Population
Bone Age determined by visual assessment of hand / wrist radiographs.
Time frame: Baseline and Month 24
Population: ITT Population
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo Daily | Bone Age (Years), Change From Baseline to Month 24, ITT Population | 2.147 Years |
| Risedronate Daily | Bone Age (Years), Change From Baseline to Month 24, ITT Population | 2.155 Years |
Comparison: A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.p-value: 0.962295% CI: [-0.304, 0.319]ANOVA
Secondary
Bone Age (Years), Change From Baseline to Month 36, ITT Population
Bone Age determined by visual assessment of hand / wrist radiographs.
Time frame: Baseline and Month 36
Population: ITT Population
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo Daily | Bone Age (Years), Change From Baseline to Month 36, ITT Population | 3.087 Years |
| Risedronate Daily | Bone Age (Years), Change From Baseline to Month 36, ITT Population | 3.096 Years |
Comparison: A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.p-value: 0.959695% CI: [-0.336, 0.354]ANOVA
Secondary
Categorization by Number of New Morphometric Vertebral Fracture at Month 12, ITT
Patients with 1 or more New Morphometric Vertebral Fracture as measured by SQ analysis of x-rays using the Genant scoring system (Ref: Genant 1993). SQ-Scores range from 0 (no fracture) to 3 (severe fracture). Incidence = SQ score is 0 at baseline and \>0 at post-baseline.
Time frame: Baseline and Month 12
Population: ITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo Daily | Categorization by Number of New Morphometric Vertebral Fracture at Month 12, ITT | No New Fractured Vertebra | 40 Participants |
| Placebo Daily | Categorization by Number of New Morphometric Vertebral Fracture at Month 12, ITT | One Fractured Vertebra | 3 Participants |
| Placebo Daily | Categorization by Number of New Morphometric Vertebral Fracture at Month 12, ITT | Two Fractured Vertebra | 2 Participants |
| Placebo Daily | Categorization by Number of New Morphometric Vertebral Fracture at Month 12, ITT | Three or more Fractured Vertebra | 3 Participants |
| Risedronate Daily | Categorization by Number of New Morphometric Vertebral Fracture at Month 12, ITT | Three or more Fractured Vertebra | 3 Participants |
| Risedronate Daily | Categorization by Number of New Morphometric Vertebral Fracture at Month 12, ITT | No New Fractured Vertebra | 60 Participants |
| Risedronate Daily | Categorization by Number of New Morphometric Vertebral Fracture at Month 12, ITT | Two Fractured Vertebra | 8 Participants |
| Risedronate Daily | Categorization by Number of New Morphometric Vertebral Fracture at Month 12, ITT | One Fractured Vertebra | 17 Participants |
Comparison: A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.p-value: 0.3658Savage Exact Test
Secondary
Categorization by Number of New Morphometric Vertebral Fracture at Month 36, ITT
Patients with 1 or more New Morphometric Vertebral Fracture as measured by SQ analysis of x-rays using the Genant scoring system (Ref: Genant 1993). SQ-Scores range from 0 (no fracture) to 3 (severe fracture). Incidence = SQ score is 0 at baseline and \>0 at post-baseline.
Time frame: Baseline and Month 36
Population: ITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo Daily | Categorization by Number of New Morphometric Vertebral Fracture at Month 36, ITT | No New Fractured Vertebra | 31 Participants |
| Placebo Daily | Categorization by Number of New Morphometric Vertebral Fracture at Month 36, ITT | One Fractured Vertebra | 6 Participants |
| Placebo Daily | Categorization by Number of New Morphometric Vertebral Fracture at Month 36, ITT | Two Fractured Vertebra | 5 Participants |
| Placebo Daily | Categorization by Number of New Morphometric Vertebral Fracture at Month 36, ITT | Three or more Fractured Vertebra | 3 Participants |
| Risedronate Daily | Categorization by Number of New Morphometric Vertebral Fracture at Month 36, ITT | Three or more Fractured Vertebra | 3 Participants |
| Risedronate Daily | Categorization by Number of New Morphometric Vertebral Fracture at Month 36, ITT | No New Fractured Vertebra | 62 Participants |
| Risedronate Daily | Categorization by Number of New Morphometric Vertebral Fracture at Month 36, ITT | Two Fractured Vertebra | 7 Participants |
| Risedronate Daily | Categorization by Number of New Morphometric Vertebral Fracture at Month 36, ITT | One Fractured Vertebra | 10 Participants |
Comparison: A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.p-value: 0.3408Savage Exact Test
Secondary
Incidence New Vertebral Fractures by SQ Score, Patients Aged 10-15 Years, Month 12, ITT Population
Patients aged 10-15 years with new morphometric vertebral fractures as measured by SQ analysis of x-rays using the Genant scoring system at Month 12 +/- 14 days. (Ref: Genant 1993). SQ Score mild - 0/no fracture to Grade 1, Moderate to Severe - change from 0/no fracture to Grade 2-3.
Time frame: Month 12
Population: ITT Population, Number of Participants Analyzed = Number of participants at baseline and Month 12 data
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo Daily | Incidence New Vertebral Fractures by SQ Score, Patients Aged 10-15 Years, Month 12, ITT Population | Number Patients with New Vertebral Fractures | 1 Participants |
| Placebo Daily | Incidence New Vertebral Fractures by SQ Score, Patients Aged 10-15 Years, Month 12, ITT Population | Number of New Vertebral Fractures | 1 Participants |
| Placebo Daily | Incidence New Vertebral Fractures by SQ Score, Patients Aged 10-15 Years, Month 12, ITT Population | Number Patients New Fractures & Mild SQ Score | 1 Participants |
| Placebo Daily | Incidence New Vertebral Fractures by SQ Score, Patients Aged 10-15 Years, Month 12, ITT Population | Number Patients New Fractures & Mod/Sev SQ Score | 0 Participants |
| Risedronate Daily | Incidence New Vertebral Fractures by SQ Score, Patients Aged 10-15 Years, Month 12, ITT Population | Number Patients New Fractures & Mod/Sev SQ Score | 1 Participants |
| Risedronate Daily | Incidence New Vertebral Fractures by SQ Score, Patients Aged 10-15 Years, Month 12, ITT Population | Number Patients with New Vertebral Fractures | 10 Participants |
| Risedronate Daily | Incidence New Vertebral Fractures by SQ Score, Patients Aged 10-15 Years, Month 12, ITT Population | Number Patients New Fractures & Mild SQ Score | 10 Participants |
| Risedronate Daily | Incidence New Vertebral Fractures by SQ Score, Patients Aged 10-15 Years, Month 12, ITT Population | Number of New Vertebral Fractures | 13 Participants |
Secondary
Incidence New Vertebral Fractures by SQ (Semi-Quantitative) Score, Patients Aged 4-9 Years, Month 12, ITT Population
Patients aged 4-9 years with new morphometric vertebral fractures as measured by SQ analysis of x-rays using the Genant scoring system at Month 12 +/- 14 days. (Ref: Genant 1993). SQ Score mild - 0/no fracture to Grade 1, Moderate to Severe - change from 0/no fracture to Grade 2-3.
Time frame: Month 12
Population: ITT Population, Number of Participants Analyzed = Number of participants with baseline and Month 12 data
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo Daily | Incidence New Vertebral Fractures by SQ (Semi-Quantitative) Score, Patients Aged 4-9 Years, Month 12, ITT Population | Number Patients with New Vertebral Fractures | 7 Participants |
| Placebo Daily | Incidence New Vertebral Fractures by SQ (Semi-Quantitative) Score, Patients Aged 4-9 Years, Month 12, ITT Population | Number of New Vertebral Fractures | 19 Participants |
| Placebo Daily | Incidence New Vertebral Fractures by SQ (Semi-Quantitative) Score, Patients Aged 4-9 Years, Month 12, ITT Population | Number Patients New Fractures & Mild SQ Score | 7 Participants |
| Placebo Daily | Incidence New Vertebral Fractures by SQ (Semi-Quantitative) Score, Patients Aged 4-9 Years, Month 12, ITT Population | Number Patients New Fractures & Mod/Sev SQ Score | 3 Participants |
| Risedronate Daily | Incidence New Vertebral Fractures by SQ (Semi-Quantitative) Score, Patients Aged 4-9 Years, Month 12, ITT Population | Number Patients New Fractures & Mod/Sev SQ Score | 3 Participants |
| Risedronate Daily | Incidence New Vertebral Fractures by SQ (Semi-Quantitative) Score, Patients Aged 4-9 Years, Month 12, ITT Population | Number Patients with New Vertebral Fractures | 19 Participants |
| Risedronate Daily | Incidence New Vertebral Fractures by SQ (Semi-Quantitative) Score, Patients Aged 4-9 Years, Month 12, ITT Population | Number Patients New Fractures & Mild SQ Score | 17 Participants |
| Risedronate Daily | Incidence New Vertebral Fractures by SQ (Semi-Quantitative) Score, Patients Aged 4-9 Years, Month 12, ITT Population | Number of New Vertebral Fractures | 32 Participants |
Secondary
Lumbar Spine Z-score - Percent Change From Baseline to Month 12, ITT Population
Lumbar Spine Z-score - number of standard deviations a patient's BMD differs from the average BMD of their age, sex, and ethnicity. Positive scores indicate BMD above the mean; Positive values are best values and negative values are worst values.
Time frame: Baseline and Month 12
Population: ITT Population
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo Daily | Lumbar Spine Z-score - Percent Change From Baseline to Month 12, ITT Population | -6.028 Units on a Scale |
| Risedronate Daily | Lumbar Spine Z-score - Percent Change From Baseline to Month 12, ITT Population | 25.648 Units on a Scale |
Comparison: A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.p-value: <0.000195% CI: [21.051, 42.3]ANCOVA
Secondary
Lumbar Spine Z-score - Percent Change From Baseline to Month 24, ITT Population
Lumbar Spine Z-score - number of standard deviations a patient's BMD differs from the average BMD of their age, sex, and ethnicity. Positive scores indicate BMD above the mean; Positive values are best values and negative values are worst values.
Time frame: Baseline and Month 24
Population: ITT Population
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo Daily | Lumbar Spine Z-score - Percent Change From Baseline to Month 24, ITT Population | 15.608 Units on a Scale |
| Risedronate Daily | Lumbar Spine Z-score - Percent Change From Baseline to Month 24, ITT Population | 29.637 Units on a Scale |
Comparison: A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.p-value: 0.079395% CI: [-1.667, 29.726]ANCOVA
Secondary
Lumbar Spine Z-score - Percent Change From Baseline to Month 36, ITT Population
Lumbar Spine Z-score - number of standard deviations a patient's BMD differs from the average BMD of their age, sex, and ethnicity. Positive scores indicate BMD above the mean; Positive values are best values and negative values are worst values.
Time frame: Baseline and Month 36
Population: ITT Population
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo Daily | Lumbar Spine Z-score - Percent Change From Baseline to Month 36, ITT Population | 19.325 Units on a Scale |
| Risedronate Daily | Lumbar Spine Z-score - Percent Change From Baseline to Month 36, ITT Population | 25.640 Units on a Scale |
Comparison: A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.p-value: 0.457595% CI: [-10.477, 23.107]ANCOVA
Secondary
New Morphometric Vertebral Fracture at Month 12, ITT Population
Morphometric Vertebral Fracture measured by semi-quantitative (SQ) analysis of x-rays using the Genant scoring system at endpoint. (Ref: Genant 1993). SQ-Scores range from 0 (no fracture) to 3 (severe fracture). New fracture = SQ score is 0 at baseline and \>0 at the specified end visit.
Time frame: Baseline and Month 12
Population: ITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo Daily | New Morphometric Vertebral Fracture at Month 12, ITT Population | At Least One New Fracture Vertebra | 8 Participants |
| Placebo Daily | New Morphometric Vertebral Fracture at Month 12, ITT Population | No New Fractured Vertebra | 40 Participants |
| Risedronate Daily | New Morphometric Vertebral Fracture at Month 12, ITT Population | At Least One New Fracture Vertebra | 28 Participants |
| Risedronate Daily | New Morphometric Vertebral Fracture at Month 12, ITT Population | No New Fractured Vertebra | 60 Participants |
Comparison: A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.p-value: 0.068Fisher Exact
Secondary
New Morphometric Vertebral Fracture at Month 36, ITT Population
Morphometric Vertebral Fracture measured by SQ analysis of x-rays using the Genant scoring system. (Ref: Genant 1993). SQ-Scores range from 0 (no fracture) to 3 (severe fracture). New fracture = SQ score is 0 at baseline and \>0 at the specified end visit.
Time frame: Baseline and Month 36
Population: ITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo Daily | New Morphometric Vertebral Fracture at Month 36, ITT Population | At Least One New Fracture Vertebra | 14 Participants |
| Placebo Daily | New Morphometric Vertebral Fracture at Month 36, ITT Population | No New Fractured Vertebra | 31 Participants |
| Risedronate Daily | New Morphometric Vertebral Fracture at Month 36, ITT Population | At Least One New Fracture Vertebra | 20 Participants |
| Risedronate Daily | New Morphometric Vertebral Fracture at Month 36, ITT Population | No New Fractured Vertebra | 62 Participants |
Comparison: A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.p-value: 0.4121Fisher Exact
Secondary
Number of Clinical Fractures, Month 12, ITT Population
Long bones include radius, ulna, humerus, tibia, fibula, femur, upper limb and lower limb fracture.
Time frame: 12 Months
Population: ITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo Daily | Number of Clinical Fractures, Month 12, ITT Population | Number of Fractures | 38 Participants |
| Placebo Daily | Number of Clinical Fractures, Month 12, ITT Population | Number of Patients with Fractures | 24 Participants |
| Placebo Daily | Number of Clinical Fractures, Month 12, ITT Population | Number of Vertebral Fractures | 0 Participants |
| Placebo Daily | Number of Clinical Fractures, Month 12, ITT Population | Number Patients with Vertebral Fractures | 0 Participants |
| Placebo Daily | Number of Clinical Fractures, Month 12, ITT Population | Number of Non-Vertebral Fractures | 38 Participants |
| Placebo Daily | Number of Clinical Fractures, Month 12, ITT Population | Number Patients with Non-Vertebral Fractures | 24 Participants |
| Placebo Daily | Number of Clinical Fractures, Month 12, ITT Population | Number Long-Bone Non-Vertebral Fractures | 27 Participants |
| Placebo Daily | Number of Clinical Fractures, Month 12, ITT Population | Number Patients Long-Bone Non-Vertebral Fractures | 17 Participants |
| Placebo Daily | Number of Clinical Fractures, Month 12, ITT Population | Number Other Non-Vertebral Fractures | 11 Participants |
| Placebo Daily | Number of Clinical Fractures, Month 12, ITT Population | Number Patients with Other Non-Vertebral Fractures | 10 Participants |
| Risedronate Daily | Number of Clinical Fractures, Month 12, ITT Population | Number Patients Long-Bone Non-Vertebral Fractures | 18 Participants |
| Risedronate Daily | Number of Clinical Fractures, Month 12, ITT Population | Number of Fractures | 42 Participants |
| Risedronate Daily | Number of Clinical Fractures, Month 12, ITT Population | Number Patients with Non-Vertebral Fractures | 29 Participants |
| Risedronate Daily | Number of Clinical Fractures, Month 12, ITT Population | Number of Patients with Fractures | 29 Participants |
| Risedronate Daily | Number of Clinical Fractures, Month 12, ITT Population | Number Patients with Other Non-Vertebral Fractures | 12 Participants |
| Risedronate Daily | Number of Clinical Fractures, Month 12, ITT Population | Number of Vertebral Fractures | 0 Participants |
| Risedronate Daily | Number of Clinical Fractures, Month 12, ITT Population | Number Long-Bone Non-Vertebral Fractures | 28 Participants |
| Risedronate Daily | Number of Clinical Fractures, Month 12, ITT Population | Number Patients with Vertebral Fractures | 0 Participants |
| Risedronate Daily | Number of Clinical Fractures, Month 12, ITT Population | Number Other Non-Vertebral Fractures | 14 Participants |
| Risedronate Daily | Number of Clinical Fractures, Month 12, ITT Population | Number of Non-Vertebral Fractures | 42 Participants |
Comparison: A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.p-value: 0.041695% CI: [0.348, 0.98]Wald test
Comparison: A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.p-value: 0.041695% CI: [0.348, 0.98]Wald Test
Comparison: A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.p-value: 0.079995% CI: [0.274, 1.076]Wald Test
Comparison: A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.p-value: 0.68295% CI: [0.304, 1.532]Wald Test
Secondary
Percent Change From Baseline in Lumbar Spine BMC (Bone Mineral Content) at Month 12, ITT Population
Time frame: Baseline and Month 12
Population: ITT Population
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo Daily | Percent Change From Baseline in Lumbar Spine BMC (Bone Mineral Content) at Month 12, ITT Population | 17.885 Percent Change |
| Risedronate Daily | Percent Change From Baseline in Lumbar Spine BMC (Bone Mineral Content) at Month 12, ITT Population | 28.218 Percent Change |
Comparison: A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.p-value: <0.000195% CI: [5.258, 15.408]ANCOVA
Secondary
Percent Change From Baseline in Lumbar Spine BMC (Bone Mineral Content) at Month 24, ITT Population
Time frame: Baseline and Month 24
Population: ITT Population
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo Daily | Percent Change From Baseline in Lumbar Spine BMC (Bone Mineral Content) at Month 24, ITT Population | 42.367 Percent Change |
| Risedronate Daily | Percent Change From Baseline in Lumbar Spine BMC (Bone Mineral Content) at Month 24, ITT Population | 48.407 Percent Change |
Comparison: A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.p-value: 178995% CI: [-2.807, 14.887]ANCOVA
Secondary
Percent Change From Baseline in Lumbar Spine BMC (Bone Mineral Content) at Month 36, ITT Population
Time frame: Baseline and Month 36
Population: ITT Population
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo Daily | Percent Change From Baseline in Lumbar Spine BMC (Bone Mineral Content) at Month 36, ITT Population | 68.054 Percent Change |
| Risedronate Daily | Percent Change From Baseline in Lumbar Spine BMC (Bone Mineral Content) at Month 36, ITT Population | 68.333 Percent Change |
Comparison: A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.p-value: 0.964695% CI: [-12.196, 12.755]ANCOVA
Secondary
Percent Change From Baseline in Lumbar Spine Bone Area at Month 12, ITT Population
Measured by DXA.
Time frame: Baseline and Month 12
Population: ITT Population
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo Daily | Percent Change From Baseline in Lumbar Spine Bone Area at Month 12, ITT Population | 8.803 Percent Change |
| Risedronate Daily | Percent Change From Baseline in Lumbar Spine Bone Area at Month 12, ITT Population | 9.817 Percent Change |
Comparison: A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.p-value: 0.415495% CI: [-1.442, 3.47]ANCOVA
Secondary
Percent Change From Baseline in Lumbar Spine Bone Area at Month 24, ITT Population
Measured by DXA.
Time frame: Baseline and Month 24
Population: ITT Population
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo Daily | Percent Change From Baseline in Lumbar Spine Bone Area at Month 24, ITT Population | 16.381 Percent Change |
| Risedronate Daily | Percent Change From Baseline in Lumbar Spine Bone Area at Month 24, ITT Population | 17.266 Percent Change |
Comparison: A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.p-value: 0.640495% CI: [-2.855, 4.623]ANCOVA
Secondary
Percent Change From Baseline in Lumbar Spine Bone Area at Month 36, ITT Population
Measured by DXA.
Time frame: Baseline and Month 36
Population: ITT Population
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo Daily | Percent Change From Baseline in Lumbar Spine Bone Area at Month 36, ITT Population | 24.952 Percent Change |
| Risedronate Daily | Percent Change From Baseline in Lumbar Spine Bone Area at Month 36, ITT Population | 23.292 Percent Change |
Comparison: A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.p-value: 0.497895% CI: [-6.499, 3.179]ANCOVA
Secondary
Percent Change From Baseline in Total Body BMC at Month 12, ITT Population
Time frame: Baseline and Month 12
Population: ITT Population
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo Daily | Percent Change From Baseline in Total Body BMC at Month 12, ITT Population | 16.483 Percent Change |
| Risedronate Daily | Percent Change From Baseline in Total Body BMC at Month 12, ITT Population | 21.977 Percent Change |
Comparison: A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.p-value: 0.00395% CI: [1.912, 9.077]ANCOVA
Secondary
Percent Change From Baseline in Total Body BMC at Month 24, ITT Population
Time frame: Baseline and Month 24
Population: ITT Population
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo Daily | Percent Change From Baseline in Total Body BMC at Month 24, ITT Population | 36.465 Percent Change |
| Risedronate Daily | Percent Change From Baseline in Total Body BMC at Month 24, ITT Population | 37.938 Percent Change |
Comparison: A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.p-value: 0.610695% CI: [-4.245, 7.192]ANCOVA
Secondary
Percent Change From Baseline in Total Body BMC at Month 36, ITT Population
Time frame: Baseline and Month 36
Population: ITT Population
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo Daily | Percent Change From Baseline in Total Body BMC at Month 36, ITT Population | 56.211 Percent Change |
| Risedronate Daily | Percent Change From Baseline in Total Body BMC at Month 36, ITT Population | 56.526 Percent Change |
Comparison: A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.p-value: 0.937295% CI: [-7.598, 8.229]ANCOVA
Secondary
Percent Change From Baseline in Total Body BMD at Month 12, ITT Population
Percent Change from baseline in Total Body Bone Mineral Density (BMD) measured by DXA.
Time frame: Baseline and Month 12
Population: ITT Population.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo Daily | Percent Change From Baseline in Total Body BMD at Month 12, ITT Population | 4.252 Percent Change |
| Risedronate Daily | Percent Change From Baseline in Total Body BMD at Month 12, ITT Population | 5.806 Percent Change |
Comparison: A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.p-value: 0.080895% CI: [-0.193, 3.301]ANCOVA
Secondary
Percent Change From Baseline in Total Body BMD at Month 24, ITT Population
Percent Change from baseline in Total Body Bone Mineral Density (BMD) measured by DXA.
Time frame: Baseline and Month 24
Population: ITT Population.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo Daily | Percent Change From Baseline in Total Body BMD at Month 24, ITT Population | 9.716 Percent Change |
| Risedronate Daily | Percent Change From Baseline in Total Body BMD at Month 24, ITT Population | 10.214 Percent Change |
Comparison: A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.p-value: 0.646695% CI: [-1.648, 2.644]ANCOVA
Secondary
Percent Change From Baseline in Total Body BMD at Month 36, ITT Population
Percent Change from baseline in Total Body Bone Mineral Density (BMD) measured by DXA.
Time frame: Baseline and Month 36
Population: ITT Population.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo Daily | Percent Change From Baseline in Total Body BMD at Month 36, ITT Population | 13.540 Percent Change |
| Risedronate Daily | Percent Change From Baseline in Total Body BMD at Month 36, ITT Population | 13.076 Percent Change |
Comparison: A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.p-value: 0.739195% CI: [-3.224, 2.294]ANCOVA
Secondary
Percent Change From Baseline in Total Body Bone Area Month 12, ITT Population
Time frame: Baseline and Month 12
Population: ITT Population
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo Daily | Percent Change From Baseline in Total Body Bone Area Month 12, ITT Population | 11.405 Percent Change |
| Risedronate Daily | Percent Change From Baseline in Total Body Bone Area Month 12, ITT Population | 14.939 Percent Change |
Comparison: A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.p-value: 0.02795% CI: [0.41, 6.658]ANCOVA
Secondary
Percent Change From Baseline in Total Body Bone Area Month 24, ITT Population
Time frame: Baseline and Month 24
Population: ITT Population
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo Daily | Percent Change From Baseline in Total Body Bone Area Month 24, ITT Population | 24.051 Percent Change |
| Risedronate Daily | Percent Change From Baseline in Total Body Bone Area Month 24, ITT Population | 25.116 Percent Change |
Comparison: A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.p-value: 0.592595% CI: [-2.868, 4.998]ANCOVA
Secondary
Percent Change From Baseline in Total Body Bone Area Month 36, ITT Population
Time frame: Baseline and Month 36
Population: ITT Population
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo Daily | Percent Change From Baseline in Total Body Bone Area Month 36, ITT Population | 37.109 Percent Change |
| Risedronate Daily | Percent Change From Baseline in Total Body Bone Area Month 36, ITT Population | 38.303 Percent Change |
Comparison: A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.p-value: 0.68495% CI: [-4.604, 6.991]ANCOVA
Secondary
Percent Change From Baseline Lumbar Spine Bone Mineral Density (BMD) at Month 24, ITT Population
Lumbar Spine Bone Mineral Density (BMD) measured by dual-energy x-ray absorptiometry (DXA)and read by central reader.
Time frame: Baseline and Month 24
Population: ITT Population
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo Daily | Percent Change From Baseline Lumbar Spine Bone Mineral Density (BMD) at Month 24, ITT Population | 21.316 Percent Change |
| Risedronate Daily | Percent Change From Baseline Lumbar Spine Bone Mineral Density (BMD) at Month 24, ITT Population | 25.754 Percent Change |
Comparison: A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.p-value: 0.062595% CI: [-0.235, 9.111]ANCOVA
Secondary
Percent Change From Baseline Lumbar Spine Bone Mineral Density (BMD) at Month 36, ITT Population
Lumbar Spine Bone Mineral Density (BMD) measured by dual-energy x-ray absorptiometry (DXA)and read by central reader.
Time frame: Baseline and Month 36
Population: ITT Population
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo Daily | Percent Change From Baseline Lumbar Spine Bone Mineral Density (BMD) at Month 36, ITT Population | 33.216 Percent Change |
| Risedronate Daily | Percent Change From Baseline Lumbar Spine Bone Mineral Density (BMD) at Month 36, ITT Population | 34.753 Percent Change |
Comparison: A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.p-value: 0.610395% CI: [-4.424, 7.497]ANCOVA
Secondary
Probability of Fracture in 12 Months (Kaplan-Meier Cumulative Incidence), ITT Population
Long bones include radius, ulna, humerus, tibia, fibula, femur, upper limb and lower limb fracture.
Time frame: Time to First Event (days) up to 12 Months
Population: ITT Population
| Arm | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| Placebo Daily | Probability of Fracture in 12 Months (Kaplan-Meier Cumulative Incidence), ITT Population | Other Non-Vertebral Fractures/Kaplan-Meier Cum. | 0.204 Probability of Fractures | 0.0576 |
| Placebo Daily | Probability of Fracture in 12 Months (Kaplan-Meier Cumulative Incidence), ITT Population | Number Patients Vertebral Fractures | 0 Probability of Fractures | — |
| Placebo Daily | Probability of Fracture in 12 Months (Kaplan-Meier Cumulative Incidence), ITT Population | Number Patients Other Non-Vertebral Fractures | 10 Probability of Fractures | — |
| Placebo Daily | Probability of Fracture in 12 Months (Kaplan-Meier Cumulative Incidence), ITT Population | Vertebral Fractures/Kaplan-Meier Cumulative Incid. | 0 Probability of Fractures | 0 |
| Placebo Daily | Probability of Fracture in 12 Months (Kaplan-Meier Cumulative Incidence), ITT Population | Number Patients All Fractures | 24 Probability of Fractures | 29 |
| Placebo Daily | Probability of Fracture in 12 Months (Kaplan-Meier Cumulative Incidence), ITT Population | Number Patients Non-Vertebral Fractures | 24 Probability of Fractures | — |
| Placebo Daily | Probability of Fracture in 12 Months (Kaplan-Meier Cumulative Incidence), ITT Population | Long Bone Non-Vertebral Fractures/Kaplan-Meier Cum | 0.3618 Probability of Fractures | 0.0714 |
| Placebo Daily | Probability of Fracture in 12 Months (Kaplan-Meier Cumulative Incidence), ITT Population | Non-Vertebral Fractures/Kaplan-Meier Cum. Incid. | 0.5043 Probability of Fractures | 0.074 |
| Placebo Daily | Probability of Fracture in 12 Months (Kaplan-Meier Cumulative Incidence), ITT Population | All Fractures/Kaplan-Meier Cumulative Incidence | 0.5043 Probability of Fractures | 0.074 |
| Placebo Daily | Probability of Fracture in 12 Months (Kaplan-Meier Cumulative Incidence), ITT Population | Number Patients Long Bone Non-Vertebral Fractures | 17 Probability of Fractures | — |
| Risedronate Daily | Probability of Fracture in 12 Months (Kaplan-Meier Cumulative Incidence), ITT Population | All Fractures/Kaplan-Meier Cumulative Incidence | 0.314 Probability of Fractures | 0.0484 |
| Risedronate Daily | Probability of Fracture in 12 Months (Kaplan-Meier Cumulative Incidence), ITT Population | Long Bone Non-Vertebral Fractures/Kaplan-Meier Cum | 0.1954 Probability of Fractures | 0.0413 |
| Risedronate Daily | Probability of Fracture in 12 Months (Kaplan-Meier Cumulative Incidence), ITT Population | Number Patients Other Non-Vertebral Fractures | 12 Probability of Fractures | — |
| Risedronate Daily | Probability of Fracture in 12 Months (Kaplan-Meier Cumulative Incidence), ITT Population | Other Non-Vertebral Fractures/Kaplan-Meier Cum. | 0.1311 Probability of Fractures | 0.0353 |
| Risedronate Daily | Probability of Fracture in 12 Months (Kaplan-Meier Cumulative Incidence), ITT Population | Number Patients All Fractures | 29 Probability of Fractures | — |
| Risedronate Daily | Probability of Fracture in 12 Months (Kaplan-Meier Cumulative Incidence), ITT Population | Number Patients Long Bone Non-Vertebral Fractures | 18 Probability of Fractures | — |
| Risedronate Daily | Probability of Fracture in 12 Months (Kaplan-Meier Cumulative Incidence), ITT Population | Number Patients Vertebral Fractures | 0 Probability of Fractures | — |
| Risedronate Daily | Probability of Fracture in 12 Months (Kaplan-Meier Cumulative Incidence), ITT Population | Vertebral Fractures/Kaplan-Meier Cumulative Incid. | 0 Probability of Fractures | 0 |
| Risedronate Daily | Probability of Fracture in 12 Months (Kaplan-Meier Cumulative Incidence), ITT Population | Number Patients Non-Vertebral Fractures | 29 Probability of Fractures | — |
| Risedronate Daily | Probability of Fracture in 12 Months (Kaplan-Meier Cumulative Incidence), ITT Population | Non-Vertebral Fractures/Kaplan-Meier Cum. Incid. | 0.314 Probability of Fractures | 0.0484 |
Comparison: A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.p-value: 0.025395% CI: [0.31, 0.922]Cox proportional hazards
Comparison: A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.p-value: 0.025395% CI: [0.31, 0.922]Cox Proportional Hazard
Comparison: A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.p-value: 0.050195% CI: [0.25, 0.95]Cox Proportional Hazards
Comparison: A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.p-value: 0.214195% CI: [0.262, 1.41]Cox Proportional Hazard
Secondary
Serum BAP - Percent Change From Baseline to Month 12, ITT Population
Serum Bone Alkaline Phosphatase (BAP - bone formation marker). Negative percent changes indicate response to treatment.
Time frame: Baseline and 12 Months
Population: ITT Population
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo Daily | Serum BAP - Percent Change From Baseline to Month 12, ITT Population | 6.783 Percent Change |
| Risedronate Daily | Serum BAP - Percent Change From Baseline to Month 12, ITT Population | -4.895 Percent Change |
Comparison: A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.p-value: 0.031895% CI: [-22.325, -1.031]ANCOVA
Secondary
Serum BAP - Percent Change From Baseline to Month 24, ITT Population
Serum Bone Alkaline Phosphatase (BAP - bone formation marker). Negative percent changes indicate response to treatment.
Time frame: Baseline and 24 Months
Population: ITT Population
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo Daily | Serum BAP - Percent Change From Baseline to Month 24, ITT Population | -11.196 Percent Change |
| Risedronate Daily | Serum BAP - Percent Change From Baseline to Month 24, ITT Population | -11.128 Percent Change |
Comparison: A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.p-value: 0.990795% CI: [-11.401, 11.536]ANCOVA
Secondary
Serum BAP - Percent Change From Baseline to Month 36, ITT Population
Serum Bone Alkaline Phosphatase (BAP - bone formation marker). Negative percent changes indicate response to treatment.
Time frame: Baseline and 36 Months
Population: ITT Population
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo Daily | Serum BAP - Percent Change From Baseline to Month 36, ITT Population | -19.884 Percent Change |
| Risedronate Daily | Serum BAP - Percent Change From Baseline to Month 36, ITT Population | -24.570 Percent Change |
Comparison: A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.p-value: 0.382695% CI: [-15.276, 5.903]ANCOVA
Secondary
Total Body Z-score- Percent Change From Baseline to Month 12, ITT Population
Total Body Z-score - number of standard deviations a patient's BMD differs from the average BMD of their age, sex, and ethnicity. Positive scores indicate BMD above the mean; Positive values are best values and negative values are worst values.
Time frame: Baseline and Month 12
Population: ITT Population, Population Description Number of Participants Analyzed = Number of participants at baseline and LOCF data
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo Daily | Total Body Z-score- Percent Change From Baseline to Month 12, ITT Population | -20.661 Units on a Scale |
| Risedronate Daily | Total Body Z-score- Percent Change From Baseline to Month 12, ITT Population | 16.933 Units on a Scale |
Comparison: A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.p-value: 0.017295% CI: [6.801, 68.386]ANCOVA
Secondary
Total Body Z-score- Percent Change From Baseline to Month 24, ITT Population
Total Body Z-score - number of standard deviations a patient's BMD differs from the average BMD of their age, sex, and ethnicity. Positive scores indicate BMD above the mean; Positive values are best values and negative values are worst values.
Time frame: Baseline and Month 24
Population: ITT Population
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo Daily | Total Body Z-score- Percent Change From Baseline to Month 24, ITT Population | 8.371 Units on a Scale |
| Risedronate Daily | Total Body Z-score- Percent Change From Baseline to Month 24, ITT Population | 7.879 Units on a Scale |
Comparison: A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.p-value: 0.978695% CI: [-36.807, 35.824]ANCOVA
Secondary
Total Body Z-score- Percent Change From Baseline to Month 36, ITT Population
Total Body Z-score - number of standard deviations a patient's BMD differs from the average BMD of their age, sex, and ethnicity. Positive scores indicate BMD above the mean; Positive values are best values and negative values are worst values.
Time frame: Baseline and Month 36
Population: ITT Population
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo Daily | Total Body Z-score- Percent Change From Baseline to Month 36, ITT Population | 7.146 Units on a Scale |
| Risedronate Daily | Total Body Z-score- Percent Change From Baseline to Month 36, ITT Population | -1.494 Units on a Scale |
Comparison: A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.p-value: 0.597195% CI: [-40.952, 23.672]ANCOVA
Secondary
Urine NTX/Cr - Percent Change From Baseline at Month 12, ITT Population
Urine type-I collagen N-telopeptide/creatinine (NTX/Cr; bone resorption marker). Negative percent changes indicate response to treatment.
Time frame: Baseline and Endpoint / Month 12
Population: ITT Population
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo Daily | Urine NTX/Cr - Percent Change From Baseline at Month 12, ITT Population | -14.556 Percent Change |
| Risedronate Daily | Urine NTX/Cr - Percent Change From Baseline at Month 12, ITT Population | -41.185 Percent Change |
Comparison: A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.p-value: <0.000195% CI: [-38.089, -15.169]ANCOVA
Secondary
Urine NTX/Cr - Percent Change From Baseline at Month 24, ITT Population
Urine type-I collagen N-telopeptide/creatinine (NTX/Cr; bone resorption marker). Negative percent changes indicate response to treatment.
Time frame: Baseline and Month 24
Population: ITT Population
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo Daily | Urine NTX/Cr - Percent Change From Baseline at Month 24, ITT Population | -40.358 Percent Change |
| Risedronate Daily | Urine NTX/Cr - Percent Change From Baseline at Month 24, ITT Population | -31.318 Percent Change |
Comparison: A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.p-value: 0.307595% CI: [-8.433, 26.512]ANCOVA
Secondary
Urine NTX/Cr - Percent Change From Baseline at Month 36, ITT Population
Urine type-I collagen N-telopeptide/creatinine (NTX/Cr; bone resorption marker). Negative percent changes indicate response to treatment.
Time frame: Baseline and Month 36
Population: ITT Population
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo Daily | Urine NTX/Cr - Percent Change From Baseline at Month 36, ITT Population | -47.570 Percent Change |
| Risedronate Daily | Urine NTX/Cr - Percent Change From Baseline at Month 36, ITT Population | -52.609 Percent Change |
Comparison: A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.p-value: 0.399895% CI: [-16.849, 6.772]ANCOVA
Secondary
Wong-Baker FACES Pain Rating Scale - Change From Baseline to Month 12, ITT Population
Wong-Baker FACES Pain Rating Scale (pain assessment scale using facial expressions, translated into a range from 0= no pain \[smiling face\] to 10= worst pain possible \[distorted face with tears\]; negative values indicate decrease in pain). Reference: Wong DL et al.
Time frame: Baseline and Month 12
Population: ITT Population
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo Daily | Wong-Baker FACES Pain Rating Scale - Change From Baseline to Month 12, ITT Population | -0.056 Units on a Scale |
| Risedronate Daily | Wong-Baker FACES Pain Rating Scale - Change From Baseline to Month 12, ITT Population | -0.409 Units on a Scale |
Comparison: A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.p-value: 0.159295% CI: [-0.845, 0.14]ANCOVA