| 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. | | Posted | | Least Squares Mean | 95% Confidence Interval | Percent Change | | Baseline and Month 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Daily | placebo tablet, once a day for one year then for two years open label risedronate | | OG001 | Risedronate Daily | risedronate tablet, once a day for one year then for two years open label risedronate once a day |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG00021.316(17.357 to 25.275)
- OG00125.754(22.860 to 28.648)
|
|
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| 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. | ANCOVA | LS means and p-value are from ANCOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline. | 0.0625 | | Mean Difference (Net) | 4.438 | | | 2-Sided | 95 | -0.235 | 9.111 | | | | No |
|
| 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. | | Posted | | Least Squares Mean | 95% Confidence Interval | Percent Change | | Baseline and Month 36 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Daily | placebo tablet, once a day for one year then for two years open label risedronate | | OG001 | Risedronate Daily | risedronate tablet, once a day for one year then for two years open label risedronate once a day |
| |
| 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. | | Posted | | Least Squares Mean | 95% Confidence Interval | Percent Change | | Baseline and Month 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Daily | placebo tablet, once a day for one year then for two years open label risedronate | | OG001 | Risedronate Daily | risedronate tablet, once a day for one year then for two years open label risedronate once a day |
| |
| 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. | | Posted | | Least Squares Mean | 95% Confidence Interval | Percent Change | | Baseline and Month 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Daily | placebo tablet, once a day for one year then for two years open label risedronate | | OG001 | Risedronate Daily | risedronate tablet, once a day for one year then for two years open label risedronate once a day |
| |
| 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. | | Posted | | Least Squares Mean | 95% Confidence Interval | Percent Change | | Baseline and Month 36 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Daily | placebo tablet, once a day for one year then for two years open label risedronate | | OG001 | Risedronate Daily | risedronate tablet, once a day for one year then for two years open label risedronate once a day |
| |
| Secondary | Percent Change From Baseline in Lumbar Spine BMC (Bone Mineral Content) at Month 12, ITT Population | | | Posted | | Least Squares Mean | 95% Confidence Interval | Percent Change | | Baseline and Month 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Daily | placebo tablet, once a day for one year then for two years open label risedronate | | OG001 | Risedronate Daily | risedronate tablet, once a day for one year then for two years open label risedronate once a day |
| |
| Secondary | Percent Change From Baseline in Lumbar Spine BMC (Bone Mineral Content) at Month 24, ITT Population | | | Posted | | Least Squares Mean | 95% Confidence Interval | Percent Change | | Baseline and Month 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Daily | placebo tablet, once a day for one year then for two years open label risedronate | | OG001 | Risedronate Daily | risedronate tablet, once a day for one year then for two years open label risedronate once a day |
| |
| Secondary | Percent Change From Baseline in Lumbar Spine BMC (Bone Mineral Content) at Month 36, ITT Population | | | Posted | | Least Squares Mean | 95% Confidence Interval | Percent Change | | Baseline and Month 36 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Daily | placebo tablet, once a day for one year then for two years open label risedronate | | OG001 | Risedronate Daily | risedronate tablet, once a day for one year then for two years open label risedronate once a day |
| |
| Secondary | Percent Change From Baseline in Total Body BMC at Month 12, ITT Population | | | Posted | | Least Squares Mean | 95% Confidence Interval | Percent Change | | Baseline and Month 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Daily | placebo tablet, once a day for one year then for two years open label risedronate | | OG001 | Risedronate Daily | risedronate tablet, once a day for one year then for two years open label risedronate once a day |
| |
| Secondary | Percent Change From Baseline in Total Body BMC at Month 24, ITT Population | | | Posted | | Least Squares Mean | 95% Confidence Interval | Percent Change | | Baseline and Month 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Daily | placebo tablet, once a day for one year then for two years open label risedronate | | OG001 | Risedronate Daily | risedronate tablet, once a day for one year then for two years open label risedronate once a day |
| |
| Secondary | Percent Change From Baseline in Total Body BMC at Month 36, ITT Population | | | Posted | | Least Squares Mean | 95% Confidence Interval | Percent Change | | Baseline and Month 36 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Daily | placebo tablet, once a day for one year then for two years open label risedronate | | OG001 | Risedronate Daily | risedronate tablet, once a day for one year then for two years open label risedronate once a day |
| |
| 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". | | Posted | | Least Squares Mean | 95% Confidence Interval | Units on a Scale | | Baseline and Month 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Daily | placebo tablet, once a day for one year then for two years open label risedronate | | OG001 | Risedronate Daily | risedronate tablet, once a day for one year then for two years open label risedronate once a day |
| |
| 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". | | Posted | | Least Squares Mean | 95% Confidence Interval | Units on a Scale | | Baseline and Month 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Daily | placebo tablet, once a day for one year then for two years open label risedronate | | OG001 | Risedronate Daily | risedronate tablet, once a day for one year then for two years open label risedronate once a day |
| |
| 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. | | Posted | | Least Squares Mean | 95% Confidence Interval | Percent Change | | Baseline and Month 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Daily | placebo tablet, once a day for one year then for two years open label risedronate | | OG001 | Risedronate Daily | risedronate tablet, once a day for one year then for two years open label risedronate once a day |
| |
| 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". | | Posted | | Least Squares Mean | 95% Confidence Interval | Units on a Scale | | Baseline and Month 36 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Daily | placebo tablet, once a day for one year then for two years open label risedronate | | OG001 | Risedronate Daily | risedronate tablet, once a day for one year then for two years open label risedronate once a day |
| |
| 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". | ITT Population, Population Description Number of Participants Analyzed = Number of participants at baseline and LOCF data | Posted | | Least Squares Mean | 95% Confidence Interval | Units on a Scale | | Baseline and Month 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Daily | placebo tablet, once a day for one year then for two years open label risedronate | | OG001 | Risedronate Daily | risedronate tablet, once a day for one year then for two years open label risedronate once a day |
| |
| 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". | | Posted | | Least Squares Mean | 95% Confidence Interval | Units on a Scale | | Baseline and Month 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Daily | placebo tablet, once a day for one year then for two years open label risedronate | | OG001 | Risedronate Daily | risedronate tablet, once a day for one year then for two years open label risedronate once a day |
| |
| 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". | | Posted | | Least Squares Mean | 95% Confidence Interval | Units on a Scale | | Baseline and Month 36 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Daily | placebo tablet, once a day for one year then for two years open label risedronate | | OG001 | Risedronate Daily | risedronate tablet, once a day for one year then for two years open label risedronate once a day |
| |
| Secondary | Percent Change From Baseline in Lumbar Spine Bone Area at Month 12, ITT Population | | | Posted | | Least Squares Mean | 95% Confidence Interval | Percent Change | | Baseline and Month 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Daily | placebo tablet, once a day for one year then for two years open label risedronate | | OG001 | Risedronate Daily | risedronate tablet, once a day for one year then for two years open label risedronate once a day |
| |
| Secondary | Percent Change From Baseline in Lumbar Spine Bone Area at Month 24, ITT Population | | | Posted | | Least Squares Mean | 95% Confidence Interval | Percent Change | | Baseline and Month 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Daily | placebo tablet, once a day for one year then for two years open label risedronate | | OG001 | Risedronate Daily | risedronate tablet, once a day for one year then for two years open label risedronate once a day |
| |
| Secondary | Percent Change From Baseline in Lumbar Spine Bone Area at Month 36, ITT Population | | | Posted | | Least Squares Mean | 95% Confidence Interval | Percent Change | | Baseline and Month 36 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Daily | placebo tablet, once a day for one year then for two years open label risedronate | | OG001 | Risedronate Daily | risedronate tablet, once a day for one year then for two years open label risedronate once a day |
| |
| Secondary | Percent Change From Baseline in Total Body Bone Area Month 12, ITT Population | | | Posted | | Least Squares Mean | 95% Confidence Interval | Percent Change | | Baseline and Month 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Daily | placebo tablet, once a day for one year then for two years open label risedronate | | OG001 | Risedronate Daily | risedronate tablet, once a day for one year then for two years open label risedronate once a day |
| |
| Secondary | Percent Change From Baseline in Total Body Bone Area Month 24, ITT Population | | | Posted | | Least Squares Mean | 95% Confidence Interval | Percent Change | | Baseline and Month 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Daily | placebo tablet, once a day for one year then for two years open label risedronate | | OG001 | Risedronate Daily | risedronate tablet, once a day for one year then for two years open label risedronate once a day |
| |
| Secondary | Percent Change From Baseline in Total Body Bone Area Month 36, ITT Population | | | Posted | | Least Squares Mean | 95% Confidence Interval | Percent Change | | Baseline and Month 36 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Daily | placebo tablet, once a day for one year then for two years open label risedronate | | OG001 | Risedronate Daily | risedronate tablet, once a day for one year then for two years open label risedronate once a day |
| |
| 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. | | Posted | | Number | | Participants | | Baseline and Month 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Daily | placebo tablet, once a day for one year then for two years open label risedronate | | OG001 | Risedronate Daily | risedronate tablet, once a day for one year then for two years open label risedronate once a day |
| |
| 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. | | Posted | | Number | | Participants | | Baseline and Month 36 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Daily | placebo tablet, once a day for one year then for two years open label risedronate | | OG001 | Risedronate Daily | risedronate tablet, once a day for one year then for two years open label risedronate once a day |
| |
| 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. | | Posted | | Number | | Participants | | Baseline and Month 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Daily | placebo tablet, once a day for one year then for two years open label risedronate | | OG001 | Risedronate Daily | risedronate tablet, once a day for one year then for two years open label risedronate once a day |
| |
| 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. | | Posted | | Number | | Participants | | Baseline and Month 36 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Daily | placebo tablet, once a day for one year then for two years open label risedronate | | OG001 | Risedronate Daily | risedronate tablet, once a day for one year then for two years open label risedronate once a day |
| |
| 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. | ITT Population, Number of Participants Analyzed = Number of participants with baseline and Month 12 data | Posted | | Number | | Participants | | Month 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Daily | placebo tablet, once a day for one year then for two years open label risedronate | | OG001 | Risedronate Daily | risedronate tablet, once a day for one year then for two years open label risedronate once a day |
| |
| 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. | ITT Population, Number of Participants Analyzed = Number of participants at baseline and Month 12 data | Posted | | Number | | Participants | | Month 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Daily | placebo tablet, once a day for one year then for two years open label risedronate | | OG001 | Risedronate Daily | risedronate tablet, once a day for one year then for two years open label risedronate once a day |
| |
| 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. | | Posted | | Number | | Probability of Fractures | | Time to First Event (days) up to 12 Months | | | | ID | Title | Description |
|---|
| OG000 | Placebo Daily | placebo tablet, once a day for one year then for two years open label risedronate | | OG001 | Risedronate Daily | risedronate tablet, once a day for one year then for two years open label risedronate once a day |
| |
| Secondary | Number of Clinical Fractures, Month 12, ITT Population | Long bones include radius, ulna, humerus, tibia, fibula, femur, upper limb and lower limb fracture. | | Posted | | Number | | Participants | | 12 Months | | | | ID | Title | Description |
|---|
| OG000 | Placebo Daily | placebo tablet, once a day for one year then for two years open label risedronate | | OG001 | Risedronate Daily | risedronate tablet, once a day for one year then for two years open label risedronate once a day |
| |
| 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. | | Posted | | Least Squares Mean | 95% Confidence Interval | Percent Change | | Baseline and 12 Months | | | | ID | Title | Description |
|---|
| OG000 | Placebo Daily | placebo tablet, once a day for one year then for two years open label risedronate | | OG001 | Risedronate Daily | risedronate tablet, once a day for one year then for two years open label risedronate once a day |
| |
| 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. | | Posted | | Least Squares Mean | 95% Confidence Interval | Percent Change | | Baseline and 24 Months | | | | ID | Title | Description |
|---|
| OG000 | Placebo Daily | placebo tablet, once a day for one year then for two years open label risedronate | | OG001 | Risedronate Daily | risedronate tablet, once a day for one year then for two years open label risedronate once a day |
| |
| 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. | | Posted | | Least Squares Mean | 95% Confidence Interval | Percent Change | | Baseline and 36 Months | | | | ID | Title | Description |
|---|
| OG000 | Placebo Daily | placebo tablet, once a day for one year then for two years open label risedronate | | OG001 | Risedronate Daily | risedronate tablet, once a day for one year then for two years open label risedronate once a day |
| |
| 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. | | Posted | | Least Squares Mean | 95% Confidence Interval | Percent Change | | Baseline and Endpoint / Month 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Daily | placebo tablet, once a day for one year then for two years open label risedronate | | OG001 | Risedronate Daily | risedronate tablet, once a day for one year then for two years open label risedronate once a day |
| |
| 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. | | Posted | | Least Squares Mean | 95% Confidence Interval | Percent Change | | Baseline and Month 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Daily | placebo tablet, once a day for one year then for two years open label risedronate | | OG001 | Risedronate Daily | risedronate tablet, once a day for one year then for two years open label risedronate once a day |
| |
| 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. | | Posted | | Least Squares Mean | 95% Confidence Interval | Percent Change | | Baseline and Month 36 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Daily | placebo tablet, once a day for one year then for two years open label risedronate | | OG001 | Risedronate Daily | risedronate tablet, once a day for one year then for two years open label risedronate once a day |
| |
| 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. | | Posted | | Least Squares Mean | 95% Confidence Interval | Units on a Scale | | Baseline and Month 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Daily | placebo tablet, once a day for one year then for two years open label risedronate | | OG001 | Risedronate Daily | risedronate tablet, once a day for one year then for two years open label risedronate once a day |
| |
| Secondary | Bone Age (Years), Change From Baseline to Month 12, ITT Population | Bone Age determined by visual assessment of hand / wrist radiographs. | | Posted | | Least Squares Mean | 95% Confidence Interval | Years | | Baseline and Month 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Daily | placebo tablet, once a day for one year then for two years open label risedronate | | OG001 | Risedronate Daily | risedronate tablet, once a day for one year then for two years open label risedronate once a day |
| |
| Secondary | Bone Age (Years), Change From Baseline to Month 24, ITT Population | Bone Age determined by visual assessment of hand / wrist radiographs. | | Posted | | Least Squares Mean | 95% Confidence Interval | Years | | Baseline and Month 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Daily | placebo tablet, once a day for one year then for two years open label risedronate | | OG001 | Risedronate Daily | risedronate tablet, once a day for one year then for two years open label risedronate once a day |
| |
| Secondary | Bone Age (Years), Change From Baseline to Month 36, ITT Population | Bone Age determined by visual assessment of hand / wrist radiographs. | | Posted | | Least Squares Mean | 95% Confidence Interval | Years | | Baseline and Month 36 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Daily | placebo tablet, once a day for one year then for two years open label risedronate | | OG001 | Risedronate Daily | risedronate tablet, once a day for one year then for two years open label risedronate once a day |
| |
| 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)] | ITT Population, Number of Participants Analyzed = Number of participants at baseline and Month 12 data | Posted | | Least Squares Mean | 95% Confidence Interval | Change in Annualized Growth Velocity | | Baseline and Month 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Daily | placebo tablet, once a day for one year then for two years open label risedronate | | OG001 | Risedronate Daily | risedronate tablet, once a day for one year then for two years open label risedronate once a day |
| |
| 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)] | ITT Population, Number of Participants Analyzed = Number of participants at baseline and Month 12 data | Posted | | Least Squares Mean | 95% Confidence Interval | Change in Annualized Growth Velocity | | Baseline and Month 36 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Daily | placebo tablet, once a day for one year then for two years open label risedronate | | OG001 | Risedronate Daily | risedronate tablet, once a day for one year then for two years open label risedronate once a day |
| |