Other Osteoporosis
Conditions
Brief summary
Two year study to determine the safety and efficacy of weekly 35 mg Risedronate doses in men with osteoporosis followed by a two year follow-up study.
Interventions
DRUGPlacebo tablet
one placebo once a week for two years followed by one 35 mg risedronate once a week for two years
DRUGRisedronate
one 35 mg risedronate once a week for two years followed by one 35 mg risedronate once a week for two years
Sponsors
Sanofi
Warner Chilcott
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
30 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Documented osteoporosis of the femoral neck and lumbar spine
Exclusion criteria
* BMI greater than or equal to 35
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), 24 Months/Endpoint, ITT Population. | Baseline to 24 Months/Endpoint | DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Site will perform at screening to determine if scan should be forwarded to central facility for analysis. Mean of 2 scans performed read by central lab to determine entry qualification. Results standardized (sBMD): Hologic sBMD = 1000 x (BMD x 1.0755), Lunar sBMD = 1000 x (BMD x 0.9522). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change From Baseline in NTx/Cr (Type I Collagen N-telopeptide/Creatinine), Month 3, ITT Population. | Baseline to Month 3 | — |
| Percent Change From Baseline in NTx/Cr, Month 6, ITT Population. | Baseline to Month 6 | — |
| Percent Change From Baseline in Lumbar Spine BMD, Month 6, ITT Population. | Baseline to Month 6 | DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines and forwarded to central laboratory for reading.DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Results standardized (sBMD): Hologic sBMD = 1000 x (BMD x 1.0755), Lunar sBMD = 1000 x (BMD x 0.9522). |
| Percent Change From Baseline in Lumbar Spine BMD, Month 12, ITT Population. | Baseline to Month 12 | DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines and forwarded to central laboratory for reading. Results standardized (sBMD): Hologic sBMD = 1000 x (BMD x 1.0755), Lunar sBMD = 1000 x (BMD x 0.9522). |
| Percent Change From Baseline in Lumbar Spine BMD, Month 24, ITT Population. | Baseline to Month 24 | DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines and forwarded to central laboratory for reading. Mean of 2 scans performed. Results standardized (sBMD): Hologic sBMD = 1000 x (BMD x 1.0755), Lunar sBMD = 1000 x (BMD x 0.9522). |
| Percent Change From Baseline in Total Proximal Femur BMD, Month 6, ITT Population. | Baseline to Month 6 | DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines and forwarded to central laboratory for reading. Results standardized (sBMD): Hologic sBMD = 1000 x (1.008 x BMD + 0.006), Lunar sBMD = 1000 x (0.979 x BMD - 0.031). |
| Percent Change From Baseline in Total Proximal Femur BMD, Month 12, ITT Population. | Baseline to Month 12 | DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines and forwarded to central laboratory for reading. Results standardized (sBMD): Hologic sBMD = 1000 x (1.008 x BMD + 0.006), Lunar sBMD = 1000 x (0.979 x BMD - 0.031). |
| Percent Change From Baseline in NTx/Cr, Month 12, ITT Population. | Baseline to Month 12 | — |
| Percent Change From Baseline in Total Proximal Femur BMD, Month 24, ITT Population. | Baseline to Month 24 | DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Scans will be forwarded to central facility for analysis. Mean of 2 scans performed will be utilized. Results standardized (sBMD): Hologic sBMD = 1000 x (1.008 x BMD + 0.006), Lunar sBMD = 1000 x (0.979 x BMD - 0.031). |
| Percent Change From Baseline in Total Proximal Femur BMD, 24 Months/Endpoint, ITT Population. | Baseline to 24 Months/Endpoint | DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Scans will be forwarded to central facility for analysis. Mean of 2 scans performed will be utilized. Results standardized (sBMD): Hologic sBMD = 1000 x (1.008 x BMD + 0.006), Lunar sBMD = 1000 x (0.979 x BMD - 0.031). |
| Percent Change From Baseline in Femoral Neck BMD, Month 6, ITT Population. | Baseline to Month 6 | DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Scans will be forwarded to central facility for analysis. Baseline femoral neck values measured on Lunar instruments will be normalized to Hologic reference. Hologic Reference BMD = (0.836 x BMD\[lunar\]) - 0.008 |
| Percent Change From Baseline in Femoral Neck BMD, Month 12, ITT Population. | Baseline to Month 12 | DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Scans will be forwarded to central facility for analysis. Baseline femoral neck values measured on Lunar instruments will be normalized to Hologic reference. Hologic reference BMD = (0.836 x BMD\[lunar\]) - 0.008 |
| Percent Change From Baseline in Femoral Neck BMD, Month 24, ITT Population. | Baseline to Month 24 | DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Scans will be forwarded to central facility for analysis. Mean of 2 scans performed will be utilized. Baseline femoral neck values measured on Lunar instruments will be normalized to Hologic reference. Hologic reference BMD = (0.836 x BMD\[lunar\]) - 0.008 |
| Percent Change From Baseline in Femoral Neck BMD, 24 Months/Endpoint, ITT Population. | Baseline to 24 Months/Endpoint | DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Scans will be forwarded to central facility for analysis. Mean of 2 scans performed will be utilized. Baseline femoral neck values measured on Lunar instruments will be normalized to Hologic reference. Hologic reference BMD = (0.836 x BMD\[lunar\]) - 0.008 |
| Percent Change From Baseline in Femoral Trochanter BMD, Month 6, ITT Population. | Baseline to Month 6 | DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Scans will be forwarded to central facility for analysis. |
| Percent Change From Baseline in Femoral Trochanter BMD, Month 12, ITT Population. | Baseline to Month 12 | DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Scans will be forwarded to central facility for analysis. |
| Percent Change From Baseline in NTx/Cr, Month 24, ITT Population. | Baseline to Month 24 | — |
| Percent Change From Baseline in CTx, 24 Months/Endpoint, ITT Population. | Baseline to 24 Months/Endpoint | — |
| Percent Change From Baseline in Femoral Trochanter BMD, 24 Months/Endpoint, ITT Population. | Baseline to 24 Months/Endpoint | DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Scans will be forwarded to central facility for analysis. |
| Percent Change From Baseline in CTx (Type I Collagen C-telopeptide), Month 3, ITT Population. | Baseline to Month 3 | — |
| Percent Change From Baseline in CTx, Month 6, ITT Population. | Baseline to Month 6 | — |
| Percent Change From Baseline in CTx, Month 12, ITT Population. | Baseline to Month 12 | — |
| Percent Change From Baseline in CTx, Month 24, ITT Population. | Baseline to Month 24 | — |
| Percent Change From Baseline in NTx/Cr, 24 Months/Endpoint, ITT Population. | Baseline to 24 Months/Endpoint | — |
| Percent Change From Baseline in BAP (Bone-specific Alkaline Phosphatase), Month 3, ITT Population. | Baseline to Month 3 | — |
| Percent Change From Baseline in BAP, Month 6, ITT Population. | Baseline to Month 6 | — |
| Percent Change From Baseline in BAP, Month 12, ITT Population. | Baseline to Month 12 | — |
| Percent Change From Baseline in BAP, Month 24, ITT Population. | Baseline to Month 24 | — |
| Percent Change From Baseline in BAP, 24 Months/Endpoint, ITT Population. | Baseline to 24 Months/Endpoint | — |
| Change From Baseline in Body Height, Month 12, ITT Population. | Baseline to Month 12 | — |
| Change From Baseline in Body Height, Month 24, ITT Population. | Baseline to Month 24 | — |
| Change From Baseline in Body Height, 24 Months/Endpoint, ITT Population. | Baseline to 24 Months/Endpoint | — |
| Percent of Responders Lumbar Spine BMD, Month 24, ITT Population | Baseline to Month 24 | responder = positive change (\>0) in lumbar spine BMD from Baseline to Month 24 |
| Cumulative Incidence of Fractures, 12 Months, ITT Population | Baseline to Month 12 | Kaplan-Meier Cumulative Incidence, fractures / 100 patients / year |
| Cumulative Incidence of Fractures, 24 Months, ITT Population | Baseline to Month 24 | Kaplan-Meier Cumulative Incidence, fractures / 100 patients / 2 years |
| Percent Change From Baseline in Femoral Trochanter BMD, Month 24, ITT Population. | Baseline to Month 24 | DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Scans will be forwarded to central facility for analysis. |
Countries
Australia, Belgium, Czechia, France, Hungary, Lebanon, Netherlands, Poland, United Kingdom, United States
Participant flow
Recruitment details
Recruitment began on 03 Jun 2002.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years | 93 |
| Risedronate 35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years | 192 |
| Total | 285 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Month 24 Double-Blind | Adverse Event | 9 | 7 |
| Month 24 Double-Blind | Did not take any study medication | 0 | 1 |
| Month 24 Double-Blind | Lost to Follow-up | 1 | 0 |
| Month 24 Double-Blind | Protocol Violation | 1 | 0 |
| Month 24 Double-Blind | Withdrawal by Subject | 7 | 9 |
| Month 48 Open-Label | Adverse Event | 4 | 4 |
| Month 48 Open-Label | Lost to Follow-up | 2 | 4 |
| Month 48 Open-Label | Withdrawal by Subject | 6 | 9 |
Baseline characteristics
| Characteristic | Placebo | Risedronate | Total |
|---|---|---|---|
| Age, Customized < 65 years | 49 participants | 120 participants | 169 participants |
| Age, Customized >=75 years | 10 participants | 20 participants | 30 participants |
| Age, Customized Between 65 and <75 years | 34 participants | 51 participants | 85 participants |
| Region of Enrollment Australia | 3 participants | 7 participants | 10 participants |
| Region of Enrollment Belgium | 12 participants | 24 participants | 36 participants |
| Region of Enrollment Czech Republic | 5 participants | 12 participants | 17 participants |
| Region of Enrollment France | 2 participants | 7 participants | 9 participants |
| Region of Enrollment Hungary | 11 participants | 20 participants | 31 participants |
| Region of Enrollment Lebanon | 2 participants | 4 participants | 6 participants |
| Region of Enrollment Netherlands | 3 participants | 7 participants | 10 participants |
| Region of Enrollment Poland | 35 participants | 73 participants | 108 participants |
| Region of Enrollment United Kingdom | 3 participants | 6 participants | 9 participants |
| Region of Enrollment United States | 17 participants | 32 participants | 49 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 93 Participants | 192 Participants | 285 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 | 66 / 93 | 134 / 191 | 46 / 67 | 97 / 151 |
| serious Total, serious adverse events | 15 / 93 | 29 / 191 | 8 / 67 | 21 / 151 |
Outcome results
Primary
Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), 24 Months/Endpoint, ITT Population.
DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Site will perform at screening to determine if scan should be forwarded to central facility for analysis. Mean of 2 scans performed read by central lab to determine entry qualification. Results standardized (sBMD): Hologic sBMD = 1000 x (BMD x 1.0755), Lunar sBMD = 1000 x (BMD x 0.9522).
Time frame: Baseline to 24 Months/Endpoint
Population: ITT Population, LOCF (Last Observation Carried Forward)
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo | Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), 24 Months/Endpoint, ITT Population. | 1.22 Percent Change |
| Risedronate | Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), 24 Months/Endpoint, ITT Population. | 5.75 Percent Change |
Comparison: A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.p-value: <0.000195% CI: [3.46, 5.6]ANOVA
Secondary
Change From Baseline in Body Height, 24 Months/Endpoint, ITT Population.
Time frame: Baseline to 24 Months/Endpoint
Population: ITT Population, LOCF (Last Observation Carried Forward)
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo | Change From Baseline in Body Height, 24 Months/Endpoint, ITT Population. | -2.39 millimeters |
| Risedronate | Change From Baseline in Body Height, 24 Months/Endpoint, ITT Population. | -2.68 millimeters |
Comparison: A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.p-value: 0.78495% CI: [-2.39, 1.81]ANOVA
Secondary
Change From Baseline in Body Height, Month 12, ITT Population.
Time frame: Baseline to Month 12
Population: ITT Population
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo | Change From Baseline in Body Height, Month 12, ITT Population. | -0.77 millimeters |
| Risedronate | Change From Baseline in Body Height, Month 12, ITT Population. | -0.92 millimeters |
Comparison: A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.p-value: 0.879495% CI: [-1.99, 1.71]ANOVA
Secondary
Change From Baseline in Body Height, Month 24, ITT Population.
Time frame: Baseline to Month 24
Population: ITT Population
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo | Change From Baseline in Body Height, Month 24, ITT Population. | -2.66 millimeters |
| Risedronate | Change From Baseline in Body Height, Month 24, ITT Population. | -3.13 millimeters |
Comparison: A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.p-value: 0.665895% CI: [-2.62, 1.67]ANOVA
Secondary
Cumulative Incidence of Fractures, 12 Months, ITT Population
Kaplan-Meier Cumulative Incidence, fractures / 100 patients / year
Time frame: Baseline to Month 12
Population: ITT Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Cumulative Incidence of Fractures, 12 Months, ITT Population | 3.4 Fractures / 100 patients / year |
| Risedronate | Cumulative Incidence of Fractures, 12 Months, ITT Population | 2.7 Fractures / 100 patients / year |
Comparison: A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.p-value: 0.728495% CI: [0.184, 3.226]Log Rank
Secondary
Cumulative Incidence of Fractures, 24 Months, ITT Population
Kaplan-Meier Cumulative Incidence, fractures / 100 patients / 2 years
Time frame: Baseline to Month 24
Population: ITT Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Cumulative Incidence of Fractures, 24 Months, ITT Population | 7.7 Fractures / 100 patients / 2 years |
| Risedronate | Cumulative Incidence of Fractures, 24 Months, ITT Population | 4.9 Fractures / 100 patients / 2 years |
Comparison: A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.p-value: 0.529395% CI: [0.245, 1.932]Log Rank
Secondary
Percent Change From Baseline in BAP, 24 Months/Endpoint, ITT Population.
Time frame: Baseline to 24 Months/Endpoint
Population: ITT Population, LOCF (Last Observation Carried Forward)
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo | Percent Change From Baseline in BAP, 24 Months/Endpoint, ITT Population. | 1.99 Percent Change |
| Risedronate | Percent Change From Baseline in BAP, 24 Months/Endpoint, ITT Population. | -25.27 Percent Change |
Comparison: A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.p-value: <0.000195% CI: [-37.63, -16.87]ANOVA
Secondary
Percent Change From Baseline in BAP (Bone-specific Alkaline Phosphatase), Month 3, ITT Population.
Time frame: Baseline to Month 3
Population: ITT Population
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo | Percent Change From Baseline in BAP (Bone-specific Alkaline Phosphatase), Month 3, ITT Population. | -8.89 percent |
| Risedronate | Percent Change From Baseline in BAP (Bone-specific Alkaline Phosphatase), Month 3, ITT Population. | -24.53 percent |
Comparison: A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.p-value: <0.000195% CI: [-19.29, -11.99]ANOVA
Secondary
Percent Change From Baseline in BAP, Month 12, ITT Population.
Time frame: Baseline to Month 12
Population: ITT Population
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo | Percent Change From Baseline in BAP, Month 12, ITT Population. | -7.11 Percent Change |
| Risedronate | Percent Change From Baseline in BAP, Month 12, ITT Population. | -29.51 Percent Change |
Comparison: A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.p-value: <0.000195% CI: [-27.8, -16.98]ANOVA
Secondary
Percent Change From Baseline in BAP, Month 24, ITT Population.
Time frame: Baseline to Month 24
Population: ITT Population
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo | Percent Change From Baseline in BAP, Month 24, ITT Population. | 2.95 percent |
| Risedronate | Percent Change From Baseline in BAP, Month 24, ITT Population. | -25.20 percent |
Comparison: A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.p-value: <0.000195% CI: [-39.84, -16.47]ANOVA
Secondary
Percent Change From Baseline in BAP, Month 6, ITT Population.
Time frame: Baseline to Month 6
Population: ITT Population
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo | Percent Change From Baseline in BAP, Month 6, ITT Population. | -8.68 Percent Change |
| Risedronate | Percent Change From Baseline in BAP, Month 6, ITT Population. | -29.78 Percent Change |
Comparison: A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.p-value: <0.000195% CI: [-25.61, -16.59]ANOVA
Secondary
Percent Change From Baseline in CTx, 24 Months/Endpoint, ITT Population.
Time frame: Baseline to 24 Months/Endpoint
Population: ITT Population, LOCF (Last Observation Carried Forward)
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo | Percent Change From Baseline in CTx, 24 Months/Endpoint, ITT Population. | 6.39 Percent Change |
| Risedronate | Percent Change From Baseline in CTx, 24 Months/Endpoint, ITT Population. | -38.76 Percent Change |
Comparison: A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.p-value: <0.000195% CI: [-57.01, -33.29]ANOVA
Secondary
Percent Change From Baseline in CTx, Month 12, ITT Population.
Time frame: Baseline to Month 12
Population: ITT Population
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo | Percent Change From Baseline in CTx, Month 12, ITT Population. | -19.12 Percent Change |
| Risedronate | Percent Change From Baseline in CTx, Month 12, ITT Population. | -61.46 Percent Change |
Comparison: A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.p-value: <0.000195% CI: [-55.99, -28.67]ANOVA
Secondary
Percent Change From Baseline in CTx, Month 24, ITT Population.
Time frame: Baseline to Month 24
Population: ITT Population
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo | Percent Change From Baseline in CTx, Month 24, ITT Population. | 9.28 Percent Change |
| Risedronate | Percent Change From Baseline in CTx, Month 24, ITT Population. | -37.27 Percent Change |
Comparison: A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.p-value: <0.000195% CI: [-59.38, -33.72]ANOVA
Secondary
Percent Change From Baseline in CTx, Month 6, ITT Population.
Time frame: Baseline to Month 6
Population: ITT Population
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo | Percent Change From Baseline in CTx, Month 6, ITT Population. | -13.72 Percent Change |
| Risedronate | Percent Change From Baseline in CTx, Month 6, ITT Population. | -58.44 Percent Change |
Comparison: A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.p-value: <0.000195% CI: [-58.01, -31.43]ANOVA
Secondary
Percent Change From Baseline in CTx (Type I Collagen C-telopeptide), Month 3, ITT Population.
Time frame: Baseline to Month 3
Population: ITT Population
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo | Percent Change From Baseline in CTx (Type I Collagen C-telopeptide), Month 3, ITT Population. | -14.56 Percent Change |
| Risedronate | Percent Change From Baseline in CTx (Type I Collagen C-telopeptide), Month 3, ITT Population. | -58.16 Percent Change |
Comparison: A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.p-value: <0.000195% CI: [-51.52, -35.67]ANOVA
Secondary
Percent Change From Baseline in Femoral Neck BMD, 24 Months/Endpoint, ITT Population.
DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Scans will be forwarded to central facility for analysis. Mean of 2 scans performed will be utilized. Baseline femoral neck values measured on Lunar instruments will be normalized to Hologic reference. Hologic reference BMD = (0.836 x BMD\[lunar\]) - 0.008
Time frame: Baseline to 24 Months/Endpoint
Population: ITT Population, LOCF (Last Observation Carried Forward)
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo | Percent Change From Baseline in Femoral Neck BMD, 24 Months/Endpoint, ITT Population. | 0.53 Percent Change |
| Risedronate | Percent Change From Baseline in Femoral Neck BMD, 24 Months/Endpoint, ITT Population. | 1.59 Percent Change |
Comparison: A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.p-value: 0.018795% CI: [0.18, 1.94]ANOVA
Secondary
Percent Change From Baseline in Femoral Neck BMD, Month 12, ITT Population.
DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Scans will be forwarded to central facility for analysis. Baseline femoral neck values measured on Lunar instruments will be normalized to Hologic reference. Hologic reference BMD = (0.836 x BMD\[lunar\]) - 0.008
Time frame: Baseline to Month 12
Population: ITT Population
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo | Percent Change From Baseline in Femoral Neck BMD, Month 12, ITT Population. | 0.62 Percent Change |
| Risedronate | Percent Change From Baseline in Femoral Neck BMD, Month 12, ITT Population. | 1.49 Percent Change |
Comparison: A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.p-value: 0.053795% CI: [-0.01, 1.74]ANOVA
Secondary
Percent Change From Baseline in Femoral Neck BMD, Month 24, ITT Population.
DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Scans will be forwarded to central facility for analysis. Mean of 2 scans performed will be utilized. Baseline femoral neck values measured on Lunar instruments will be normalized to Hologic reference. Hologic reference BMD = (0.836 x BMD\[lunar\]) - 0.008
Time frame: Baseline to Month 24
Population: ITT Population
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo | Percent Change From Baseline in Femoral Neck BMD, Month 24, ITT Population. | 0.42 Percent Change |
| Risedronate | Percent Change From Baseline in Femoral Neck BMD, Month 24, ITT Population. | 1.65 Percent Change |
Comparison: A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.p-value: 0.008195% CI: [0.32, 2.15]ANOVA
Secondary
Percent Change From Baseline in Femoral Neck BMD, Month 6, ITT Population.
DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Scans will be forwarded to central facility for analysis. Baseline femoral neck values measured on Lunar instruments will be normalized to Hologic reference. Hologic Reference BMD = (0.836 x BMD\[lunar\]) - 0.008
Time frame: Baseline to Month 6
Population: ITT Population
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo | Percent Change From Baseline in Femoral Neck BMD, Month 6, ITT Population. | 0.48 Percent Change |
| Risedronate | Percent Change From Baseline in Femoral Neck BMD, Month 6, ITT Population. | 0.98 Percent Change |
Comparison: A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.p-value: 0.253895% CI: [-0.36, 1.36]ANOVA
Secondary
Percent Change From Baseline in Femoral Trochanter BMD, 24 Months/Endpoint, ITT Population.
DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Scans will be forwarded to central facility for analysis.
Time frame: Baseline to 24 Months/Endpoint
Population: ITT Population, LOCF (Last Observation Carried Forward)
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo | Percent Change From Baseline in Femoral Trochanter BMD, 24 Months/Endpoint, ITT Population. | 0.57 Percent Change |
| Risedronate | Percent Change From Baseline in Femoral Trochanter BMD, 24 Months/Endpoint, ITT Population. | 2.73 Percent Change |
Comparison: A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.p-value: <0.000195% CI: [1.22, 3.08]ANOVA
Secondary
Percent Change From Baseline in Femoral Trochanter BMD, Month 12, ITT Population.
DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Scans will be forwarded to central facility for analysis.
Time frame: Baseline to Month 12
Population: ITT Population
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo | Percent Change From Baseline in Femoral Trochanter BMD, Month 12, ITT Population. | 0.81 Percent Change |
| Risedronate | Percent Change From Baseline in Femoral Trochanter BMD, Month 12, ITT Population. | 1.89 Percent Change |
Comparison: A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.p-value: 0.012995% CI: [0.23, 1.92]ANOVA
Secondary
Percent Change From Baseline in Femoral Trochanter BMD, Month 24, ITT Population.
DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Scans will be forwarded to central facility for analysis.
Time frame: Baseline to Month 24
Population: ITT Population
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo | Percent Change From Baseline in Femoral Trochanter BMD, Month 24, ITT Population. | 0.52 Percent Change |
| Risedronate | Percent Change From Baseline in Femoral Trochanter BMD, Month 24, ITT Population. | 2.83 Percent Change |
Comparison: A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.p-value: <0.000195% CI: [1.35, 3.26]ANOVA
Secondary
Percent Change From Baseline in Femoral Trochanter BMD, Month 6, ITT Population.
DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Scans will be forwarded to central facility for analysis.
Time frame: Baseline to Month 6
Population: ITT Population
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo | Percent Change From Baseline in Femoral Trochanter BMD, Month 6, ITT Population. | 0.67 Percent Change |
| Risedronate | Percent Change From Baseline in Femoral Trochanter BMD, Month 6, ITT Population. | 1.24 Percent Change |
Comparison: A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.p-value: 0.140895% CI: [-0.19, 1.34]ANOVA
Secondary
Percent Change From Baseline in Lumbar Spine BMD, Month 12, ITT Population.
DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines and forwarded to central laboratory for reading. Results standardized (sBMD): Hologic sBMD = 1000 x (BMD x 1.0755), Lunar sBMD = 1000 x (BMD x 0.9522).
Time frame: Baseline to Month 12
Population: ITT Population
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo | Percent Change From Baseline in Lumbar Spine BMD, Month 12, ITT Population. | 1.42 Percent Change |
| Risedronate | Percent Change From Baseline in Lumbar Spine BMD, Month 12, ITT Population. | 4.60 Percent Change |
Comparison: A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.p-value: <0.000195% CI: [2.19, 4.16]ANOVA
Secondary
Percent Change From Baseline in Lumbar Spine BMD, Month 24, ITT Population.
DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines and forwarded to central laboratory for reading. Mean of 2 scans performed. Results standardized (sBMD): Hologic sBMD = 1000 x (BMD x 1.0755), Lunar sBMD = 1000 x (BMD x 0.9522).
Time frame: Baseline to Month 24
Population: ITT Population
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo | Percent Change From Baseline in Lumbar Spine BMD, Month 24, ITT Population. | 1.40 Percent Change |
| Risedronate | Percent Change From Baseline in Lumbar Spine BMD, Month 24, ITT Population. | 5.98 Percent Change |
Comparison: A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.p-value: <0.000195% CI: [3.49, 5.66]ANOVA
Secondary
Percent Change From Baseline in Lumbar Spine BMD, Month 6, ITT Population.
DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines and forwarded to central laboratory for reading.DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Results standardized (sBMD): Hologic sBMD = 1000 x (BMD x 1.0755), Lunar sBMD = 1000 x (BMD x 0.9522).
Time frame: Baseline to Month 6
Population: ITT Population
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo | Percent Change From Baseline in Lumbar Spine BMD, Month 6, ITT Population. | 1.03 Percent Change |
| Risedronate | Percent Change From Baseline in Lumbar Spine BMD, Month 6, ITT Population. | 3.60 Percent Change |
Comparison: A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.p-value: <0.000195% CI: [1.66, 3.47]ANOVA
Secondary
Percent Change From Baseline in NTx/Cr, 24 Months/Endpoint, ITT Population.
Time frame: Baseline to 24 Months/Endpoint
Population: ITT Population, LOCF (Last Observation Carried Forward)
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo | Percent Change From Baseline in NTx/Cr, 24 Months/Endpoint, ITT Population. | -20.45 Percent Change |
| Risedronate | Percent Change From Baseline in NTx/Cr, 24 Months/Endpoint, ITT Population. | -36.82 Percent Change |
Comparison: A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.p-value: 0.000395% CI: [-25.24, -7.49]ANOVA
Secondary
Percent Change From Baseline in NTx/Cr, Month 12, ITT Population.
Time frame: Baseline to Month 12
Population: ITT Population
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo | Percent Change From Baseline in NTx/Cr, Month 12, ITT Population. | -16.46 Percent Change |
| Risedronate | Percent Change From Baseline in NTx/Cr, Month 12, ITT Population. | -38.42 Percent Change |
Comparison: A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.p-value: <0.000195% CI: [-30.75, -13.17]ANOVA
Secondary
Percent Change From Baseline in NTx/Cr, Month 24, ITT Population.
Time frame: Baseline to Month 24
Population: ITT Population
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo | Percent Change From Baseline in NTx/Cr, Month 24, ITT Population. | -22.27 Percent Change |
| Risedronate | Percent Change From Baseline in NTx/Cr, Month 24, ITT Population. | -37.38 Percent Change |
Comparison: A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.p-value: 0.001295% CI: [-24.2, -6.02]ANOVA
Secondary
Percent Change From Baseline in NTx/Cr, Month 6, ITT Population.
Time frame: Baseline to Month 6
Population: ITT Population
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo | Percent Change From Baseline in NTx/Cr, Month 6, ITT Population. | -7.98 Percent Change |
| Risedronate | Percent Change From Baseline in NTx/Cr, Month 6, ITT Population. | -29.97 Percent Change |
Comparison: A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.p-value: <0.000195% CI: [-31.08, -12.91]ANOVA
Secondary
Percent Change From Baseline in NTx/Cr (Type I Collagen N-telopeptide/Creatinine), Month 3, ITT Population.
Time frame: Baseline to Month 3
Population: ITT Population
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo | Percent Change From Baseline in NTx/Cr (Type I Collagen N-telopeptide/Creatinine), Month 3, ITT Population. | -17.41 Percent Change |
| Risedronate | Percent Change From Baseline in NTx/Cr (Type I Collagen N-telopeptide/Creatinine), Month 3, ITT Population. | -33.28 Percent Change |
Comparison: A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.p-value: <0.000195% CI: [-23.43, -8.32]ANOVA
Secondary
Percent Change From Baseline in Total Proximal Femur BMD, 24 Months/Endpoint, ITT Population.
DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Scans will be forwarded to central facility for analysis. Mean of 2 scans performed will be utilized. Results standardized (sBMD): Hologic sBMD = 1000 x (1.008 x BMD + 0.006), Lunar sBMD = 1000 x (0.979 x BMD - 0.031).
Time frame: Baseline to 24 Months/Endpoint
Population: ITT Population, LOCF (Last Observation Carried Forward)
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo | Percent Change From Baseline in Total Proximal Femur BMD, 24 Months/Endpoint, ITT Population. | 0.24 Percent Change |
| Risedronate | Percent Change From Baseline in Total Proximal Femur BMD, 24 Months/Endpoint, ITT Population. | 1.71 Percent Change |
Comparison: A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.p-value: <0.000195% CI: [0.76, 2.17]ANOVA
Secondary
Percent Change From Baseline in Total Proximal Femur BMD, Month 12, ITT Population.
DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines and forwarded to central laboratory for reading. Results standardized (sBMD): Hologic sBMD = 1000 x (1.008 x BMD + 0.006), Lunar sBMD = 1000 x (0.979 x BMD - 0.031).
Time frame: Baseline to Month 12
Population: ITT Population
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo | Percent Change From Baseline in Total Proximal Femur BMD, Month 12, ITT Population. | 0.74 Percent Change |
| Risedronate | Percent Change From Baseline in Total Proximal Femur BMD, Month 12, ITT Population. | 1.38 Percent Change |
Comparison: A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.p-value: 0.034695% CI: [0.05, 1.25]ANOVA
Secondary
Percent Change From Baseline in Total Proximal Femur BMD, Month 24, ITT Population.
DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Scans will be forwarded to central facility for analysis. Mean of 2 scans performed will be utilized. Results standardized (sBMD): Hologic sBMD = 1000 x (1.008 x BMD + 0.006), Lunar sBMD = 1000 x (0.979 x BMD - 0.031).
Time frame: Baseline to Month 24
Population: ITT Population
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo | Percent Change From Baseline in Total Proximal Femur BMD, Month 24, ITT Population. | 0.06 Percent Change |
| Risedronate | Percent Change From Baseline in Total Proximal Femur BMD, Month 24, ITT Population. | 1.76 Percent Change |
Comparison: A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.p-value: <0.000195% CI: [0.98, 2.41]ANOVA
Secondary
Percent Change From Baseline in Total Proximal Femur BMD, Month 6, ITT Population.
DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines and forwarded to central laboratory for reading. Results standardized (sBMD): Hologic sBMD = 1000 x (1.008 x BMD + 0.006), Lunar sBMD = 1000 x (0.979 x BMD - 0.031).
Time frame: Baseline to Month 6
Population: ITT Population
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo | Percent Change From Baseline in Total Proximal Femur BMD, Month 6, ITT Population. | 0.76 Percent Change |
| Risedronate | Percent Change From Baseline in Total Proximal Femur BMD, Month 6, ITT Population. | 1.16 Percent Change |
Comparison: A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.p-value: 0.185695% CI: [-0.19, 0.99]ANOVA
Secondary
Percent of Responders Lumbar Spine BMD, Month 24, ITT Population
responder = positive change (\>0) in lumbar spine BMD from Baseline to Month 24
Time frame: Baseline to Month 24
Population: ITT Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percent of Responders Lumbar Spine BMD, Month 24, ITT Population | 60.3 Percentage of Participants |
| Risedronate | Percent of Responders Lumbar Spine BMD, Month 24, ITT Population | 89.5 Percentage of Participants |
Comparison: A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.p-value: <0.0001Cochran-Mantel-Haenszel