Post Menopausal Osteoporosis
Conditions
Brief summary
This study will compare the efficacy and safety of different treatment regimens of oral Bonviva tablets in women with post-menopausal osteoporosis. Patients will also receive daily supplementation with vitamin D and calcium. The anticipated time of study treatment is 2+ years, and the target sample size is 500+ individuals.
Interventions
2.5mg po daily
DIETARY_SUPPLEMENTCalcium
500 mg/day
DIETARY_SUPPLEMENTVitamin D
400 IU/day
Sponsors
Hoffmann-La Roche
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
FEMALE
Age
55 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* women 55-80 years of age; * post-menopausal for \>= 5 years; * ambulatory.
Exclusion criteria
* malignant disease diagnosed within the previous 10 years (except basal cell cancer that has been successfully removed); * breast cancer within the previous 20 years; * allergy to bisphosphonates; * previous treatment with an intravenous bisphosphonate at any time; * previous treatment with an oral bisphosphonate within the last 6 months, \>1 month of treatment within the last year, or \>3 months of treatment within the last 2 years.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Relative Change From Baseline at One Year (12 Months) in Mean Lumbar Spine (L2 - L4) Bone Mineral Density | From Baseline (Month 0) to Month 12 | Relative change in Bone Mineral Density (BMD) is the percentage change from baseline of BMD of vertebrae L2 - L4 that are not fractured and not affected by an osteoarthritic process to such a degree that accurate measurement of BMD would be considered jeopardized by the central reading center after 12 months of treatment. It is calculated as the sum of bone mineral content divided by the sum of area of all lumbar vertebrae L2 - L4 that are not fractured and not affected by an osteoarthritic process at Month 12. Participants available at particular time point for assessment were included in the analysis. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Femoral Neck BMD Above or Equal to Baseline at Months 12 and 24 | Months 12 and 24 | A participant is a responder if the mean femoral neck BMD had remained the same or increased above baseline. |
| Relative Change From Baseline at Two Years (24 Months) in Mean Lumbar Spine (L2-L4) BMD | From Baseline (Month 0) to Month 24 | Relative change in BMD is the percentage change from baseline of BMD of vertebrae L2 - L4 that are not fractured and not affected by an osteoarthritic process to such a degree that accurate measurement of BMD would be considered jeopardized by the central reading center after 24 months of treatment. It is calculated as the sum of bone mineral content divided by the sum of area of all lumbar vertebrae L2 - L4 that are not fractured and not affected by an osteoarthritic process at Month 24. |
| Absolute Change From Baseline at One Year (12 Months) and Two Years (24 Months) in Mean Lumbar Spine (L2-L4) BMD | From Baseline (Month 0) to Months 12 and 24 | The absolute change (g/cm\^2) from baseline in mean BMD of the lumbar spine (L2 - L4) at one and two years. A difference in the mean values between the active groups and the control was calculated. |
| Relative Change From Baseline at One Year (12 Months) and Two Years (24 Months) in Mean Proximal Femur ( Total Hip, Trochanter, Femoral Neck) BMD | From Baseline (Month 0) to Months 12 and 24 | Proximal femur BMD was measured by dual-energy X ray absorptiometry at baseline, after one and two years of treatment and was read by a central reading center. |
| Absolute Change From Baseline at One Year (12 Months) and Two Years (24 Months) in Mean Proximal Femur ( Total Hip, Trochanter, Femoral Neck) BMD. | From Baseline (Month 0) to Months 12 and 24 | Proximal femur BMD was measured by dual-energy X-ray absorptiometry at baseline, after one and two years of treatment and was read by a central reading center |
| Percentage of Participants With Mean Lumbar Spine (L2 - L4) BMD Above or Equal to Baseline at Months 12 and 24 | Months 12 and 24 | A participant is a responder if the mean lumber spine (L2 - L4) BMD had remained the same or increased above baseline. |
| Percentage of Participants With Total Hip BMD Above or Equal to Baseline at Months 12 and 24 | Months 12 and 24 | A participant is a responder if the mean total hip BMD had remained the same or increased above baseline. |
| Percentage of Participants With Trochanter BMD Above or Equal to Baseline at Months 12 and 24 | Months 12 and 24 | A participant is a responder if the mean trochanter BMD had remained the same or increased above baseline. |
| Percentage of Participants With Mean Trochanter and Lumbar Spine BMD Above or Equal to Baseline at Months 12 and 24 | Months 12 and 24 | A participant is a responder if the mean trochanter and lumbar spine BMD had remained the same or increased above baseline. |
| Percentage of Participants With Mean Femoral Neck and Lumbar Spine BMD Above or Equal to Baseline at Months 12 and 24 | Months 12 and 24 | A participant is a responder if the mean femoral neck and lumbar spine BMD had remained the same or increased above baseline. |
| Relative Change In Baseline in Serum C-telopeptide of Alpha-chain of Type I Collagen [ CTX] ] to Months 3, 6, 12, and 24 | From Baseline (Month 0) to Months 3, 6, 12, 24 | Serum CTX, a biochemical marker of bone resorption, was assessed using the Elecsys S-CTX-I assay (an ElectroChemiLuminescence Immunoassay (ECLIA) Technique). |
| Absolute Change In Baseline in Serum CTX to Months 12 and 24 | From Baseline (Month 0) to Months 12 and 24 | Serum CTX, a biochemical marker of bone resorption, was assessed using the Elecsys S-CTX-I assay (an ElectroChemiLuminescence Immunoassay (ECLIA) Technique). |
| Number of Participants With Any Adverse Events and Serious Adverse Event | Up to Month 24 | An Adverse Event (AE) is any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect. |
| Number Of Participants With Marked Laboratory Abnormalities | Up to Month 24 | Marked laboratory abnormalities were defined as those values that were outside the reference range and showed a clinically relevant change from baseline. The reference range for hemoglobin was 110-200 (gram per liter \[g/L\]), hematocrit was 0.31-0.56 fraction, white blood cells (WBC) was 3.0-18.0 (10\*9/L), serum glutamic-pyruvic transaminase (SGPT/ALT) was 0-110 IU/L, blood urea nitrogen (BUN) was 0.0-14.3 (millimoles per Liter \[mmol/L\]), Chloride was 95-115 (mmol/L), Potassium was 3.0 - 6.0 (mmol/L), Sodium was 130-150 (mmol/L), Calcium was 2.00-2.90 (mmol/L), Phosphate was 0.75 - 1.60 (mmol/L) and Creatinine was 0- 154 (micromoles/liter \[umol/L\]. |
| Percentage of Participants With Mean Total Hip and Lumbar Spine BMD Above or Equal to Baseline at Months 12 and 24 | Months 12 and 24 | A participant is a responder if the mean total hip and mean lumbar spine BMD had remained the same or increased above baseline. |
Countries
Australia, Belgium, Brazil, Canada, Czechia, Denmark, France, Germany, Hungary, Italy, Mexico, Norway, Poland, Romania, South Africa, Spain, Switzerland, United Kingdom, United States
Participant flow
Recruitment details
The study was conducted from 26 April 2002 to 08 Dec 2004 across 65 centers in the world.
Pre-assignment details
A total of 1609 participants were randomized, of which 1602 received the study drug.
Participants by arm
| Arm | Count |
|---|---|
| Ibandronate 2.5 mg Participants received 2.5 mg ibandronate PO daily and an oblong placebo tablet PO monthly Participants also received calcium 500 mg /day and vitamin D 400 IU/day. | 395 |
| Ibandronate 50/50 mg Participants received 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day. | 396 |
| Ibandronate 100 mg Participants received 100 mg ibandronate PO monthly divided over two consecutive days (50 mg tablet/day) and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day. | 396 |
| Ibandronate 150 mg Participants received 150 mg ibandronate PO monthly taken on a single day and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day. | 396 |
| Total | 1,583 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 41 | 32 | 44 | 37 |
| Overall Study | Did not follow-up | 5 | 5 | 4 | 5 |
| Overall Study | Early improvement | 6 | 5 | 3 | 0 |
| Overall Study | Lost to Follow-up | 3 | 2 | 4 | 5 |
| Overall Study | Withdrawal by Subject | 20 | 29 | 29 | 32 |
Baseline characteristics
| Characteristic | Ibandronate 2.5 mg | Ibandronate 50/50 mg | Ibandronate 100 mg | Ibandronate 150 mg | Total |
|---|---|---|---|---|---|
| Age, Continuous | 65.8 years STANDARD_DEVIATION 6.61 | 66.0 years STANDARD_DEVIATION 6.71 | 66.2 years STANDARD_DEVIATION 6.38 | 66.2 years STANDARD_DEVIATION 6.64 | 66.0 years STANDARD_DEVIATION 6.58 |
| Sex: Female, Male Female | 395 Participants | 396 Participants | 396 Participants | 396 Participants | 1583 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 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 | 190 / 395 | 190 / 396 | 191 / 396 | 182 / 396 |
| serious Total, serious adverse events | 38 / 395 | 54 / 396 | 55 / 396 | 45 / 396 |
Outcome results
Primary
Relative Change From Baseline at One Year (12 Months) in Mean Lumbar Spine (L2 - L4) Bone Mineral Density
Relative change in Bone Mineral Density (BMD) is the percentage change from baseline of BMD of vertebrae L2 - L4 that are not fractured and not affected by an osteoarthritic process to such a degree that accurate measurement of BMD would be considered jeopardized by the central reading center after 12 months of treatment. It is calculated as the sum of bone mineral content divided by the sum of area of all lumbar vertebrae L2 - L4 that are not fractured and not affected by an osteoarthritic process at Month 12. Participants available at particular time point for assessment were included in the analysis.
Time frame: From Baseline (Month 0) to Month 12
Population: The per-protocol(PP) population included participants in Intent-to-treat(ITT) population who were randomized, received at least one dose of medication and had at least one valid efficacy(BMD or Serum CTX)follow-up data point;defined as any measurement that can be scientifically compared to baseline measurement, and had no major protocol violations.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ibandronate 2.5 mg | Relative Change From Baseline at One Year (12 Months) in Mean Lumbar Spine (L2 - L4) Bone Mineral Density | 3.7427 Percent change | Standard Deviation 4.0149 |
| Ibandronate 50/50 mg | Relative Change From Baseline at One Year (12 Months) in Mean Lumbar Spine (L2 - L4) Bone Mineral Density | 4.3395 Percent change | Standard Deviation 3.9557 |
| Ibandronate 100 mg | Relative Change From Baseline at One Year (12 Months) in Mean Lumbar Spine (L2 - L4) Bone Mineral Density | 4.0328 Percent change | Standard Deviation 3.6815 |
| Ibandronate 150 mg | Relative Change From Baseline at One Year (12 Months) in Mean Lumbar Spine (L2 - L4) Bone Mineral Density | 4.7611 Percent change | Standard Deviation 3.8931 |
p-value: 0.04595% CI: [0.013, 1.216]ANOVA
p-value: 0.33895% CI: [-0.312, 0.906]ANOVA
p-value: 0.00195% CI: [0.395, 1.605]ANOVA
Secondary
Absolute Change From Baseline at One Year (12 Months) and Two Years (24 Months) in Mean Lumbar Spine (L2-L4) BMD
The absolute change (g/cm\^2) from baseline in mean BMD of the lumbar spine (L2 - L4) at one and two years. A difference in the mean values between the active groups and the control was calculated.
Time frame: From Baseline (Month 0) to Months 12 and 24
Population: The PP population consisted of all participants in the ITT population who had no major violations of the protocol. n = number of participants evaluable at particular time of assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ibandronate 2.5 mg | Absolute Change From Baseline at One Year (12 Months) and Two Years (24 Months) in Mean Lumbar Spine (L2-L4) BMD | At 12 months, n = 314, 322, 306, 314 | 0.028 g/cm2 | Standard Deviation 0.0291 |
| Ibandronate 2.5 mg | Absolute Change From Baseline at One Year (12 Months) and Two Years (24 Months) in Mean Lumbar Spine (L2-L4) BMD | At 24 months, n = 294, 294, 278, 291 | 0.036 g/cm2 | Standard Deviation 0.0337 |
| Ibandronate 50/50 mg | Absolute Change From Baseline at One Year (12 Months) and Two Years (24 Months) in Mean Lumbar Spine (L2-L4) BMD | At 24 months, n = 294, 294, 278, 291 | 0.039 g/cm2 | Standard Deviation 0.0355 |
| Ibandronate 50/50 mg | Absolute Change From Baseline at One Year (12 Months) and Two Years (24 Months) in Mean Lumbar Spine (L2-L4) BMD | At 12 months, n = 314, 322, 306, 314 | 0.033 g/cm2 | Standard Deviation 0.0298 |
| Ibandronate 100 mg | Absolute Change From Baseline at One Year (12 Months) and Two Years (24 Months) in Mean Lumbar Spine (L2-L4) BMD | At 12 months, n = 314, 322, 306, 314 | 0.030 g/cm2 | Standard Deviation 0.0271 |
| Ibandronate 100 mg | Absolute Change From Baseline at One Year (12 Months) and Two Years (24 Months) in Mean Lumbar Spine (L2-L4) BMD | At 24 months, n = 294, 294, 278, 291 | 0.042 g/cm2 | Standard Deviation 0.0313 |
| Ibandronate 150 mg | Absolute Change From Baseline at One Year (12 Months) and Two Years (24 Months) in Mean Lumbar Spine (L2-L4) BMD | At 12 months, n = 314, 322, 306, 314 | 0.036 g/cm2 | Standard Deviation 0.029 |
| Ibandronate 150 mg | Absolute Change From Baseline at One Year (12 Months) and Two Years (24 Months) in Mean Lumbar Spine (L2-L4) BMD | At 24 months, n = 294, 294, 278, 291 | 0.049 g/cm2 | Standard Deviation 0.033 |
Secondary
Absolute Change From Baseline at One Year (12 Months) and Two Years (24 Months) in Mean Proximal Femur ( Total Hip, Trochanter, Femoral Neck) BMD.
Proximal femur BMD was measured by dual-energy X-ray absorptiometry at baseline, after one and two years of treatment and was read by a central reading center
Time frame: From Baseline (Month 0) to Months 12 and 24
Population: The PP population consisted of all participants in the ITT population who had no major violations of the protocol. n = number of participants evaluable at particular time of assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ibandronate 2.5 mg | Absolute Change From Baseline at One Year (12 Months) and Two Years (24 Months) in Mean Proximal Femur ( Total Hip, Trochanter, Femoral Neck) BMD. | Total hip At Month 12, n = 315,319,306,316 | 0.014 g/cm2 | Standard Deviation 0.0204 |
| Ibandronate 2.5 mg | Absolute Change From Baseline at One Year (12 Months) and Two Years (24 Months) in Mean Proximal Femur ( Total Hip, Trochanter, Femoral Neck) BMD. | Total hip At Month 24, n = 292,291,277,290 | 0.018 g/cm2 | Standard Deviation 0.0225 |
| Ibandronate 2.5 mg | Absolute Change From Baseline at One Year (12 Months) and Two Years (24 Months) in Mean Proximal Femur ( Total Hip, Trochanter, Femoral Neck) BMD. | Trochanter At Month 12, n = 315,319,306,316 | 0.018 g/cm2 | Standard Deviation 0.0228 |
| Ibandronate 2.5 mg | Absolute Change From Baseline at One Year (12 Months) and Two Years (24 Months) in Mean Proximal Femur ( Total Hip, Trochanter, Femoral Neck) BMD. | Trochanter At Month 24, n = 292,291,277,290 | 0.023 g/cm2 | Standard Deviation 0.0241 |
| Ibandronate 2.5 mg | Absolute Change From Baseline at One Year (12 Months) and Two Years (24 Months) in Mean Proximal Femur ( Total Hip, Trochanter, Femoral Neck) BMD. | Femoral neck At Month 12, n = 315,319,306,316 | 0.011 g/cm2 | Standard Deviation 0.023 |
| Ibandronate 2.5 mg | Absolute Change From Baseline at One Year (12 Months) and Two Years (24 Months) in Mean Proximal Femur ( Total Hip, Trochanter, Femoral Neck) BMD. | Femoral neck At Month 24, n = 315,319,306,316 | 0.012 g/cm2 | Standard Deviation 0.0265 |
| Ibandronate 50/50 mg | Absolute Change From Baseline at One Year (12 Months) and Two Years (24 Months) in Mean Proximal Femur ( Total Hip, Trochanter, Femoral Neck) BMD. | Femoral neck At Month 24, n = 315,319,306,316 | 0.013 g/cm2 | Standard Deviation 0.0272 |
| Ibandronate 50/50 mg | Absolute Change From Baseline at One Year (12 Months) and Two Years (24 Months) in Mean Proximal Femur ( Total Hip, Trochanter, Femoral Neck) BMD. | Trochanter At Month 24, n = 292,291,277,290 | 0.027 g/cm2 | Standard Deviation 0.0259 |
| Ibandronate 50/50 mg | Absolute Change From Baseline at One Year (12 Months) and Two Years (24 Months) in Mean Proximal Femur ( Total Hip, Trochanter, Femoral Neck) BMD. | Total hip At Month 12, n = 315,319,306,316 | 0.016 g/cm2 | Standard Deviation 0.0205 |
| Ibandronate 50/50 mg | Absolute Change From Baseline at One Year (12 Months) and Two Years (24 Months) in Mean Proximal Femur ( Total Hip, Trochanter, Femoral Neck) BMD. | Trochanter At Month 12, n = 315,319,306,316 | 0.020 g/cm2 | Standard Deviation 0.0238 |
| Ibandronate 50/50 mg | Absolute Change From Baseline at One Year (12 Months) and Two Years (24 Months) in Mean Proximal Femur ( Total Hip, Trochanter, Femoral Neck) BMD. | Total hip At Month 24, n = 292,291,277,290 | 0.021 g/cm2 | Standard Deviation 0.0241 |
| Ibandronate 50/50 mg | Absolute Change From Baseline at One Year (12 Months) and Two Years (24 Months) in Mean Proximal Femur ( Total Hip, Trochanter, Femoral Neck) BMD. | Femoral neck At Month 12, n = 315,319,306,316 | 0.011 g/cm2 | Standard Deviation 0.0226 |
| Ibandronate 100 mg | Absolute Change From Baseline at One Year (12 Months) and Two Years (24 Months) in Mean Proximal Femur ( Total Hip, Trochanter, Femoral Neck) BMD. | Total hip At Month 24, n = 292,291,277,290 | 0.026 g/cm2 | Standard Deviation 0.0237 |
| Ibandronate 100 mg | Absolute Change From Baseline at One Year (12 Months) and Two Years (24 Months) in Mean Proximal Femur ( Total Hip, Trochanter, Femoral Neck) BMD. | Trochanter At Month 12, n = 315,319,306,316 | 0.022 g/cm2 | Standard Deviation 0.0206 |
| Ibandronate 100 mg | Absolute Change From Baseline at One Year (12 Months) and Two Years (24 Months) in Mean Proximal Femur ( Total Hip, Trochanter, Femoral Neck) BMD. | Trochanter At Month 24, n = 292,291,277,290 | 0.030 g/cm2 | Standard Deviation 0.0263 |
| Ibandronate 100 mg | Absolute Change From Baseline at One Year (12 Months) and Two Years (24 Months) in Mean Proximal Femur ( Total Hip, Trochanter, Femoral Neck) BMD. | Femoral neck At Month 24, n = 315,319,306,316 | 0.017 g/cm2 | Standard Deviation 0.0248 |
| Ibandronate 100 mg | Absolute Change From Baseline at One Year (12 Months) and Two Years (24 Months) in Mean Proximal Femur ( Total Hip, Trochanter, Femoral Neck) BMD. | Femoral neck At Month 12, n = 315,319,306,316 | 0.012 g/cm2 | Standard Deviation 0.0228 |
| Ibandronate 100 mg | Absolute Change From Baseline at One Year (12 Months) and Two Years (24 Months) in Mean Proximal Femur ( Total Hip, Trochanter, Femoral Neck) BMD. | Total hip At Month 12, n = 315,319,306,316 | 0.020 g/cm2 | Standard Deviation 0.019 |
| Ibandronate 150 mg | Absolute Change From Baseline at One Year (12 Months) and Two Years (24 Months) in Mean Proximal Femur ( Total Hip, Trochanter, Femoral Neck) BMD. | Femoral neck At Month 12, n = 315,319,306,316 | 0.014 g/cm2 | Standard Deviation 0.0224 |
| Ibandronate 150 mg | Absolute Change From Baseline at One Year (12 Months) and Two Years (24 Months) in Mean Proximal Femur ( Total Hip, Trochanter, Femoral Neck) BMD. | Femoral neck At Month 24, n = 315,319,306,316 | 0.020 g/cm2 | Standard Deviation 0.0257 |
| Ibandronate 150 mg | Absolute Change From Baseline at One Year (12 Months) and Two Years (24 Months) in Mean Proximal Femur ( Total Hip, Trochanter, Femoral Neck) BMD. | Total hip At Month 24, n = 292,291,277,290 | 0.031 g/cm2 | Standard Deviation 0.0199 |
| Ibandronate 150 mg | Absolute Change From Baseline at One Year (12 Months) and Two Years (24 Months) in Mean Proximal Femur ( Total Hip, Trochanter, Femoral Neck) BMD. | Trochanter At Month 24, n = 292,291,277,290 | 0.035 g/cm2 | Standard Deviation 0.0231 |
| Ibandronate 150 mg | Absolute Change From Baseline at One Year (12 Months) and Two Years (24 Months) in Mean Proximal Femur ( Total Hip, Trochanter, Femoral Neck) BMD. | Total hip At Month 12, n = 315,319,306,316 | 0.022 g/cm2 | Standard Deviation 0.019 |
| Ibandronate 150 mg | Absolute Change From Baseline at One Year (12 Months) and Two Years (24 Months) in Mean Proximal Femur ( Total Hip, Trochanter, Femoral Neck) BMD. | Trochanter At Month 12, n = 315,319,306,316 | 0.026 g/cm2 | Standard Deviation 0.0211 |
Secondary
Absolute Change In Baseline in Serum CTX to Months 12 and 24
Serum CTX, a biochemical marker of bone resorption, was assessed using the Elecsys S-CTX-I assay (an ElectroChemiLuminescence Immunoassay (ECLIA) Technique).
Time frame: From Baseline (Month 0) to Months 12 and 24
Population: The PP population consisted of all participants in the ITT population who had no major violations of the protocol. n = number of participants evaluable at particular time of assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ibandronate 2.5 mg | Absolute Change In Baseline in Serum CTX to Months 12 and 24 | Month 12, n = 272, 276, 276, 267 | -0.323 ng/ml | Standard Deviation 0.2292 |
| Ibandronate 2.5 mg | Absolute Change In Baseline in Serum CTX to Months 12 and 24 | Month 24, n = 221, 215, 211, 235 | -0.285 ng/ml | Standard Deviation 0.2052 |
| Ibandronate 50/50 mg | Absolute Change In Baseline in Serum CTX to Months 12 and 24 | Month 24, n = 221, 215, 211, 235 | -0.298 ng/ml | Standard Deviation 0.198 |
| Ibandronate 50/50 mg | Absolute Change In Baseline in Serum CTX to Months 12 and 24 | Month 12, n = 272, 276, 276, 267 | -0.326 ng/ml | Standard Deviation 0.2212 |
| Ibandronate 100 mg | Absolute Change In Baseline in Serum CTX to Months 12 and 24 | Month 24, n = 221, 215, 211, 235 | -0.312 ng/ml | Standard Deviation 0.2398 |
| Ibandronate 100 mg | Absolute Change In Baseline in Serum CTX to Months 12 and 24 | Month 12, n = 272, 276, 276, 267 | -0.340 ng/ml | Standard Deviation 0.2287 |
| Ibandronate 150 mg | Absolute Change In Baseline in Serum CTX to Months 12 and 24 | Month 12, n = 272, 276, 276, 267 | -0.377 ng/ml | Standard Deviation 0.2135 |
| Ibandronate 150 mg | Absolute Change In Baseline in Serum CTX to Months 12 and 24 | Month 24, n = 221, 215, 211, 235 | -0.340 ng/ml | Standard Deviation 0.2062 |
Secondary
Number of Participants With Any Adverse Events and Serious Adverse Event
An Adverse Event (AE) is any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect.
Time frame: Up to Month 24
Population: The safety population consisted of all participants who were randomized and received at least one dose of the study medication, and who have at least one follow-up data point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ibandronate 2.5 mg | Number of Participants With Any Adverse Events and Serious Adverse Event | Any AE | 302 Participants |
| Ibandronate 2.5 mg | Number of Participants With Any Adverse Events and Serious Adverse Event | SAE | 38 Participants |
| Ibandronate 50/50 mg | Number of Participants With Any Adverse Events and Serious Adverse Event | SAE | 54 Participants |
| Ibandronate 50/50 mg | Number of Participants With Any Adverse Events and Serious Adverse Event | Any AE | 313 Participants |
| Ibandronate 100 mg | Number of Participants With Any Adverse Events and Serious Adverse Event | Any AE | 318 Participants |
| Ibandronate 100 mg | Number of Participants With Any Adverse Events and Serious Adverse Event | SAE | 55 Participants |
| Ibandronate 150 mg | Number of Participants With Any Adverse Events and Serious Adverse Event | Any AE | 317 Participants |
| Ibandronate 150 mg | Number of Participants With Any Adverse Events and Serious Adverse Event | SAE | 45 Participants |
Secondary
Number Of Participants With Marked Laboratory Abnormalities
Marked laboratory abnormalities were defined as those values that were outside the reference range and showed a clinically relevant change from baseline. The reference range for hemoglobin was 110-200 (gram per liter \[g/L\]), hematocrit was 0.31-0.56 fraction, white blood cells (WBC) was 3.0-18.0 (10\*9/L), serum glutamic-pyruvic transaminase (SGPT/ALT) was 0-110 IU/L, blood urea nitrogen (BUN) was 0.0-14.3 (millimoles per Liter \[mmol/L\]), Chloride was 95-115 (mmol/L), Potassium was 3.0 - 6.0 (mmol/L), Sodium was 130-150 (mmol/L), Calcium was 2.00-2.90 (mmol/L), Phosphate was 0.75 - 1.60 (mmol/L) and Creatinine was 0- 154 (micromoles/liter \[umol/L\].
Time frame: Up to Month 24
Population: The safety population consisted of all participants who were randomized and received at least one dose of the study medication, and who have at least one follow-up data point. n = number of participants evaluable at particular time of assessment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ibandronate 2.5 mg | Number Of Participants With Marked Laboratory Abnormalities | Potassium Low, n = 389,390,385,383 | 0 Participants |
| Ibandronate 2.5 mg | Number Of Participants With Marked Laboratory Abnormalities | Chloride Low, n =3 89,390,385,384 | 3 Participants |
| Ibandronate 2.5 mg | Number Of Participants With Marked Laboratory Abnormalities | ALT (SGPT) High, n = 390,390,385,385 | 9 Participants |
| Ibandronate 2.5 mg | Number Of Participants With Marked Laboratory Abnormalities | Hematocrit Low, n = 389,387,382,385 | 2 Participants |
| Ibandronate 2.5 mg | Number Of Participants With Marked Laboratory Abnormalities | Creatinine High, n = 390,390,385,385 | 1 Participants |
| Ibandronate 2.5 mg | Number Of Participants With Marked Laboratory Abnormalities | BUN High, n = 390,390,385,385 | 2 Participants |
| Ibandronate 2.5 mg | Number Of Participants With Marked Laboratory Abnormalities | Calcium High, n = 390,390,385,385 | 1 Participants |
| Ibandronate 2.5 mg | Number Of Participants With Marked Laboratory Abnormalities | Hemoglobin High, n = 389,389,382,385 | 0 Participants |
| Ibandronate 2.5 mg | Number Of Participants With Marked Laboratory Abnormalities | Hemoglobin Low, n = 389,389,382,385 | 3 Participants |
| Ibandronate 2.5 mg | Number Of Participants With Marked Laboratory Abnormalities | Phosphate Low, n = 390,390,385,385 | 2 Participants |
| Ibandronate 2.5 mg | Number Of Participants With Marked Laboratory Abnormalities | Sodium Low, n = 389,390,385,384 | 2 Participants |
| Ibandronate 2.5 mg | Number Of Participants With Marked Laboratory Abnormalities | Sodium High, n = 389,390,385,384 | 0 Participants |
| Ibandronate 2.5 mg | Number Of Participants With Marked Laboratory Abnormalities | WBC Low, n = 389,389,382,385 | 1 Participants |
| Ibandronate 2.5 mg | Number Of Participants With Marked Laboratory Abnormalities | Phosphate High, n = 390,390,385,385 | 4 Participants |
| Ibandronate 50/50 mg | Number Of Participants With Marked Laboratory Abnormalities | Sodium Low, n = 389,390,385,384 | 1 Participants |
| Ibandronate 50/50 mg | Number Of Participants With Marked Laboratory Abnormalities | Hematocrit Low, n = 389,387,382,385 | 0 Participants |
| Ibandronate 50/50 mg | Number Of Participants With Marked Laboratory Abnormalities | Hemoglobin High, n = 389,389,382,385 | 0 Participants |
| Ibandronate 50/50 mg | Number Of Participants With Marked Laboratory Abnormalities | Hemoglobin Low, n = 389,389,382,385 | 3 Participants |
| Ibandronate 50/50 mg | Number Of Participants With Marked Laboratory Abnormalities | WBC Low, n = 389,389,382,385 | 1 Participants |
| Ibandronate 50/50 mg | Number Of Participants With Marked Laboratory Abnormalities | ALT (SGPT) High, n = 390,390,385,385 | 8 Participants |
| Ibandronate 50/50 mg | Number Of Participants With Marked Laboratory Abnormalities | BUN High, n = 390,390,385,385 | 0 Participants |
| Ibandronate 50/50 mg | Number Of Participants With Marked Laboratory Abnormalities | Creatinine High, n = 390,390,385,385 | 1 Participants |
| Ibandronate 50/50 mg | Number Of Participants With Marked Laboratory Abnormalities | Chloride Low, n =3 89,390,385,384 | 3 Participants |
| Ibandronate 50/50 mg | Number Of Participants With Marked Laboratory Abnormalities | Potassium Low, n = 389,390,385,383 | 0 Participants |
| Ibandronate 50/50 mg | Number Of Participants With Marked Laboratory Abnormalities | Sodium High, n = 389,390,385,384 | 0 Participants |
| Ibandronate 50/50 mg | Number Of Participants With Marked Laboratory Abnormalities | Calcium High, n = 390,390,385,385 | 0 Participants |
| Ibandronate 50/50 mg | Number Of Participants With Marked Laboratory Abnormalities | Phosphate High, n = 390,390,385,385 | 3 Participants |
| Ibandronate 50/50 mg | Number Of Participants With Marked Laboratory Abnormalities | Phosphate Low, n = 390,390,385,385 | 2 Participants |
| Ibandronate 100 mg | Number Of Participants With Marked Laboratory Abnormalities | Sodium Low, n = 389,390,385,384 | 0 Participants |
| Ibandronate 100 mg | Number Of Participants With Marked Laboratory Abnormalities | WBC Low, n = 389,389,382,385 | 4 Participants |
| Ibandronate 100 mg | Number Of Participants With Marked Laboratory Abnormalities | Hemoglobin High, n = 389,389,382,385 | 1 Participants |
| Ibandronate 100 mg | Number Of Participants With Marked Laboratory Abnormalities | Chloride Low, n =3 89,390,385,384 | 0 Participants |
| Ibandronate 100 mg | Number Of Participants With Marked Laboratory Abnormalities | Calcium High, n = 390,390,385,385 | 0 Participants |
| Ibandronate 100 mg | Number Of Participants With Marked Laboratory Abnormalities | Sodium High, n = 389,390,385,384 | 1 Participants |
| Ibandronate 100 mg | Number Of Participants With Marked Laboratory Abnormalities | Potassium Low, n = 389,390,385,383 | 0 Participants |
| Ibandronate 100 mg | Number Of Participants With Marked Laboratory Abnormalities | Hematocrit Low, n = 389,387,382,385 | 1 Participants |
| Ibandronate 100 mg | Number Of Participants With Marked Laboratory Abnormalities | BUN High, n = 390,390,385,385 | 0 Participants |
| Ibandronate 100 mg | Number Of Participants With Marked Laboratory Abnormalities | Hemoglobin Low, n = 389,389,382,385 | 6 Participants |
| Ibandronate 100 mg | Number Of Participants With Marked Laboratory Abnormalities | ALT (SGPT) High, n = 390,390,385,385 | 8 Participants |
| Ibandronate 100 mg | Number Of Participants With Marked Laboratory Abnormalities | Phosphate Low, n = 390,390,385,385 | 2 Participants |
| Ibandronate 100 mg | Number Of Participants With Marked Laboratory Abnormalities | Creatinine High, n = 390,390,385,385 | 0 Participants |
| Ibandronate 100 mg | Number Of Participants With Marked Laboratory Abnormalities | Phosphate High, n = 390,390,385,385 | 3 Participants |
| Ibandronate 150 mg | Number Of Participants With Marked Laboratory Abnormalities | Creatinine High, n = 390,390,385,385 | 1 Participants |
| Ibandronate 150 mg | Number Of Participants With Marked Laboratory Abnormalities | Chloride Low, n =3 89,390,385,384 | 3 Participants |
| Ibandronate 150 mg | Number Of Participants With Marked Laboratory Abnormalities | Phosphate High, n = 390,390,385,385 | 1 Participants |
| Ibandronate 150 mg | Number Of Participants With Marked Laboratory Abnormalities | Potassium Low, n = 389,390,385,383 | 1 Participants |
| Ibandronate 150 mg | Number Of Participants With Marked Laboratory Abnormalities | Hemoglobin Low, n = 389,389,382,385 | 3 Participants |
| Ibandronate 150 mg | Number Of Participants With Marked Laboratory Abnormalities | Hematocrit Low, n = 389,387,382,385 | 3 Participants |
| Ibandronate 150 mg | Number Of Participants With Marked Laboratory Abnormalities | Sodium High, n = 389,390,385,384 | 2 Participants |
| Ibandronate 150 mg | Number Of Participants With Marked Laboratory Abnormalities | Hemoglobin High, n = 389,389,382,385 | 0 Participants |
| Ibandronate 150 mg | Number Of Participants With Marked Laboratory Abnormalities | Sodium Low, n = 389,390,385,384 | 0 Participants |
| Ibandronate 150 mg | Number Of Participants With Marked Laboratory Abnormalities | Phosphate Low, n = 390,390,385,385 | 1 Participants |
| Ibandronate 150 mg | Number Of Participants With Marked Laboratory Abnormalities | Calcium High, n = 390,390,385,385 | 1 Participants |
| Ibandronate 150 mg | Number Of Participants With Marked Laboratory Abnormalities | ALT (SGPT) High, n = 390,390,385,385 | 8 Participants |
| Ibandronate 150 mg | Number Of Participants With Marked Laboratory Abnormalities | BUN High, n = 390,390,385,385 | 0 Participants |
| Ibandronate 150 mg | Number Of Participants With Marked Laboratory Abnormalities | WBC Low, n = 389,389,382,385 | 4 Participants |
Secondary
Percentage of Participants With Femoral Neck BMD Above or Equal to Baseline at Months 12 and 24
A participant is a responder if the mean femoral neck BMD had remained the same or increased above baseline.
Time frame: Months 12 and 24
Population: The PP population consisted of all participants in the ITT population who had no major violations of the protocol. n = number of participants evaluable at particular time of assessment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ibandronate 2.5 mg | Percentage of Participants With Femoral Neck BMD Above or Equal to Baseline at Months 12 and 24 | At Month 12, n = 315,319,306,316 | 71.1 Percentage of participants |
| Ibandronate 2.5 mg | Percentage of Participants With Femoral Neck BMD Above or Equal to Baseline at Months 12 and 24 | At Month 24, n = 292,291,277,289 | 69.2 Percentage of participants |
| Ibandronate 50/50 mg | Percentage of Participants With Femoral Neck BMD Above or Equal to Baseline at Months 12 and 24 | At Month 24, n = 292,291,277,289 | 71.1 Percentage of participants |
| Ibandronate 50/50 mg | Percentage of Participants With Femoral Neck BMD Above or Equal to Baseline at Months 12 and 24 | At Month 12, n = 315,319,306,316 | 72.4 Percentage of participants |
| Ibandronate 100 mg | Percentage of Participants With Femoral Neck BMD Above or Equal to Baseline at Months 12 and 24 | At Month 12, n = 315,319,306,316 | 69.0 Percentage of participants |
| Ibandronate 100 mg | Percentage of Participants With Femoral Neck BMD Above or Equal to Baseline at Months 12 and 24 | At Month 24, n = 292,291,277,289 | 78.7 Percentage of participants |
| Ibandronate 150 mg | Percentage of Participants With Femoral Neck BMD Above or Equal to Baseline at Months 12 and 24 | At Month 12, n = 315,319,306,316 | 75.3 Percentage of participants |
| Ibandronate 150 mg | Percentage of Participants With Femoral Neck BMD Above or Equal to Baseline at Months 12 and 24 | At Month 24, n = 292,291,277,289 | 81.0 Percentage of participants |
Secondary
Percentage of Participants With Mean Femoral Neck and Lumbar Spine BMD Above or Equal to Baseline at Months 12 and 24
A participant is a responder if the mean femoral neck and lumbar spine BMD had remained the same or increased above baseline.
Time frame: Months 12 and 24
Population: The PP population consisted of all participants in the ITT population who had no major violations of the protocol. n = number of participants evaluable at particular time of assessment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ibandronate 2.5 mg | Percentage of Participants With Mean Femoral Neck and Lumbar Spine BMD Above or Equal to Baseline at Months 12 and 24 | At Month 12, n = 314,318,304,310 | 62.4 Percentage of participants |
| Ibandronate 2.5 mg | Percentage of Participants With Mean Femoral Neck and Lumbar Spine BMD Above or Equal to Baseline at Months 12 and 24 | At Month 24, n = 292,291,276,287 | 63.4 Percentage of participants |
| Ibandronate 50/50 mg | Percentage of Participants With Mean Femoral Neck and Lumbar Spine BMD Above or Equal to Baseline at Months 12 and 24 | At Month 24, n = 292,291,276,287 | 63.9 Percentage of participants |
| Ibandronate 50/50 mg | Percentage of Participants With Mean Femoral Neck and Lumbar Spine BMD Above or Equal to Baseline at Months 12 and 24 | At Month 12, n = 314,318,304,310 | 64.5 Percentage of participants |
| Ibandronate 100 mg | Percentage of Participants With Mean Femoral Neck and Lumbar Spine BMD Above or Equal to Baseline at Months 12 and 24 | At Month 12, n = 314,318,304,310 | 60.9 Percentage of participants |
| Ibandronate 100 mg | Percentage of Participants With Mean Femoral Neck and Lumbar Spine BMD Above or Equal to Baseline at Months 12 and 24 | At Month 24, n = 292,291,276,287 | 71.0 Percentage of participants |
| Ibandronate 150 mg | Percentage of Participants With Mean Femoral Neck and Lumbar Spine BMD Above or Equal to Baseline at Months 12 and 24 | At Month 12, n = 314,318,304,310 | 68.7 Percentage of participants |
| Ibandronate 150 mg | Percentage of Participants With Mean Femoral Neck and Lumbar Spine BMD Above or Equal to Baseline at Months 12 and 24 | At Month 24, n = 292,291,276,287 | 75.6 Percentage of participants |
Secondary
Percentage of Participants With Mean Lumbar Spine (L2 - L4) BMD Above or Equal to Baseline at Months 12 and 24
A participant is a responder if the mean lumber spine (L2 - L4) BMD had remained the same or increased above baseline.
Time frame: Months 12 and 24
Population: The PP population consisted of all participants in the ITT population who had no major violations of the protocol. n = number of participants evaluable at particular time of assessment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ibandronate 2.5 mg | Percentage of Participants With Mean Lumbar Spine (L2 - L4) BMD Above or Equal to Baseline at Months 12 and 24 | At Month 12, n = 314,322,306,314 | 83.8 Percentage of participants |
| Ibandronate 2.5 mg | Percentage of Participants With Mean Lumbar Spine (L2 - L4) BMD Above or Equal to Baseline at Months 12 and 24 | At Month 24, n = 294,294,278,291 | 86.4 Percentage of participants |
| Ibandronate 50/50 mg | Percentage of Participants With Mean Lumbar Spine (L2 - L4) BMD Above or Equal to Baseline at Months 12 and 24 | At Month 24, n = 294,294,278,291 | 87.8 Percentage of participants |
| Ibandronate 50/50 mg | Percentage of Participants With Mean Lumbar Spine (L2 - L4) BMD Above or Equal to Baseline at Months 12 and 24 | At Month 12, n = 314,322,306,314 | 87.6 Percentage of participants |
| Ibandronate 100 mg | Percentage of Participants With Mean Lumbar Spine (L2 - L4) BMD Above or Equal to Baseline at Months 12 and 24 | At Month 12, n = 314,322,306,314 | 86.6 Percentage of participants |
| Ibandronate 100 mg | Percentage of Participants With Mean Lumbar Spine (L2 - L4) BMD Above or Equal to Baseline at Months 12 and 24 | At Month 24, n = 294,294,278,291 | 87.8 Percentage of participants |
| Ibandronate 150 mg | Percentage of Participants With Mean Lumbar Spine (L2 - L4) BMD Above or Equal to Baseline at Months 12 and 24 | At Month 12, n = 314,322,306,314 | 90.8 Percentage of participants |
| Ibandronate 150 mg | Percentage of Participants With Mean Lumbar Spine (L2 - L4) BMD Above or Equal to Baseline at Months 12 and 24 | At Month 24, n = 294,294,278,291 | 93.5 Percentage of participants |
Secondary
Percentage of Participants With Mean Total Hip and Lumbar Spine BMD Above or Equal to Baseline at Months 12 and 24
A participant is a responder if the mean total hip and mean lumbar spine BMD had remained the same or increased above baseline.
Time frame: Months 12 and 24
Population: The PP population consisted of all participants in the ITT population who had no major violations of the protocol. n = number of participants evaluable at particular time of assessment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ibandronate 2.5 mg | Percentage of Participants With Mean Total Hip and Lumbar Spine BMD Above or Equal to Baseline at Months 12 and 24 | At Month 12, n = 314,318,304,310 | 65.6 Percentage of participants |
| Ibandronate 2.5 mg | Percentage of Participants With Mean Total Hip and Lumbar Spine BMD Above or Equal to Baseline at Months 12 and 24 | At Month 24, n = 292,291,276,287 | 70.5 Percentage of participants |
| Ibandronate 50/50 mg | Percentage of Participants With Mean Total Hip and Lumbar Spine BMD Above or Equal to Baseline at Months 12 and 24 | At Month 24, n = 292,291,276,287 | 75.3 Percentage of participants |
| Ibandronate 50/50 mg | Percentage of Participants With Mean Total Hip and Lumbar Spine BMD Above or Equal to Baseline at Months 12 and 24 | At Month 12, n = 314,318,304,310 | 72.3 Percentage of participants |
| Ibandronate 100 mg | Percentage of Participants With Mean Total Hip and Lumbar Spine BMD Above or Equal to Baseline at Months 12 and 24 | At Month 12, n = 314,318,304,310 | 77.6 Percentage of participants |
| Ibandronate 100 mg | Percentage of Participants With Mean Total Hip and Lumbar Spine BMD Above or Equal to Baseline at Months 12 and 24 | At Month 24, n = 292,291,276,287 | 79.3 Percentage of participants |
| Ibandronate 150 mg | Percentage of Participants With Mean Total Hip and Lumbar Spine BMD Above or Equal to Baseline at Months 12 and 24 | At Month 12, n = 314,318,304,310 | 83.5 Percentage of participants |
| Ibandronate 150 mg | Percentage of Participants With Mean Total Hip and Lumbar Spine BMD Above or Equal to Baseline at Months 12 and 24 | At Month 24, n = 292,291,276,287 | 87.1 Percentage of participants |
Secondary
Percentage of Participants With Mean Trochanter and Lumbar Spine BMD Above or Equal to Baseline at Months 12 and 24
A participant is a responder if the mean trochanter and lumbar spine BMD had remained the same or increased above baseline.
Time frame: Months 12 and 24
Population: The PP population consisted of all participants in the ITT population who had no major violations of the protocol. n = number of participants evaluable at particular time of assessment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ibandronate 2.5 mg | Percentage of Participants With Mean Trochanter and Lumbar Spine BMD Above or Equal to Baseline at Months 12 and 24 | At Month 12, n = 314,318,304,310 | 68.8 Percentage of participants |
| Ibandronate 2.5 mg | Percentage of Participants With Mean Trochanter and Lumbar Spine BMD Above or Equal to Baseline at Months 12 and 24 | At Month 24, n = 292,291,276,287 | 75.7 Percentage of participants |
| Ibandronate 50/50 mg | Percentage of Participants With Mean Trochanter and Lumbar Spine BMD Above or Equal to Baseline at Months 12 and 24 | At Month 24, n = 292,291,276,287 | 77.3 Percentage of participants |
| Ibandronate 50/50 mg | Percentage of Participants With Mean Trochanter and Lumbar Spine BMD Above or Equal to Baseline at Months 12 and 24 | At Month 12, n = 314,318,304,310 | 75.5 Percentage of participants |
| Ibandronate 100 mg | Percentage of Participants With Mean Trochanter and Lumbar Spine BMD Above or Equal to Baseline at Months 12 and 24 | At Month 12, n = 314,318,304,310 | 78.0 Percentage of participants |
| Ibandronate 100 mg | Percentage of Participants With Mean Trochanter and Lumbar Spine BMD Above or Equal to Baseline at Months 12 and 24 | At Month 24, n = 292,291,276,287 | 80.1 Percentage of participants |
| Ibandronate 150 mg | Percentage of Participants With Mean Trochanter and Lumbar Spine BMD Above or Equal to Baseline at Months 12 and 24 | At Month 12, n = 314,318,304,310 | 84.2 Percentage of participants |
| Ibandronate 150 mg | Percentage of Participants With Mean Trochanter and Lumbar Spine BMD Above or Equal to Baseline at Months 12 and 24 | At Month 24, n = 292,291,276,287 | 88.2 Percentage of participants |
Secondary
Percentage of Participants With Total Hip BMD Above or Equal to Baseline at Months 12 and 24
A participant is a responder if the mean total hip BMD had remained the same or increased above baseline.
Time frame: Months 12 and 24
Population: The PP population consisted of all participants in the ITT population who had no major violations of the protocol. n = number of participants evaluable at particular time of assessment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ibandronate 2.5 mg | Percentage of Participants With Total Hip BMD Above or Equal to Baseline at Months 12 and 24 | At Month 12, n = 315,319,306,306 | 76.8 Percentage of participants |
| Ibandronate 2.5 mg | Percentage of Participants With Total Hip BMD Above or Equal to Baseline at Months 12 and 24 | At Month 24, n = 292,291,277,289 | 78.4 Percentage of participants |
| Ibandronate 50/50 mg | Percentage of Participants With Total Hip BMD Above or Equal to Baseline at Months 12 and 24 | At Month 24, n = 292,291,277,289 | 83.2 Percentage of participants |
| Ibandronate 50/50 mg | Percentage of Participants With Total Hip BMD Above or Equal to Baseline at Months 12 and 24 | At Month 12, n = 315,319,306,306 | 81.2 Percentage of participants |
| Ibandronate 100 mg | Percentage of Participants With Total Hip BMD Above or Equal to Baseline at Months 12 and 24 | At Month 12, n = 315,319,306,306 | 86.9 Percentage of participants |
| Ibandronate 100 mg | Percentage of Participants With Total Hip BMD Above or Equal to Baseline at Months 12 and 24 | At Month 24, n = 292,291,277,289 | 88.8 Percentage of participants |
| Ibandronate 150 mg | Percentage of Participants With Total Hip BMD Above or Equal to Baseline at Months 12 and 24 | At Month 12, n = 315,319,306,306 | 90.5 Percentage of participants |
| Ibandronate 150 mg | Percentage of Participants With Total Hip BMD Above or Equal to Baseline at Months 12 and 24 | At Month 24, n = 292,291,277,289 | 93.4 Percentage of participants |
Secondary
Percentage of Participants With Trochanter BMD Above or Equal to Baseline at Months 12 and 24
A participant is a responder if the mean trochanter BMD had remained the same or increased above baseline.
Time frame: Months 12 and 24
Population: The PP population consisted of all participants in the ITT population who had no major violations of the protocol. n = number of participants evaluable at particular time of assessment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ibandronate 2.5 mg | Percentage of Participants With Trochanter BMD Above or Equal to Baseline at Months 12 and 24 | At Month 24, n = 292,291,277,289 | 84.2 Percentage of participants |
| Ibandronate 2.5 mg | Percentage of Participants With Trochanter BMD Above or Equal to Baseline at Months 12 and 24 | At Month 12, n = 315,319,306,316 | 80.0 Percentage of participants |
| Ibandronate 50/50 mg | Percentage of Participants With Trochanter BMD Above or Equal to Baseline at Months 12 and 24 | At Month 12, n = 315,319,306,316 | 83.1 Percentage of participants |
| Ibandronate 50/50 mg | Percentage of Participants With Trochanter BMD Above or Equal to Baseline at Months 12 and 24 | At Month 24, n = 292,291,277,289 | 86.6 Percentage of participants |
| Ibandronate 100 mg | Percentage of Participants With Trochanter BMD Above or Equal to Baseline at Months 12 and 24 | At Month 12, n = 315,319,306,316 | 88.2 Percentage of participants |
| Ibandronate 100 mg | Percentage of Participants With Trochanter BMD Above or Equal to Baseline at Months 12 and 24 | At Month 24, n = 292,291,277,289 | 89.9 Percentage of participants |
| Ibandronate 150 mg | Percentage of Participants With Trochanter BMD Above or Equal to Baseline at Months 12 and 24 | At Month 24, n = 292,291,277,289 | 94.1 Percentage of participants |
| Ibandronate 150 mg | Percentage of Participants With Trochanter BMD Above or Equal to Baseline at Months 12 and 24 | At Month 12, n = 315,319,306,316 | 92.4 Percentage of participants |
Secondary
Relative Change From Baseline at One Year (12 Months) and Two Years (24 Months) in Mean Proximal Femur ( Total Hip, Trochanter, Femoral Neck) BMD
Proximal femur BMD was measured by dual-energy X ray absorptiometry at baseline, after one and two years of treatment and was read by a central reading center.
Time frame: From Baseline (Month 0) to Months 12 and 24
Population: The PP population consisted of all participants in the ITT population who had no major violations of the protocol. n = number of participants evaluable at particular time of assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ibandronate 2.5 mg | Relative Change From Baseline at One Year (12 Months) and Two Years (24 Months) in Mean Proximal Femur ( Total Hip, Trochanter, Femoral Neck) BMD | Total hip At Month 12, n = 315,319,306,316 | 1.9626 Percent change | Standard Deviation 2.8311 |
| Ibandronate 2.5 mg | Relative Change From Baseline at One Year (12 Months) and Two Years (24 Months) in Mean Proximal Femur ( Total Hip, Trochanter, Femoral Neck) BMD | Total hip At Month 24, n = 292,291,277,289 | 2.4955 Percent change | Standard Deviation 3.0884 |
| Ibandronate 2.5 mg | Relative Change From Baseline at One Year (12 Months) and Two Years (24 Months) in Mean Proximal Femur ( Total Hip, Trochanter, Femoral Neck) BMD | Trochanter At Month 12, n = 315,319,306,316 | 3.1917 Percent change | Standard Deviation 4.1268 |
| Ibandronate 2.5 mg | Relative Change From Baseline at One Year (12 Months) and Two Years (24 Months) in Mean Proximal Femur ( Total Hip, Trochanter, Femoral Neck) BMD | Trochanter At Month 24, n = 292,291,277,289 | 4.0204 Percent change | Standard Deviation 4.346 |
| Ibandronate 2.5 mg | Relative Change From Baseline at One Year (12 Months) and Two Years (24 Months) in Mean Proximal Femur ( Total Hip, Trochanter, Femoral Neck) BMD | Femoral neck At Month 12, n = 315,319,306,316 | 1.7164 Percent change | Standard Deviation 3.6233 |
| Ibandronate 2.5 mg | Relative Change From Baseline at One Year (12 Months) and Two Years (24 Months) in Mean Proximal Femur ( Total Hip, Trochanter, Femoral Neck) BMD | Femoral neck At Month 24, n=292,291,277,289 | 1.9087 Percent change | Standard Deviation 4.2212 |
| Ibandronate 50/50 mg | Relative Change From Baseline at One Year (12 Months) and Two Years (24 Months) in Mean Proximal Femur ( Total Hip, Trochanter, Femoral Neck) BMD | Femoral neck At Month 24, n=292,291,277,289 | 2.0581 Percent change | Standard Deviation 4.1189 |
| Ibandronate 50/50 mg | Relative Change From Baseline at One Year (12 Months) and Two Years (24 Months) in Mean Proximal Femur ( Total Hip, Trochanter, Femoral Neck) BMD | Trochanter At Month 24, n = 292,291,277,289 | 4.6289 Percent change | Standard Deviation 4.5518 |
| Ibandronate 50/50 mg | Relative Change From Baseline at One Year (12 Months) and Two Years (24 Months) in Mean Proximal Femur ( Total Hip, Trochanter, Femoral Neck) BMD | Total hip At Month 12, n = 315,319,306,316 | 2.2172 Percent change | Standard Deviation 2.7504 |
| Ibandronate 50/50 mg | Relative Change From Baseline at One Year (12 Months) and Two Years (24 Months) in Mean Proximal Femur ( Total Hip, Trochanter, Femoral Neck) BMD | Trochanter At Month 12, n = 315,319,306,316 | 3.4931 Percent change | Standard Deviation 4.0876 |
| Ibandronate 50/50 mg | Relative Change From Baseline at One Year (12 Months) and Two Years (24 Months) in Mean Proximal Femur ( Total Hip, Trochanter, Femoral Neck) BMD | Total hip At Month 24, n = 292,291,277,289 | 2.8132 Percent change | Standard Deviation 3.2408 |
| Ibandronate 50/50 mg | Relative Change From Baseline at One Year (12 Months) and Two Years (24 Months) in Mean Proximal Femur ( Total Hip, Trochanter, Femoral Neck) BMD | Femoral neck At Month 12, n = 315,319,306,316 | 1.8141 Percent change | Standard Deviation 3.4391 |
| Ibandronate 100 mg | Relative Change From Baseline at One Year (12 Months) and Two Years (24 Months) in Mean Proximal Femur ( Total Hip, Trochanter, Femoral Neck) BMD | Total hip At Month 24, n = 292,291,277,289 | 3.5165 Percent change | Standard Deviation 3.2831 |
| Ibandronate 100 mg | Relative Change From Baseline at One Year (12 Months) and Two Years (24 Months) in Mean Proximal Femur ( Total Hip, Trochanter, Femoral Neck) BMD | Trochanter At Month 12, n = 315,319,306,316 | 3.8226 Percent change | Standard Deviation 3.7077 |
| Ibandronate 100 mg | Relative Change From Baseline at One Year (12 Months) and Two Years (24 Months) in Mean Proximal Femur ( Total Hip, Trochanter, Femoral Neck) BMD | Trochanter At Month 24, n = 292,291,277,289 | 5.3135 Percent change | Standard Deviation 4.7335 |
| Ibandronate 100 mg | Relative Change From Baseline at One Year (12 Months) and Two Years (24 Months) in Mean Proximal Femur ( Total Hip, Trochanter, Femoral Neck) BMD | Femoral neck At Month 24, n=292,291,277,289 | 2.6209 Percent change | Standard Deviation 3.8339 |
| Ibandronate 100 mg | Relative Change From Baseline at One Year (12 Months) and Two Years (24 Months) in Mean Proximal Femur ( Total Hip, Trochanter, Femoral Neck) BMD | Femoral neck At Month 12, n = 315,319,306,316 | 1.8797 Percent change | Standard Deviation 3.4998 |
| Ibandronate 100 mg | Relative Change From Baseline at One Year (12 Months) and Two Years (24 Months) in Mean Proximal Femur ( Total Hip, Trochanter, Femoral Neck) BMD | Total hip At Month 12, n = 315,319,306,316 | 2.6878 Percent change | Standard Deviation 2.6646 |
| Ibandronate 150 mg | Relative Change From Baseline at One Year (12 Months) and Two Years (24 Months) in Mean Proximal Femur ( Total Hip, Trochanter, Femoral Neck) BMD | Femoral neck At Month 12, n = 315,319,306,316 | 2.1914 Percent change | Standard Deviation 3.4842 |
| Ibandronate 150 mg | Relative Change From Baseline at One Year (12 Months) and Two Years (24 Months) in Mean Proximal Femur ( Total Hip, Trochanter, Femoral Neck) BMD | Femoral neck At Month 24, n=292,291,277,289 | 3.1195 Percent change | Standard Deviation 4.0549 |
| Ibandronate 150 mg | Relative Change From Baseline at One Year (12 Months) and Two Years (24 Months) in Mean Proximal Femur ( Total Hip, Trochanter, Femoral Neck) BMD | Total hip At Month 24, n = 292,291,277,289 | 4.1601 Percent change | Standard Deviation 2.8335 |
| Ibandronate 150 mg | Relative Change From Baseline at One Year (12 Months) and Two Years (24 Months) in Mean Proximal Femur ( Total Hip, Trochanter, Femoral Neck) BMD | Trochanter At Month 24, n = 292,291,277,289 | 6.1755 Percent change | Standard Deviation 4.255 |
| Ibandronate 150 mg | Relative Change From Baseline at One Year (12 Months) and Two Years (24 Months) in Mean Proximal Femur ( Total Hip, Trochanter, Femoral Neck) BMD | Total hip At Month 12, n = 315,319,306,316 | 3.0092 Percent change | Standard Deviation 2.7105 |
| Ibandronate 150 mg | Relative Change From Baseline at One Year (12 Months) and Two Years (24 Months) in Mean Proximal Femur ( Total Hip, Trochanter, Femoral Neck) BMD | Trochanter At Month 12, n = 315,319,306,316 | 4.5904 Percent change | Standard Deviation 3.9436 |
Secondary
Relative Change From Baseline at Two Years (24 Months) in Mean Lumbar Spine (L2-L4) BMD
Relative change in BMD is the percentage change from baseline of BMD of vertebrae L2 - L4 that are not fractured and not affected by an osteoarthritic process to such a degree that accurate measurement of BMD would be considered jeopardized by the central reading center after 24 months of treatment. It is calculated as the sum of bone mineral content divided by the sum of area of all lumbar vertebrae L2 - L4 that are not fractured and not affected by an osteoarthritic process at Month 24.
Time frame: From Baseline (Month 0) to Month 24
Population: The PP population consisted of all participants in the ITT population who had no major violations of the protocol.Participants available at particular time point for assessment were included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ibandronate 2.5 mg | Relative Change From Baseline at Two Years (24 Months) in Mean Lumbar Spine (L2-L4) BMD | 4.9623 Percent change | Standard Deviation 4.6525 |
| Ibandronate 50/50 mg | Relative Change From Baseline at Two Years (24 Months) in Mean Lumbar Spine (L2-L4) BMD | 5.3350 Percent change | Standard Deviation 4.8235 |
| Ibandronate 100 mg | Relative Change From Baseline at Two Years (24 Months) in Mean Lumbar Spine (L2-L4) BMD | 5.5760 Percent change | Standard Deviation 4.228 |
| Ibandronate 150 mg | Relative Change From Baseline at Two Years (24 Months) in Mean Lumbar Spine (L2-L4) BMD | 6.5503 Percent change | Standard Deviation 4.5118 |
Secondary
Relative Change In Baseline in Serum C-telopeptide of Alpha-chain of Type I Collagen [ CTX] ] to Months 3, 6, 12, and 24
Serum CTX, a biochemical marker of bone resorption, was assessed using the Elecsys S-CTX-I assay (an ElectroChemiLuminescence Immunoassay (ECLIA) Technique).
Time frame: From Baseline (Month 0) to Months 3, 6, 12, 24
Population: The PP population consisted of all participants in the ITT population who had no major violations of the protocol. n = number of participants evaluable at particular time of assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ibandronate 2.5 mg | Relative Change In Baseline in Serum C-telopeptide of Alpha-chain of Type I Collagen [ CTX] ] to Months 3, 6, 12, and 24 | At Month 3, n = 269,278,271,276 | -49.5458 Percent change | Standard Deviation 30.8286 |
| Ibandronate 2.5 mg | Relative Change In Baseline in Serum C-telopeptide of Alpha-chain of Type I Collagen [ CTX] ] to Months 3, 6, 12, and 24 | At Month 6, n = 270,272,274,278 | 55.5900 Percent change | Standard Deviation 34.1672 |
| Ibandronate 2.5 mg | Relative Change In Baseline in Serum C-telopeptide of Alpha-chain of Type I Collagen [ CTX] ] to Months 3, 6, 12, and 24 | At Month 12, n = 272,276,276,267 | -58.8244 Percent change | Standard Deviation 29.825 |
| Ibandronate 2.5 mg | Relative Change In Baseline in Serum C-telopeptide of Alpha-chain of Type I Collagen [ CTX] ] to Months 3, 6, 12, and 24 | At Month 24, n = 221,215,211,235 | -51.2360 Percent change | Standard Deviation 37.9032 |
| Ibandronate 50/50 mg | Relative Change In Baseline in Serum C-telopeptide of Alpha-chain of Type I Collagen [ CTX] ] to Months 3, 6, 12, and 24 | At Month 6, n = 270,272,274,278 | -53.9838 Percent change | Standard Deviation 27.3557 |
| Ibandronate 50/50 mg | Relative Change In Baseline in Serum C-telopeptide of Alpha-chain of Type I Collagen [ CTX] ] to Months 3, 6, 12, and 24 | At Month 12, n = 272,276,276,267 | -57.5363 Percent change | Standard Deviation 27.2271 |
| Ibandronate 50/50 mg | Relative Change In Baseline in Serum C-telopeptide of Alpha-chain of Type I Collagen [ CTX] ] to Months 3, 6, 12, and 24 | At Month 24, n = 221,215,211,235 | -51.3040 Percent change | Standard Deviation 27.9844 |
| Ibandronate 50/50 mg | Relative Change In Baseline in Serum C-telopeptide of Alpha-chain of Type I Collagen [ CTX] ] to Months 3, 6, 12, and 24 | At Month 3, n = 269,278,271,276 | -46.4771 Percent change | Standard Deviation 26.5096 |
| Ibandronate 100 mg | Relative Change In Baseline in Serum C-telopeptide of Alpha-chain of Type I Collagen [ CTX] ] to Months 3, 6, 12, and 24 | At Month 12, n = 272,276,276,267 | -58.1046 Percent change | Standard Deviation 33.5095 |
| Ibandronate 100 mg | Relative Change In Baseline in Serum C-telopeptide of Alpha-chain of Type I Collagen [ CTX] ] to Months 3, 6, 12, and 24 | At Month 6, n = 270,272,274,278 | -55.9614 Percent change | Standard Deviation 31.2801 |
| Ibandronate 100 mg | Relative Change In Baseline in Serum C-telopeptide of Alpha-chain of Type I Collagen [ CTX] ] to Months 3, 6, 12, and 24 | At Month 24, n = 221,215,211,235 | -49.5567 Percent change | Standard Deviation 44.9707 |
| Ibandronate 100 mg | Relative Change In Baseline in Serum C-telopeptide of Alpha-chain of Type I Collagen [ CTX] ] to Months 3, 6, 12, and 24 | At Month 3, n = 269,278,271,276 | -50.2368 Percent change | Standard Deviation 28.1576 |
| Ibandronate 150 mg | Relative Change In Baseline in Serum C-telopeptide of Alpha-chain of Type I Collagen [ CTX] ] to Months 3, 6, 12, and 24 | At Month 24, n = 221,215,211,235 | 61.8822 Percent change | Standard Deviation 28.2309 |
| Ibandronate 150 mg | Relative Change In Baseline in Serum C-telopeptide of Alpha-chain of Type I Collagen [ CTX] ] to Months 3, 6, 12, and 24 | At Month 6, n = 270,272,274,278 | -66.4354 Percent change | Standard Deviation 25.4762 |
| Ibandronate 150 mg | Relative Change In Baseline in Serum C-telopeptide of Alpha-chain of Type I Collagen [ CTX] ] to Months 3, 6, 12, and 24 | At Month 3, n = 269,278,271,276 | -57.3433 Percent change | Standard Deviation 33.9505 |
| Ibandronate 150 mg | Relative Change In Baseline in Serum C-telopeptide of Alpha-chain of Type I Collagen [ CTX] ] to Months 3, 6, 12, and 24 | At Month 12, n = 272,276,276,267 | -67.0703 Percent change | Standard Deviation 41.4563 |