Post Menopausal Osteoporosis
Conditions
Brief summary
This study will assess the efficacy and safety of intravenous administration of Bonviva regimens in women with post-menopausal osteoporosis, compared to oral daily administration. 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
2mg iv every 2 months
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 Percent Change From Baseline in Mean Bone Mineral Density (BMD) of Lumbar Spine (L2-L4) at 12 Months | Baseline and Month 12 | BMD was measured by a single dual-energy x-ray absorptiometry (DXA) scan of the lumbar spine at the time of screening and at Month 12. The change in BMD was defined as the relative difference between the last individual measurement available at 12 months and Baseline, using the following formula: Relative change = 100 x (BMD at 1 year - BMD at Baseline) / (BMD at Baseline) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Absolute Change From Baseline in Mean BMD of Lumbar Spine (L2 - L4) at Month 12 and Month 24 | Baseline, Month 12 and Month 24 | BMD was measured by a single dual-energy x-ray absorptiometry (DXA) scan of the lumbar spine at screening, Month 12 and Month 24. The absolute change from Baseline in mean BMD of the lumbar spine (L2-L4) was defined as the difference between the last individual measurement available at Month 12 or Month 24 and Baseline. Only participants with data available at particular timepoint were analyzed. |
| Relative Percent Change From Baseline in BMD of Proximal Femur (Consisting of Total Hip, Trochanter, and Femoral Neck) at Month 12 and 24 | Baseline, Month 12 and Month 24 | BMD was measured by a single DXA scan of the proximal femur at the time of screening, Month 12 and Month 24.The change in BMD of the proximal femur (total hip, trochanter, femoral neck) was defined as the relative difference between the last individual measurement available at Month 12 or Month 24and Baseline, using the following formula: Relative change = 100 x (BMD at 1 year/2year - BMD at Baseline) / (BMD at Baseline). BMD of fractured bones that could impact the scan area were not taken into account. Only participants with data available at particular timepoint were analyzed. |
| Absolute Change From Baseline in BMD of Proximal Femur (Consisting of Total Hip, Trochanter, and Femoral Neck) at Month 12 and 24 | Baseline, Month 12 and Month 24 | BMD was measured by a single DXA scan of the proximal femur at the time of screening, Month 12 and Month 24. The absolute change in BMD was defined as the difference between the last individual measurement available at Month 12 or Month 24 and Baseline. BMD of fractured bones that could impact the scan area were not taken into account. Only participants with data available at particular timepoint were analyzed. |
| Relative Change From Baseline in Serum C-telopeptide of Alpha-chain of Type I Collagen (CTX) at Month 6, 12, and 24 | Baseline, At Month 6, 12, and 24. | Serum CTX, a biochemical marker of bone resorption, was measured using the Elecsys s-CTX-I assay, an electrochemiluminescence immunoassay (ECLIA) technique. Samples for serum CTX measurements were collected from participants immediately prior to their IV dosing. Thus, the values reported here represent trough or residual values taken at the end of the 2 month or 3 month IV dosing interval. The change in serum CTX was defined as the relative difference between the last individual measurement available at Month 6 or Month 12 or Month 24 and Baseline, using the following formula: Relative change = 100 x (CTX at Month 6/Month 12/Month 24- CTX at Baseline) / (CTX at Baseline). Only participants with data available at particular timepoint were analyzed. |
| Absolute Change From Baseline in Serum CTX at Month 6, 12, and 24 | Baseline, At Month 6, 12, and 24. | Serum CTX, a biochemical marker of bone resorption, was measured using the Elecsys s-CTX-I assay, an electrochemiluminescence immunoassay (ECLIA) technique. Samples for serum CTX measurements were collected from participants immediately prior to their IV dosing. Thus, the values reported here represent trough or residual values taken at the end of the 2 month or 3 month IV dosing interval. The absolute change from Baseline in serum CTX was defined as the difference between the last individual measurement available at Month 6 or Month 12 or Month 24 and Baseline. Only participants with data available at particular timepoint were analyzed. |
| Percentage of Participants With Mean Lumbar Spine (L2 - L4) BMD Above or Equal to Baseline at Month 12 and 24 | At Month 12 and 24 | A participant is a responder if the mean lumber spine (L2 - L4) BMD had remained the same or increased above baseline. Only participants with data available at particular timepoint were analyzed. |
| Percentage of Participants With Total Hip BMD Above or Equal to Baseline at Month 12 and 24 | At Month 12 and 24 | A participant is a responder if the mean total hip BMD had remained the same or increased above baseline. Only participants with data available at particular timepoint were analyzed. |
| Relative Percent Change From Baseline in Mean BMD of Lumbar Spine (L2-L4) at 24 Months | Baseline and Month 24 | BMD was measured by a single dual-energy x-ray absorptiometry (DXA) scan of the lumbar spine at the time of screening and at Month 24. The change in BMD was defined as the relative difference between the last individual measurement available at 24 months and Baseline, using the following formula: Relative change = 100 x (BMD at 1 year - BMD at Baseline) / (BMD at Baseline) |
| Percentage of Participants With Femoral Neck BMD Above or Equal to Baseline at Month 12 and 24 | At Month 12 and 24 | A participant is a responder if the mean femoral neck BMD had remained the same or increased above baseline. Only participants with data available at particular timepoint were analyzed. |
| Percentage of Participants With Mean Total Hip and Lumbar Spine BMD Above or Equal to Baseline at Month 12 and 24 | At Month 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. Only participants with data available at particular timepoint were analyzed. |
| Percentage of Participants With Mean Trochanter and Lumbar Spine BMD Above or Equal to Baseline at Month 12 and 24 | At Month 12 and 24 | A participant is a responder if the mean trochanter and lumbar spine BMD had remained the same or increased above baseline. Only participants with data available at particular timepoint were analyzed. |
| Percentage of Participants With Mean Femoral Neck and Lumbar Spine BMD Above or Equal to Baseline at Month 12 and 24 | At Month 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. Only participants with data available at particular timepoint were analyzed. |
| Number of Participants Who Experienced Any Adverse Events (AEs) or Serious Adverse Events (SAEs) | Approximately 2 years | An 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 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 Any Marked Abnormality in Laboratory Parameters | Approximately 2 years | Marked laboratory test value abnormalities (high and low) are those which exceed the marked reference range (i.e., a reference range greater than the standard reference range) and which also represents a clinically relevant change from baseline of at least a designated amount. The indicated abnormal laboratory parameters (along with their marked reference range) are as follows: low and high Hematocrit (0.36 - 0.60 fraction), low and high hemoglobin (11.0 - 20.0 g/dL), low and high platelets (100 - 700 \* 10\^9/L), low and high white blood cell (WBC) (3.0 - 18.0 \* 10\^9/L), high alanine aminotransferase (ALAT) (0 - 60 U/L), high blood urea nitrogen (BUN) (0 - 14.3 mmol/L) , high creatinine (0 - 154 mmol/L), low albumin (27.0 - 48.0 g/L), low and high chloride (95 - 115 mmol/L), low potassium (3.0 - 6.0 mmol/L), low sodium (130 - 150 mmol/L), high calcium (2.00 - 2.90 mmol/L), low and high phosphate (0.75 - 1.60 mmol/L). |
| Percentage of Participants With Trochanter BMD Above or Equal to Baseline at Month 12 and 24 | At Month 12 and 24 | A participant is a responder if the mean trochanter BMD had remained the same or increased above baseline. Only participants with data available at particular timepoint were analyzed. |
Countries
Australia, Belgium, Canada, Czechia, Denmark, France, Germany, Hungary, Italy, Mexico, Norway, Poland, South Africa, Spain, United Kingdom, United States
Participant flow
Recruitment details
A total of 1804 participants were screened for the study, from which 1395 participants were enrolled and randomized into treatment with ibandronate. The trial was conducted at 58 centers in 16 countries from June 2002 to May 2005.
Pre-assignment details
Out of the 1395 participants who were randomized into the study, only 1382 participants received at least one dose of trial treatment and had at least one follow-up assessment as 4 participants did not have safety follow-up and 9 participants did not receive trial treatment.
Participants by arm
| Arm | Count |
|---|---|
| Ibandronate 2.5mg Daily Participants received 2.5 milligrams (mg) of ibandronate orally daily and IV placebo injection at intervals of either 2 or 3 months for a total treatment period of 24 months. | 465 |
| Ibandronate 2mg q 2 mo IV Participants received 2 mg of ibandronate intravenously (IV) every two months and placebo tablet daily for a total treatment period of 24 months. | 448 |
| Ibandronate 3mg q 3 mo IV Participants received 3 mg of ibandronate IV every three months and placebo tablet daily for a total treatment period of 24 months. | 469 |
| Total | 1,382 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 46 | 41 | 53 |
| Overall Study | Death | 3 | 3 | 2 |
| Overall Study | Husband ill | 0 | 1 | 0 |
| Overall Study | Lost to Follow-up | 2 | 6 | 6 |
| Overall Study | Out of station | 0 | 1 | 1 |
| Overall Study | Poor compliance | 0 | 1 | 0 |
| Overall Study | Protocol Violation | 1 | 3 | 0 |
| Overall Study | Social reasons | 1 | 0 | 0 |
| Overall Study | Study participation was terminated | 0 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 28 | 30 | 35 |
Baseline characteristics
| Characteristic | Ibandronate 2.5mg Daily | Ibandronate 2mg q 2 mo IV | Ibandronate 3mg q 3 mo IV | Total |
|---|---|---|---|---|
| Age, Continuous | 65.7 Years STANDARD_DEVIATION 6.08 | 66.6 Years STANDARD_DEVIATION 6.26 | 65.8 Years STANDARD_DEVIATION 6.3 | 66.0 Years STANDARD_DEVIATION 6.22 |
| Sex: Female, Male Female | 465 Participants | 448 Participants | 469 Participants | 1382 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 301 / 465 | 316 / 448 | 284 / 469 |
| serious Total, serious adverse events | 67 / 465 | 73 / 448 | 62 / 469 |
Outcome results
Primary
Relative Percent Change From Baseline in Mean Bone Mineral Density (BMD) of Lumbar Spine (L2-L4) at 12 Months
BMD was measured by a single dual-energy x-ray absorptiometry (DXA) scan of the lumbar spine at the time of screening and at Month 12. The change in BMD was defined as the relative difference between the last individual measurement available at 12 months and Baseline, using the following formula: Relative change = 100 x (BMD at 1 year - BMD at Baseline) / (BMD at Baseline)
Time frame: Baseline and Month 12
Population: Per protocol population: Participants who were randomized, received at least one dose of study medication and had at least one efficacy (BMD or serum CTX) follow-up data point and did not have any major violations of the protocol.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ibandronate 2.5mg Daily | Relative Percent Change From Baseline in Mean Bone Mineral Density (BMD) of Lumbar Spine (L2-L4) at 12 Months | 3.8199 Percent Change | Standard Deviation 3.8576 |
| Ibandronate 2mg q 2 mo IV | Relative Percent Change From Baseline in Mean Bone Mineral Density (BMD) of Lumbar Spine (L2-L4) at 12 Months | 5.0872 Percent Change | Standard Deviation 3.8746 |
| Ibandronate 3mg q 3 mo IV | Relative Percent Change From Baseline in Mean Bone Mineral Density (BMD) of Lumbar Spine (L2-L4) at 12 Months | 4.8188 Percent Change | Standard Deviation 3.7613 |
Comparison: The primary hypothesis was that the difference in the effects of daily oral ibandronate and IV ibandronate (2mg q 2 mo IV) on the relative change in lumbar spine BMD (L2 - L4) was small, no more than 1%, the margin of clinical equivalence.p-value: <0.00195% CI: [0.701, 1.814]ANOVA
Comparison: The primary hypothesis was that the difference in the effects of daily oral ibandronate and IV ibandronate (3mg q 3 mo IV) on the relative change in lumbar spine BMD (L2 - L4) was small, no more than 1%, the margin of clinical equivalence.p-value: <0.00195% CI: [0.471, 1.578]ANOVA
Secondary
Absolute Change From Baseline in BMD of Proximal Femur (Consisting of Total Hip, Trochanter, and Femoral Neck) at Month 12 and 24
BMD was measured by a single DXA scan of the proximal femur at the time of screening, Month 12 and Month 24. The absolute change in BMD was defined as the difference between the last individual measurement available at Month 12 or Month 24 and Baseline. BMD of fractured bones that could impact the scan area were not taken into account. Only participants with data available at particular timepoint were analyzed.
Time frame: Baseline, Month 12 and Month 24
Population: Per protocol population: Participants who were randomized, received at least one dose of study medication and had at least one efficacy (BMD or serum CTX) follow-up data point and did not have any major violations of the protocol.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ibandronate 2.5mg Daily | Absolute Change From Baseline in BMD of Proximal Femur (Consisting of Total Hip, Trochanter, and Femoral Neck) at Month 12 and 24 | Total hip, Month 12, n = 364, 343, 357 | 0.013 Absolute Change (g/cm^2) | Standard Deviation 0.0202 |
| Ibandronate 2.5mg Daily | Absolute Change From Baseline in BMD of Proximal Femur (Consisting of Total Hip, Trochanter, and Femoral Neck) at Month 12 and 24 | Trochanter, Month 12, n = 364, 343, 357 | 0.016 Absolute Change (g/cm^2) | Standard Deviation 0.0229 |
| Ibandronate 2.5mg Daily | Absolute Change From Baseline in BMD of Proximal Femur (Consisting of Total Hip, Trochanter, and Femoral Neck) at Month 12 and 24 | Trochanter, Month 24, n = 330, 316, 333 | 0.019 Absolute Change (g/cm^2) | Standard Deviation 0.0256 |
| Ibandronate 2.5mg Daily | Absolute Change From Baseline in BMD of Proximal Femur (Consisting of Total Hip, Trochanter, and Femoral Neck) at Month 12 and 24 | Femoral neck , Month 12, n = 364, 343, 357 | 0.010 Absolute Change (g/cm^2) | Standard Deviation 0.0243 |
| Ibandronate 2.5mg Daily | Absolute Change From Baseline in BMD of Proximal Femur (Consisting of Total Hip, Trochanter, and Femoral Neck) at Month 12 and 24 | Femoral neck , Month 24, n = 330, 316, 333 | 0.014 Absolute Change (g/cm^2) | Standard Deviation 0.0258 |
| Ibandronate 2.5mg Daily | Absolute Change From Baseline in BMD of Proximal Femur (Consisting of Total Hip, Trochanter, and Femoral Neck) at Month 12 and 24 | Total hip, Month 24, n = 330, 316, 333 | 0.015 Absolute Change (g/cm^2) | Standard Deviation 0.0259 |
| Ibandronate 2mg q 2 mo IV | Absolute Change From Baseline in BMD of Proximal Femur (Consisting of Total Hip, Trochanter, and Femoral Neck) at Month 12 and 24 | Total hip, Month 24, n = 330, 316, 333 | 0.025 Absolute Change (g/cm^2) | Standard Deviation 0.0211 |
| Ibandronate 2mg q 2 mo IV | Absolute Change From Baseline in BMD of Proximal Femur (Consisting of Total Hip, Trochanter, and Femoral Neck) at Month 12 and 24 | Femoral neck , Month 12, n = 364, 343, 357 | 0.013 Absolute Change (g/cm^2) | Standard Deviation 0.0227 |
| Ibandronate 2mg q 2 mo IV | Absolute Change From Baseline in BMD of Proximal Femur (Consisting of Total Hip, Trochanter, and Femoral Neck) at Month 12 and 24 | Femoral neck , Month 24, n = 330, 316, 333 | 0.018 Absolute Change (g/cm^2) | Standard Deviation 0.0279 |
| Ibandronate 2mg q 2 mo IV | Absolute Change From Baseline in BMD of Proximal Femur (Consisting of Total Hip, Trochanter, and Femoral Neck) at Month 12 and 24 | Total hip, Month 12, n = 364, 343, 357 | 0.018 Absolute Change (g/cm^2) | Standard Deviation 0.0192 |
| Ibandronate 2mg q 2 mo IV | Absolute Change From Baseline in BMD of Proximal Femur (Consisting of Total Hip, Trochanter, and Femoral Neck) at Month 12 and 24 | Trochanter, Month 12, n = 364, 343, 357 | 0.022 Absolute Change (g/cm^2) | Standard Deviation 0.0209 |
| Ibandronate 2mg q 2 mo IV | Absolute Change From Baseline in BMD of Proximal Femur (Consisting of Total Hip, Trochanter, and Femoral Neck) at Month 12 and 24 | Trochanter, Month 24, n = 330, 316, 333 | 0.029 Absolute Change (g/cm^2) | Standard Deviation 0.0242 |
| Ibandronate 3mg q 3 mo IV | Absolute Change From Baseline in BMD of Proximal Femur (Consisting of Total Hip, Trochanter, and Femoral Neck) at Month 12 and 24 | Trochanter, Month 12, n = 364, 343, 357 | 0.020 Absolute Change (g/cm^2) | Standard Deviation 0.025 |
| Ibandronate 3mg q 3 mo IV | Absolute Change From Baseline in BMD of Proximal Femur (Consisting of Total Hip, Trochanter, and Femoral Neck) at Month 12 and 24 | Trochanter, Month 24, n = 330, 316, 333 | 0.026 Absolute Change (g/cm^2) | Standard Deviation 0.0322 |
| Ibandronate 3mg q 3 mo IV | Absolute Change From Baseline in BMD of Proximal Femur (Consisting of Total Hip, Trochanter, and Femoral Neck) at Month 12 and 24 | Total hip, Month 12, n = 364, 343, 357 | 0.016 Absolute Change (g/cm^2) | Standard Deviation 0.0213 |
| Ibandronate 3mg q 3 mo IV | Absolute Change From Baseline in BMD of Proximal Femur (Consisting of Total Hip, Trochanter, and Femoral Neck) at Month 12 and 24 | Femoral neck , Month 12, n = 364, 343, 357 | 0.014 Absolute Change (g/cm^2) | Standard Deviation 0.024 |
| Ibandronate 3mg q 3 mo IV | Absolute Change From Baseline in BMD of Proximal Femur (Consisting of Total Hip, Trochanter, and Femoral Neck) at Month 12 and 24 | Total hip, Month 24, n = 330, 316, 333 | 0.022 Absolute Change (g/cm^2) | Standard Deviation 0.0278 |
| Ibandronate 3mg q 3 mo IV | Absolute Change From Baseline in BMD of Proximal Femur (Consisting of Total Hip, Trochanter, and Femoral Neck) at Month 12 and 24 | Femoral neck , Month 24, n = 330, 316, 333 | 0.018 Absolute Change (g/cm^2) | Standard Deviation 0.0278 |
Secondary
Absolute Change From Baseline in Mean BMD of Lumbar Spine (L2 - L4) at Month 12 and Month 24
BMD was measured by a single dual-energy x-ray absorptiometry (DXA) scan of the lumbar spine at screening, Month 12 and Month 24. The absolute change from Baseline in mean BMD of the lumbar spine (L2-L4) was defined as the difference between the last individual measurement available at Month 12 or Month 24 and Baseline. Only participants with data available at particular timepoint were analyzed.
Time frame: Baseline, Month 12 and Month 24
Population: Per protocol population: Participants who were randomized, received at least one dose of study medication and had at least one efficacy (BMD or serum CTX) follow-up data point and did not have any major violations of the protocol.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ibandronate 2.5mg Daily | Absolute Change From Baseline in Mean BMD of Lumbar Spine (L2 - L4) at Month 12 and Month 24 | Month 24, n= 334, 320, 334 | 0.036 Absolute Change (g/cm^2) | Standard Deviation 0.0361 |
| Ibandronate 2.5mg Daily | Absolute Change From Baseline in Mean BMD of Lumbar Spine (L2 - L4) at Month 12 and Month 24 | Month 12, n= 368, 350, 359 | 0.028 Absolute Change (g/cm^2) | Standard Deviation 0.0287 |
| Ibandronate 2mg q 2 mo IV | Absolute Change From Baseline in Mean BMD of Lumbar Spine (L2 - L4) at Month 12 and Month 24 | Month 24, n= 334, 320, 334 | 0.047 Absolute Change (g/cm^2) | Standard Deviation 0.0347 |
| Ibandronate 2mg q 2 mo IV | Absolute Change From Baseline in Mean BMD of Lumbar Spine (L2 - L4) at Month 12 and Month 24 | Month 12, n= 368, 350, 359 | 0.037 Absolute Change (g/cm^2) | Standard Deviation 0.0282 |
| Ibandronate 3mg q 3 mo IV | Absolute Change From Baseline in Mean BMD of Lumbar Spine (L2 - L4) at Month 12 and Month 24 | Month 24, n= 334, 320, 334 | 0.046 Absolute Change (g/cm^2) | Standard Deviation 0.0357 |
| Ibandronate 3mg q 3 mo IV | Absolute Change From Baseline in Mean BMD of Lumbar Spine (L2 - L4) at Month 12 and Month 24 | Month 12, n= 368, 350, 359 | 0.035 Absolute Change (g/cm^2) | Standard Deviation 0.0269 |
Secondary
Absolute Change From Baseline in Serum CTX at Month 6, 12, and 24
Serum CTX, a biochemical marker of bone resorption, was measured using the Elecsys s-CTX-I assay, an electrochemiluminescence immunoassay (ECLIA) technique. Samples for serum CTX measurements were collected from participants immediately prior to their IV dosing. Thus, the values reported here represent trough or residual values taken at the end of the 2 month or 3 month IV dosing interval. The absolute change from Baseline in serum CTX was defined as the difference between the last individual measurement available at Month 6 or Month 12 or Month 24 and Baseline. Only participants with data available at particular timepoint were analyzed.
Time frame: Baseline, At Month 6, 12, and 24.
Population: Per protocol population: Participants who were randomized, received at least one dose of study medication and had at least one efficacy (BMD or serum CTX) follow-up data point and did not have any major violations of the protocol.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ibandronate 2.5mg Daily | Absolute Change From Baseline in Serum CTX at Month 6, 12, and 24 | Month 6, n = 358, 342, 345 | -0.318 Absolute Change (ng/mL) | Standard Deviation 0.255 |
| Ibandronate 2.5mg Daily | Absolute Change From Baseline in Serum CTX at Month 6, 12, and 24 | Month 24, n = 310, 301, 298 | -0.324 Absolute Change (ng/mL) | Standard Deviation 0.2693 |
| Ibandronate 2.5mg Daily | Absolute Change From Baseline in Serum CTX at Month 6, 12, and 24 | Month 12, n = 360, 342, 347 | -0.321 Absolute Change (ng/mL) | Standard Deviation 0.2624 |
| Ibandronate 2mg q 2 mo IV | Absolute Change From Baseline in Serum CTX at Month 6, 12, and 24 | Month 12, n = 360, 342, 347 | -0.318 Absolute Change (ng/mL) | Standard Deviation 0.2239 |
| Ibandronate 2mg q 2 mo IV | Absolute Change From Baseline in Serum CTX at Month 6, 12, and 24 | Month 6, n = 358, 342, 345 | -0.322 Absolute Change (ng/mL) | Standard Deviation 0.2015 |
| Ibandronate 2mg q 2 mo IV | Absolute Change From Baseline in Serum CTX at Month 6, 12, and 24 | Month 24, n = 310, 301, 298 | -0.285 Absolute Change (ng/mL) | Standard Deviation 0.2092 |
| Ibandronate 3mg q 3 mo IV | Absolute Change From Baseline in Serum CTX at Month 6, 12, and 24 | Month 12, n = 360, 342, 347 | -0.290 Absolute Change (ng/mL) | Standard Deviation 0.2196 |
| Ibandronate 3mg q 3 mo IV | Absolute Change From Baseline in Serum CTX at Month 6, 12, and 24 | Month 24, n = 310, 301, 298 | -0.276 Absolute Change (ng/mL) | Standard Deviation 0.2323 |
| Ibandronate 3mg q 3 mo IV | Absolute Change From Baseline in Serum CTX at Month 6, 12, and 24 | Month 6, n = 358, 342, 345 | -0.281 Absolute Change (ng/mL) | Standard Deviation 0.2018 |
Secondary
Number of Participants Who Experienced Any Adverse Events (AEs) or Serious Adverse Events (SAEs)
An 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 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: Approximately 2 years
Population: Safety Population: All participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ibandronate 2.5mg Daily | Number of Participants Who Experienced Any Adverse Events (AEs) or Serious Adverse Events (SAEs) | Any AE | 408 participants |
| Ibandronate 2.5mg Daily | Number of Participants Who Experienced Any Adverse Events (AEs) or Serious Adverse Events (SAEs) | Any SAE | 67 participants |
| Ibandronate 2mg q 2 mo IV | Number of Participants Who Experienced Any Adverse Events (AEs) or Serious Adverse Events (SAEs) | Any AE | 397 participants |
| Ibandronate 2mg q 2 mo IV | Number of Participants Who Experienced Any Adverse Events (AEs) or Serious Adverse Events (SAEs) | Any SAE | 73 participants |
| Ibandronate 3mg q 3 mo IV | Number of Participants Who Experienced Any Adverse Events (AEs) or Serious Adverse Events (SAEs) | Any AE | 400 participants |
| Ibandronate 3mg q 3 mo IV | Number of Participants Who Experienced Any Adverse Events (AEs) or Serious Adverse Events (SAEs) | Any SAE | 62 participants |
Secondary
Number of Participants With Any Marked Abnormality in Laboratory Parameters
Marked laboratory test value abnormalities (high and low) are those which exceed the marked reference range (i.e., a reference range greater than the standard reference range) and which also represents a clinically relevant change from baseline of at least a designated amount. The indicated abnormal laboratory parameters (along with their marked reference range) are as follows: low and high Hematocrit (0.36 - 0.60 fraction), low and high hemoglobin (11.0 - 20.0 g/dL), low and high platelets (100 - 700 \* 10\^9/L), low and high white blood cell (WBC) (3.0 - 18.0 \* 10\^9/L), high alanine aminotransferase (ALAT) (0 - 60 U/L), high blood urea nitrogen (BUN) (0 - 14.3 mmol/L) , high creatinine (0 - 154 mmol/L), low albumin (27.0 - 48.0 g/L), low and high chloride (95 - 115 mmol/L), low potassium (3.0 - 6.0 mmol/L), low sodium (130 - 150 mmol/L), high calcium (2.00 - 2.90 mmol/L), low and high phosphate (0.75 - 1.60 mmol/L).
Time frame: Approximately 2 years
Population: Safety Population: All participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point. Only participants with data available for the indicated laboratory abnormality were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ibandronate 2.5mg Daily | Number of Participants With Any Marked Abnormality in Laboratory Parameters | Phosphate - Low, n = 453, 434, 456 | 6 participants |
| Ibandronate 2.5mg Daily | Number of Participants With Any Marked Abnormality in Laboratory Parameters | Creatinine - High, n = 453, 434, 456 | 0 participants |
| Ibandronate 2.5mg Daily | Number of Participants With Any Marked Abnormality in Laboratory Parameters | ALAT (SGPT) - High, n = 453, 434, 456 | 13 participants |
| Ibandronate 2.5mg Daily | Number of Participants With Any Marked Abnormality in Laboratory Parameters | Phosphate - High, n = 453, 434, 456 | 7 participants |
| Ibandronate 2.5mg Daily | Number of Participants With Any Marked Abnormality in Laboratory Parameters | Albumin - Low, n = 453, 434, 456 | 0 participants |
| Ibandronate 2.5mg Daily | Number of Participants With Any Marked Abnormality in Laboratory Parameters | Hemoglobin - High, n = 453, 433, 456 | 0 participants |
| Ibandronate 2.5mg Daily | Number of Participants With Any Marked Abnormality in Laboratory Parameters | Calcium - High, n = 453, 434, 456 | 0 participants |
| Ibandronate 2.5mg Daily | Number of Participants With Any Marked Abnormality in Laboratory Parameters | Chloride - High, n = 453, 433, 456 | 1 participants |
| Ibandronate 2.5mg Daily | Number of Participants With Any Marked Abnormality in Laboratory Parameters | WBC - High, n = 453, 433, 456 | 0 participants |
| Ibandronate 2.5mg Daily | Number of Participants With Any Marked Abnormality in Laboratory Parameters | Potassium - Low, n = 453, 433, 456 | 0 participants |
| Ibandronate 2.5mg Daily | Number of Participants With Any Marked Abnormality in Laboratory Parameters | Chloride - Low, n = 453, 433, 456 | 4 participants |
| Ibandronate 2.5mg Daily | Number of Participants With Any Marked Abnormality in Laboratory Parameters | Platelets - High, n = 452, 431, 455 | 0 participants |
| Ibandronate 2.5mg Daily | Number of Participants With Any Marked Abnormality in Laboratory Parameters | Hematocrit - low, n = 453, 433, 456 | 0 participants |
| Ibandronate 2.5mg Daily | Number of Participants With Any Marked Abnormality in Laboratory Parameters | WBC - Low, n = 453, 433, 456 | 4 participants |
| Ibandronate 2.5mg Daily | Number of Participants With Any Marked Abnormality in Laboratory Parameters | Hemoglobin - Low n = 453, 433, 456 | 2 participants |
| Ibandronate 2.5mg Daily | Number of Participants With Any Marked Abnormality in Laboratory Parameters | Hematocrit - High, n = 453, 433, 456 | 0 participants |
| Ibandronate 2.5mg Daily | Number of Participants With Any Marked Abnormality in Laboratory Parameters | Sodium - Low, n = 453, 433, 456 | 0 participants |
| Ibandronate 2.5mg Daily | Number of Participants With Any Marked Abnormality in Laboratory Parameters | BUN - High, n = 453, 434, 456 | 1 participants |
| Ibandronate 2.5mg Daily | Number of Participants With Any Marked Abnormality in Laboratory Parameters | Platelets - Low, n = 452, 431, 455 | 2 participants |
| Ibandronate 2mg q 2 mo IV | Number of Participants With Any Marked Abnormality in Laboratory Parameters | WBC - Low, n = 453, 433, 456 | 4 participants |
| Ibandronate 2mg q 2 mo IV | Number of Participants With Any Marked Abnormality in Laboratory Parameters | Hemoglobin - Low n = 453, 433, 456 | 5 participants |
| Ibandronate 2mg q 2 mo IV | Number of Participants With Any Marked Abnormality in Laboratory Parameters | Platelets - High, n = 452, 431, 455 | 2 participants |
| Ibandronate 2mg q 2 mo IV | Number of Participants With Any Marked Abnormality in Laboratory Parameters | Platelets - Low, n = 452, 431, 455 | 0 participants |
| Ibandronate 2mg q 2 mo IV | Number of Participants With Any Marked Abnormality in Laboratory Parameters | WBC - High, n = 453, 433, 456 | 1 participants |
| Ibandronate 2mg q 2 mo IV | Number of Participants With Any Marked Abnormality in Laboratory Parameters | Hemoglobin - High, n = 453, 433, 456 | 1 participants |
| Ibandronate 2mg q 2 mo IV | Number of Participants With Any Marked Abnormality in Laboratory Parameters | ALAT (SGPT) - High, n = 453, 434, 456 | 12 participants |
| Ibandronate 2mg q 2 mo IV | Number of Participants With Any Marked Abnormality in Laboratory Parameters | BUN - High, n = 453, 434, 456 | 2 participants |
| Ibandronate 2mg q 2 mo IV | Number of Participants With Any Marked Abnormality in Laboratory Parameters | Creatinine - High, n = 453, 434, 456 | 2 participants |
| Ibandronate 2mg q 2 mo IV | Number of Participants With Any Marked Abnormality in Laboratory Parameters | Albumin - Low, n = 453, 434, 456 | 1 participants |
| Ibandronate 2mg q 2 mo IV | Number of Participants With Any Marked Abnormality in Laboratory Parameters | Chloride - High, n = 453, 433, 456 | 0 participants |
| Ibandronate 2mg q 2 mo IV | Number of Participants With Any Marked Abnormality in Laboratory Parameters | Potassium - Low, n = 453, 433, 456 | 1 participants |
| Ibandronate 2mg q 2 mo IV | Number of Participants With Any Marked Abnormality in Laboratory Parameters | Sodium - Low, n = 453, 433, 456 | 1 participants |
| Ibandronate 2mg q 2 mo IV | Number of Participants With Any Marked Abnormality in Laboratory Parameters | Calcium - High, n = 453, 434, 456 | 1 participants |
| Ibandronate 2mg q 2 mo IV | Number of Participants With Any Marked Abnormality in Laboratory Parameters | Phosphate - High, n = 453, 434, 456 | 4 participants |
| Ibandronate 2mg q 2 mo IV | Number of Participants With Any Marked Abnormality in Laboratory Parameters | Phosphate - Low, n = 453, 434, 456 | 3 participants |
| Ibandronate 2mg q 2 mo IV | Number of Participants With Any Marked Abnormality in Laboratory Parameters | Hematocrit - High, n = 453, 433, 456 | 0 participants |
| Ibandronate 2mg q 2 mo IV | Number of Participants With Any Marked Abnormality in Laboratory Parameters | Hematocrit - low, n = 453, 433, 456 | 2 participants |
| Ibandronate 2mg q 2 mo IV | Number of Participants With Any Marked Abnormality in Laboratory Parameters | Chloride - Low, n = 453, 433, 456 | 3 participants |
| Ibandronate 3mg q 3 mo IV | Number of Participants With Any Marked Abnormality in Laboratory Parameters | Creatinine - High, n = 453, 434, 456 | 0 participants |
| Ibandronate 3mg q 3 mo IV | Number of Participants With Any Marked Abnormality in Laboratory Parameters | Platelets - High, n = 452, 431, 455 | 1 participants |
| Ibandronate 3mg q 3 mo IV | Number of Participants With Any Marked Abnormality in Laboratory Parameters | Phosphate - High, n = 453, 434, 456 | 6 participants |
| Ibandronate 3mg q 3 mo IV | Number of Participants With Any Marked Abnormality in Laboratory Parameters | BUN - High, n = 453, 434, 456 | 0 participants |
| Ibandronate 3mg q 3 mo IV | Number of Participants With Any Marked Abnormality in Laboratory Parameters | Calcium - High, n = 453, 434, 456 | 0 participants |
| Ibandronate 3mg q 3 mo IV | Number of Participants With Any Marked Abnormality in Laboratory Parameters | Phosphate - Low, n = 453, 434, 456 | 2 participants |
| Ibandronate 3mg q 3 mo IV | Number of Participants With Any Marked Abnormality in Laboratory Parameters | WBC - Low, n = 453, 433, 456 | 2 participants |
| Ibandronate 3mg q 3 mo IV | Number of Participants With Any Marked Abnormality in Laboratory Parameters | Hemoglobin - Low n = 453, 433, 456 | 5 participants |
| Ibandronate 3mg q 3 mo IV | Number of Participants With Any Marked Abnormality in Laboratory Parameters | Hematocrit - High, n = 453, 433, 456 | 1 participants |
| Ibandronate 3mg q 3 mo IV | Number of Participants With Any Marked Abnormality in Laboratory Parameters | WBC - High, n = 453, 433, 456 | 2 participants |
| Ibandronate 3mg q 3 mo IV | Number of Participants With Any Marked Abnormality in Laboratory Parameters | ALAT (SGPT) - High, n = 453, 434, 456 | 18 participants |
| Ibandronate 3mg q 3 mo IV | Number of Participants With Any Marked Abnormality in Laboratory Parameters | Chloride - Low, n = 453, 433, 456 | 3 participants |
| Ibandronate 3mg q 3 mo IV | Number of Participants With Any Marked Abnormality in Laboratory Parameters | Chloride - High, n = 453, 433, 456 | 0 participants |
| Ibandronate 3mg q 3 mo IV | Number of Participants With Any Marked Abnormality in Laboratory Parameters | Hematocrit - low, n = 453, 433, 456 | 5 participants |
| Ibandronate 3mg q 3 mo IV | Number of Participants With Any Marked Abnormality in Laboratory Parameters | Potassium - Low, n = 453, 433, 456 | 0 participants |
| Ibandronate 3mg q 3 mo IV | Number of Participants With Any Marked Abnormality in Laboratory Parameters | Platelets - Low, n = 452, 431, 455 | 1 participants |
| Ibandronate 3mg q 3 mo IV | Number of Participants With Any Marked Abnormality in Laboratory Parameters | Sodium - Low, n = 453, 433, 456 | 1 participants |
| Ibandronate 3mg q 3 mo IV | Number of Participants With Any Marked Abnormality in Laboratory Parameters | Albumin - Low, n = 453, 434, 456 | 0 participants |
| Ibandronate 3mg q 3 mo IV | Number of Participants With Any Marked Abnormality in Laboratory Parameters | Hemoglobin - High, n = 453, 433, 456 | 1 participants |
Secondary
Percentage of Participants With Femoral Neck BMD Above or Equal to Baseline at Month 12 and 24
A participant is a responder if the mean femoral neck BMD had remained the same or increased above baseline. Only participants with data available at particular timepoint were analyzed.
Time frame: At Month 12 and 24
Population: Per protocol population: Participants who were randomized, received at least one dose of study medication and had at least one efficacy (BMD or serum CTX) follow-up data point and did not have any major violations of the protocol.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ibandronate 2.5mg Daily | Percentage of Participants With Femoral Neck BMD Above or Equal to Baseline at Month 12 and 24 | Above baseline, Month 12, n = 364, 343, 357 | 65.1 Percentage of participants |
| Ibandronate 2.5mg Daily | Percentage of Participants With Femoral Neck BMD Above or Equal to Baseline at Month 12 and 24 | Above baseline, Month 24, n = 330, 316, 333 | 67.6 Percentage of participants |
| Ibandronate 2mg q 2 mo IV | Percentage of Participants With Femoral Neck BMD Above or Equal to Baseline at Month 12 and 24 | Above baseline, Month 12, n = 364, 343, 357 | 74.1 Percentage of participants |
| Ibandronate 2mg q 2 mo IV | Percentage of Participants With Femoral Neck BMD Above or Equal to Baseline at Month 12 and 24 | Above baseline, Month 24, n = 330, 316, 333 | 77.5 Percentage of participants |
| Ibandronate 3mg q 3 mo IV | Percentage of Participants With Femoral Neck BMD Above or Equal to Baseline at Month 12 and 24 | Above baseline, Month 12, n = 364, 343, 357 | 70.0 Percentage of participants |
| Ibandronate 3mg q 3 mo IV | Percentage of Participants With Femoral Neck BMD Above or Equal to Baseline at Month 12 and 24 | Above baseline, Month 24, n = 330, 316, 333 | 76.6 Percentage of participants |
Secondary
Percentage of Participants With Mean Femoral Neck and Lumbar Spine BMD Above or Equal to Baseline at Month 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. Only participants with data available at particular timepoint were analyzed.
Time frame: At Month 12 and 24
Population: Per protocol population: Participants who were randomized, received at least one dose of study medication and had at least one efficacy (BMD or serum CTX) follow-up data point and did not have any major violations of the protocol.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ibandronate 2.5mg Daily | Percentage of Participants With Mean Femoral Neck and Lumbar Spine BMD Above or Equal to Baseline at Month 12 and 24 | Above baseline, Month 12, n = 363, 343, 355 | 58.4 Percentage of participants |
| Ibandronate 2.5mg Daily | Percentage of Participants With Mean Femoral Neck and Lumbar Spine BMD Above or Equal to Baseline at Month 12 and 24 | Above baseline, Month 24, n = 330, 314, 332 | 59.7 Percentage of participants |
| Ibandronate 2mg q 2 mo IV | Percentage of Participants With Mean Femoral Neck and Lumbar Spine BMD Above or Equal to Baseline at Month 12 and 24 | Above baseline, Month 12, n = 363, 343, 355 | 69.4 Percentage of participants |
| Ibandronate 2mg q 2 mo IV | Percentage of Participants With Mean Femoral Neck and Lumbar Spine BMD Above or Equal to Baseline at Month 12 and 24 | Above baseline, Month 24, n = 330, 314, 332 | 72.3 Percentage of participants |
| Ibandronate 3mg q 3 mo IV | Percentage of Participants With Mean Femoral Neck and Lumbar Spine BMD Above or Equal to Baseline at Month 12 and 24 | Above baseline, Month 12, n = 363, 343, 355 | 64.5 Percentage of participants |
| Ibandronate 3mg q 3 mo IV | Percentage of Participants With Mean Femoral Neck and Lumbar Spine BMD Above or Equal to Baseline at Month 12 and 24 | Above baseline, Month 24, n = 330, 314, 332 | 71.7 Percentage of participants |
Secondary
Percentage of Participants With Mean Lumbar Spine (L2 - L4) BMD Above or Equal to Baseline at Month 12 and 24
A participant is a responder if the mean lumber spine (L2 - L4) BMD had remained the same or increased above baseline. Only participants with data available at particular timepoint were analyzed.
Time frame: At Month 12 and 24
Population: Per protocol population: Participants who were randomized, received at least one dose of study medication and had at least one efficacy (BMD or serum CTX) follow-up data point and did not have any major violations of the protocol.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ibandronate 2.5mg Daily | Percentage of Participants With Mean Lumbar Spine (L2 - L4) BMD Above or Equal to Baseline at Month 12 and 24 | Above baseline, Month 12, n = 368, 350, 359 | 85.1 Percentage of participants |
| Ibandronate 2.5mg Daily | Percentage of Participants With Mean Lumbar Spine (L2 - L4) BMD Above or Equal to Baseline at Month 12 and 24 | Above baseline, Month 24, n = 334, 320, 334 | 84.7 Percentage of participants |
| Ibandronate 2mg q 2 mo IV | Percentage of Participants With Mean Lumbar Spine (L2 - L4) BMD Above or Equal to Baseline at Month 12 and 24 | Above baseline, Month 12, n = 368, 350, 359 | 92.3 Percentage of participants |
| Ibandronate 2mg q 2 mo IV | Percentage of Participants With Mean Lumbar Spine (L2 - L4) BMD Above or Equal to Baseline at Month 12 and 24 | Above baseline, Month 24, n = 334, 320, 334 | 92.8 Percentage of participants |
| Ibandronate 3mg q 3 mo IV | Percentage of Participants With Mean Lumbar Spine (L2 - L4) BMD Above or Equal to Baseline at Month 12 and 24 | Above baseline, Month 12, n = 368, 350, 359 | 91.6 Percentage of participants |
| Ibandronate 3mg q 3 mo IV | Percentage of Participants With Mean Lumbar Spine (L2 - L4) BMD Above or Equal to Baseline at Month 12 and 24 | Above baseline, Month 24, n = 334, 320, 334 | 92.8 Percentage of participants |
Secondary
Percentage of Participants With Mean Total Hip and Lumbar Spine BMD Above or Equal to Baseline at Month 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. Only participants with data available at particular timepoint were analyzed.
Time frame: At Month 12 and 24
Population: Per protocol population: Participants who were randomized, received at least one dose of study medication and had at least one efficacy (BMD or serum CTX) follow-up data point and did not have any major violations of the protocol.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ibandronate 2.5mg Daily | Percentage of Participants With Mean Total Hip and Lumbar Spine BMD Above or Equal to Baseline at Month 12 and 24 | Above baseline, Month 12, n = 363, 343, 355 | 66.9 Percentage of participants |
| Ibandronate 2.5mg Daily | Percentage of Participants With Mean Total Hip and Lumbar Spine BMD Above or Equal to Baseline at Month 12 and 24 | Above baseline, Month 24, n = 330, 314, 332 | 68.8 Percentage of participants |
| Ibandronate 2mg q 2 mo IV | Percentage of Participants With Mean Total Hip and Lumbar Spine BMD Above or Equal to Baseline at Month 12 and 24 | Above baseline, Month 24, n = 330, 314, 332 | 83.1 Percentage of participants |
| Ibandronate 2mg q 2 mo IV | Percentage of Participants With Mean Total Hip and Lumbar Spine BMD Above or Equal to Baseline at Month 12 and 24 | Above baseline, Month 12, n = 363, 343, 355 | 80.5 Percentage of participants |
| Ibandronate 3mg q 3 mo IV | Percentage of Participants With Mean Total Hip and Lumbar Spine BMD Above or Equal to Baseline at Month 12 and 24 | Above baseline, Month 24, n = 330, 314, 332 | 80.1 Percentage of participants |
| Ibandronate 3mg q 3 mo IV | Percentage of Participants With Mean Total Hip and Lumbar Spine BMD Above or Equal to Baseline at Month 12 and 24 | Above baseline, Month 12, n = 363, 343, 355 | 76.3 Percentage of participants |
Secondary
Percentage of Participants With Mean Trochanter and Lumbar Spine BMD Above or Equal to Baseline at Month 12 and 24
A participant is a responder if the mean trochanter and lumbar spine BMD had remained the same or increased above baseline. Only participants with data available at particular timepoint were analyzed.
Time frame: At Month 12 and 24
Population: Per protocol population: Participants who were randomized, received at least one dose of study medication and had at least one efficacy (BMD or serum CTX) follow-up data point and did not have any major violations of the protocol.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ibandronate 2.5mg Daily | Percentage of Participants With Mean Trochanter and Lumbar Spine BMD Above or Equal to Baseline at Month 12 and 24 | Above baseline, Month 24, n = 330, 314, 332 | 70.9 Percentage of participants |
| Ibandronate 2.5mg Daily | Percentage of Participants With Mean Trochanter and Lumbar Spine BMD Above or Equal to Baseline at Month 12 and 24 | Above baseline, Month 12, n = 363, 343, 355 | 68.0 Percentage of participants |
| Ibandronate 2mg q 2 mo IV | Percentage of Participants With Mean Trochanter and Lumbar Spine BMD Above or Equal to Baseline at Month 12 and 24 | Above baseline, Month 24, n = 330, 314, 332 | 85.7 Percentage of participants |
| Ibandronate 2mg q 2 mo IV | Percentage of Participants With Mean Trochanter and Lumbar Spine BMD Above or Equal to Baseline at Month 12 and 24 | Above baseline, Month 12, n = 363, 343, 355 | 83.4 Percentage of participants |
| Ibandronate 3mg q 3 mo IV | Percentage of Participants With Mean Trochanter and Lumbar Spine BMD Above or Equal to Baseline at Month 12 and 24 | Above baseline, Month 12, n = 363, 343, 355 | 79.7 Percentage of participants |
| Ibandronate 3mg q 3 mo IV | Percentage of Participants With Mean Trochanter and Lumbar Spine BMD Above or Equal to Baseline at Month 12 and 24 | Above baseline, Month 24, n = 330, 314, 332 | 83.1 Percentage of participants |
Secondary
Percentage of Participants With Total Hip BMD Above or Equal to Baseline at Month 12 and 24
A participant is a responder if the mean total hip BMD had remained the same or increased above baseline. Only participants with data available at particular timepoint were analyzed.
Time frame: At Month 12 and 24
Population: Per protocol population: Participants who were randomized, received at least one dose of study medication and had at least one efficacy (BMD or serum CTX) follow-up data point and did not have any major violations of the protocol.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ibandronate 2.5mg Daily | Percentage of Participants With Total Hip BMD Above or Equal to Baseline at Month 12 and 24 | Above baseline, Month 12, n = 364, 343, 357 | 74.5 Percentage of participants |
| Ibandronate 2.5mg Daily | Percentage of Participants With Total Hip BMD Above or Equal to Baseline at Month 12 and 24 | Above baseline, Month 24, n = 330, 316, 333 | 77.0 Percentage of participants |
| Ibandronate 2mg q 2 mo IV | Percentage of Participants With Total Hip BMD Above or Equal to Baseline at Month 12 and 24 | Above baseline, Month 12, n = 364, 343, 357 | 86.0 Percentage of participants |
| Ibandronate 2mg q 2 mo IV | Percentage of Participants With Total Hip BMD Above or Equal to Baseline at Month 12 and 24 | Above baseline, Month 24, n = 330, 316, 333 | 88.6 Percentage of participants |
| Ibandronate 3mg q 3 mo IV | Percentage of Participants With Total Hip BMD Above or Equal to Baseline at Month 12 and 24 | Above baseline, Month 12, n = 364, 343, 357 | 82.6 Percentage of participants |
| Ibandronate 3mg q 3 mo IV | Percentage of Participants With Total Hip BMD Above or Equal to Baseline at Month 12 and 24 | Above baseline, Month 24, n = 330, 316, 333 | 85.6 Percentage of participants |
Secondary
Percentage of Participants With Trochanter BMD Above or Equal to Baseline at Month 12 and 24
A participant is a responder if the mean trochanter BMD had remained the same or increased above baseline. Only participants with data available at particular timepoint were analyzed.
Time frame: At Month 12 and 24
Population: Per protocol population: Participants who were randomized, received at least one dose of study medication and had at least one efficacy (BMD or serum CTX) follow-up data point and did not have any major violations of the protocol.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ibandronate 2.5mg Daily | Percentage of Participants With Trochanter BMD Above or Equal to Baseline at Month 12 and 24 | Above baseline, Month 12, n = 364, 343, 357 | 76.6 Percentage of participants |
| Ibandronate 2.5mg Daily | Percentage of Participants With Trochanter BMD Above or Equal to Baseline at Month 12 and 24 | Above baseline, Month 24, n = 330, 316, 333 | 80.0 Percentage of participants |
| Ibandronate 2mg q 2 mo IV | Percentage of Participants With Trochanter BMD Above or Equal to Baseline at Month 12 and 24 | Above baseline, Month 12, n = 364, 343, 357 | 88.6 Percentage of participants |
| Ibandronate 2mg q 2 mo IV | Percentage of Participants With Trochanter BMD Above or Equal to Baseline at Month 12 and 24 | Above baseline, Month 24, n = 330, 316, 333 | 92.1 Percentage of participants |
| Ibandronate 3mg q 3 mo IV | Percentage of Participants With Trochanter BMD Above or Equal to Baseline at Month 12 and 24 | Above baseline, Month 12, n = 364, 343, 357 | 86.3 Percentage of participants |
| Ibandronate 3mg q 3 mo IV | Percentage of Participants With Trochanter BMD Above or Equal to Baseline at Month 12 and 24 | Above baseline, Month 24, n = 330, 316, 333 | 88.6 Percentage of participants |
Secondary
Relative Change From Baseline in Serum C-telopeptide of Alpha-chain of Type I Collagen (CTX) at Month 6, 12, and 24
Serum CTX, a biochemical marker of bone resorption, was measured using the Elecsys s-CTX-I assay, an electrochemiluminescence immunoassay (ECLIA) technique. Samples for serum CTX measurements were collected from participants immediately prior to their IV dosing. Thus, the values reported here represent trough or residual values taken at the end of the 2 month or 3 month IV dosing interval. The change in serum CTX was defined as the relative difference between the last individual measurement available at Month 6 or Month 12 or Month 24 and Baseline, using the following formula: Relative change = 100 x (CTX at Month 6/Month 12/Month 24- CTX at Baseline) / (CTX at Baseline). Only participants with data available at particular timepoint were analyzed.
Time frame: Baseline, At Month 6, 12, and 24.
Population: Per protocol population: Participants who were randomized, received at least one dose of study medication and had at least one efficacy (BMD or serum CTX) follow-up data point and did not have any major violations of the protocol.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ibandronate 2.5mg Daily | Relative Change From Baseline in Serum C-telopeptide of Alpha-chain of Type I Collagen (CTX) at Month 6, 12, and 24 | Month 6, n = 358, 342, 345 | -54.715 Percent Change | Standard Deviation 30.282 |
| Ibandronate 2.5mg Daily | Relative Change From Baseline in Serum C-telopeptide of Alpha-chain of Type I Collagen (CTX) at Month 6, 12, and 24 | Month 24, n = 310, 301, 298 | -51.549 Percent Change | Standard Deviation 35.0888 |
| Ibandronate 2.5mg Daily | Relative Change From Baseline in Serum C-telopeptide of Alpha-chain of Type I Collagen (CTX) at Month 6, 12, and 24 | Month 12, n = 360, 342, 347 | -54.387 Percent Change | Standard Deviation 33.281 |
| Ibandronate 2mg q 2 mo IV | Relative Change From Baseline in Serum C-telopeptide of Alpha-chain of Type I Collagen (CTX) at Month 6, 12, and 24 | Month 12, n = 360, 342, 347 | -48.042 Percent Change | Standard Deviation 95.3711 |
| Ibandronate 2mg q 2 mo IV | Relative Change From Baseline in Serum C-telopeptide of Alpha-chain of Type I Collagen (CTX) at Month 6, 12, and 24 | Month 24, n = 310, 301, 298 | -41.338 Percent Change | Standard Deviation 76.8201 |
| Ibandronate 2mg q 2 mo IV | Relative Change From Baseline in Serum C-telopeptide of Alpha-chain of Type I Collagen (CTX) at Month 6, 12, and 24 | Month 6, n = 358, 342, 345 | -55.539 Percent Change | Standard Deviation 42.6206 |
| Ibandronate 3mg q 3 mo IV | Relative Change From Baseline in Serum C-telopeptide of Alpha-chain of Type I Collagen (CTX) at Month 6, 12, and 24 | Month 24, n = 310, 301, 298 | -44.325 Percent Change | Standard Deviation 38.1338 |
| Ibandronate 3mg q 3 mo IV | Relative Change From Baseline in Serum C-telopeptide of Alpha-chain of Type I Collagen (CTX) at Month 6, 12, and 24 | Month 6, n = 358, 342, 345 | -51.196 Percent Change | Standard Deviation 31.0579 |
| Ibandronate 3mg q 3 mo IV | Relative Change From Baseline in Serum C-telopeptide of Alpha-chain of Type I Collagen (CTX) at Month 6, 12, and 24 | Month 12, n = 360, 342, 347 | -49.873 Percent Change | Standard Deviation 36.0415 |
Secondary
Relative Percent Change From Baseline in BMD of Proximal Femur (Consisting of Total Hip, Trochanter, and Femoral Neck) at Month 12 and 24
BMD was measured by a single DXA scan of the proximal femur at the time of screening, Month 12 and Month 24.The change in BMD of the proximal femur (total hip, trochanter, femoral neck) was defined as the relative difference between the last individual measurement available at Month 12 or Month 24and Baseline, using the following formula: Relative change = 100 x (BMD at 1 year/2year - BMD at Baseline) / (BMD at Baseline). BMD of fractured bones that could impact the scan area were not taken into account. Only participants with data available at particular timepoint were analyzed.
Time frame: Baseline, Month 12 and Month 24
Population: Per protocol population: Participants who were randomized, received at least one dose of study medication and had at least one efficacy (BMD or serum CTX) follow-up data point and did not have any major violations of the protocol.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ibandronate 2.5mg Daily | Relative Percent Change From Baseline in BMD of Proximal Femur (Consisting of Total Hip, Trochanter, and Femoral Neck) at Month 12 and 24 | Total hip, Month 12, n = 364, 343, 357 | 1.7857 Percent Change | Standard Deviation 2.8171 |
| Ibandronate 2.5mg Daily | Relative Percent Change From Baseline in BMD of Proximal Femur (Consisting of Total Hip, Trochanter, and Femoral Neck) at Month 12 and 24 | Total hip , Month 24, n = 330, 316, 333 | 2.2011 Percent Change | Standard Deviation 3.6997 |
| Ibandronate 2.5mg Daily | Relative Percent Change From Baseline in BMD of Proximal Femur (Consisting of Total Hip, Trochanter, and Femoral Neck) at Month 12 and 24 | Trochanter, Month 12, n = 364, 343, 357 | 2.9721 Percent Change | Standard Deviation 4.1651 |
| Ibandronate 2.5mg Daily | Relative Percent Change From Baseline in BMD of Proximal Femur (Consisting of Total Hip, Trochanter, and Femoral Neck) at Month 12 and 24 | Trochanter, Month 24, n = 330, 316, 333 | 3.4669 Percent Change | Standard Deviation 4.7241 |
| Ibandronate 2.5mg Daily | Relative Percent Change From Baseline in BMD of Proximal Femur (Consisting of Total Hip, Trochanter, and Femoral Neck) at Month 12 and 24 | Femoral neck, Month 12, n = 364, 343, 357 | 1.6129 Percent Change | Standard Deviation 4.105 |
| Ibandronate 2.5mg Daily | Relative Percent Change From Baseline in BMD of Proximal Femur (Consisting of Total Hip, Trochanter, and Femoral Neck) at Month 12 and 24 | Femoral neck, Month 24, n = 330, 316, 333 | 2.2457 Percent Change | Standard Deviation 4.3015 |
| Ibandronate 2mg q 2 mo IV | Relative Percent Change From Baseline in BMD of Proximal Femur (Consisting of Total Hip, Trochanter, and Femoral Neck) at Month 12 and 24 | Femoral neck, Month 24, n = 330, 316, 333 | 2.7449 Percent Change | Standard Deviation 4.1996 |
| Ibandronate 2mg q 2 mo IV | Relative Percent Change From Baseline in BMD of Proximal Femur (Consisting of Total Hip, Trochanter, and Femoral Neck) at Month 12 and 24 | Total hip, Month 12, n = 364, 343, 357 | 2.5150 Percent Change | Standard Deviation 2.6737 |
| Ibandronate 2mg q 2 mo IV | Relative Percent Change From Baseline in BMD of Proximal Femur (Consisting of Total Hip, Trochanter, and Femoral Neck) at Month 12 and 24 | Trochanter, Month 24, n = 330, 316, 333 | 5.0428 Percent Change | Standard Deviation 4.464 |
| Ibandronate 2mg q 2 mo IV | Relative Percent Change From Baseline in BMD of Proximal Femur (Consisting of Total Hip, Trochanter, and Femoral Neck) at Month 12 and 24 | Femoral neck, Month 12, n = 364, 343, 357 | 1.9700 Percent Change | Standard Deviation 3.5537 |
| Ibandronate 2mg q 2 mo IV | Relative Percent Change From Baseline in BMD of Proximal Femur (Consisting of Total Hip, Trochanter, and Femoral Neck) at Month 12 and 24 | Total hip , Month 24, n = 330, 316, 333 | 3.3699 Percent Change | Standard Deviation 2.9749 |
| Ibandronate 2mg q 2 mo IV | Relative Percent Change From Baseline in BMD of Proximal Femur (Consisting of Total Hip, Trochanter, and Femoral Neck) at Month 12 and 24 | Trochanter, Month 12, n = 364, 343, 357 | 4.0275 Percent Change | Standard Deviation 3.889 |
| Ibandronate 3mg q 3 mo IV | Relative Percent Change From Baseline in BMD of Proximal Femur (Consisting of Total Hip, Trochanter, and Femoral Neck) at Month 12 and 24 | Total hip , Month 24, n = 330, 316, 333 | 3.1279 Percent Change | Standard Deviation 4.5422 |
| Ibandronate 3mg q 3 mo IV | Relative Percent Change From Baseline in BMD of Proximal Femur (Consisting of Total Hip, Trochanter, and Femoral Neck) at Month 12 and 24 | Trochanter, Month 12, n = 364, 343, 357 | 3.8144 Percent Change | Standard Deviation 6.0921 |
| Ibandronate 3mg q 3 mo IV | Relative Percent Change From Baseline in BMD of Proximal Femur (Consisting of Total Hip, Trochanter, and Femoral Neck) at Month 12 and 24 | Femoral neck, Month 24, n = 330, 316, 333 | 2.7849 Percent Change | Standard Deviation 4.6723 |
| Ibandronate 3mg q 3 mo IV | Relative Percent Change From Baseline in BMD of Proximal Femur (Consisting of Total Hip, Trochanter, and Femoral Neck) at Month 12 and 24 | Trochanter, Month 24, n = 330, 316, 333 | 4.9165 Percent Change | Standard Deviation 7.5057 |
| Ibandronate 3mg q 3 mo IV | Relative Percent Change From Baseline in BMD of Proximal Femur (Consisting of Total Hip, Trochanter, and Femoral Neck) at Month 12 and 24 | Total hip, Month 12, n = 364, 343, 357 | 2.3604 Percent Change | Standard Deviation 3.5156 |
| Ibandronate 3mg q 3 mo IV | Relative Percent Change From Baseline in BMD of Proximal Femur (Consisting of Total Hip, Trochanter, and Femoral Neck) at Month 12 and 24 | Femoral neck, Month 12, n = 364, 343, 357 | 2.3055 Percent Change | Standard Deviation 3.9283 |
Secondary
Relative Percent Change From Baseline in Mean BMD of Lumbar Spine (L2-L4) at 24 Months
BMD was measured by a single dual-energy x-ray absorptiometry (DXA) scan of the lumbar spine at the time of screening and at Month 24. The change in BMD was defined as the relative difference between the last individual measurement available at 24 months and Baseline, using the following formula: Relative change = 100 x (BMD at 1 year - BMD at Baseline) / (BMD at Baseline)
Time frame: Baseline and Month 24
Population: Per protocol population: Participants who were randomized, received at least one dose of study medication and had at least one efficacy (BMD or serum CTX) follow-up data point and did not have any major violations of the protocol.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ibandronate 2.5mg Daily | Relative Percent Change From Baseline in Mean BMD of Lumbar Spine (L2-L4) at 24 Months | 4.8412 Percent Change | Standard Deviation 4.8654 |
| Ibandronate 2mg q 2 mo IV | Relative Percent Change From Baseline in Mean BMD of Lumbar Spine (L2-L4) at 24 Months | 6.3999 Percent Change | Standard Deviation 4.7392 |
| Ibandronate 3mg q 3 mo IV | Relative Percent Change From Baseline in Mean BMD of Lumbar Spine (L2-L4) at 24 Months | 6.2777 Percent Change | Standard Deviation 5.0049 |