| Primary | Relative Change From Baseline in Mean Bone Mineral Density (BMD) of the Lumbar Spine (L2 to L4) at Month 12 | BMD was measured by a single dual-energy x-ray absorptiometry (DEXA) scan of the lumbar spine at the time of screening and at Month 12. A BMD measurement was considered unsuitable in case of detection of a fracture, an osteoarthritic process, or a scanning artifact that could not be removed to such a degree that accurate measurement of BMD would be considered jeopardized by the central reading center. 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) | The ITT population included participants who were randomized, received at least one dose of the trial medication and had baseline and at least one follow-up evaluation data point. | Posted | | Least Squares Mean | Standard Error | Percentage | | Baseline and Month 12 | | | | ID | Title | Description |
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| OG000 | Placebo | Participants with postmenopausal osteopenia were administered matching placebo tablet orally once monthly. All participants received OSCAL tablet (containing 500 mg calcium and 400 international units [IU] vitamin D) once a day as dietary supplements for the duration of the study. Participants received a total of 12 months of treatment and were followed for an additional period of 15 days. | | OG001 | Ibandronate (IBN) 150 mg Monthly | Participants with postmenopausal osteopenia were administered 150 mg Ibandronate (IBN) tablet orally once monthly. All participants received OSCAL tablet (containing 500 mg/d calcium and 400 international units [IU]/d vitamin D) once a day as dietary supplements, for the duration of the study. Participants received a total of 12 months of treatment and were followed for an additional period of 15 days. |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG000-0.3941± 0.4148
- OG0013.7285± 0.4229
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| H0 (null hypothesis): There was no statistically significant difference between monthly treatment with 150 mg oral IBN and monthly treatment with placebo in relative change from baseline of mean lumbar spine (L2-L4 BMD). H1 (alternative hypothesis): There was a statistically significant difference between monthly treatment with 150 mg oral IBN and monthly treatment with placebo in relative change from baseline of mean lumbar spine (L2-L4 BMD). | ANOVA | | <0.0001 | The primary analysis was an ANOVA (two way classification), including treatment group and time since menopause (as a binary variable; 0.5-3 years, >3 years) as independent factors. | Mean Difference (Net) | 4.1226 | | | 2-Sided | 95 | 2.9613 | 5.2838 | | | | No |
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| Secondary | Absolute Change From Baseline in Mean Lumbar Spine BMD at Month 12 | BMD was measured by a single dual-energy x-ray absorptiometry (DEXA) scan of the lumbar spine at the time of screening and at Month 12. A BMD measurement was considered unsuitable in case of detection of a fracture, an osteoarthritic process, or a scanning artifact that could not be removed to such a degree that accurate measurement of BMD would be considered jeopardized by the central reading center. The absolute change from Baseline in mean BMD of the lumbar spine (L2-L4) was measured as g/cm^2 and summarized using descriptive statistics. | The ITT population included participants who were randomized, received at least one dose of the trial medication and had baseline and at least one follow-up evaluation data point. | Posted | | Mean | Standard Deviation | g/cm^2 | | Baseline and Month 12 | | | | ID | Title | Description |
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| OG000 | Placebo | Participants with postmenopausal osteopenia were administered matching placebo tablet orally once monthly. All participants received OSCAL tablet (containing 500 mg calcium and 400 international units [IU] vitamin D) once a day as dietary supplements for the duration of the study. Participants received a total of 12 months of treatment and were followed for an additional period of 15 days. | | OG001 | Ibandronate (IBN) 150 mg Monthly | Participants with postmenopausal osteopenia were administered 150 mg Ibandronate (IBN) tablet orally once monthly. All participants received OSCAL tablet (containing 500 mg/d calcium and 400 international units [IU]/d vitamin D) once a day as dietary supplements, for the duration of the study. Participants received a total of 12 months of treatment and were followed for an additional period of 15 days. |
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| Secondary | Relative Change From Baseline in Mean Proximal Femur BMD at Month 12 | BMD was measured by a single DEXA scan of the proximal femur at the time of screening and at Month 12. The relative (%) change from Baseline in BMD of the proximal femur (total hip, trochanter, femoral neck) at Month 12 was summarized using descriptive statistics. BMD of fractured bones that could impact the scan area were not taken into account. | The ITT population included participants who were randomized, received at least one dose of the trial medication and had baseline and at least one follow-up evaluation data point. | Posted | | Mean | Standard Deviation | Percentage | | Baseline and Month 12 | | | | ID | Title | Description |
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| OG000 | Placebo | Participants with postmenopausal osteopenia were administered matching placebo tablet orally once monthly. All participants received OSCAL tablet (containing 500 mg calcium and 400 international units [IU] vitamin D) once a day as dietary supplements for the duration of the study. Participants received a total of 12 months of treatment and were followed for an additional period of 15 days. | | OG001 | Ibandronate (IBN) 150 mg Monthly | Participants with postmenopausal osteopenia were administered 150 mg Ibandronate (IBN) tablet orally once monthly. All participants received OSCAL tablet (containing 500 mg/d calcium and 400 international units [IU]/d vitamin D) once a day as dietary supplements, for the duration of the study. Participants received a total of 12 months of treatment and were followed for an additional period of 15 days. |
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| Secondary | Absolute Change From Baseline in BMD of the Proximal Femur at Month 12 | BMD was measured by a single DEXA scan of the proximal femur at the time of screening and at Month 12. The absolute change from baseline in BMD of the proximal femur (total hip, trochanter, femoral neck) at Month 12 was summarized using descriptive statistics. BMD of fractured bones that could impact the scan area were not taken into account. | The ITT population included participants who were randomized, received at least one dose of the trial medication and had baseline and at least one follow-up evaluation data point. | Posted | | Mean | Standard Deviation | g/cm^2 | | Baseline and Month 12 | | | | ID | Title | Description |
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| OG000 | Placebo | Participants with postmenopausal osteopenia were administered matching placebo tablet orally once monthly. All participants received OSCAL tablet (containing 500 mg calcium and 400 international units [IU] vitamin D) once a day as dietary supplements for the duration of the study. Participants received a total of 12 months of treatment and were followed for an additional period of 15 days. | | OG001 | Ibandronate (IBN) 150 mg Monthly | Participants with postmenopausal osteopenia were administered 150 mg Ibandronate (IBN) tablet orally once monthly. All participants received OSCAL tablet (containing 500 mg/d calcium and 400 international units [IU]/d vitamin D) once a day as dietary supplements, for the duration of the study. Participants received a total of 12 months of treatment and were followed for an additional period of 15 days. |
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| Secondary | Relative Change From Baseline in Serum C-telopeptide Crosslinks of Type 1 Collagen (CTX) | Fasting blood samples were collected from participants for analysis of serum CTX (sCTX), which is a biochemical marker of bone resorption. Relative change from baseline of sCTX after 3, 6, and 12 months of treatment was summarized using descriptive statistics. | The ITT population included participants who were randomized, received at least one dose of the trial medication and had baseline and at least one follow-up evaluation data point. n = the number of participants analyzed at a given time point. | Posted | | Median | 95% Confidence Interval | Percentage | | Baseline and 3, 6 and 12 months | | | | ID | Title | Description |
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| OG000 | Placebo | Participants with postmenopausal osteopenia were administered matching placebo tablet orally once monthly. All participants received OSCAL tablet (containing 500 mg calcium and 400 international units [IU] vitamin D) once a day as dietary supplements for the duration of the study. Participants received a total of 12 months of treatment and were followed for an additional period of 15 days. | | OG001 | Ibandronate (IBN) 150 mg Monthly | Participants with postmenopausal osteopenia were administered 150 mg Ibandronate (IBN) tablet orally once monthly. All participants received OSCAL tablet (containing 500 mg/d calcium and 400 international units [IU]/d vitamin D) once a day as dietary supplements, for the duration of the study. Participants received a total of 12 months of treatment and were followed for an additional period of 15 days. |
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| Secondary | Absolute Change From Baseline in sCTX | Fasting blood samples were collected from participants for analysis of sCTX, which is a biochemical marker of bone resorption. Absolute change from baseline of sCTX after 3, 6, and 12 months of treatment was summarized using descriptive statistics. | The ITT population included participants who were randomized, received at least one dose of the trial medication and had baseline and at least one follow-up evaluation data point. n = the number of participants analyzed at a given time point. | Posted | | Median | 95% Confidence Interval | ng/ml | | Baseline and 3, 6, 12 months | | | | ID | Title | Description |
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| OG000 | Placebo | Participants with postmenopausal osteopenia were administered matching placebo tablet orally once monthly. All participants received OSCAL tablet (containing 500 mg calcium and 400 international units [IU] vitamin D) once a day as dietary supplements for the duration of the study. Participants received a total of 12 months of treatment and were followed for an additional period of 15 days. | | OG001 | Ibandronate (IBN) 150 mg Monthly | Participants with postmenopausal osteopenia were administered 150 mg Ibandronate (IBN) tablet orally once monthly. All participants received OSCAL tablet (containing 500 mg/d calcium and 400 international units [IU]/d vitamin D) once a day as dietary supplements, for the duration of the study. Participants received a total of 12 months of treatment and were followed for an additional period of 15 days. |
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| Secondary | Percentage of Responders | Percent responders were defined as follows: Participants with a) lumbar spine (LS) BMD, equal to or above Baseline at Month 12 b) proximal femur BMD, equal to or above Baseline at Month 12 c) Both lumbar spine and proximal femur BMD, equal or above Baseline at Month 12. BMD of the lumbar spine was defined as the BMD of at least two vertebrae (L2-L4) that were not fractured and not affected by an osteoarthritic process, or a scanning artifact that could not be removed to such a degree that accurate measurement of BMD would be considered jeopardized by the central reading center. Proximal femur included total hip, trochanter and femoral neck sites. | The ITT population included participants who were randomized, received at least one dose of the trial medication and had baseline and at least one follow-up evaluation data point. | Posted | | Number | | Percentage | | Up to 12 months | | | | ID | Title | Description |
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| OG000 | Placebo | Participants with postmenopausal osteopenia who were administered matching placebo tablet PO once monthly. All participants received 500 mg/d calcium and 400 international units [IU]/d vitamin D as dietary supplements consisting of one tablet a day of OSCAL for the duration of the study. Participants received 12 months of treatment and were followed for an additional period of 15 days. | | OG001 | Ibandronate (IBN) 150 mg Monthly | Participants with postmenopausal osteopenia who were administered 150 mg IBN tablet orally (PO) once monthly. All participants received 500 mg/d calcium and 400 international units [IU]/d vitamin D as dietary supplements consisting of one tablet a day of OSCAL for the duration of the study. Participants received 12 months of treatment and were followed for an additional period of 15 days. |
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| Secondary | Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs) | An AE is any untoward medical occurrence in a participant who is 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 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. | The safety population included participants who had at least one dose of the trial medication documented in the CRF whether withdrawn prematurely or not. | Posted | | Number | | participants | | Up to 15 days after end of study treatment (Approximately 2 years) | | | | ID | Title | Description |
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| OG000 | Placebo | Participants with postmenopausal osteopenia were administered matching placebo tablet orally once monthly. All participants received OSCAL tablet (containing 500 mg calcium and 400 international units [IU] vitamin D) once a day as dietary supplements for the duration of the study. Participants received a total of 12 months of treatment and were followed for an additional period of 15 days. | | OG001 | Ibandronate (IBN) 150 mg Monthly | |
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| Secondary | Number of Participants With Marked Laboratory Abnormalities | Blood for laboratory tests was taken at screening and immediately before participants received their monthly study medication at months 3, 6, and 12. The laboratory tests included: Hematology [white blood cells (WBCs), platelets, hematocrit, and hemoglobin] and Chemistry [albumin, creatinine, blood urea nitrogen (BUN), alanine aminotransferase (ALT), total calcium, 25-hydroxy vitamin D, phosphate, magnesium, sodium, potassium, and chloride]. | The safety population included participants who had at least one dose of the trial medication documented in the CRF whether withdrawn prematurely or not. | Posted | | Number | | participants | | Screening up to 12 months | | | | ID | Title | Description |
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| OG000 | Placebo | Participants with postmenopausal osteopenia were administered matching placebo tablet orally once monthly. All participants received OSCAL tablet (containing 500 mg calcium and 400 international units [IU] vitamin D) once a day as dietary supplements for the duration of the study. Participants received a total of 12 months of treatment and were followed for an additional period of 15 days. | | OG001 | Ibandronate (IBN) 150 mg Monthly | Participants with postmenopausal osteopenia were administered 150 mg Ibandronate (IBN) tablet orally once monthly. All participants received OSCAL tablet (containing 500 mg/d calcium and 400 international units [IU]/d vitamin D) once a day as dietary supplements, for the duration of the study. Participants received a total of 12 months of treatment and were followed for an additional period of 15 days. |
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