Post Menopausal Osteoporosis
Conditions
Brief summary
This single arm, open label study will assess the efficacy and safety of and compliance to treatment with Bonviva/Boniva (ibandronate) in biphosphonate-naïve patients with post-menopausal osteoporosis. Patients will receive Bonviva/Boniva at a dose of 3 mg intravenously every three months. Anticipated time on study treatment is 12 months with a follow-up of 12 months.
Interventions
3 mg intravenously every 3 months
Sponsors
Hoffmann-La Roche
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Female patients, \> 50 years of age * Diagnosed osteoporosis * Bone mineral density \< minus 2.5 SD or osteoporotic fracture * At least 3 years after menopause
Exclusion criteria
* Impaired renal function * Contra-indication to Calcium or Vitamin D therapy * Previous or current treatment with biphosphonates
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change From Baseline in Mean Hip BMD at Month 24 | Baseline, Month 24 | Percent change was calculated as \[(measure at time t - measure at baseline)/measure at baseline\]\*100, where t=24 months. The baseline value is used as a reference to calculate the relative change from baseline. |
| Percent Change From Baseline in Mean Lumbar Spine Bone Mineral Density (BMD) at Month 12 | Baseline, Month 12 | Percent change was calculated as \[(measure at time t minus \[-\] measure at baseline) divided by (/) measure at baseline\] multiplied by (\*) 100, where t=12 months. The baseline value is used as a reference to calculate the relative change from baseline. |
| Percent Change From Baseline in Mean Lumbar Spine BMD at Month 24 | Baseline, Month 24 | Percent change was calculated as \[(measure at time t - measure at baseline)/measure at baseline\]\*100, where t=24 months. The baseline value is used as a reference to calculate the relative change from baseline. |
| Percent Change From Baseline in Mean Hip Bone BMD at Month 12 | Baseline, Month 12 | Percent change was calculated as \[(measure at time t - measure at baseline)/measure at baseline\]\*100, where t=12 months. The baseline value is used as a reference to calculate the relative change from baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Correlation Coefficient of Participant's Profile With Compliance | Baseline up to Month 12 | Participant's profile included age, year since menopause, fracture history, and BMD at baseline. |
| Percent Change From Baseline in Lumbar Spine T-score at Month 12 and 24 | Baseline, Month 12, Month 24 | Percent change was calculated as \[(measure at time t - measure at baseline)/measure at baseline\]\*100, where t=12 and 24 months. The baseline value is used as a reference to calculate the relative change from baseline. T-score is the number of standard deviations above or below the mean for a healthy 30 year old adult of the same sex and ethnicity as the participant. A T-score with above -1 is normal bone density level. A T-score between -1 and -2.5 means that the bone density is below normal and it might be a sign of an osteopenia and may also lead into osteoporosis. A T-score below -2.5 indicates osteoporosis. A T-score below -2.5 in combination with a prevalent fracture indicates serious osteoporosis. |
| Percent Change From Baseline in Total Hip T-score at Month 12 and 24 | Baseline, Month 12, Month 24 | Percent change was calculated as \[(measure at time t - measure at baseline)/measure at baseline\]\*100, where t=12 and 24 months. The baseline value is used as a reference to calculate the relative change from baseline. T-score is the number of standard deviations above or below the mean for a healthy 30 year old adult of the same sex and ethnicity as the participant. A T-score with above -1 is normal bone density level. A T-score between -1 and -2.5 means that the bone density is below normal and it might be a sign of an osteopenia and may also lead into osteoporosis. A T-score below -2.5 indicates osteoporosis. A T-score below -2.5 in combination with a prevalent fracture indicates serious osteoporosis. |
| Percentage of Participants Who Received All Planned Study Medication (Compliance) | Baseline up to Month 12 | — |
Countries
Bosnia and Herzegovina
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Ibandronate Participants received 3 mg ibandronate via intravenous injection, every 3 months for a total of 12 months (total of 4 injections). | 40 |
| Total | 40 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 5 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Ibandronate |
|---|---|
| Age, Continuous | 60.60 years STANDARD_DEVIATION 5.812 |
| Sex: Female, Male Female | 40 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 20 / 40 |
| serious Total, serious adverse events | 9 / 40 |
Outcome results
Primary
Percent Change From Baseline in Mean Hip BMD at Month 24
Percent change was calculated as \[(measure at time t - measure at baseline)/measure at baseline\]\*100, where t=24 months. The baseline value is used as a reference to calculate the relative change from baseline.
Time frame: Baseline, Month 24
Population: ITT population. Here number of participants analyzed included participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ibandronate | Percent Change From Baseline in Mean Hip BMD at Month 24 | 1.71 percent change | Standard Deviation 5.09 |
p-value: 0.056Paired t-test
Primary
Percent Change From Baseline in Mean Hip Bone BMD at Month 12
Percent change was calculated as \[(measure at time t - measure at baseline)/measure at baseline\]\*100, where t=12 months. The baseline value is used as a reference to calculate the relative change from baseline.
Time frame: Baseline, Month 12
Population: ITT population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ibandronate | Percent Change From Baseline in Mean Hip Bone BMD at Month 12 | 2.68 percent change | Standard Deviation 4.66 |
p-value: 0.001Paired t-test
Primary
Percent Change From Baseline in Mean Lumbar Spine BMD at Month 24
Percent change was calculated as \[(measure at time t - measure at baseline)/measure at baseline\]\*100, where t=24 months. The baseline value is used as a reference to calculate the relative change from baseline.
Time frame: Baseline, Month 24
Population: ITT population. Here number of participants analyzed included participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ibandronate | Percent Change From Baseline in Mean Lumbar Spine BMD at Month 24 | 5.27 percent change | Standard Deviation 8 |
p-value: <0.0005Paired t-test
Primary
Percent Change From Baseline in Mean Lumbar Spine Bone Mineral Density (BMD) at Month 12
Percent change was calculated as \[(measure at time t minus \[-\] measure at baseline) divided by (/) measure at baseline\] multiplied by (\*) 100, where t=12 months. The baseline value is used as a reference to calculate the relative change from baseline.
Time frame: Baseline, Month 12
Population: ITT population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ibandronate | Percent Change From Baseline in Mean Lumbar Spine Bone Mineral Density (BMD) at Month 12 | 5.67 percent change | Standard Deviation 7.86 |
p-value: <0.0005Paired t-test
Secondary
Correlation Coefficient of Participant's Profile With Compliance
Participant's profile included age, year since menopause, fracture history, and BMD at baseline.
Time frame: Baseline up to Month 12
Population: ITT population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ibandronate | Correlation Coefficient of Participant's Profile With Compliance | NA correlation coefficient |
Secondary
Percentage of Participants Who Received All Planned Study Medication (Compliance)
Time frame: Baseline up to Month 12
Population: ITT population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ibandronate | Percentage of Participants Who Received All Planned Study Medication (Compliance) | 100 percentage of participants |
Secondary
Percent Change From Baseline in Lumbar Spine T-score at Month 12 and 24
Percent change was calculated as \[(measure at time t - measure at baseline)/measure at baseline\]\*100, where t=12 and 24 months. The baseline value is used as a reference to calculate the relative change from baseline. T-score is the number of standard deviations above or below the mean for a healthy 30 year old adult of the same sex and ethnicity as the participant. A T-score with above -1 is normal bone density level. A T-score between -1 and -2.5 means that the bone density is below normal and it might be a sign of an osteopenia and may also lead into osteoporosis. A T-score below -2.5 indicates osteoporosis. A T-score below -2.5 in combination with a prevalent fracture indicates serious osteoporosis.
Time frame: Baseline, Month 12, Month 24
Population: ITT population. Here n included participants who were evaluable at specified time point for the given arm.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ibandronate | Percent Change From Baseline in Lumbar Spine T-score at Month 12 and 24 | Change at Month 12 (n=40) | 13.47 percent change | Standard Deviation 12.23 |
| Ibandronate | Percent Change From Baseline in Lumbar Spine T-score at Month 12 and 24 | Change at Month 24 (n=35) | 12.48 percent change | Standard Deviation 13.43 |
p-value: <0.0005Wilcoxon signed rank test
p-value: <0.0005Wilcoxon signed rank test
Secondary
Percent Change From Baseline in Total Hip T-score at Month 12 and 24
Percent change was calculated as \[(measure at time t - measure at baseline)/measure at baseline\]\*100, where t=12 and 24 months. The baseline value is used as a reference to calculate the relative change from baseline. T-score is the number of standard deviations above or below the mean for a healthy 30 year old adult of the same sex and ethnicity as the participant. A T-score with above -1 is normal bone density level. A T-score between -1 and -2.5 means that the bone density is below normal and it might be a sign of an osteopenia and may also lead into osteoporosis. A T-score below -2.5 indicates osteoporosis. A T-score below -2.5 in combination with a prevalent fracture indicates serious osteoporosis.
Time frame: Baseline, Month 12, Month 24
Population: ITT population. Here n included participants who were evaluable at specified time point for the given arm.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ibandronate | Percent Change From Baseline in Total Hip T-score at Month 12 and 24 | Change at Month 12 (n=40) | 9.31 percent change | Standard Deviation 16.75 |
| Ibandronate | Percent Change From Baseline in Total Hip T-score at Month 12 and 24 | Change at Month 24 (n=35) | 5.98 percent change | Standard Deviation 17.9 |
p-value: <0.0005Paired t-test
p-value: 0.027Paired t-test