Phase 3
Completed N=1,602
MOBILE Study - A Study of Bonviva (Ibandronate) Regimens in Women With Post-Menopausal Osteoporosis
Post Menopausal Osteoporosis
Source: ClinicalTrials.gov NCT00048061 ↗
Enrolled (actual)
1,602
Serious AEs
12.1%
Results posted
May 2016
Primary outcomePrimary: Relative Change From Baseline at One Year (12 Months) in Mean Lumbar Spine (L2 - L4) Bone Mineral Density — 3.7427; 4.3395; 4.0328; 4.7611 Percent change — p=0.045
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Relative Change From Baseline at One Year (12 Months) in Mean Lumbar Spine (L2 - L4) Bone Mineral Density |
3.7427; 4.3395; 4.0328; 4.7611 | 0.045 sig |
| SECONDARY Relative Change From Baseline at Two Years (24 Months) in Mean Lumbar Spine (L2-L4) BMD |
4.9623; 5.3350; 5.5760; 6.5503 | — |
| SECONDARY Absolute Change From Baseline at One Year (12 Months) and Two Years (24 Months) in Mean Lumbar Spine (L2-L4) BMD |
0.028; 0.033; 0.030; 0.036; 0.036; 0.039 | — |
| 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 |
1.9626; 2.2172; 2.6878; 3.0092; 2.4955; 2.8132 | — |
| 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. |
0.014; 0.016; 0.020; 0.022; 0.018; 0.021 | — |
| SECONDARY Percentage of Participants With Mean Lumbar Spine (L2 - L4) BMD Above or Equal to Baseline at Months 12 and 24 |
83.8; 87.6; 86.6; 90.8; 86.4; 87.8 | — |
| SECONDARY Percentage of Participants With Total Hip BMD Above or Equal to Baseline at Months 12 and 24 |
76.8; 81.2; 86.9; 90.5; 78.4; 83.2 | — |
| SECONDARY Percentage of Participants With Trochanter BMD Above or Equal to Baseline at Months 12 and 24 |
80.0; 83.1; 88.2; 92.4; 84.2; 86.6 | — |
| SECONDARY Percentage of Participants With Femoral Neck BMD Above or Equal to Baseline at Months 12 and 24 |
71.1; 72.4; 69.0; 75.3; 69.2; 71.1 | — |
| SECONDARY Percentage of Participants With Mean Total Hip and Lumbar Spine BMD Above or Equal to Baseline at Months 12 and 24 |
65.6; 72.3; 77.6; 83.5; 70.5; 75.3 | — |
| SECONDARY Percentage of Participants With Mean Trochanter and Lumbar Spine BMD Above or Equal to Baseline at Months 12 and 24 |
68.8; 75.5; 78.0; 84.2; 75.7; 77.3 | — |
| SECONDARY Percentage of Participants With Mean Femoral Neck and Lumbar Spine BMD Above or Equal to Baseline at Months 12 and 24 |
62.4; 64.5; 60.9; 68.7; 63.4; 63.9 | — |
| SECONDARY Relative Change In Baseline in Serum C-telopeptide of Alpha-chain of Type I Collagen [ CTX] ] to Months 3, 6, 12, and 24 |
-49.5458; -46.4771; -50.2368; -57.3433; 55.5900; -53.9838 | — |
| SECONDARY Absolute Change In Baseline in Serum CTX to Months 12 and 24 |
-0.323; -0.326; -0.340; -0.377; -0.285; -0.298 | — |
| SECONDARY Number of Participants With Any Adverse Events and Serious Adverse Event |
302; 313; 318; 317; 38; 54 | — |
| SECONDARY Number Of Participants With Marked Laboratory Abnormalities |
2; 0; 1; 3; 0; 0 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00048061). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.