Phase 3
N=1,382
DIVA Study - A Study of Different Regimens of Intravenous Administration of Bonviva (Ibandronate) in Women With Post-Menopausal Osteoporosis
Post Menopausal Osteoporosis
Bottom Line
View on ClinicalTrials.gov: NCT00048074 ↗Enrolled (actual)
1,382
Serious AEs
14.6%
Results posted
Feb 2016
Primary outcome: Primary: Relative Percent Change From Baseline in Mean Bone Mineral Density (BMD) of Lumbar Spine (L2-L4) at 12 Months — 3.8199; 5.0872; 4.8188 Percent Change — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- ibandronate [Bonviva/Boniva] (Drug)
- Age
- Adult, Older Adult · 55+ yrs
- Sex
- Female
- Sponsor
- Hoffmann-La Roche
- Primary completion
- May 2005
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Relative Percent Change From Baseline in Mean Bone Mineral Density (BMD) of Lumbar Spine (L2-L4) at 12 Months |
3.8199; 5.0872; 4.8188 | <0.001 sig |
| SECONDARY Relative Percent Change From Baseline in Mean BMD of Lumbar Spine (L2-L4) at 24 Months |
4.8412; 6.3999; 6.2777 | — |
| SECONDARY Absolute Change From Baseline in Mean BMD of Lumbar Spine (L2 - L4) at Month 12 and Month 24 |
0.028; 0.037; 0.035; 0.036; 0.047; 0.046 | — |
| SECONDARY Relative Percent Change From Baseline in BMD of Proximal Femur (Consisting of Total Hip, Trochanter, and Femoral Neck) at Month 12 and 24 |
1.7857; 2.5150; 2.3604; 2.2011; 3.3699; 3.1279 | — |
| SECONDARY Absolute Change From Baseline in BMD of Proximal Femur (Consisting of Total Hip, Trochanter, and Femoral Neck) at Month 12 and 24 |
0.013; 0.018; 0.016; 0.015; 0.025; 0.022 | — |
| SECONDARY Relative Change From Baseline in Serum C-telopeptide of Alpha-chain of Type I Collagen (CTX) at Month 6, 12, and 24 |
-54.715; -55.539; -51.196; -54.387; -48.042; -49.873 | — |
| SECONDARY Absolute Change From Baseline in Serum CTX at Month 6, 12, and 24 |
-0.318; -0.322; -0.281; -0.321; -0.318; -0.290 | — |
| SECONDARY Percentage of Participants With Mean Lumbar Spine (L2 - L4) BMD Above or Equal to Baseline at Month 12 and 24 |
85.1; 92.3; 91.6; 84.7; 92.8; 92.8 | — |
| SECONDARY Percentage of Participants With Total Hip BMD Above or Equal to Baseline at Month 12 and 24 |
74.5; 86.0; 82.6; 77.0; 88.6; 85.6 | — |
| SECONDARY Percentage of Participants With Trochanter BMD Above or Equal to Baseline at Month 12 and 24 |
76.6; 88.6; 86.3; 80.0; 92.1; 88.6 | — |
| SECONDARY Percentage of Participants With Femoral Neck BMD Above or Equal to Baseline at Month 12 and 24 |
65.1; 74.1; 70.0; 67.6; 77.5; 76.6 | — |
| SECONDARY Percentage of Participants With Mean Total Hip and Lumbar Spine BMD Above or Equal to Baseline at Month 12 and 24 |
66.9; 80.5; 76.3; 68.8; 83.1; 80.1 | — |
| SECONDARY Percentage of Participants With Mean Trochanter and Lumbar Spine BMD Above or Equal to Baseline at Month 12 and 24 |
68.0; 83.4; 79.7; 70.9; 85.7; 83.1 | — |
| SECONDARY Percentage of Participants With Mean Femoral Neck and Lumbar Spine BMD Above or Equal to Baseline at Month 12 and 24 |
58.4; 69.4; 64.5; 59.7; 72.3; 71.7 | — |
| SECONDARY Number of Participants Who Experienced Any Adverse Events (AEs) or Serious Adverse Events (SAEs) |
408; 397; 400; 67; 73; 62 | — |
| SECONDARY Number of Participants With Any Marked Abnormality in Laboratory Parameters |
0; 0; 1; 0; 2; 5 | — |
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.
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 (NCT00048074). 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.