Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Ibandronate · 10 trials · 6 indications
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 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 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.
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.
BMD will be assessed using an analysis of covariance model (ANCOVA) with datea obtained from dual-Energy X-ray absorptiometry scans.
The CIQ was completed in Part A by all the participants. The information from the CIQ was used to determine the percentage of current daily or weekly bisphosphonate users for whom monthly ibandronate represented a potentially more satisfactory therapeutic option. In the CIQ participants were asked to answer either 'yes' or 'no' to the following 3 questions: 1. I would prefer a monthly oral dosing schedule to my current (daily or weekly) dosing schedule. 2. More than once per month, I have experienced stomach upset within 48 hours of taking my osteoporosis medication. 3. Over the past 3 months, I have missed taking 3 or more doses of my current (daily or weekly) osteoporosis medication.
Percentage of participants who reported preference for monthly ibandronate were reported.
Participants with a positive change from their baseline CSS at Month 6 are considered those participants who are satisfied with once-monthly dosing of ibandronate after 6 months of use were reported. The CSS is scaled from 0 to 100 and is an average of the 4 domain scores of the Osteoporosis Patient Satisfaction Questionnaire (OPSAT-Q): Convenience (questions 1 to 6), Quality of Life (questions 7 and 8), Overall Satisfaction (questions 9 and 10) and Side Effects (questions 11 to 16). Higher scores indicating greater satisfaction.
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)
Relative change in Bone Mineral Density (BMD) is the percentage change from baseline of BMD of vertebrae L2 - L4 that are not fractured and not affected by an osteoarthritic process to such a degree that accurate measurement of BMD would be considered jeopardized by the central reading center after 12 months of treatment. It is calculated as the sum of bone mineral content divided by the sum of area of all lumbar vertebrae L2 - L4 that are not fractured and not affected by an osteoarthritic process at Month 12. Participants available at particular time point for assessment were included in the analysis.
| Arm | Type | Description |
|---|---|---|
| Single Arm | EXPERIMENTAL | - |
| 1 | EXPERIMENTAL | - |
| 2 | PLACEBO_COMPARATOR | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Ibandronate | EXPERIMENTAL | - |
| Ibandronate IV Infusion | EXPERIMENTAL | Participants will receive ibandronate, 6 mg via IV infusion, every 3 to 4 weeks for 4 months. |
| Ibandronate PO Tablet | EXPERIMENTAL | Participants will receive ibandronate, 50 mg PO daily, for 4 months. |
| Ibandronate 15-Minute Infusion | EXPERIMENTAL | Participants will receive ibandronate IV infusions over a 15-minute interval. |
| Ibandronate 60-Minute Infusion | ACTIVE_COMPARATOR | Participants will receive ibandronate IV infusions over a 60-minute interval. |
| 3 | EXPERIMENTAL | oral placebo daily and IV ibandronate 3 mg q 3 mo |
| Ibandronate 2.5 mg | ACTIVE_COMPARATOR | Participants will receive 2.5 milligram (mg) ibandronate Per oral (PO) daily and an oblong placebo tablet PO monthly. Participants will also receive calcium 500 mg /day and vitamin D 400 international units (IU)/day . |
| Ibandronate 50/50 mg | EXPERIMENTAL | Participants will receive 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants will also receive calcium 500 mg /day and vitamin D 400 IU/day. |
| Ibandronate 100 mg | EXPERIMENTAL | Participants will receive 100 mg ibandronate PO monthly divided over two consecutive days (50 mg tablet/day) and a round placebo tablet PO daily. Participants will also receive calcium 500 mg /day and vitamin D 400 IU/day |
| Ibandronate 150 mg | EXPERIMENTAL | Participants will receive 150 mg ibandronate PO monthly taken on a single day and a round placebo tablet PO daily. Participants will also receive calcium 500 mg /day and vitamin D 400 IU/day |
| Name | Type | Description |
|---|---|---|
| ibandronate [Bonviva/Boniva] | DRUG | 3 mg intravenously every 3 months |
| Placebo | DRUG | Placebo i.v. single dose |
| Ibandronate | DRUG | Ibandronate orally (tablet) at a dose of 150 mg once per month |
| Calcium | DIETARY_SUPPLEMENT | 500 mg/day |
| Vitamin D | DIETARY_SUPPLEMENT | 400 IU/day |
| ibandronate [Bondronat] | DRUG | 6mg iv on days 1-3 |
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 cur...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Zimmer Biomet Holdings, Inc. | ZBH | 1 | - | Undisclosed |
| Precision BioSciences, Inc. | DTIL | 1 | N/A | Undisclosed |
| SI-BONE, Inc. | SIBN | 1 | - | Undisclosed |
Ibandronate is a small molecule bisphosphonate used for post-menopausal osteoporosis, post-menopausal osteopenia, male osteoporosis, bone pain, bone neoplasms, and neoplasm metastasis. It is being developed by Roche Holding AG (RHHBY) and is currently in Phase 3 clinical development for these endocrine-related conditions.
Ibandronate is a bisphosphonate that inhibits bone resorption. It works by binding to hydroxyapatite in bone and inhibiting osteoclast activity, thereby reducing bone turnover and increasing bone mineral density. This mechanism helps prevent fractures and manage conditions like osteoporosis.
Ibandronate is developed by Roche Holding AG, which trades under the ticker RHHBY. Roche is conducting Phase 3 clinical trials for the drug across multiple indications, including post-menopausal osteoporosis and male osteoporosis.
Ibandronate is in Phase 3 clinical development. It has completed three Phase 3 trials with a total enrollment of 3,045 participants. The drug is investigational and not yet approved, as it remains in clinical development for its studied indications.
Ibandronate has completed three Phase 3 trials: NCT00048074 (DIVA study in post-menopausal osteoporosis, 1,395 patients), NCT00397839 (male osteoporosis, 135 patients), and NCT00493623 (BONDIR study in osteoporosis after vertebral fracture, 68 patients). All trials are completed.
Yes, Ibandronate is also known as Bonviva. Clinical trials such as the DIVA study (NCT00048074) and BONDIR study (NCT00493623) refer to intravenous Bonviva, which is the brand name for Ibandronate. This name is used in studies for post-menopausal osteoporosis and osteoporosis.