Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ibandronate · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Participants will receive 3 placebo tablets once a month, for 3 months, on the first day of each treatment cycle. |
| ibandronate 100 mg | EXPERIMENTAL | Participants will receive 2 ibandronate 50 mg tablets and 1 placebo tablet once a month, for 3 months, on the first day of each treatment cycle. |
| ibandronate 150 mg | EXPERIMENTAL | Participants will receive 3 ibandronate 50 mg tablets once a month, for 3 months, on the first day of each treatment cycle. |
| Name | Type | Description |
|---|---|---|
| Placebo | DRUG | tablets |
| ibandronate | DRUG | 50 mg tablets |
Inclusion Criteria: -postmenopausal for at least 3 years, with osteoporosis at any of the following sites: \[BMD \> 2.0 standard deviations below young normal mean bone mass for the hip trochanter, PA lumbar spine (L1 to L4), total hip, or femoral neck based on the normative database provided by eac...
Ibandronate is a small molecule being studied for the treatment of postmenopausal osteoporosis, a condition that weakens bones in women after menopause. It is currently in Phase 3 clinical development as an investigational drug, meaning it has not yet been approved for this use.
Ibandronate is being developed by Organon & Co., a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol OGN. The company is conducting clinical trials to evaluate the drug's safety and efficacy for postmenopausal osteoporosis.
Ibandronate is in Phase 3 clinical development. It is an investigational drug, not yet approved by regulatory authorities. One Phase 3 trial has been completed, involving 203 participants with postmenopausal osteoporosis.
Ibandronate has one completed Phase 3 clinical trial registered as NCT00092053, titled "Study of Investigational Drug in Osteoporosis (MK-0217-908)." The trial enrolled 203 women aged 50 years and older with postmenopausal osteoporosis and was placebo-controlled, randomized, and double-blind.
Ibandronate is not FDA approved. It is an investigational drug currently in Phase 3 clinical development for postmenopausal osteoporosis. Its safety and efficacy have not been fully established, and it has not received marketing authorization from the FDA or other regulatory bodies.