Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
denosumab · 4 trials · 2 indications
Bone mineral density (BMD) is the amount of bone mineral in bone tissue. BMD scan was done using dual energy x-ray absorptiometry (DXA). It is used to identify osteoporosis, determine risk for fractures, and measure response to osteoporosis treatment. The percentage change from Baseline for BMD was calcuated as the value at the indicated time point minus the Baseline value multiplied by 100 and divided by the Baseline value. The analysis was performed by Analysis of Covariance (ANCOVA) model adjusted for treatment, region and Baseline BMD for the skeletal site under consideration as a continuous covariate for assessment. Region and treatment by region interaction was included in the model. Screening visit was considered as Baseline for BMD. For participants who withdrew early, the missing BMD assessments was estimated by the Last Observation Carried Forward (LOCF), provided the assessment was taken on or after at least one month on-therapy.
Bone mineral density (BMD) at the lumbar spine was measured by the dual-energy x-ray absorptiometry (DXA) scanner. The mean percent change from Baseline in BMD was calculated as: (value at Month 6 minus Baseline value) \* 100 / Baseline value. Analysis was performed using an Analysis of Covariance (ANCOVA) model with terms for treatment and baseline BMD at the lumbar spine (as a continuous covariate).
Mean percent change from Baseline in lumbar spine bone mineral density (BMD) was measured by the dual-energy x-ray absorptiometry (DXA) scanner. Analyses were performed using the Analysis of Covariance (ANCOVA) model adjusting for treatment and Baseline BMD for the skeletal site under consideration as a continuous covariate. Percentage change from Baseline=(measure at Month 6 - measure at Baseline) divided by the measure at Baseline \* 100.
subjects incidence of treatment adverse events, including clinically-significant changes in physical examinations, laboratory safety tests, ECG and vital signs
| Arm | Type | Description |
|---|---|---|
| Denosumab 60mg | EXPERIMENTAL | injection |
| Placebo | PLACEBO_COMPARATOR | injection |
| Arm 1 | EXPERIMENTAL | denosumab 60mg subcutaneous injection, single dose at the start of the 6-month double-blind treatment |
| Arm 2 | PLACEBO_COMPARATOR | placebo subcutaneous injection, single dose at the start of the 6-month double-blind treatment |
| Arm 3 | EXPERIMENTAL | open-label phase follows the double-blind phase, denosumab 60mg subcutaneous injection, single dose at the start of the 6-month open-label phase |
| denosumab 60 mg | EXPERIMENTAL | solution |
| denosumab 120 mg | EXPERIMENTAL | solution |
| Name | Type | Description |
|---|---|---|
| Denosumab | DRUG | Injection |
| Placebo | DRUG | Injection |
| Elemental Calcium | DIETARY_SUPPLEMENT | Oral, at least 600 mg |
| Vitamin D | DIETARY_SUPPLEMENT | Oral, at least 400 IU |
| open-label denosumab | DRUG | open-label phase: 60mg subcutaneous injection, single dose |
| denosumab 60mg | DRUG | solution |
| denosumab 120 mg | DRUG | solution |
Inclusion Criteria: * Subject is willing and able to provide written informed consent. * Of Chinese origin - defined as being born in China, having four ethnic Chinese grandparents. * Ambulatory woman between the age of 60 and 90 years, inclusive. * The subject has a BMD absolute value consistent w...
Denosumab/mL is a monoclonal antibody being developed for musculoskeletal conditions, specifically osteoporosis, postmenopausal osteoporosis, and bone fractures. It is currently in Phase 3 clinical development and is being studied in postmenopausal women with osteoporosis and in patients with bone metastases from solid tumors.
Denosumab/mL is being developed by GSK plc, a global biopharmaceutical company. GSK plc is listed on the stock exchange under the ticker symbol GSK. The company is conducting Phase 3 clinical trials to evaluate the efficacy and safety of Denosumab/mL in various bone-related conditions.
Denosumab/mL is in Phase 3 clinical development. It is an investigational drug and has not yet been approved by regulatory authorities. All three completed Phase 3 trials have finished, and the drug is not currently in any active clinical trials.
Denosumab/mL has completed three Phase 3 clinical trials. These include NCT01457950 in Korean postmenopausal women with osteoporosis, NCT01495000 in Indian postmenopausal women with osteoporosis, and NCT01920568 comparing Denosumab with zoledronic acid in patients with bone metastases from solid tumors. A fourth trial, NCT02014467, was also completed in Chinese postmenopausal women.
Denosumab/mL is a monoclonal antibody that targets RANKL, a protein involved in bone resorption. It is being studied for osteoporosis and bone fractures. The drug is not currently approved and is in Phase 3 trials. Its mechanism of action is similar to other denosumab products, but specific brand names have not been provided.