Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study will estimate the total time for the preparation and administration of denosumab and the total time for the preparation and administration of pamidronate.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Group A | Active Comparator | 1 dose of denosumab every 4 weeks for 2 doses, followed by 1 dose of pamidronate every 4 weeks for 2 doses. |
|
| Treatment Group B | Active Comparator | 1 dose of pamidronate every 4 weeks for 2 doses, followed by 1 dose of denosumab every 4 weeks for 2 doses. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| denosumab | Biological | Treatment Group A - 120 mg SC dose every 4 weeks at Day 1 and week 5 Treatment Group B - 120 mg SC dose every 4 weeks at Week 9 and Week 13 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total duration (in hours, minutes and seconds) for investigational product preparation and administration | Day 1 | |
| Total duration (in hours, minutes and seconds) for investigational product preparation and administration | Week 5 | |
| Total duration (in hours, minutes and seconds) for investigational product preparation and administration | Week 9 | |
| Total duration (in hours, minutes and seconds) for investigational product preparation and administration | Week 13 |
Not provided
Not provided
Inclusion Criteria:
Diagnosis of metastatic bone disease secondary to a solid tumor (eg, breast cancer, lung cancer, etc).
An Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Subject is one of the following:
Subject has a serum calcium or albumin-adjusted serum calcium ≥ 2.0 mmol/L (8.0 mg/dL) and ≤ 2.9 mmol/L (11.5 mg/dL)
Exclusion Criteria:
Diagnosis with metastatic bone disease secondary to multiple myeloma or prostate cancer.
Severe renal impairment (creatinine clearance < 30 mL/min)
Subject is being considered for ambulatory pamidronate administration using an infuser device (ie, "baby bottle").
A known active infection with Hepatitis B virus or Hepatitis C virus.
Subject has known positive results for human immunodeficiency virus (HIV).Subject has a history of other malignancy within the past 5 years, other than:
Subject has a history or current evidence of osteonecrosis/osteomyelitis of the jaw, active dental or jaw condition that requires oral surgery, non-healed dental/oral surgery, or planned invasive dental procedure over the course of the study.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
Not provided
Not provided
| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
Not provided
| ID | Term |
|---|---|
| D001847 | Bone Diseases |
| ID | Term |
|---|---|
| D009140 | Musculoskeletal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069448 | Denosumab |
| D000077268 | Pamidronate |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| pamidronate | Drug | Treatment Group A - 90 mg IV dose every 4 weeks at Week 9 and Week 13 Treatment Group B - 90 mg IV dose every 4 weeks at Day 1 and Week 5 |
|
|
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D004164 | Diphosphonates |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |