Last reviewed · How we verify
Placebo to Denosumab
Denosumab is a monoclonal antibody that binds to RANKL (receptor activator of nuclear factor kappa-B ligand) and prevents bone resorption by inhibiting osteoclast formation and activation.
Denosumab is a monoclonal antibody that binds to RANKL (receptor activator of nuclear factor kappa-B ligand) and prevents bone resorption by inhibiting osteoclast formation and activation. Used for Postmenopausal osteoporosis in women at high risk of fracture, Bone loss in men receiving androgen deprivation therapy for prostate cancer, Bone loss in women receiving aromatase inhibitor therapy for breast cancer.
At a glance
| Generic name | Placebo to Denosumab |
|---|---|
| Sponsor | Amgen |
| Drug class | RANKL inhibitor (monoclonal antibody) |
| Target | RANKL (Receptor Activator of Nuclear Factor Kappa-B Ligand) |
| Modality | Small molecule |
| Therapeutic area | Bone metabolism / Osteoporosis |
| Phase | FDA-approved |
Mechanism of action
Denosumab blocks the interaction between RANKL and its receptor RANK on osteoclast precursor cells, thereby preventing osteoclast maturation and bone resorption. This leads to increased bone mineral density and reduced fracture risk in conditions characterized by excessive bone loss. Unlike bisphosphonates, denosumab does not require renal function for efficacy and acts through a targeted biological mechanism rather than direct effects on bone mineralization.
Approved indications
- Postmenopausal osteoporosis in women at high risk of fracture
- Bone loss in men receiving androgen deprivation therapy for prostate cancer
- Bone loss in women receiving aromatase inhibitor therapy for breast cancer
- Giant cell tumor of bone
- Prevention of skeletal-related events in patients with bone metastases from solid tumors
Common side effects
- Hypocalcemia
- Osteonecrosis of the jaw
- Atypical femoral fractures
- Infections
- Back pain
- Arthralgia
Key clinical trials
- Bone Loss Prevention With Zoledronic Acid or Denosumab in Critically Ill Adults (PHASE2)
- Preserving Geriatric Muscle With an Osteoporosis Medication (PHASE4)
- Denosumab to Prevent High-Turnover Bone Loss After Bariatric Surgery (PHASE4)
- RANKL Inhibition and Mammographic Breast Density (PHASE2)
- Treatment With Zoledronate Subsequent to Denosumab in Osteoporosis 2 (ZOLARMAB2) (PHASE4)
- Denosumab for Type 1 Diabetes (PHASE1, PHASE2)
- RANKL Inhibition to Combat Sarcopenia in Hip Fracture Patients (PHASE3)
- Studying the Effect of Denosumab on Preventing Breast Cancer in Women With a BRCA1 Germline Mutation (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Placebo to Denosumab CI brief — competitive landscape report
- Placebo to Denosumab updates RSS · CI watch RSS
- Amgen portfolio CI