Adults 60 to 90, female only, with Osteoporosis. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Participants With New Vertebral FracturesPrimary· 36 months
A new vertebral fracture, assessed by lateral spine X-ray using Genant semiquantitative scoring method, was identified as an ≥ 1 grade increase from the Baseline grade of 0 in any vertebra from T4 to L4. New vertebral fractures included morphometric vertebral fractures (assessed at scheduled visits and not associated with signs or symptoms \[or both\] indicative of a fracture) and clinical vertebral fractures (assessed at either a scheduled or unscheduled visit and associated with any signs and/or symptoms indicative of a fracture, excluding any fracture associated with high trauma severity or
Group
Value
95% CI
Placebo
264
Denosumab 60 mg Q6M
86
Number of Participants With Nonvertebral FracturesSecondary· 36 months
Nonvertebral fractures (osteoporotic) were those occurring on study excluding those of the vertebrae (cervical, thoracic, and lumbar), skull, facial, mandible, metacarpus, finger phalanges, and toe phalanges. Fractures associated with high trauma severity (fractures that were the result of a fall from higher than the height of a stool, chair, first rung on a ladder or equivalent (\> 20 inches) or was the result of severe trauma other than a fall) and pathologic fractures were excluded from this category. Nonvertebral fractures were required to be confirmed either by radiographs or other diagno
Group
Value
95% CI
Placebo
293
Denosumab 60 mg Q6M
238
Number of Participants With a Hip FractureSecondary· 36 months
Hip fractures are a subset of nonvertebral fractures including femur neck, femur intertrochanter, and femur subtrochanter.
Group
Value
95% CI
Placebo
43
Denosumab 60 mg Q6M
26
Adverse events — posted to ClinicalTrials.gov
Time frame: 36 months.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Placebo
Serious: 972/3876 (25%)
Deaths: —
Denosumab 60 mg Q6M
Serious: 1004/3886 (26%)
Deaths: —
Serious adverse events (872 terms)
Reaction
System
Placebo
Denosumab 60 mg Q6M
Osteoarthritis
Musculoskeletal and connective tissue disorders
—
—
Atrial fibrillation
Cardiac disorders
—
—
Pneumonia
Infections and infestations
—
—
Breast cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
NCT07537972 — Denosumab Strategy for Liver Cancer With Bone Metastases
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NCT07283887 — Romosozumab and Denosumab, Alone or Combined, in Postmenopausal Osteoporosis
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· recruiting
NCT06374459 — Zunsemetinib in Combination With Capecitabine in Patients With Hormone Receptor-Positive and HER2-Negative Metastatic Br
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NCT06524960 — Denosumab for Type 1 Diabetes
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Other recruiting trials for Osteoporosis
Currently open trials in the same condition.
NCT07027306 — The Osteoporotic Fracture Classification-based Scoring System for Treatment Decision in Thoracolumbar Osteoporotic Fract
· recruiting
NCT07367776 — Patient Education in Osteoporosis (RCT-PATOS)
· NA
· recruiting
NCT06731608 — OsteoPorotic fracTure preventION System (OPTIONS) Research Study
· NA
· recruiting
NCT07083557 — Routine Validation and Reproducibility Testing of Laboratory Assays and Research Techniques Used for Endocrine, Cardiome
· recruiting
Other Amgen trials
Trials by the same sponsor.
NCT07223190 — A Study Evaluating Subcutaneous Versus Intravenous Blinatumomab in Newly Diagnosed Adults With B-cell Precursor Acute Ly
· Phase 3
· not yet recruiting
NCT07493512 — Trial of Xaluritamig in Adults With Metastatic Castration-resistant Prostate Cancer
· Phase 1
· not yet recruiting
NCT07531095 — Study of Tarlatamab + ZL-1310 +/- Anti-programmed Death Ligand 1 (Anti-PD-L1) in Small Cell Lung Cancer (SCLC)
· Phase 1
· not yet recruiting
NCT06987539 — A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Inebilizumab in Children With Gen
· Phase 2
· recruiting
NCT05909761 — Observational Safety Study in Women With Neuromyelitis Optica Spectrum Disorder (NMOSD) Exposed to UPLIZNA® During Pregn
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Amgen
Last refreshed: 8 November 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00089791.