Phase 3 Completed N=1,262 Randomized Quadruple-blind Treatment

Denosumab Fracture Intervention Randomized Placebo Controlled Trial in Japanese Patients With Osteoporosis

Osteoporosis

Source: ClinicalTrials.gov NCT00680953 ↗

Enrolled (actual)

1,262

Serious AEs

13.6%

Results posted

Feb 2014

Primary outcomePrimary: Incidence of New or Worsening Vertebral Fractures in Osteoporotic Subjects Treated With Denosumab Compared to Placebo — 3.6; 10.3; 7.2 Vertebral fractures — p=0.0001

Summary

Evaluate the efficacy and safety of denosumab in the treatment of involutional (postmenopausal and senile) osteoporotic subjects with prevalent fragility vertebral fracture(s)

Outcome Measures

Outcome	Result	p-value
PRIMARY Incidence of New or Worsening Vertebral Fractures in Osteoporotic Subjects Treated With Denosumab Compared to Placebo	3.6; 10.3; 7.2	0.0001 sig
SECONDARY The Percentage of Non-vertebral Fractures	4.1; 4.1; 2.7	0.9951
SECONDARY Percentage of Participants With Hip Fractures in Osteoporotic Participants Treated With Denosumab Compared to Treatment With Placebo.	0.0; 0.5; 0.0	0.1568

Eligibility Criteria

Inclusion Criteria

Involutional (postmenopausal and senile) osteoporosis with prevalent fragility vertebral fractures

Exclusion Criteria

Any underlying condition, (other than BMD) that might have resulted in abnormal bone metabolism

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Data sourced from ClinicalTrials.gov (NCT00680953). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.