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

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

Osteoporosis

Bottom Line

View on ClinicalTrials.gov: NCT00680953 ↗

Enrolled (actual)

1,262

Serious AEs

13.6%

Results posted

Feb 2014

Primary outcome: Primary: 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

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Denosumab (Drug); Placebo (Drug); Alendronate sodium hydrate (Drug)
Age: Adult, Older Adult · 50+ yrs
Sex: All
Sponsor: Daiichi Sankyo Co., Ltd.
Primary completion: Jun 2012

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

Summary

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

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

View full record on ClinicalTrials.gov →

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.