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

NCT00680953 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1262

Last updated 2015-03-12

Study results available
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Summary

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

Conditions

Interventions

DRUG

Denosumab

Subcutaneous injection every 6 months for 24 months, followed by a 12-month period of denosumab (subcutaneously - every six months).

DRUG

Placebo

Subcutaneous injection every 6 months for 24 months, followed by a 12-month period of denosumab (subcutaneously - every six months).

DRUG

Alendronate sodium hydrate

Oral tablet once a week for 24 months

Sponsors & Collaborators

  • Daiichi Sankyo Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Daiichi Sankyo · R&D Division, Daiichi Sankyo Co., Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-05-31
Primary Completion
2012-06-30
Completion
2012-07-31

Countries

  • Japan

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00680953 on ClinicalTrials.gov