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

PHASE3CompletedINTERVENTIONAL
Enrollment

1,262

Participants

Timeline

Start Date

May 31, 2008

Primary Completion Date

June 30, 2012

Study Completion Date

July 31, 2012

Conditions
Osteoporosis
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

Trial Locations (4)

Unknown

Fukuoka

Osaka

Sapporo

Tokyo

Sponsors
All Listed Sponsors
lead

Daiichi Sankyo Co., Ltd.

INDUSTRY