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

Daiichi Sankyo

Status and phase: Completed; Phase 3

Conditions: Osteoporosis

Treatments: Drug: Alendronate sodium hydrate; Drug: Denosumab; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00680953

AMG162-A-J301

Details and patient eligibility

About

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

Enrollment: 1,262 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,262 participants in 3 patient groups, including a placebo group

1

Experimental group

Description:

Denosumab (subcutaneously - every 6 months) + daily calcium and vitamin D supplements for 24 months, followed by a 12-month period of denosumab (subcutaneously - every 6 months).

Treatment:

Drug: Denosumab

2

Placebo Comparator group

Description:

Placebo (subcutaneously every 6 months) + daily calcium and vitamin D supplements for 24 months, followed by a 12-month period of denosumab (subcutaneously - every 6 months).

Treatment:

Drug: Placebo

3

Active Comparator group

Description:

Alendronate sodium hydrate oral tablets weekly + daily calcium and vitamin D supplements for 24 months (open label reference arm).

Treatment:

Drug: Alendronate sodium hydrate