ONO-5920/YM529 Confirmatory Study in Involutional Osteoporosis Patients

Astellas

Status and phase: Completed; Phase 3; Phase 2

Conditions: Osteoporosis; Bone Loss, Age-Related

Treatments: Drug: YM529 / ONO-5920

Study type: Interventional

Funder types: Industry

Identifiers

NCT00794443

529-CL-028

ONO-5920-05

Details and patient eligibility

About

This is a multi-center double-blind parallel-group study in involutional osteoporosis patients to compare the efficacy and safety of monthly oral intermittent formulation ONO-5920/YM529 with its daily formulation.

Enrollment: 692 patients

Sex: All

Ages: 45+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients whose bone mineral density is <70% of Young Adult Mean (YAM), or <80% of YAM who have fragile fracture history
• Patients can walk on his/her own
• Written informed consent has been obtained from the patient.

Exclusion criteria

• Sequential osteoporosis patients or patients with other disorders showing low bone mass
• Patients with the findings that influence measurement of lumbar vertebral bone mineral density by the DXA method
• Patients who are unable to keep raising or standing for ≥30 min
• Patients with peptic ulcer
• Patients who have experienced anamnesis or gastrectomy (total extraction)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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692 participants in 3 patient groups

1. Monthly - Dose 1

Experimental group

Description:

Monthly intermittent administration, dose 1

Treatment:

Drug: YM529 / ONO-5920

2. Monthly - Dose 2

Experimental group

Description:

Monthly intermittent administration, dose 2

Treatment:

Drug: YM529 / ONO-5920

3. Daily

Active Comparator group

Description:

Daily administration

Treatment:

Drug: YM529 / ONO-5920