Study of AK156 in Primary Osteoporosis Patients

Osteoporosis Clinical Trial

Official title:

Phase 3 Study of AK156 in Primary Osteoporosis Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01522521
• Other study ID #: AK156 III-1
• Status: Completed
• Phase: Phase 3
• First received: January 27, 2012
• Last updated: October 1, 2015
• Start date: February 2012
• Est. completion date: January 2015

Study information

• Verified date: October 2015
• Source: Asahi Kasei Pharma Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to investigate the efficacy and safety of AK156 in Japanese patients with primary osteoporosis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years to 89 Years

Eligibility

Inclusion Criteria:

• Patients diagnosed with primary osteoporosis

• Patients who have vertebral fractures at the time of screening

Exclusion Criteria:

• Patients diagnosed with secondary osteoporosis

• Patients with a current uncontrolled medical disorder or other condition which makes the patient unsuitable for the study

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoporosis

Intervention

Drug:
• AK156
zoledronic acid (i.v.)/year + daily calcium and vitamin D for 2 years
• Placebo
placebo (i.v.)/year + daily calcium and vitamin D for 2 years

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Asahi Kasei Pharma Corporation

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	New vertebral fractures	Reduction in the incidence rate of new fragility vertebral fractures	2 Years	No
Secondary	Vertebral fractures (worsening and new)	The incidence rate of fragility vertebral fractures (worsening and new)	2 Years	No
Secondary	Clinical fractures	The incidence rate of Clinical fractures	2 Years	No
Secondary	Bone mineral density	The percent change from baseline in bone mineral density of lumbar spine and hip	2 Years	No
Secondary	Bone metabolic marker	The percent change from baseline in bone metabolic marker	2 Years	No