JPRN-jRCT1080221967
Completed
Phase 4
The post-marketing clinical randomized study of eldecalcitol on fall-related physical performance in Japanese osteoporotic patients with frailty
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Chugai Pharmaceutical Co., Ltd.
- Enrollment
- 124
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
A randomized, open-label, controlled clinical trial has been conducted with 124 female patients aged 65 or over with osteoporosis. Patients were randomly assigned to receive either 0.75 mcg of ELD once-a-day or 35 mg of ALN once-a-week for 24 weeks. The primary endpoint was the change in a postural balance index, adjusted composite equilibrium score (CES) of sensory organization test (SOT). There was no statistically significant difference between the two groups.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Osteoporosis patients with normal walking speed is within between 0\.5m/sec and 1\.2m/sec.
Exclusion Criteria
- •Patients: those take psychotropic agents, or anabolic agents, etc., and those physical performances are diagnosed to be influenced by above agents. Patients received agents that affect bone metabolism within 8 weeks before the treatment start.
- •Patients with disease(s) accompanied by high risk of falls except for osteoporosis.
- •Patients with disease(s) characterized by low bone mass except for osteoporosis.
Outcomes
Primary Outcomes
Not specified
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