Evaluation of Falls and Frailty; Eldecalcitol Clinical Trial (EFFECT) study
- Conditions
- Primary osteoporosis
- Registration Number
- JPRN-jRCT1080221967
- Lead Sponsor
- Chugai Pharmaceutical Co., Ltd.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- Female
- Target Recruitment
- 124
Osteoporosis patients with normal walking speed is within between 0.5m/sec and 1.2m/sec.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method efficacy<br>Physical Performance<br>Composite Equilibrium Score of Sensory Organization Test
- Secondary Outcome Measures
Name Time Method safety<br>efficacy<br>Physical performance and safety<br>Sensory Organization Test Scores except Composite Equilibrium Score, Motor Control Test, Adaptation Test, Walking Speed, Leg Strength, Timed Up and Go, Static Balance with Eyes Open, Grip Strength