Evaluation of Falls and Frailty; Eldecalcitol Clinical Trial (EFFECT) study

The post-marketing clinical randomized study of eldecalcitol on fall-related physical performance in Japanese osteoporotic patients with frailty

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT1080221967

Enrollment

120

Registered

2012-11-19

Start date

2012-11-27

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary osteoporosis

Interventions

investigational material(s) Generic name etc : Eldecalcitol INN of investigational material : Eldecalcitol Therapeutic category code : 311 Vitamin A, D and preparations Dosage and Administration for I

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: Osteoporosis patients with normal walking speed is within between 0.5m/sec and 1.2m/sec.

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
efficacy Physical Performance Composite Equilibrium Score of Sensory Organization Test	—

Secondary

Measure	Time frame
safety efficacy Physical performance and safety 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	—

Countries

Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026