Observational study of preventive effects of locomotive syndrome by treating osteoporosis

JRCT ID: jRCT1040210025

Registered date:27/05/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Primary osteoporosis
• Date of first enrollment: 27/05/2021
• Target sample size: 120
• Study type: Observational

Outcome(s)

• Primary Outcome: Relationship between changes in the 25-question Geriatric Locomotive Function Scale and changes in bone density

Secondary Outcome

1. Relationship between changes in the 25-question Geriatric Locomotive Function Scale and each factor (age, BMI, mean daily step count, grip strength, presence of osteoarthritis or low back pain or knee pain, whether locomotion training was practiced, TRACP-5b, P1NP)
2. (Target: Patients whose baseline is not locomotive syndrome)
Relationship between whether they became locomotive syndrome in an year and each factor

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Female

Include criteria

1. Postmenopausal women with osteoporosis
2. Patients who used bisphosphonate and were given the pamphlet of exercise (locomotion training)
3. Written informed consent

Exclude criteria

1. Previous romosozumab or denosumab or teriparatide or bisphosphonate use
2. Hypocalcemia
3. Patients judged to be in appropriate for study

Related Information

• Primary Sponsor: Sobue Naohisa