comparison of short term efficacy of osteoporosis drugs against osteoporotic vertebral fractures

JRCT ID: jRCT1061230099

Registered date:07/02/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: vertebral fracture
• Date of first enrollment: 07/02/2024
• Target sample size: 60
• Study type: Interventional

Intervention(s)

romosozumab(105mg) given on once-monthly, for 6 month.
risedoronate acid(75mg) given on once-monthly, for 6 month.

Outcome(s)

• Primary Outcome: Weeks until NRS (Numerical Rating Scale) decreases to 4

Secondary Outcome

1)Pain score using PDAS, RDQ, PCS and QOL score using EQ-5D
2)Terms of fracture healing by X-ray
3)Change of bone mineral density and bone turnover markers
4)Side effect

Key inclusion & exclusion criteria

• Age minimum: >= 50age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1)Patients with vertebral fracture with vertebral body compression on X-ray and with vertebral body signal sntensity change on MRI.
2)Patients with osteoporosis with high risk of oste oporotic fractures.
3)Patients with more than 5 score of NRS(Numerical Rating Scale) at first visiting
4)Patients aged 50 years or older at the time of consect acquisition.
5)Patients who received sufficient explanation before participating in this study, and obtained the patient's free will to consent to the document after sufficient understanding.
6)Inpatients and outpatients

Exclude criteria

1)Patients under treatment for osteoporosis at the time of injury.
2)Patients due to high energy trauma.
3)patients with severe kidney disease(eGFR<30).
4)Patients with hypocalcemia
5)Patients who cannot answer the questionnaire due to dementia
6)Patients who need invasive dental treatment
7)Patients who are judged by the principal investigator and the research coordinator to be
inappropriate as research subjects

Related Information

• Primary Sponsor: Tetsunaga Tomoko