Zoledronate dose comparison study for patients with a proximal femur fracture

JRCT ID: jRCTs071240037

Registered date:22/07/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Proximal femur fracture
• Date of first enrollment: 22/07/2024
• Target sample size: 70
• Study type: Interventional
• Intervention(s): Patients with a proximal femur fracture are randomly assigned to be treated with 5 mg or 2.5 mg of zoledronate.

Outcome(s)

• Primary Outcome: Rate of change in bone mineral density after 24 months of administration and group difference in rate of change.

Secondary Outcome

At 12 and 24 months after administration, rate of change in bone mineral density and bone-related markers, and group differences in rate of change.
Amount of change in body temperature and pain up to 7 days after administration. At 7 days after administration, amount of change in serum Cre and Ca, and group differences in amount of change.

Key inclusion & exclusion criteria

• Age minimum: >= 50age old
• Age maximum: Not applicable
• Gender: Both
• Include criteria: Patients receiving osteoporosis treatment after surgical treatment for a proximal femur fracture (fragility fracture)
• Exclude criteria: Patients with severe renal dysfunction (eGFR<35 mL/min/1.73 m2)

Related Information

• Primary Sponsor: Osaki Makoto
• Secondary Sponsor: Chiba Ko