NIPH Clinical Trials Search

Zoledronate dose comparison study for patients with a proximal femur fracture

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	Proximal femur fracture
Date of first enrollment	13/11/2024
Target sample size	70
Countries of recruitment
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)