NIPH Clinical Trials Search

Elongation of administration interval of bone modifying agents in lung cancer patients with bone metastases

Basic Information

Recruitment status	Pending
Health condition(s) or Problem(s) studied	Lung cancer patients with bone metastases
Date of first enrollment	18/02/2025
Target sample size	80
Countries of recruitment
Study type	Interventional
Intervention(s)	Interval of bone modifying agent administration is normal or elongated.

Outcome(s)

Primary Outcome	change in the bone mineral density 4 months and 8 months later
Secondary Outcome	occurence of skeletal related events, osteonecrosis of the jaw, and other adverse events

Key inclusion & exclusion criteria

Age minimum	Not applicable
Age maximum	Not applicable
Gender	Both
Include criteria	Target subjects are those who fulfill all of the followings. 1. Those who are 18 years or older diagnosed with lung cancer by histology or cytology. 2. Those who have already received bone modifying agents more than twice. 3. Main organ function is maintained. WBC>3000, Hb>8.0g/dl, Plt 100000/mm3 AST/ALT<2.5*upper normal limit, Cr<1.5*upper normal limit, modified Ca>8.5mg/dl and <11.0mg/dl 4. Those without osteonecrosis of the jaw.
Exclude criteria	1. Those whose pain of bone metastases are not well controlled. 2. Those with symptom of spinal cord compression. 3. Those with prognosis are expected to be within 3 months. 4. Those in whom physician consider not appropriate