Effect of zoledronic acid on osteoporosis for the chronic stroke patients

JRCT ID: jRCT1031190091

Registered date:03/09/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: stroke
• Date of first enrollment: 03/09/2019
• Target sample size: 30
• Study type: Interventional
• Intervention(s): Injection of Zoledronic Acid Hydrate 15mg once a year

Outcome(s)

• Primary Outcome: Bone Mineral Density of lumbar spine and bilateral femur necks
• Secondary Outcome: Bone metabolism marker, Physical function test, Fragility fracture

Key inclusion & exclusion criteria

• Age minimum: >= 60age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1.Hemiparesis patients based on first onset stroke.
2.Age more than 60 years.
3.More than 90 days from onset of stroke.
4.Patients who could come to outpatients clinic following to the study protocol.
5.Witten informed consent.

Exclude criteria

1)Patients receiving other therapies which affect bone metabolism (teriparatide, denosumab, bisphosphonate injection and zoledronic acid).
2)Allergy against zoledronic acid or other bisphosphonate.
3)Severe renal failure ( eGFR<35ml/min)
4)Hypocalcemia (albumin-adjusted Ca <8.5mg/dl)
5)Severe complications
6)History of operation for lumber spine or femur fracture.
7)Severe denegerative spondylosis or severe hip arthrosis
8)Currently receiving invasive dental treatment such as tooth extraction, or shortly after tooth extraction
9) History of osteonecrosis of jaw

Related Information

• Primary Sponsor: Fujiwara Toshiyuki