Effect of zoledronic acid on osteoporosis for the chronic stroke patients

Phase 4

• Conditions: stroke; D020521

• Registration Number: JPRN-jRCT1031190091
• Lead Sponsor: Fujiwara Toshiyuki

Brief Summary

This study was ended without registration of subjects.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-09-03
• Study Completion: 2021-09-22
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 0

Inclusion 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.

Exclusion 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Bone Mineral Density of lumbar spine and bilateral femur necks

Secondary Outcome Measures

Name	Time	Method
Bone metabolism marker, Physical function test, Fragility fracture