Multi-centric randomized open-label comparative study for influence of bisphosphonate on fracture healing in patients with spinal compression fractures or femoral neck fractures

UMIN ID: UMIN000000838

Registered date:01/10/2007

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Osteoporotic spinal compression fractures and femoral neck fractures
• Date of first enrollment: 2007/10/01
• Target sample size: 100
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Sodium risedronate hydrate was given from 1 week after injury or surgery in group A.
Sodium risedronate hydrate was given from 3 months after injury or surgery in group B.

Outcome(s)

• Primary Outcome: Fracture healing is assessed with X ray film and computed tomograhy, and QOL is assessed with questionnaires.
• Secondary Outcome: Bone mineral density, visual analogue scale and bone markers are measured.

Key inclusion & exclusion criteria

• Age minimum: 65years-old
• Age maximum: 90years-old
• Gender: Male and Female
• Exclude criteria: Exclusion criteria are patients treated with bisphosphonate within 3 months, fractures resulted from high energy trauma, patients contraindicant to bisphosphonate, and patients judged inadequate to include this study by doctors.

Related Information

• Primary Sponsor: Department of Orthopaedic Surgery, Dokkyo Medical University Koshigaya Hospital
• Source(s) of Monetary Support: Department of Orthopaedic Surgery, Dokkyo Medical University Koshigaya Hospital