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Prospective clinical trial to establish optimal strategy of conservative management for osteoporotic vertebral fractures

Prospective clinical trial to establish optimal strategy of conservative management for osteoporotic vertebral fractures - Prospective study on different conservative managements for osteoporotic vertebral fractures

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000003109
Enrollment
48
Registered
2010-02-01
Start date
2007-08-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

osteoporotic vertebral fracture

Interventions

3 weeks bed rest followed by 9 weeks of semi-rigid brace wear. After, immediate ambulation, 4 weeks plaster cast fixation, followed by 4 weeks semi-rigid brace, then, 4 weeks ready-made corset wear. I

Sponsors

Japanese Orthopaedic Association, Spine and Spinal Cord Disease Committee
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. Female between 65 and 90 years of age 2. Sustained a vertebral fracture between T11 and L2 level 3. Clear diagnosis of vertebral fracture can be established on plain radiographs and MRI 4. Satisfies diagnositic criteria for idiopathic osteoporosis 5. Has no motor paralysis 6. Written consent can be obtain from herself or a family member

Exclusion criteria

Exclusion criteria: Patient who 1. has pathological fracture 2. has malignancies 3. has participated in a different trail on osteoporosis within 6 months 4. is unable to undergo MRI 5. had been unable to walk before injury 6. has unhealed previous vertebral fractures 7. has demintia 8. is judged inappropriate to participate in this study by the investigators 8. has severe general complications that hampers proper rehabilitation

Design outcomes

Primary

MeasureTime frame
bone union, development of pseudoarthorosis, progression of vertebral compression on plain radiogarphs

Secondary

MeasureTime frame
assessment of pain (visual analog scale), neurological functions, SF-36, bone density (DXA)

Countries

Japan

Contacts

Public ContactKazuhiro Chiba

School of Medicine, Keio University Department of Orthopaedic Surgery

kchiba@sc.itc.keio.ac.jp03-5363-3812

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026