Status:
UNKNOWN
Effects of Denosumab on Bone Fusion in Osteoporotic Patients After Lumbar Fusion
Lead Sponsor:
Shanghai Changzheng Hospital
Conditions:
Osteoporosis
Fusion of Spine, Lumbar Region
Eligibility:
All Genders
50+ years
Phase:
PHASE4
Brief Summary
Lumbar fusion is an accepted and effective technique for the treatment of lumbar degenerative disease. As the population ages, disability associated with spinal pathology and spinal surgery is rapidly...
Eligibility Criteria
Inclusion
- Diagnosis of degenerative lumbar diseases with symptoms of low-back pain and/or leg pain for at least 3 months, which was not be adequately controlled by nonoperative treatments.
- Diagnosis of osteoporosis, defined as a bone mineral density (BMD) at lumbar or femoral neck with 2.5 standard deviations or more below the mean peak bone mass (T scores \<-2.5 SD) measured by dual-energy X-ray absorptiometry (DXA).
- Patients will be underwent single-level or two-level lumbar interbody fusion.
Exclusion
- Paget disease of bone,
- Low laboratory tests for calcium,
- Previous radiation treatment or fusion surgery to lumbar spine,
- Bone tumors,
- Bone infection,
- Acute vertebral fractures
- Severe spinal deformities such as degenerative scoliosis,
- Other metabolic bone disease,
- History of a anti-osteoporosis medication
- Combined with severe morbidities,
- Uncorrected bleeding diatheses
- Application of steroids.
Key Trial Info
Start Date :
October 9 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2023
Estimated Enrollment :
116 Patients enrolled
Trial Details
Trial ID
NCT05203588
Start Date
October 9 2021
End Date
October 1 2023
Last Update
January 24 2022
Active Locations (1)
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1
Shanghai Changzheng Hospital
Shanghai, Shanghai Municipality, China, 200003