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Anterior fusion and fixation with desomumab and cervical spine

Evaluation of bone mineral density and function at 1 year after anterior cervical fusion and internal fixation with desomumab in a parallel double-blind randomized controlled clinical trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100051544
Enrollment
Unknown
Registered
2021-09-26
Start date
2021-09-28
Completion date
Unknown
Last updated
2022-06-20

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

Conditions

Cervical spondylosis

Interventions

Group 1:denosumab
Group 2:placebo

Sponsors

The First Affiliated Hospital of Southern University of Science and Technology (Shenzhen People's Hospital)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 90 Years

Inclusion criteria

Inclusion criteria: Patients aged 40 to 90 years with radiculopathy or cervical myelopathy presented with radiculopathy, clumsy hands, gait disorders, hyperreflexia, Babinski's sign, bladder dysfunction, ankle clonus, and 2 or more horizontal spinal cord compression, as confirmed by MRI or CT at the C3-C7 vertebral level.

Exclusion criteria

Exclusion criteria: Cervical C2-C7 kyphosis greater than 5 degrees (measured by standing cervical lateral radiographs), segmental kyphosis, structurally significant ossification of the posterior longitudinal ligament, prior cervical spine surgery, or other health-related conditions (nervous system).

Design outcomes

Primary

MeasureTime frame
osteocalcin in the N terminal molecular fragment;n-terminal propeptide P1NP of procollagen type 1;c-terminal crosslinking type 1 collagen terminal peptide CTx;serum total calcium;parathyroid hormone;total phosphorus;total alkaline phosphatase;albumin;Dual - energy X-ray examination of lumbar spine bone mineral density;hip bone mineral density;Bone marrow edema and adjacent intervertebral disc were detected by MRI;Cervical curvature;The operation section;Anti-osteoporosis drugs;Duration of symptoms;cobb angle;Nonsteroidal pain medication use;Numeric Rating Scale;Visual Analog Scale;the modified Japanese Orthopaedic Association;Neck Disability Index;

Secondary

MeasureTime frame
Quality-adjusted life years;EuroQol- 5 Dimension;

Countries

China

Contacts

Public ContactWang Hongyu

The First Affiliated Hospital of Southern University of Science and Technology (Shenzhen People's Hospital)

wanghongyu790039663@126.com+86 18241651300

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026