Effects of denosumab on the healing process of posterior lumbar interbody fusion: a prospective randomized trial

Status

Recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2100054910

Enrollment

Unknown

Registered

2021-12-29

Start date

2022-02-10

Completion date

Unknown

Last updated

2022-12-12

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

Conditions

Osteoporosis

Interventions

Experimental group:Desuzumab injection

Control group:Conventional treatment

Eligibility

Sex/Gender

All

Age

35 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. Patients with severe clinical and neurological symptoms caused by lumbar degenerative diseases (lumbar spinal stenosis, lumbar disc herniation, degenerative lumbar spondylolisthesis and degenerative lumbar scoliosis) verified by MRI (magnetic resonance imaging), CT (computed tomography) and X-ray; 2. Patients with non-surgical treatment failure and requiring surgical treatment; 3. DXA (dual energy X-ray absorptiometry) patients with confirmed low bone mass or osteoporosis.

Exclusion criteria

Exclusion criteria: 1. Patients who had spinal surgery or fracture at the segment to be operated on; 2. Patients with bone tumor, metabolic bone disease, bone Paget disease, hypercalcemia and high serum alkaline phosphatase; 3. Patients with severe cardiovascular or pulmonary diseases who cannot withstand surgical stress.

Design outcomes

Primary

Measure	Time frame
Bone density;Bone metabolic markers;Lumbar spine CT;	—

Countries

China

Contacts

Public ContactSi Haipeng

Qilu Hospital of Shandong University

sihaipeng1978@email.sdu.edu.cn+86 18560082571

Outcome results

None listed

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