Denosumab Effect on Bone Quality and Function After Lumbar Fusion Surgery

NCT05415657 | Completed DMC

• 1 other identifier: ShenzhenPH spine01
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

Degenerative lumbar spinal diseases have become a common health problem and the most frequent indication for spinal surgery in elderly individuals. It mainly contain lumbar spinal stenosis and spondylolisthesis, occurs in most people over 60 years of age, and patients primarily diagnosed with lumbar degenerative disease are more likely to have osteoporosis. Our study was to explore denosumab effect on bone quality and functional status in osteopenia patients with lumbar degenerative diseases after lumbar fusion surgery.

Conditions

Osteopenia; Spine Fusion; Denosumab Allergy

Outcome Measures

Primary Outcomes (7)

• Lumbar bone mineral density (BMD)

  Lumbar vertebral (L1 to L4, except the surgery segment) BMD were determined at baseline, 6 and 12 months via Dual-energy X-ray.

  up to 12 months

• Total hip BMD

  Total hip BMD were determined at baseline, 6 and 12 months via Dual-energy X-ray.

  up to 12 months

• Femoral neck BMD

  Femoral neck BMD were determined at baseline, 6 and 12 months via Dual-energy X-ray.

  up to 12 months

• Type 1 n-terminal propeptide P1NP

  Bone formation marker, type 1 n-terminal propeptide P1NP were determined at baseline, 6 and 12 months after surgery.

  up to 12 months

• C-terminal crosslinking type 1 collagen terminal peptide CTX

  Bone resorption marker, C-terminal crosslinked type 1 collagen terminal peptide, CTX were assessed at baseline, 6 and 12 months after surgery.

  up to 12 months

• Visual analog scale (VAS) back

  VAS score for back pain were assessed at baseline, 6 and 12 months. Use a ruler about 10cm long, one side is marked with "0" and the other "10" respectively. A score of 0 indicates no pain, 10 indicates the most unbearable pain.

  up to 12 months

• VAS leg

  VAS score for leg pain were assessed at baseline, 6 and 12 months. Use a ruler about 10cm long, one side is marked with "0" and the other "10" respectively. A score of 0 indicates no pain, 10 indicates the most unbearable pain

  up to 12 months

Secondary Outcomes (8)

• EQ-5D quality of life questionnaire

  up to 12 month

• Roland-Morris Disability Questionnaire

  up to 12 month

• QUALEFFO-31 Questionnaire

  up to 12 month

• Lumbar Fusion rate

  up to 12 month

• New fracture rate

  up to 12 month

Study Arms (2)

Denosumab

EXPERIMENTAL

Denosumab 60 mg were injected subcutaneously Q6M on the same day after lumbar fusion surgery, and all patients received calcium supplementation 1200 mg/D and vitamin D 800 IU/D.

Drug: Denosumab

Placebo

PLACEBO COMPARATOR

Equal volume of saline (0.9%) as placebo were injected subcutaneously Q6M on the same day after lumbar fusion surgery, and all patients received calcium supplementation 1200 mg/D and vitamin D 800 IU/D.

Drug: Placebo

Interventions

Denosumab DRUG

Denosumab 60 mg per 6 month were injected subcutaneously on the same day after lumbar fusion surgery, and all participants received calcium supplementation 1200 mg/D and vitamin D 800 IU/D.

Also known as: Denosumab 6 month/subcutaneous

Denosumab

Placebo DRUG

Equal volume of saline (0.9%) as placebo Q6M were injected subcutaneously on the same day after lumbar fusion surgery, and all participants received calcium supplementation 1200 mg/D and vitamin D 800 IU/D.

Also known as: Placebo 6 month/subcutaneous

Placebo

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants aged 40 to 85 years
• who diagnosed with lumbar spinal stenosis or lumbar spondylolisthesis
• osteopenia with BMD T score between -1.0 and -2.5 via dual-energy X-ray
• low back pain or leg numbness or weakness
• MRI demonstrated signs of nerve compression

You may not qualify if:

• cauda equina syndrome
• progressive neurologic deficit
• history of cancer
• scoliosis greater than 15°
• back open surgery history
• have contraindications for surgery
• who had anti-osteoporosis medication within 6 weeks

Sponsors & Collaborators

• Shenzhen People's Hospital: lead

Study Sites (1)

ShenzhenPH

Shenzhen, Guangdong, 518000, China

Location

MeSH Terms

Conditions

Bone Diseases, Metabolic

Interventions

Denosumab; Injections, Subcutaneous

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Injections; Drug Administration Routes; Drug Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2022
• First Posted: June 13, 2022
• Study Start: January 12, 2020
• Primary Completion: January 5, 2023
• Study Completion: January 10, 2023
• Last Updated: January 18, 2023

Record last verified: 2022-12

Locations

CN (1)