Denosumab vs Zoledronate After Lumbar Fusion

Denosumab vs Zoledronate Efficacy in Osteopenic Patients With Lumbar Degenerative Disease After Lumbar Fusion Surgery

The aim of the study was to compare denosumab and zoledronate efficacy in bone mass, bone turnover markers (BTMs), Visual Analogue Scale (VAS) for leg and back, EuroQol Five-Dimension (EQ-5D) scores, Quality of Life Questionnaire of the European Foundation for Osteoporosis-31 (QUALEFFO-31) scores, and Roland-Morris Disability Functioning Questionnaire (RMDQ) scores, secondary fracture, complications and adverse events after lumbar fusion.

Study Overview

• Status: Recruiting
• Conditions: Osteopenia; Lumbar Spondylolisthesis
• Intervention / Treatment: Drug: Zoledronate; Drug: Denosumab 60 mg/ml [Prolia]

Detailed Description

Lumbar degenerative disease including spinal stenosis and lumbar spondylolisthesis were the most common reason lead to older patients disability, which was the main indication for older patients to perform lumbar fusion surgery. For patients with lumbar degenerative disease older than 50 years old, a proportion of patients had osteoporosis. The trial aims to investigate whether denosumab versus zoledronate acid in osteopenic patients with lumbar fusion surgery.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Hongyu Wang, Doctor; Phone Number: 18241651300; Email: wanghongyu790039663@126.com
• Study Contact Backup: Name: Song Wang, Master; Phone Number: 18085243269; Email: 835990429@qq.com

Study Locations

• China
  • Guangdong
    • Shenzhen, Guangdong, China, 518000
      • Recruiting
      • ShenzhenPH
      • Contact: Hongyu Wang, Doctor; Phone Number: 18241651300; Email: wanghongyu790039663@126.com
      • Contact: Song Wang, Master; Phone Number: 18085243269; Email: 2362380008@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Participants aged 40 to 85 years

  • who diagnosed with lumbar spinal stenosis or lumbar spondylolisthesis
  • osteopenia with BMD T score between -1 and -2.5 via dual energy X-ray
  • low back pain or leg numbness or weakness
  • MRI demonstrated signs of nerve compression
  • patients with one or two level symptoms.

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Denosumab; denosumab (60 mg subcutaneously, per 6 month)	Drug: Denosumab 60 mg/ml [Prolia]; 60 mg subcutaneously per 6 month; Other Names: Denosumab 6 month/subcutaneous
Active Comparator: zoledronate; zoledronate (5mg, intravenous infusion once a year)	Drug: Zoledronate; 5mg, intravenous infusion once a year; Other Names: Zoledronic acid

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 month via dual-energy X-ray	up to 12 months
Procollagen type 1 n-terminal propeptide (P1NP)	Bone formation marker, P1NP were determined at baseline, 6 and 12 months after surgery	up to 12 months
C-terminal cross-linked type 1 collagen terminal peptide (CTX)	Bone resorption marker, CTX were determined at baseline, 6 and 12 months after surgery	up to 12 months
Visual analog scale (VAS) back	The VAS score for back pain were determined at baseline, 6 and 12 month. 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
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Roland-Morris Disability Questionnaire	The Roland-Morris Disability Questionnaire is scored by 24 adding up the number of items checked "yes" on different low back pain-related daily activity disabilities. Total scores range from 0 to 24, with higher scores 24 indicating a higher level of disability related to low back pain and lowest 0 represents no back pain.	up to 12 month
The QUALEFFO-31 Questionnaire	The Quality of Life Questionnaire of the European Foundation for Osteoporosis-31 (QUALEFFO-31), which contains three domains including pain, physical function, and mental function. This scale is assessed on a scale of 0 to 100, with 0 indicating the highest QoL and 100 the lowest.	up to 12 month
The EQ-5D Questionnaire	The EuroQol five-dimension (EQ-5D) questionnaire evaluates health status consisting five dimensions: mobility, selfcare, performance of usual activities, pain or discomfort, and anxiety or depression. After conversion, the index was between 0 and 1.0 (minimum score: 0, indicating worst health state; full score:1.0, indicating full health).	up to 12 month
New fracture rate	New fracture rate containing vertebral fracture and non-vertebral fracture was assessed at 12 month after surgery. The lowest score was 0, the highest score was 100%. The lower score 0 represents no secondary fracture.	up to 12 month
Complications	Complications including cage subsidence, pedicle screw loosening, infection, peripheral nerve injury, and recurrent symptoms were assessed.	up to 12 month
Adverse events	The main adverse events including deep venous thrombosis, pneumonia, acute renal failure, pulmonary embolism, myocardial infarction, influenza, transfer to intensive care unit, joint pain, headache, nausea, osteonecrosis of the jaw, atypical femoral fracture and rash.	up to 12 month

Collaborators and Investigators

• Sponsor: Shenzhen People's Hospital
• Investigators: Study Chair: Songlin Peng, Doctor, Shenzhen People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2020
• Primary Completion (Anticipated): February 26, 2023
• Study Completion (Anticipated): February 28, 2023

Study Registration Dates

• First Submitted: November 25, 2022
• First Submitted That Met QC Criteria: November 25, 2022
• First Posted (Actual): December 6, 2022

Study Record Updates

• Last Update Posted (Estimate): February 21, 2023
• Last Update Submitted That Met QC Criteria: February 18, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spondylolysis; Spondylosis; Bone Diseases, Metabolic; Spondylolisthesis; Physiological Effects of Drugs; Bone Density Conservation Agents; Zoledronic Acid; Denosumab
• Other Study ID Numbers: ShenzhenPH spine06

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No