Denosumab vs Zoledronate After Lumbar Fusion

Osteopenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05638399
• Other study ID #: ShenzhenPH spine06
• Status: Recruiting
• Phase: Phase 3
• Start date: January 15, 2020
• Est. completion date: February 28, 2023

Study information

• Verified date: February 2023
• Source: Shenzhen People's Hospital
• Contact: Hongyu Wang, Doctor
• Phone: 18241651300
• Email: wanghongyu790039663[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: February 28, 2023
• Est. primary completion date: February 26, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Bone Diseases, Metabolic
• Lumbar Spondylolisthesis
• Osteopenia
• Spondylolisthesis

Intervention

Drug:
• Denosumab 60 mg/ml [Prolia]
60 mg subcutaneously per 6 month
• Zoledronate
5mg, intravenous infusion once a year

Locations

Country	Name	City	State
China	ShenzhenPH	Shenzhen	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Shenzhen People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Total hip BMD	Total hip BMD were determined at baseline, 6 and 12 months via dual-energy X-ray	up to 12 months
Primary	Femoral neck BMD	Femoral neck BMD were determined at baseline, 6 and 12 month via dual-energy X-ray	up to 12 months
Primary	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
Primary	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
Primary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Complications	Complications including cage subsidence, pedicle screw loosening, infection, peripheral nerve injury, and recurrent symptoms were assessed.	up to 12 month
Secondary	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