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Completed

NCT Number: NCT05415657

Denosumab Effect on Bone Quality and Function After Lumbar Fusion Surgery

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.

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Key information

Conditions

Osteopenia Bone Diseases Bone Diseases, Metabolic Denosumab Allergy Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases Spine Fusion

Age range

40 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

ShenzhenPH

Shenzhen, Guangdong, 518000, China

About this study

However, It was still unknown for denosumab effect on osteopenia patients after lumbar fusion. Bone mineral density(BMD), bone turnover marker, lumbar functional status Roland-Morris Disability Functioning Questionnaire (RMDQ) and quality of life EuroQol Five-Dimension (EQ-5D), and Quality of Life Questionnaire of the European Foundation for Osteoporosis-31 (QUALEFFO-31) score, rate of new fracture, re-operation, lumbar fusion, complications or adverse events were still unknown. Our study will explore the effect of denosumab on lumbar, total hip, femoral neck BMD and bone turnover markers, functional status EQ-5D, QUALEFFO-31 and RMDQ score of participants after lumbar fusion at 12 months follow-up.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

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

Treatment and study plan

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.

Other names: Denosumab 6 month/subcutaneous

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.

Other names: Placebo 6 month/subcutaneous

Primary outcomes

  1. Lumbar bone mineral density (BMD)

    Time frame: up to 12 months

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

  2. Total hip BMD

    Time frame: up to 12 months

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

  3. Femoral neck BMD

    Time frame: up to 12 months

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

  4. Type 1 n-terminal propeptide P1NP

    Time frame: up to 12 months

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

  5. C-terminal crosslinking type 1 collagen terminal peptide CTX

    Time frame: up to 12 months

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

  6. Visual analog scale (VAS) back

    Time frame: up to 12 months

    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.

  7. VAS leg

    Time frame: up to 12 months

    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

Secondary outcomes

  1. EQ-5D quality of life questionnaire

    Time frame: up to 12 month

    EQ-5D descriptive system is a preference-based quality of life measure with one question for each of the five dimensions that include mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. From this, a quality of life score can be calculated ranging from -0.594, indicating a health state worse than death where 0 is death, to 1, indicating full health

  2. Roland-Morris Disability Questionnaire

    Time frame: up to 12 month

    The Roland-Morris Disability Questionnaire is a health status measure designed to be completed by patients to assess physical disability due to low back pain. The lowest score is 0, the highest 24. The higher the score, the more severe the dysfunction.

  3. QUALEFFO-31 Questionnaire

    Time frame: up to 12 month

    QUALEFFO-31, which contains three domains including pain, physical function, and mental function. The worse the health related quality of life condition, the higher the score. This scale is assessed on a scale of 0 to 100, with 0 indicating the highest QoL and 100 the lowest.

  4. Lumbar Fusion rate

    Time frame: up to 12 month

    We determined lumbar fusion rate via CT at 12 month after surgery.The lowest rate is 0, the highest 100%. The higher the score represents higher fusion rate.

  5. New fracture rate

    Time frame: up to 12 month

    New fracture rate including new 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 represents no fracture.

  6. Reoperation rate

    Time frame: up to 12 month

    Reoperation rate was assessed at 12 month after surgery. The lowest reoperation rate was 0, the highest score was 100%.

  7. Complications

    Time frame: up to 12 month

    Complications such as cage subsidence, pedicle screw loosening, infection, peripheral nerve injury, recurrent symptoms were assessed at 12 months follow-up.

  8. Adverse effect

    Time frame: up to 12 month

    The main adverse effect including deep vein thrombosis, rash, joint pain, headache, nausea, pneumonia, necrosis of jaw, atypical femoral fracture, pulmonary embolism, transfer to intensive care unit (ICU), stroke, acute renal failure, myocardial infarction and so on.

Sponsors and collaborators

Lead sponsor

Shenzhen People's Hospital

Other

Registry information

Official study title

Denosumab Protects Bone Loss and Function in Osteopenia Patients With Lumbar Degenerative Diseases After Lumbar Fusion Surgery, a Randomized, Placebo Controlled Trial.

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Jun 13, 2022
Registry last updated
Jan 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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