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Completed

NCT Number: NCT05058443

Denosumab and Osteoporotic Vertebral Compression Fracture

This study aimed to investigate the effect of denosumab on bone mineral density(BMD), bone turnover markers(BTMs), functional status, secondary fracture rate, and adverse effects in osteoporotic vertebral compression fracture (OVCF) patients after vertebroplasty during a 12-month follow-up period.

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Key information

Conditions

Osteoporotic Vertebral Compression Fracture

Age range

50 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

ShenzhenPH

Shenzhen, Guangdong, 518000, China

About this study

We performed a single-center, placebo-controlled, randomized clinical trial in the Department of Spinal Surgery located at the First Affiliated Hospital of Southern University of Science and Technology (Shenzhen People's Hospital). All patients underwent vertebroplasty and randomly received denosumab treatment or placebo control after surgery. The BMDs (lumbar, total hip, and femoral neck) and BTMs were assessed at baseline, 6, and 12 months post-operation. The visual analog scale (VAS) score for back pain, and function status questionnaires, including EuroQol five-dimension (EQ-5D), the Quality of Life Questionnaire of the European Foundation for Osteoporosis-31 (QUALEFFO-31), and the Roland-Morris Disability Functioning Questionnaire (RMDQ),secondary fracture rate, and adverse effects in OVCF patients after vertebroplasty during a 12-month follow-up period.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Must be age between 50 and 90 years old
  • X-ray diagnosis of 1 or 2 segment vertebral compression fractures from T4 to L5
  • Bone mineral density T value less than -1 via dual-energy X-ray
  • A recent fracture history less than 6 weeks
  • MRI show bone marrow edema of fractured vertebrae
  • low back pain, local paravertebral tenderness

Exclusion criteria

  • Must be able to have no intervertebral fissure
  • Must be able to have no infection
  • Must be able to have no malignancy
  • Must be able to have no neurological dysfunction
  • Must be able to have no previous use of anti-osteoporosis drugs
  • Must be able to have no inability to perform magnetic resonance imaging
  • Must be able to have no prior back open surgery
  • Must be able to have no other established contraindications for elective surgery

Treatment and study plan

Denosumab 60 mg/ml [Prolia]

Drug

denosumab subcutaneously every 6 months (Q6M)

Other names: Denosumab

Placebo

Drug

placebo subcutaneously every 6 months (Q6M)

Other names: equal volume of saline (0.9%)

Primary outcomes

  1. Procollagen type 1 n-terminal propeptide (P1NP)

    Time frame: up to 12 months

    Bone formation marker, P1NP were determined at baseline, 6 and 12 months after surgery.

  2. C-terminal cross-linked type 1 collagen terminal peptide (CTX)

    Time frame: up to 12 months

    Bone resorption marker, CTX were determined at baseline, 6 and 12 months after surgery

  3. 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.

  4. 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.

  5. Femoral neck BMD

    Time frame: up to 12 months

    Femoral neck BMD were determined at baseline, 6 and 12 month via dual-energy X-ray

  6. Visual analog scale (VAS) back

    Time frame: up to 12 months

    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.

Secondary outcomes

  1. The Roland-Morris Disability Questionnaire

    Time frame: up to 12 month

    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.

  2. The QUALEFFO-31 Questionnaire

    Time frame: up to 12 month

    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.

  3. The EQ-5D Questionnaire

    Time frame: up to 12 month

    The EQ-5D questionnaire evaluates health status consisting five dimensions: mobility, self-care, 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).

  4. Secondary fracture rate

    Time frame: up to 12 month

    Secondary 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.

  5. Adverse events

    Time frame: up to 12 month

    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.

Sponsors and collaborators

Lead sponsor

Shenzhen People's Hospital

Other

Registry information

Official study title

Denosumab Protects Bone Loss and Function in Patients With Osteoporotic Vertebral Compression Fracture After Percutaneous Vertebroplasty: a Randomized Placebo-controlled Clinical Trial

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Sep 27, 2021
Registry last updated
Feb 21, 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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