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Completed

NCT Number: NCT05598606

Denosumab vs Zoledronate After Vertebroplasty

Osteoporotic vertebral compression fracture (OVCF) patients had a proportion of secondary fractures after percutaneous vertebroplasty (PVP). Denosumab and zoledronate acid is both effective to prevent bone loss for OVCF postmenopausal women. However, trial evidence comparing effect of denosumab vs zoledronate after PVP was unknown. The study aims to assess the efficiency of denosumab vs zoledronate for OVCF patients bone mineral density (BMD), bone turnover markers (BTMs), secondary fracture and adverse events after PVP.

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Key information

Conditions

Denosumab Allergy Zoledronic Acid Allergy

Age range

50 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

ShenzhenPH

Shenzhen, Guangdong, 518000, China

About this study

Whether denosumab was non-inferior than zoledronate in improving bone mineral density (BMD), bone turnover markers (BTMs), functional status questionnaires, and secondary fracture in elderly patients with OVCF after PVP remains unknown. A prospective, randomized, placebo-controlled clinical trial in OVCF patients with PVP was performed. This study aimed to investigate the efficiency of denosumab vs zoledronate on BMD, BTMs, functional status, secondary fracture rate, and adverse events in OVCF patients after PVP during a 12-month follow-up period.

Who can participate

Healthy volunteers accepted: No

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 Injection

Drug

1 ml (60 mg) of denosumab (Prolia; Amgen, Inc) subcutaneous injection plus intravenous placebo every 6 months (Q6M)

Other names: Denosumab 6 month/subcutaneous

Zoledronate

Drug

Intravenous zoledronic acid 5 mg plus subcutaneous placebo every 12 months

Other names: Zoledronic acid intravenous once a year

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 month via dual-energy X-ray

  4. 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.

  5. 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

  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 EuroQol five-dimension (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 vs Zoledronate in Patients With Osteoporotic Vertebral Compression Fracture After Percutaneous Vertebroplasty: A Randomized Controlled Trial

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Oct 28, 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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