Denosumab vs Zoledronate After Vertebroplasty

Southern University of Science and Technology

Status and phase: Completed; Phase 4

Conditions: Zoledronic Acid Allergy; Denosumab Allergy

Treatments: Drug: Denosumab Injection; Drug: Zoledronate

Study type: Interventional

Funder types: Other

Identifiers

NCT05598606

ShenzhenPH denosumab

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 75 patients

Sex: All

Ages: 50 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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75 participants in 2 patient groups

Denosumab

Experimental group

Description:

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

Treatment:

Drug: Denosumab Injection

zoledronate

Active Comparator group

Description:

Intravenous zoledronic acid 5 mg plus subcutaneous placebo every 12 months.

Treatment:

Drug: Zoledronate