Clinical trial NCT05598606: Denosumab vs Zoledronate After Vertebroplasty
Official title: Denosumab vs Zoledronate in Patients With Osteoporotic Vertebral Compression Fracture After Percutaneous Vertebroplasty: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Denosumab Allergy
Zoledronic Acid Allergy
Lead sponsor: Shenzhen People's Hospital
Sponsor class: OTHER
First posted: 2022-10-28
Enrollment: 75
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Lumbar bone mineral density(BMD)
timeFrame: up to 12 months
measure: Total hip BMD
timeFrame: up to 12 months
measure: Femoral neck BMD
timeFrame: up to 12 months
measure: Procollagen type 1 n-terminal propeptide (P1NP)
timeFrame: up to 12 months
measure: C-terminal cross-linked type 1 collagen terminal peptide (CTX)
timeFrame: up to 12 months
measure: Visual analog scale (VAS) back
timeFrame: up to 12 months
Secondary outcomes:
measure: The Roland-Morris Disability Questionnaire
timeFrame: up to 12 month
measure: The QUALEFFO-31 Questionnaire
timeFrame: up to 12 month
measure: The EQ-5D Questionnaire
timeFrame: up to 12 month
measure: Secondary fracture rate
timeFrame: up to 12 month
measure: Adverse events
timeFrame: up to 12 month
Other outcomes:
Locations:
city: Shenzhen
country: China
facility: ShenzhenPH
state: Guangdong
Study officials:
affiliation: Shenzhen People's Hospital
name: Xiao Xiao, Doctor
role: PRINCIPAL_INVESTIGATOR
References: