Denosumab vs Zoledronate After Vertebroplasty

Phase 4

Completed

• Conditions: Denosumab Allergy; Zoledronic Acid Allergy
• Interventions: Drug: Denosumab Injection; Drug: Zoledronate

• Registration Number: NCT05598606
• Lead Sponsor: Shenzhen People's Hospital

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.

Study Timeline

• Study Start: 2021-01-12
• Study First Submitted: 2022-10-25
• Study First Submitted QC: 2022-10-25
• Study First Posted: 2022-10-28
• Status Verified: 2023-01
• Primary Completion: 2023-01-10
• Study Completion: 2023-01-14
• Last Update Submitted: 2023-01-15
• Last Update Posted: 2023-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Denosumab	Denosumab Injection	1 ml (60 mg) of denosumab (Prolia; Amgen, Inc) subcutaneous injection plus intravenous placebo every 6 months
zoledronate	Zoledronate	Intravenous zoledronic acid 5 mg plus subcutaneous placebo every 12 months.

Primary Outcome Measures

Name	Time	Method
Femoral neck BMD	up to 12 months	Femoral neck BMD were determined at baseline, 6 and 12 month via dual-energy X-ray
Lumbar bone mineral density(BMD)	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
C-terminal cross-linked type 1 collagen terminal peptide (CTX)	up to 12 months	Bone resorption marker, CTX were determined at baseline, 6 and 12 months after surgery
Visual analog scale (VAS) back	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.
Total hip BMD	up to 12 months	Total hip BMD were determined at baseline, 6 and 12 months via dual-energy X-ray.
Procollagen type 1 n-terminal propeptide (P1NP)	up to 12 months	Bone formation marker, P1NP were determined at baseline, 6 and 12 months after surgery.

Secondary Outcome Measures

Name	Time	Method
The QUALEFFO-31 Questionnaire	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.
The EQ-5D Questionnaire	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).
The Roland-Morris Disability Questionnaire	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.
Secondary fracture rate	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.
Adverse events	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.

Trial Locations

Locations (1)

ShenzhenPH; 🇨🇳 Shenzhen, Guangdong, China