Denosumab vs Zoledronate After Vertebroplasty

NCT05598606 | Completed Phase 4 DMC

• 1 other identifier: ShenzhenPH denosumab
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Denosumab Allergy; Zoledronic Acid Allergy

Outcome Measures

Primary Outcomes (6)

• Lumbar bone mineral density(BMD)

  Lumbar vertebral (L1 to L4, except the surgery segment) BMD were determined at baseline, 6 and 12 months via dual- energy X-ray

  up to 12 months

• Total hip BMD

  Total hip BMD were determined at baseline, 6 and 12 months via dual-energy X-ray.

  up to 12 months

• Femoral neck BMD

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

  up to 12 months

• Procollagen type 1 n-terminal propeptide (P1NP)

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

  up to 12 months

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

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

  up to 12 months

• Visual analog scale (VAS) back

  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.

  up to 12 months

Secondary Outcomes (5)

• The Roland-Morris Disability Questionnaire

  up to 12 month

• The QUALEFFO-31 Questionnaire

  up to 12 month

• The EQ-5D Questionnaire

  up to 12 month

• Secondary fracture rate

  up to 12 month

• Adverse events

  up to 12 month

Study Arms (2)

Denosumab

EXPERIMENTAL

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

Drug: Denosumab Injection

zoledronate

ACTIVE COMPARATOR

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

Drug: Zoledronate

Interventions

Denosumab Injection DRUG

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

Also known as: Denosumab 6 month/subcutaneous

Denosumab

Zoledronate DRUG

Intravenous zoledronic acid 5 mg plus subcutaneous placebo every 12 months

Also known as: Zoledronic acid intravenous once a year

zoledronate

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shenzhen People's Hospital: lead

Study Sites (1)

ShenzhenPH

Shenzhen, Guangdong, 518000, China

Location

MeSH Terms

Interventions

Denosumab; Injections, Subcutaneous; Zoledronic Acid

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Injections; Drug Administration Routes; Drug Therapy; Therapeutics; Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Xiao Xiao, Doctor

  Shenzhen People's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants were randomized using a block randomization model (block size 5). Computer-generated, random-number sequences were prepared by an experienced statistician. Consecutive treatment allocations were stored in sealed opaque envelopes and assigned to doctors. Patients and doctors were blinded to the assignments; all researchers and data analysts were blinded as to the allocation during the 12-month follow-up period.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2022
• First Posted: October 28, 2022
• Study Start: January 12, 2021
• Primary Completion: January 10, 2023
• Study Completion: January 14, 2023
• Last Updated: January 18, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)