Clinical trial

Denosumab vs Zoledronate Efficacy in Osteopenic Patients With Lumbar Degenerative Disease After Lumbar Fusion Surgery

Name

ShenzhenPH spine06

Description

The aim of the study was to compare denosumab and zoledronate efficacy in bone mass, bone turnover markers (BTMs), Visual Analogue Scale (VAS) for leg and back, EuroQol Five-Dimension (EQ-5D) scores, Quality of Life Questionnaire of the European Foundation for Osteoporosis-31 (QUALEFFO-31) scores, and Roland-Morris Disability Functioning Questionnaire (RMDQ) scores, secondary fracture, complications and adverse events after lumbar fusion.

Trial arms

Trial start

2020-01-15

Estimated PCD

2023-02-26

Trial end

2023-02-28

Status

Recruiting

Phase

Early phase I

Treatment

Denosumab 60 mg/ml [Prolia]

60 mg subcutaneously per 6 month

Arms:

Denosumab

Other names:

Denosumab 6 month/subcutaneous

Zoledronate

5mg, intravenous infusion once a year

Arms:

zoledronate

Other names:

Zoledronic acid

Size

100

Primary endpoint

Lumbar bone mineral density(BMD)

up to 12 months

Total hip BMD

up to 12 months

Femoral neck BMD

up to 12 months

Procollagen type 1 n-terminal propeptide (P1NP)

up to 12 months

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

up to 12 months

Visual analog scale (VAS) back

up to 12 months

Eligibility criteria

Inclusion Criteria: * Participants aged 40 to 85 years * who diagnosed with lumbar spinal stenosis or lumbar spondylolisthesis * osteopenia with BMD T score between -1 and -2.5 via dual energy X-ray * low back pain or leg numbness or weakness * MRI demonstrated signs of nerve compression * patients with one or two level symptoms. Exclusion Criteria: * cauda equina syndrome * progressive neurologic deficit * history of cancer * scoliosis greater than 15° * back open surgery history * have contraindications for surgery * who had anti-osteoporosis medication within 6 weeks

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 100, 'type': 'ESTIMATED'}}

Updated at

2023-02-21

1 organization

2 products

2 indications

Organization

Shenzhen People's Hospital

Product

Indication

Indication

Product