Clinical trial

Denosumab vs Alendronate in Patients With Osteoporotic Vertebral Compression Fracture After Percutaneous Vertebroplasty: A Randomized Controlled Trial

Name

ShenzhenPH06

Description

Osteoporotic vertebral compression fracture (OVCF) patients had a proportion of secondary fractures after percutaneous vertebroplasty (PVP). Denosumab and alendronate 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 alendronate for OVCF patients bone mineral density (BMD), bone turnover markers (BTMs), secondary fracture and adverse events after PVP

Trial arms

Trial start

2021-01-03

Estimated PCD

2023-09-20

Trial end

2023-10-25

Status

Recruiting

Treatment

Denosumab

1 ml (60 mg) of denosumab (Prolia; Amgen, Inc) subcutaneous injection

Arms:

Denosumab

Other names:

Denosumab 6 month/subcutaneous

Alendronate

oral 70 mg alendronate sodium weekly plus subcutaneous placebo per 6 month.

Arms:

alendronate

Other names:

oral alendronate

Placebo

oral placebo weekly

Arms:

Denosumab, alendronate

Size

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: * Must be age between 50 and 85 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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 90, 'type': 'ESTIMATED'}}

Updated at

2023-02-21

1 organization

2 products

1 drug

1 indication

Organization

Shenzhen People's Hospital

Product

Indication

Product

Drug