Denosumab vs Zoledronate After Vertebroplasty

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-12

Study Completion Date

2023-01-14

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Denosumab Allergy Zoledronic Acid Allergy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

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.

Study Groups

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Denosumab

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

Group Type EXPERIMENTAL

Denosumab Injection

Intervention Type DRUG

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

zoledronate

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

Group Type ACTIVE_COMPARATOR

Zoledronate

Intervention Type DRUG

Intravenous zoledronic acid 5 mg plus subcutaneous placebo every 12 months

Interventions

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Denosumab Injection

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

Intervention Type DRUG

Zoledronate

Intravenous zoledronic acid 5 mg plus subcutaneous placebo every 12 months

Intervention Type DRUG

Other Intervention Names

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Denosumab 6 month/subcutaneous Zoledronic acid intravenous once a year

Eligibility Criteria

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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

Minimum Eligible Age

50 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No