Denosumab and Osteoporotic Vertebral Compression Fracture

Phase 2

Completed

• Conditions: Osteoporotic Vertebral Compression Fracture
• Interventions: Drug: Denosumab 60 mg/ml [Prolia]; Drug: Placebo

• Registration Number: NCT05058443
• Lead Sponsor: Shenzhen People's Hospital

Brief Summary

This study aimed to investigate the effect of denosumab on bone mineral density(BMD), bone turnover markers(BTMs), functional status, secondary fracture rate, and adverse effects in osteoporotic vertebral compression fracture (OVCF) patients after vertebroplasty during a 12-month follow-up period.

Detailed Description

We performed a single-center, placebo-controlled, randomized clinical trial in the Department of Spinal Surgery located at the First Affiliated Hospital of Southern University of Science and Technology (Shenzhen People's Hospital). All patients underwent vertebroplasty and randomly received denosumab treatment or placebo control after surgery. The BMDs (lumbar, total hip, and femoral neck) and BTMs were assessed at baseline, 6, and 12 months post-operation. The visual analog scale (VAS) score for back pain, and function status questionnaires, including EuroQol five-dimension (EQ-5D), the Quality of Life Questionnaire of the European Foundation for Osteoporosis-31 (QUALEFFO-31), and the Roland-Morris Disability Functioning Questionnaire (RMDQ),secondary fracture rate, and adverse effects in OVCF patients after vertebroplasty during a 12-month follow-up period.

Study Timeline

• Study Start: 2020-01-06
• Study First Submitted: 2021-09-16
• Study First Submitted QC: 2021-09-16
• Study First Posted: 2021-09-27
• Primary Completion: 2022-08-05
• Study Completion: 2022-08-10
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-18
• Last Update Posted: 2023-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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 60 mg/ml [Prolia]	Denosumab 60 mg were injected subcutaneously every 6 months (Q6M)
Placebo	Placebo	Equal volume of saline (0.9%) as placebo were injected subcutaneously every 6 months (Q6M)

Primary Outcome Measures

Name	Time	Method
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.
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
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.
Total hip BMD	up to 12 months	Total hip BMD were determined at baseline, 6 and 12 months via dual-energy X-ray.
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.
Femoral neck BMD	up to 12 months	Femoral neck BMD were determined at baseline, 6 and 12 month via dual-energy X-ray

Secondary Outcome Measures

Name	Time	Method
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.
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 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).
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