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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
75
1 ml (60 mg) of denosumab (Prolia; Amgen, Inc) subcutaneous injection plus intravenous placebo every 6 months (Q6M)
Intravenous zoledronic acid 5 mg plus subcutaneous placebo every 12 months
ShenzhenPH
Shenzhen, Guangdong, China
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
Time frame: up to 12 months
Total hip BMD
Total hip BMD were determined at baseline, 6 and 12 months via dual-energy X-ray.
Time frame: up to 12 months
Femoral neck BMD
Femoral neck BMD were determined at baseline, 6 and 12 month via dual-energy X-ray
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: up to 12 months
The Roland-Morris Disability Questionnaire
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.
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Time frame: up to 12 month
The QUALEFFO-31 Questionnaire
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.
Time frame: up to 12 month
The EQ-5D Questionnaire
The EuroQol five-dimension (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).
Time frame: up to 12 month
Secondary fracture rate
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.
Time frame: up to 12 month
Adverse events
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.
Time frame: up to 12 month