Denosumab vs Zoledronate After Vertebroplasty

• Sponsor: Shenzhen People's Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT05598606
• Collaborator: (none)
• Enrollment: 75
• Location: 1
• Arms: 2
• Actual Duration (Months): 24
• Patients Per Site Per Month: 3.1

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Denosumab Allergy; Zoledronic Acid Allergy	Drug: Denosumab Injection; Drug: Zoledronate	Phase 4

Detailed Description

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 Design

• Study Type: Interventional
• Actual Enrollment: 75 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Masking Description: 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.
• Primary Purpose: Treatment
• Official Title: Denosumab vs Zoledronate in Patients With Osteoporotic Vertebral Compression Fracture After Percutaneous Vertebroplasty: A Randomized Controlled Trial
• Actual Study Start Date: Jan 12, 2021
• Actual Primary Completion Date: Jan 10, 2023
• Actual Study Completion Date: Jan 14, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Denosumab 1 ml (60 mg) of denosumab (Prolia; Amgen, Inc) subcutaneous injection plus intravenous placebo every 6 months	Drug: Denosumab Injection; 1 ml (60 mg) of denosumab (Prolia; Amgen, Inc) subcutaneous injection plus intravenous placebo every 6 months (Q6M); Other Names: Denosumab 6 month/subcutaneous
Active Comparator: zoledronate Intravenous zoledronic acid 5 mg plus subcutaneous placebo every 12 months.	Drug: Zoledronate; Intravenous zoledronic acid 5 mg plus subcutaneous placebo every 12 months; Other Names: Zoledronic acid intravenous once a year

Outcome Measures

Primary Outcome Measures

1. 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

2. Total hip BMD [up to 12 months]

   Total hip BMD were determined at baseline, 6 and 12 months via dual-energy X-ray.

3. Femoral neck BMD [up to 12 months]

   Femoral neck BMD were determined at baseline, 6 and 12 month via dual-energy X-ray

4. 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.

5. 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

6. 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.

Secondary Outcome Measures

1. 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.

2. 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.

3. The EQ-5D Questionnaire [up to 12 month]

   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).

4. 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.

5. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	ShenzhenPH	Shenzhen	Guangdong	China	518000

Sponsors and Collaborators

• Shenzhen People's Hospital

Investigators

• Principal Investigator: Xiao Xiao, Doctor, Shenzhen People's Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Shenzhen People's Hospital
• ClinicalTrials.gov Identifier: NCT05598606
• Other Study ID Numbers: ShenzhenPH denosumab
• First Posted: Oct 28, 2022
• Last Update Posted: Jan 18, 2023
• Last Verified: Jan 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Hypersensitivity; Zoledronic Acid; Denosumab

Study Results

No Results Posted as of Jan 18, 2023