Denosumab vs Alendronate After Vertebroplasty

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

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

Study Overview

• Status: Recruiting
• Conditions: Denosumab Allergy
• Intervention / Treatment: Drug: Denosumab; Drug: Placebo; Drug: Alendronate

Detailed Description

Whether denosumab was non-inferior than alendronate 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 alendronate 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
• Enrollment (Anticipated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hongyu Wang, Doctor; Phone Number: 18241651300; Email: wanghongyu790039663@126.com
• Study Contact Backup: Name: Song Wang, Master; Phone Number: 18085243269; Email: 2362380008@qq.com

Study Locations

• China
  • Guangdong
    • Shenzhen, Guangdong, China, 518000
      • Recruiting
      • ShenZhen People's Hospital
      • Contact: Hongyu Wang, Doctor; Phone Number: 18241651300; Email: wanghongyu790039663@126.com
      • Contact: Song Wang, Master; Phone Number: 18085243269; Email: 2362380008@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Denosumab; 1 ml (60 mg) of denosumab (Prolia; Amgen, Inc) subcutaneous injection plus intravenous placebo every 6 months	Drug: Denosumab; 1 ml (60 mg) of denosumab (Prolia; Amgen, Inc) subcutaneous injection; Other Names: Denosumab 6 month/subcutaneous; Drug: Placebo; oral placebo weekly
Active Comparator: alendronate; oral 70 mg alendronate sodium weekly.	Drug: Placebo; oral placebo weekly; Drug: Alendronate; oral 70 mg alendronate sodium weekly plus subcutaneous placebo per 6 month.; Other Names: oral alendronate

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The EQ-5D Questionnaire	The EuroQol five-dimension (EQ-5D) questionnaire evaluates health status consisting five dimensions: mobility, selfcare, 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).	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.	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.	up to 12 month
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	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	up to 12 month

Collaborators and Investigators

• Sponsor: Shenzhen People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 3, 2021
• Primary Completion (Anticipated): September 20, 2023
• Study Completion (Anticipated): October 25, 2023

Study Registration Dates

• First Submitted: December 15, 2022
• First Submitted That Met QC Criteria: December 21, 2022
• First Posted (Actual): December 22, 2022

Study Record Updates

• Last Update Posted (Estimate): February 21, 2023
• Last Update Submitted That Met QC Criteria: February 18, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Bone Density Conservation Agents; Alendronate; Denosumab
• Other Study ID Numbers: ShenzhenPH06

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No