A Trial of Vertebroplasty for Painful Chronic Osteoporotic Vertebral

Status Completed

Clinical Trial Summary

Background The standard care in patients with a painful osteoporotic vertebral compression fracture (VCF) is conservative therapy. Percutaneous vertebroplasty (PV), a minimally invasive technique, is a relatively new treatment option. Recent randomized controlled trials (RCT) provide conflicting results: two sham-controlled studies showed no benefit of PV while an unmasked but controlled RCT (VERTOS II) found effective pain relief at acceptable costs in patients with acute VCFs. A still ongoing masked RCT (VERTOS IV) focuses on acute VCFs defined as ≤ 6 weeks. VERTOS III focused on conservative treatment and found that half of patients still had disabling pain after 3 months or longer. These patients with sustained pain after 3 months may benefit from PV. Objective To compare pain relief after PV with a sham intervention in selected patients with a chronic osteoporotic VCF ( three months or longer) using the same strict inclusion criteria as in VERTOS II an IV. Secondary outcome measures are back pain related disability and quality of life. Methods The VERTOS V study is a prospective RCT with pain relief as primary endpoint. Inclusion criteria are a VCF of thoracic level 5 or lower with focal tenderness at fracture level, assessed by an internist on physical examination and a Visual Analogue Scale (VAS) score ≥ 5 for three months or longer, decreased bone density defined as T score ≤ -1 and age 50 years or older. 94 patients will be included, 47 in each arm. Crossovers are not allowed. Follow-up is at regular intervals during one year period with VAS score for pain as primary endpoint. Secondary endpoints are back pain related disability and quality of life measured with the Quality of Life Questionnaire of the European Foundation for Osteoporosis and physical function measured with the Roland Morris Disability questionnaire. Conclusion Vertos V is a methodologically sound masked randomised sham controlled trial of vertebroplasty in patients with sustained pain 3 months or longer after a vertebral compression fracture.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01963039
Study type	Interventional
Source	Elisabeth-TweeSteden Ziekenhuis
Contact
Status	Completed
Phase	N/A
Start date	May 2013
Completion date	September 3, 2020

View Details

See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT06287502` - Efficacy of Structured Exercise-Nutritional Intervention on Sarcopenia in Patients With Osteoporosis	N/A
Completed	`NCT03822078` - Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Denosumab (AMG 162) in Japanese Postmenopausal Women	Phase 1
Recruiting	`NCT05845021` - Surgeon-Initiated Bone Health Referral Pathway in Patients Undergoing Lower Extremity Arthroplasty	N/A
Completed	`NCT00092066` - A Study to Evaluate the Safety, Tolerability, and Efficacy of an Investigational Drug and Dietary Supplement in Men and Postmenopausal Women With Osteoporosis (0217A-227)	Phase 3
Recruiting	`NCT04754711` - Interest of Nutritional Care of Children With Sickle Cell Disease on Bone Mineral Density and Body Composition	N/A
Completed	`NCT04736693` - Replication of the HORIZON Pivotal Fracture Trial in Healthcare Claims Data
Completed	`NCT02922478` - Role of Comorbidities in Chronic Heart Failure Study
Recruiting	`NCT02616627` - Association Between DXA Results and the Complications, Clinical Courses and Outcomes in Chronic Dialysis Patients
Recruiting	`NCT02635022` - Fragility Fracture Liaison Service and Anti-osteoporosis Medication Monitoring Service Study
Active, not recruiting	`NCT02617303` - Prevention of Falls and Its Consequences in Elderly People	N/A
Completed	`NCT02566655` - Clinical Trial of Intravenous Infusion of Fucosylated Bone Marrow Mesenchyme Cells in Patients With Osteoporosis	Phase 1
Not yet recruiting	`NCT02223572` - Secondary Fracture Prevention in Patients Who Suffered From Osteoporotic Fracture	N/A
Completed	`NCT03420716` - Symbiotic Yogurt, Calcium Absorption and Bone Health in Young Adult Women	N/A
Completed	`NCT02559648` - Denosumab vs Placebo in Patients With Thalassemia Major and Osteoporosis	Phase 2
Not yet recruiting	`NCT01854086` - Compliance and Persistence With Osteoporosis Treatment and Attitude Towards Future Therapy Among Post-menopausal Israeli Women During Drug Treatment or Drug Holiday	N/A
Unknown status	`NCT01913834` - Nasally and sc Administered Teriparatide in Healthy Volunteers	Phase 1
Completed	`NCT02003716` - DeFRA Questionnaire as an Anamnestic Form	N/A
Completed	`NCT01401556` - C-STOP Fracture Trial	N/A
Completed	`NCT01694784` - Understanding and Discouraging Overuse of Potentially Harmful Screening Tests	N/A
Completed	`NCT01757340` - Calorie Restriction With Leucine Supplementation	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

A Trial of Vertebroplasty for Painful Chronic Osteoporotic Vertebral Fractures (Vertos V) — VERTOSV

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms