A Phase 4 interventional study of Augmentation vertebroplasty and Augmentation and prophylactic vertebroplasty in Osteoporosis and Vertebral Fracture, sponsored by University of Bern. Terminated at 1 site in Switzerland. Open to participants aged 55 Years and older. Per ClinicalTrials.gov, last updated 2023-03-16.
Sponsored by University of Bern · Phase 4, Interventional, and Treatment
Among 26 studies in Osteoporosis with a site in Switzerland — 2 open to participants now, 2 under way, none of them phase 3. Osteoporosis · Switzerland.
Among the 26 studies in Osteoporosis with a site in Switzerland, this one is the 12th largest by planned enrollment of the 18 interventional ones that give a count, is one of 2 that started in 2015, is one of 2 in phase 4, and was the 19th registered.
1,601 studies on the registry are indexed under Osteoporosis; 209 are open to participants now.
Browse Osteoporosis studies →2 of the 26 studies in Osteoporosis with a site in Switzerland are open now. Recruiting first, the newest first:
AO Foundation, AO Spine · Sites in Switzerland, United States, Argentina and 11 more countries
Ages 50+
University Department of Geriatric Medicine FELIX PLATTER · Sites in Switzerland
A study can be open while its sites in Switzerland have not opened yet or have stopped. Only those recruiting at a site in Switzerland →
Of the 132 Osteoporosis studies recruiting now, 76 (58%) set no upper age limit and 20 (15%) stop at 75 or younger; 9 take children under 18; 36 take healthy volunteers.
This study: 55 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
26 studies; the count open now beside each. This study's row is marked.
First in 2003; this study’s year is marked. 2 started in 2015.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 100 is above the median of 88 across 1,084 interventional studies indexed under Osteoporosis.
Median enrollment 149 across the 18 interventional studies, 358 across the 8 observational. Of the 22 that completed or were terminated, 5 (23%) have results posted.
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6 of 26 have an industry lead sponsor. The 10 most frequent:
University of Bern is the lead sponsor of 209 studies on the registry; 46 are open to participants now.
University of Bern has 1 study filed under Osteoporosis — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 26 studies in Osteoporosis with a site in Switzerland, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
Vertebroplasty itself is challenged regarding its clinical efficacy. While two randomized controlled trials (RCTs) with substantial methodological problems have led to an intense discussion another RCT with larger case numbers, more representative inclusion criteria and a more consistent and sound methodology has revealed results that mirror the investigators' own clinical experience. In their daily practice, the investigators have further advanced their treatment concept and routinely apply prophylactic augmentations with VP using an algorithm. Biomechanical studies support their approach, but clinical studies are rare so far. Prophylactic augmentation with balloon kyphoplasty has not shown convincing effects in a small pilot study. Given the above mentioned methodological and clinical disputes and the call for high-evidence studies about VP, the investigators aim at generating a reliable sample size calculation and preliminary results for a future multicenter RCT about prophylactic adjacent level augmentation with VP in single level osteoporotic compression fractures.
Background
Despite current academic debates percutaneous vertebroplasty (VP) has been convincingly used for the treatment of osteoporotic compression fractures all around the world. Polymethylmethacrylate bone cement is directly injected into a fractured vertebral body through one or two bone biopsy needles to stabilize the fracture fragments and to possibly improve the vertebral body height. The fracture pain represents a significant burden for the patients, limiting physical function, quality of life and increasing social isolation.
The immediate and clinically relevant pain alleviation after vertebroplasty does therefore have a large impact on patients' mobility, autonomy and quality of life.
The current state of the art in the treatment of acute osteoporotic vertebral compression fractures that are nonresponsive to conservative treatment is still augmentation of the fractures with VP or balloon kyphoplasty (BKP) given an intact posterior vertebral body wall. BKP is claimed to be saver by reducing the occurrence of cement leakages and more effective in reducing the fracture, i.e. reconstituting vertebral body height. While the first argument largely depends on the definition of an adverse event, i.e. is an asymptomatic radiologically visible cement leakage truly a complication, the second argument could not hold its promise since the regained vertebral body height is partially lost after balloon deflation. This problem is tackled by further developed BKP technologies like vertebral body stenting (VBS). From a cost-effectiveness perspective, VP is superior to conservative medical care and one can postulate that it is hence also more cost-effective than BKP which is a much more costly treatment option.In addition, it is the only prophylactic augmentation option that does not "destroy" intact unfractured bone structures by deployment of the balloon but does only augment them. It is hence the least aggressive augmentation option for prophylaxis.
Osteoporosis as the underlying disease leads to an increased risk of fractures of the adjacent vertebral bodies, with incidences up to 22% in the first year. After fracture augmentation new fractures in the spine can occur. This leads to reoperations in a frail population with high numbers of American Society of Anaesthesiologists (ASA) 3-4 patients. Any non-life-saving surgical intervention in these patients needs to be avoided. Therefore, prophylactic augmentation of the adjacent non-fractured vertebral bodies is a treatment option which is safe and may reduce reoperation rates. Since VP is currently under scientific and clinical scrutiny and calls for level-one-evidence become audible everywhere, the investigators plan to assess the hypothesis that prophylactic augmentation significantly decreases reoperation rates for adjacent new fractures with a randomized controlled trial.
Objective
The aim of the proposed study is to show the effect of preventive augmentations of adjacent vertebral bodies on 6 (12) months reoperation rates.
Subjects with an acute (\<= 6 weeks) single level osteoporotic compression fracture, meeting the inclusion criteria and having no exclusion criterion will be randomized to either single level fracture fixation with vertebroplasty or triple level augmentation with VP fixation of the fracture and additional prophylactic vertebroplasty in both adjacent levels. The hypothesis is that prophylactic VP augmentation of both adjacent vertebral bodies in acute single level osteoporotic compression fractures results in significantly lower reoperation rates for new spinal fractures within 6 months after surgery compared to isolated single level fracture fixation.
Methods
This is an open label mono-center randomized controlled pilot trial. Given the timeframe and budget of the study, the investigators aim at conducting a pilot trial for clinically verifying the sample size calculation in order to have a sound basis of information for planning a larger multicenter trial. The inclusion of primary cases will last for 12 months, the followup intervals for each case will be 2 and 6 months since the large majority of new fractures appears within that time window. 12 months followup will be conducted by mail/telephone interview. Preliminary calculation of results, i.e. a new corrected sample size will hence be carried out at the end of one and a half years. Two treatment groups will be compared:
Group 1: single level fracture fixation with vertebroplasty, Group 2: triple level augmentation with VP fixation of the fracture and additional prophylactic vertebroplasty in both the adjacent levels.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Single level fracture fixation with vertebroplasty
Procedure: Augmentation vertebroplasty
Triple level augmentation with VP fixation of the fracture and additional prophylactic vertebroplasty in both the adjacent levels
Procedure: Augmentation and prophylactic vertebroplasty
Cement augmentation of fractured vertebral body
Cement augmentation of fractured vertebral body and prophylactic augmentation of both adjacent vertebral bodies
Number of new operations within 6 months after vertebroplasty due to adjacent or distant segment fracture.
Measured by interview, clinical \& radiographic assessment
Time frame: 6 months after index surgery
Disease specific quality of life (COMI back form)
Measured by questionnaire
Time frame: 6 months after index surgery
General quality of life
Measured by questionnaire
Time frame: 6 months after index surgery
The record gives a start of Jan 2015, a primary completion of Feb 2022 and a completion of Feb 2022. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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