Osteoporosis Treatment

Vertebroplasty Benefits Questioned in Recent Studies

cmaynard — Wed, 12 Aug 2009 08:59:45 -0700

August 13, 2009
by: Sylvia Marten

Recent studies have questioned the minimally-invasive spine surgery [url:1064,type=|term|,content=|vertebroplasty|], specifically noting that there was no apparent benefit from the procedure as compared to a simulated treatment that mimicked a vertebroplasty but lacked one key element.

Led by researchers from the Mayo Clinic, one study compared function and pain in patients who had [url:6027,type=|node|,content=|vertebroplasty surgery|] and a placebo group who had their backs numbed but did not receive an injection of the bone cement.

More specifically:

131 patients were randomly assigned to either a vertebroplasty or the simulated procedure in eight medical centers in the United States, United Kingdom and Australia
68 patients were treated with vertebroplasty
63 patients were given the simulated treatment.

According to the study’s findings as published in the New England Journal of Medicine, there was no difference between the treatments after one month: both groups experienced significant and similar reductions in disability and pain, making it impossible to declare a better treatment, and calling into question, at least according to some, the benefit of vertebroplasty.

While one researcher noted that the study isn’t saying that vertebroplasty is ineffective, it does raise the argument of whether the improvements are actually the result of sedation, local anesthesia or other factors as opposed to the injection of bone cement.

Other Research on Vertebroplasty Supports Mayo Study

The findings of the Mayo-led study coincided with the results of a separate study by the Australian government. In this study that was also recently published in the The New England Journal of Medicine:

78 patients with 1 or 2 unhealed vertebral fractures of less than 12 months in duration participated in the multi-centered study
38 of those patients underwent vertebroplasty
40 patients were placed in the control group.

The primary outcome of overall pain (on a scale of 1-10) was measured at 1 week and 3 and 6 months. According to the findings, both groups of patients experienced significant but similar improvements in pain; in other words, once again there was no major difference establishing one of the two treatments as being more beneficial.

Update: On Thursday, October 16, 2009, the North American Spine Society (NASS) issued a response to these two randomized controlled trials. After reviewing the studies, the NASS noted how it was not looking to discredit these studies or the integrity of their authors, but was rather interested in exploring the disconnect between the findings of these two studies and previous findings on vertebroplasty. Read the NASS response below:

Newly Released Vertebroplasty RCTs: A Tale of Two Trials.

What Do These Findings Reveal about Vertebroplasty?

A lot of opinions have been formed in the week since the release of the results from these first two studies to examine the effect of vertebroplasty. Some doctors have said that these independent studies reveal that vertebroplasty is not beneficial and should be performed only in clinical research trials designed to continue studying its effectiveness.

Other doctors have raised concerns about the vertebroplasty research, including the lack of willing participants, small patient sizes and a flaw in the study that allowed patients to crossover from one treatment to the other. Others have cited the need for more research beyond two trials.

Of course, the issue is an important one for several reasons:

An estimated 100,000 vertebroplasty procedures were performed last year in the United States, according to a Wall Street Journal story. While the risks of vertebroplasty (specifically, leaking bone cement leading to soft tissue damage, nerve pain and compression, pulmonary embolism, respiratory or cardiac failure, and/or even death) are extremely small, it would make no sense to expose patients to such risks if the benefits of the surgery did not outweigh them.
With 250,000 vertebral fractures diagnosed each year, it’s vital that patients are receiving and paying for care that is actually beneficial; the same goes for doctors in terms of performing and paying for vertebroplasty. According to the Wall Street Journal story, vertebroplasty can cost anywhere from $2,000 to $5,000.
Amidst the debate on health care reform, legislators will certainly be interested in the actual benefits of vertebroplasty (which is covered by Medicare) as they go back and forth on legislation. According to a doctor at Dartmouth in a Forbes article, Medicare paid for 40,000 vertebroplasty procedures last year at a price of roughly $3,000 each.

More Information:

[url:1614,type=|node|]
[url:930,type=|node|,content=|When Is Back Pain a Fracture?|]
[url:699,type=|node|,content=|Definitive Guide to Osteoporosis Fractures|]
[url:926,type=|node|,content=|What You Need to Know about Osteoporosis|]
[url:934,type=|node|,content=|4 Proven Steps to Prevent Osteoporosis Fractures|]
[url:15644,type=|node|,content=|Conservative Treatments for Osteoporosis and Surgery for Vertebral Fractures|]

Osteoporosis Needs to Be Treated after a Spine Fracture

Ben Parr — Thu, 23 Oct 2008 11:46:31 -0700

By: Stephanie Burke
October 23rd, 2008

More than 10 million Americans aged 50 and older suffer from osteoporosis, a degenerative bone disease caused by decreased bone density. Originally thought to be a women’s disease, it is now known that [url:933,type=|node|,content=|30% of sufferers are men|].

Osteoporosis is one of the leading causes of [url:930,type=|node|,content=|vertebral compression fractures|] (VCF), which will affect more than 50% of women and 30% of men during their lifetime. Oftentimes, doctors will treat the fracture without identifying or treating this underlying cause. A previous fracture is the greatest risk factor for a new fracture; studies show that the rate of refracture after osteoporosis-related vertebral fractures is 20% within the first year. This underscores the need for timely diagnosis and treatment.

A retrospective study was conducted in which the 2002 medical records of 156 patients (average age: 77.3) were obtained from a large military health-care system. All patients sampled were 50 years or older and had previously sustained a vertebral compression fracture. The purpose of the study was to determine the proportion of patients followed up with osteoporosis interventions within one year of being treated for their [url:930,type=|node|,content=|spine fracture|].

Overall, The Percentage of Patients Receiving Osteoporosis Treatment is Low

The study found that one year after sustaining a vertebral compression fracture, a relatively low percentage of patients were being [url:924,type=|node|,content=|treated for osteoporosis|] - the underlying cause of the fracture.

28% (vs. 6-7 previously) of patients not previously being treated for osteoporosis were started on a new active osteoporosis medication
35% (vs. 15% previously) were started on any new medication for the treatment of osteoporosis

While this study demonstrates a general trend toward increased diagnosis and treatment, these numbers are still less than ideal.

Osteoporosis Undertreated in Men

Another finding was that significantly lower rates of interventions were prescribed to males who had sustained an osteoporosis-related spine fracture. The risk of subsequent fractures, especially in the spine, is almost double in males than females, suggesting that osteoporosis treatment after a vertebral compression fracture is even more critical in males.

Posted by: Stephanie Burke

Source: The Spine Journal, September/October 2008. Official Journal of the North American Spine Journal

Additional Reading:

[url:930,type=|node|]

When is Back Pain a Fracture?

spine-health — Tue, 11 Dec 2007 21:32:53 -0800

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Definitive Guide to Osteoporosis

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Osteoporosis is a thinning of the bones that causes them to become porous and fragile. It affects women more than men, is associated with aging, and progresses more rapidly after menopause. The good news is that osteoporosis is largely preventable and treatable.
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The Spinous Process and Vertebral Fractures

Ben Parr — Sun, 01 Mar 2009 09:49:52 -0800

A physician answers patient questions about a fracture of the spinous process.

Question: What could happen if I don't undergo surgery for a fracture?

On June 20, 2002, I suffered a fracture of my C-7 vertebrae by doing a somersault on a hard surface. I have seen a neurosurgeon who says we will play the “wait and see game.” I pretty much have broken off the whole spinal process and have some ligament damage.
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Kyphoplasty Surgery and Back Pain Relief

Ben Parr — Sun, 01 Mar 2009 09:49:47 -0800

A physician answers patient questions about kyphoplasty for back pain relief.

Question: Kyphoplasty for permanent pain relief

I had a laminectomy 11 years ago, which seemed successful at the time. The surgery lasted many years (6 or 7) and now pain has emerged, suspected cause is pressure at the S-I joint. I have had many years of injections into the joint with minimal short term relief.
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Kyphoplasty and Vertebroplasty for Spinal Fractures

Ben Parr — Sun, 01 Mar 2009 09:48:38 -0800

A physician answers patient questions about the effectiveness of kyphoplasty and vertebroplasty.

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What is the difference between kyphoplasty and vertebroplasty with respect to the time limitations on the effectiveness of the treatments from the time of the bone fracture?
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Spine Fracture Treatment Options

Ben Parr — Wed, 17 Dec 2008 13:53:47 -0800

Treatment Options for a Spine Fracture

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Ben Parr — Wed, 10 Sep 2008 09:08:30 -0700

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Osteoporosis: Diagnosis and Treatment of Painful Spine Fractures

spine-health — Thu, 24 Jan 2008 13:43:45 -0800

Dr. Jeffrey Spivak discusses sudden onset of acute or severe back pain and when you should be concerned that the new pain is related to or caused by a spinal fracture. He makes recommendations about how long to wait before seeing a doctor, and what kinds of tests should be performed once you do go to your physician. In the second video, he discusses treatment options once you have been diagnosed with a spinal fracture.
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Kyphoplasty

spine-health — Fri, 04 Jan 2008 07:53:04 -0800

Definition

A surgical procedure that expands and stabilizes compression fractures of the spine.

During kyphoplasty, a balloon device is introduced into the spine and inflated to expand the bone. The cavity created by the balloon is then filled with a bone cement mixture. With this process completed, an internal cast is formed inside the vertebral body with the goals of reducing pain, stabilizing a damaged area and/or restoring lost height in the vertebral body.
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Kyphoplasty: Osteoporosis Fracture Treatment

spine-health — Thu, 03 Jan 2008 11:19:43 -0800

Kyphoplasty is a minimally invasive surgical procedure used for treating vertebral fractures resulting from osteoporosis. This interactive video takes you step by step through kyphoplasty spine surgery.
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Osteoporosis Medications

spine-health — Mon, 17 Dec 2007 08:42:12 -0800

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Sources of Calcium in Food

spine-health — Mon, 17 Dec 2007 08:42:12 -0800

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Preserving Bone Density

spine-health — Mon, 17 Dec 2007 08:42:11 -0800

After puberty, bone growth ends but bone density increases until roughly age 30. Absorption and retention of calcium decreases while calcium losses increase, leaving a requirement that is estimated to be 1000 mg/day.

The drainage of calcium from bone occurs in all humans at a steady pace, but women are clearly more at risk for losses. Variability in calcium loss is best seen in pregnancy when calcium is taken from the mother’s stores for deposition in the fetus. Also, lactation creates an ongoing need for further calcium supplementation in women.
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Vertebroplasty and Kyphoplasty: Percutaneous Injection Procedures for Vertebral Fractures

spine-health — Wed, 12 Dec 2007 00:03:20 -0800

On This Page:

Vertebroplasty

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Kyphoplasty Considerations and Alternatives

spine-health — Wed, 12 Dec 2007 00:03:19 -0800

Timing of Kyphoplasty surgery

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Back/Neck Surgery Intro

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Kyphoplasty for Vertebral Compression Fractures

spine-health — Wed, 12 Dec 2007 00:03:19 -0800

Kyphoplasty overview
Kyphoplasty is an elective surgery designed to achieve three main goals in patients suffering from painful vertebral compression fractures:
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Pain Relief After a Vertebral Compression Fracture

spine-health — Wed, 12 Dec 2007 00:03:14 -0800

Kyphoplasty for spine fractures

When a painful fracture from osteoporosis occurs in the spine, kyphoplasty is a treatment option designed to help reduce or eliminate the pain, restore height of the vertebral body and reduce spinal deformity. Vertebral compression fractures from osteoporosis are quite common, occurring in approximately twenty percent of women over the age of seventy years old.
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Mr. WW’s Kyphoplasty Procedure

spine-health — Wed, 12 Dec 2007 00:03:13 -0800

Mr. WW had an extensive history of medical problems, including high blood pressure, severe coronary artery (heart) disease and a seizure disorder, so he was felt to be at high risk for general anesthesia and thus local anesthesia was employed during the kyphoplasty procedure as the sole pain-numbing agent.
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Description of Kyphoplasty Surgery

spine-health — Wed, 12 Dec 2007 00:03:13 -0800
The goals of the kyphoplasty surgical procedure are designed to stop the pain caused by a spinal fracture, to stabilize the bone, and to restore some or all of the lost vertebral body height due to the compression fracture.

During kyphoplasty surgery, a small incision is made in the back through which the doctor places a narrow tube.
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Vertebral Fracture Treated with Kyphoplasty: Case Review

spine-health — Wed, 12 Dec 2007 00:03:13 -0800

The following set of images outlines one patient's experience with the use of kyphoplasty to treat a vertebral compression fracture.
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Kyphoplasty for an Osteoporosis Fracture

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Osteoporosis: 4 Proven Steps to Prevent Osteoporosis Fractures

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What is Osteoporosis?

spine-health — Tue, 11 Dec 2007 21:32:53 -0800

As defined by the World Health Organization, osteoporosis is a generalized skeletal disorder of low bone mass (thinning of the bone) and deterioration in its architecture, causing susceptibility to fracture.

There are two types of osteoporosis:
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Monitoring Osteoporosis

spine-health — Tue, 11 Dec 2007 21:32:53 -0800

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Diagnosing Vertebral Compression Fractures

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Stopping Smoking, Alcohol Abuse

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Osteoporosis Fracture - Patients' Advice

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Patients share tips on experiences with spinal fractures

Osteoporosis fractures keep my back in pain

I had a sore back which kept getting worse. My doctor prescribed a physiotherapist, several times a week. My back seemed to feel worse, I was diagnosed with osteoporosis after my yearly checkup in May of 2007 and I had lost an inch in height, so she sent me to get a bone density test, and an x-ray, showed I had already had fractures that were healing and more recent ones. My doc put me on didrocal right away.
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