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Bisphosphonate risks cannot be ignored

- Irish Medical Times

07/24/2011 - In the US, there are an estimated 14 million patients taking oral bisphosphonates for osteoporosis or off-label for osteopoenia.

Alendronate (mostly as Fosamax) has caused 96 per cent of the bisphosphonate- induced osteonecrosis of the jaws (BIONJ) known to Prof Robert E Marx, from the Miller School of Medicine in Miami, and this is primarily because of dosing.

Oral and intravenous bisphosphonate treatment precludes extractions or implant treatment for years — or, more likely, indefinitely — after treatment, as the half-life of these drugs in the bones is over 11 years.

This important, comprehensive, graphic publication has great clarity, showing that bisphosphonate-induced osteonecrosis is the same disease as ‘phossy jaw’, which was mentioned in the British Medical Journal as far back as 1899, which was due to heated vapour phosphate exposure in the matchstick industry.

The preface to both the first and second edition of this book is a compelling read, where the realities of complications related to bisphosphonate treatments are uncovered, along with the lessons learned late from relying on too short a timeframe in drug trials for complications to surface.

Zoledronate (Zometa) taken intravenously in the treatment of metastatic bone disease and alendronate (Fosamax) taken orally for the treatment of osteoporosis are singled out as the most toxic and these are documented to produce the vast majority of BIONJ.
Orthopaedic surgeons are seeing spontaneous and/or low-energy femur fractures related to long-term (even over years) use of alendronate (mostly as Fosamax).

Alendronate

Prof Marx shows a case of atypical fracture of the femur caused by extended use of alendronate. Prednisolone increases the toxicity of bisphosphonates and those with steroid-induced osteoporosis are at greater risk of developing osteonecrosis.

The action and pharmacokinetics of the bisphosphonate family is clearly explained and how intravenous and/or oral doses of bisphosphonate accumulate in the bone matrix. Osteoclasts that resorb bone containing a bisphosphonate ingest the bisphosphonate that causes osteoclast cell death.

Hypermineralisation is seen with bisphosphonate toxicity as sclerosis of the lamina dura, followed by more generalised osteosclerosis in the alveolar bone.

Dental radiographs

A dental periapical radiograph may clearly show sclerosis of the lamina dura.
An example is shown in a patient treated for osteoporosis with an oral bisphosphonate for four years.

Widening of the periodontal ligament space, tooth mobility unrelated to alveolar bone loss and deep bone pain without an apparent dental aetiology are signs of significant bisphosphonate bone toxicity.

Prof Marx refers to Dixon et al, who documented that the remodelling rate of alveolar bone is, for instance, many times that of the tibia and similarly the mandible, which accounts for the higher uptake of bisphosphonates in the alveolar bone and mandible — the main sites of pathology associated with bisphosphonate-induced osteonecrosis. In other words, the jaws get an overdose of bisphosphonates.

Spontaneous bone exposure related to oral bisphosphonates (triggered by occlusal forces axially loading), particularly in the lingual cortex in the molar regions, accounts for more than 50 per cent of cases and this cannot be prevented, even with the best dental care.

BIONJ has 10 times the incidence of that in femurs and vertebral bones.
After bisphosphonate accumulation, the lamina dura cannot remodel as normal and becomes sclerosed. If trauma such as tooth extraction occurs, instead of new bone forming, it becomes necrotic. Root canal treatment and crown amputation are a better option.

Where teeth are mobile grade 1 or 2, splinting is preferable. Edentulous areas under dentures may also develop bisphosphonate-induced osteonecrosis.
Prof Marx advises practitioners (medical and dental) to not only note the fact that a patient has had treatment with bisphosphonates but the dose, duration, frequency and mode of intake of treatment — as well as a note of steroid or methotrexate treatment at the same time as bisphosphonates.

Prof Marx advises, “Medical oncologists would be well advised to refer all patients who have indications for bisphosphonate therapy to an experienced dentist for an urgent examination to achieve optimum dental health.”

Trigger events

Any dental procedure that increases the demand for bone renewal in the jaws — such as periodontal disease, dental abscesses, and traumatic occlusion;
Invasive dental procedures, extractions, implant placement, periodontal surgery, apicetomy etc;

Edentulous areas under dentures may also develop BIONJ due to the occlusal pressure causing remodelling of the alveolar crest;

Established osteonecrosis is best referred to an oral and maxillofacial surgeon.
Prof Marx recommends a treatment schedule that is specific to the clinical stage of the osteonecrosis.

Discontinuation of the oral bisphosphonate may lead to gradual improvement and even spontaneous healing of exposed bone responsive to local debridement after 6-12 months and the CTX C-terminal cross-linking telopeptide value increases, reducing the risk of ONJ. CTX is an index of osteoclast function.

Prof Marx has treated 238 cases of bisphosphonate-induced osteonecrosis of the jaw to date and presents in some detail 16 case studies most representative of the spectrum of patients seen.

Although most cases of osteonecrosis of the jaw related to Fosamax Side Effects have occurred after dental work several cases have been reported to occur without any prior dental work. If you are currently taking Fosamax you may be at risk of developing osteonecrosis. If you have been injured by Fosamax side effects such as ONJ or femur/thigh fractures you may be entitled to compensation. For more information about your legal rights contact the Fosamax Attorneys of Ennis & Ennis, P.A. today. If you or a loved one have experienced low energy femur fracture due to the use of Foasamax, call the Foasamax attorneys of Ennis & Ennis, P.A. today or fill out our free case evaluation form on this page.