Pamidronate infusion timing in Charcot Rx

nicpod1 · Dec 15, 2005

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Within my Diabetic foot team, we tend to infuse Pamidronate asap at the same time as immobilisation upon detection of an acute Charcot.

However, after chatting to a member of a local Orthopaedic team recently, they have been using the osteopaenia that comes with the Charcot to their advantage by casting the foot and ankle (normal 'serial' type casting) with the Charcot still active until they acheive a 'good' position. I don't even think they use Pamidronate.

This 'moulding' whilst the process is still active would seem to me to make a lot of sense and if you infused with Pamidronate only once the foot/ankle was in a good position, this would seem perfect!?

I haven't done a lit. search on this yet, but if anyone had any evidence-based rationale for timing of Pamidronate infusion or has had similarly good results with 'moulding', I'd be pleased to hear!

Thanks all!

Armstrong · Dec 15, 2005

Charcot and bisphosphonates

Dear Nicpod:

While the use of a bisphosphonate like pamidronate makes some degree of sense in the early stages of Charcot, there are few data to identify when or if it has significant benefit. Recent discussions surrounding modulation of another pathway, this one involving osteoprotegerin (OPG) and RANK-L, might prove more therapeutically beneficial. The best potential pharmaceutical candidate presently available for this is intranasal calcitonin. If you want a bit more on this, I would direct you to:

Jeffcoate, W. (2004). Vascular calcification and osteolysis in diabetic neuropathy-is RANK-L the missing link? Diabetologia, 47(9), 1488-1492.

Jeffcoate WJ, Game F, Cavanagh PR The role of proinflammatory cytokines in the cause of neuropathic osteoarthropathy (acute Charcot foot) in diabetes. Lancet. 366(9502):2058-61, 2005 Dec 10.

Cheers,

-DGA

David G. Armstrong, DPM, PhD
Chicago, IL, USA

Michael Bilinsky · Dec 17, 2005

Bisphosponate drugs including, Zometa, Aredia & Fosamax , plus others are quite helpful, if the patient doesn't get "Dead Jaw" Osteonecrosis of the jaw and potentially affecting other joints. It has been reported by the International Multiple Myeloma Foundation that 1+/10 will get the condition and it is devastating to the patient's life. Much worse than the underlying condition. Read the articles on mpowelllaw.com and decide if you are comfortable prescribing these medications.
Michael Bilinsky D.P.M

nicpod1 · Dec 20, 2005

Thank you Michael and David,

It would certainly seem that intranasal calcitonin would be a better arrangement, purely from a delivery point of view more than anything else as it takes 3-4 hours to inffuse the Pamidronate and it has to be done as a day-case appointment, incurring a waiting list of sorts!

As I am a Podiatrist in the UK, I do not prescribe this drug myself, rather the Consultant Diabetologists within the team instigate it. I have to say, it is used on all active Charcot (we probably see between 1 and 3 every month), but there has been no lock-jaw and the BNF (British National Formulary) does not list it as a complication (though it does have associated complications like myalgia etc), but I will look on the website for more info!

Have either of you had experience of serial casting the foot/ankle into a 'better' position whilst the Charcot is still active and before trying to stabilise the bone pharmacologically?

Many thanks for your help!

NewsBot · Dec 1, 2007

Michael Bilinsky said: ↑

quite helpful, if the patient doesn't get "Dead Jaw" Osteonecrosis of the jaw and potentially affecting other joints.
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Thats now the subject of litigation:

CTV.ca are reporting:
Fosamax users seek class-action status

Lawyers for Fosamax users who believe their jaws were damaged by the osteoporosis drug on Friday asked a federal judge to order Merck & Co. to provide a dental monitoring program for the drug's users.

The lawyers made the suggestion to U.S. District Judge John F. Keenan as they argued for the case to be certified as a class-action, in order to pursue claims by users who believe the drug caused osteonecrosis of the jaw, a condition in which portions of the jaw bone die, sometimes leaving the bone exposed.

Timothy M. O'Brien, a lawyer for plaintiffs, said hundreds of thousands of patients would benefit from a dental monitoring program that would include regular dental screenings, X-rays and lab tests, all aimed at preventing the need for dental surgery.

Paul Strain, a Merck attorney, called Fosamax a "life altering and life saving drug" that helps to prevent the kind of bone fractures that can hasten the deaths of people as they age. He said the drug was a pioneer 11 years ago.

Strain also said there was no proven link between degeneration of the jaw bone in some patients and Fosamax.

Damage to the jaw bone can result in many ways, including from using steroids, from diseases or weaknesses in the body and from poor dental hygiene.

O'Brien said as many as one in every 296 patients who use Fosamax develop the severe damage to the jaw, though Merck disputed the figure. O'Brien said jaws were more susceptible to damage because they are used so frequently and are under greater stress than most bones.

Keenan did not immediately rule after hearing arguments.

Vance Andrus, another lawyer for the plaintiffs, argued a class-action certification would allow for a trial where a jury could decide whether Fosamax is toxic and hazardous and whether Merck was negligent and should have warned users of dangers.
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Full story

NewsBot · Jan 8, 2008

The FDA have just issued this warning:
Information for Healthcare Professionals
Bisphosphonates (marketed as Actonel, Actonel+Ca, Aredia, Boniva, Didronel, Fosamax, Fosamax+D, Reclast, Skelid, and Zometa)

FDA ALERT [1/7/2008]: FDA is highlighting the possibility of severe and sometimes incapacitating bone, joint, and/or muscle (musculoskeletal) pain in patients taking bisphosphonates. Although severe musculoskeletal pain is included in the prescribing information for all bisphosphonates, the association between bisphosphonates and severe musculoskeletal pain may be overlooked by healthcare professionals, delaying diagnosis, prolonging pain and/or impairment, and necessitating the use of analgesics.

The severe musculoskeletal pain may occur within days, months, or years after starting a bisphosphonate. Some patients have reported complete relief of symptoms after discontinuing the bisphosphonate, whereas others have reported slow or incomplete resolution. The risk factors for and incidence of severe musculoskeletal pain associated with bisphosphonates are unknown.

This severe musculoskeletal pain is in contrast to the acute phase response characterized by fever, chills, bone pain, myalgias, and arthralgias that sometimes accompanies initial administration of intravenous bisphosphonates and may occur with initial exposure to once-weekly or once-monthly doses of oral bisphosphonates. The symptoms related to the acute phase response tend to resolve within several days with continued drug use.

Healthcare professionals should consider whether bisphosphonate use might be responsible for severe musculoskeletal pain in patients who present with these symptoms and consider temporary or permanent discontinuation of the drug.
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NewsBot · Jun 19, 2013

A comparative study of zoledronic acid and once weekly Alendronate in the management of acute Charcot arthropathy of foot in patients with diabetes mellitus.
Bharath R, Bal A, Sundaram S, Unnikrishnan AG, Praveen VP, Bhavani N, Nair V, Jayakumar RV, Kumar H.
Indian J Endocrinol Metab. 2013 Jan;17(1):110-6

AIM:
The aim of this study was to assess and compare the response to two forms of treatment-immobilization with zoledronic acid injection and immobilization with oral weekly Alendronate, in patients with diabetes mellitus and acute Charcot arthropathy (CA) of foot in terms of clinical and radiological parameters.
MATERIAL AND METHODS:
Patients attending the endocrinology and podiatry clinic with history of diabetes mellitus and Acute CA were taken for study. The patients were randomized into two treatment groups. Group Z-zoledronic acid injection along with total contact cast (TCC). Group A-Tab. Alendronate 70 mg. once a week till the complete clinical resolution of acute CA along with TCC. Forty-five patients were randomized and 40 of them completed the study. The primary end point was complete clinical resolution of acute CA-defined as temperature difference between normal and affected foot <1°F.
RESULTS:
Among the 40 patients, 30 (75%) had complete clinical resolution. The mean number of days taken for complete clinical resolution since the initiation of treatment (either Zoledronic acid or Alendronate) was approximately 122 days. There was no significant difference in a number of days required for complete clinical resolution, between the two forms of therapy. There was more than 50% reduction in the visual score between the baseline and the final scan. The target to non-target ratio in the skeletal phase also showed an average of 40% reduction from the baseline to the final skeletal scintigraphy.
CONCLUSION:
Both Intravenous Zoledronic acid and oral alendronate had comparable efficacy with respect to the time taken for attaining complete clinical resolution of acute CA of foot. However, Alendronate therapy was cost effective among the two. (99m)Tc MDP bone scan can be used as an adjuvant to the clinical parameters in assessing the response to therapy.
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NewsBot · Aug 8, 2018

Role of bisphosphonates in the management of acute Charcot foot.
Durgia H et al
World J Diabetes. 2018 Jul 15;9(7):115-126.

Diabetes mellitus is the most common cause of Charcot neuropathy affecting foot and ankle. Acute Charcot foot (CF) presents with a red and swollen foot in contrast to the painless deformed one of chronic CF. Enhanced osteoclastogenesis plays a central role in the pathogenesis of acute CF. Many studies have shown elevated levels of bone turnover markers in patients with acute CF confirming it. These findings have led clinicians to use anti-resorptive agents [bisphosphonates (BP), calcitonin, and denosumab] along with immobilization and offloading in acute CF patients. The maximum evidence among all anti-resorptive agents is available for BPs, although its quality is low. Pamidronate has been shown to reduce the markers of activity of CF like raised skin temperature, pain, edema, and bone turnover markers in the majority of studies. Intravenous BPs are known to cause acute phase reactions leading to flu-like illness following their first infusion, which can be ameliorated by oral acetaminophen. Alendronate is the only oral BP used in these patients. It needs to be taken on an empty stomach with a full glass of water to avoid esophagitis. The side-effects and contraindications to BPs should be kept in mind while treating acute CF patients with them.
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