Saturday, September 16, 2006

Once-Yearly Treatment for Osteoporosis

Excellent news on the osteoporosis front:

An experimental treatment for bone-thinning osteoporosis appears to prevent spine and hip fractures even though it is given only once a year, eliminating the need for a strict daily pill regimen, preliminary data show.

Reclast, given as an annual, 15-minute infusion, reduced risk of new spine fractures by 70 percent and of hip fractures by 40 percent, according to data supplied by maker Novartis Pharmaceuticals Corp. The drug, chemically known as zoledronic acid, also reduced the risk of fractures elsewhere, according to a just-completed, international study of 7,736 postmenopausal women with osteoporosis.

Side effects* were generally minor and short-lived, said Novartis, of East Hanover, N.J.


Lead researcher Dennis Black, a professor of epidemiology at University of California-San Francisco, said that like Fosamax and other pills, Reclast slows down the speed at which cells called osteoclasts break down bone while other cells build it back up.

"If you take Fosamax every week for a year, you'll get a similar effect on bone density," Black said.

He noted that Reclast is part of a decade-long trend of researchers developing osteoporosis drugs taken less and less frequently: Some pills are taken only once a month, and one drug is available as a shot every three months.

Dr. Thomas Cavalieri, director of the New Jersey Institute for Successful Aging, said Reclast will be very significant, if approved, because many osteoporosis patients stop taking their medicine in the first year. One reason is that the pills can cause irritation and ulcers in the esophagus; to limit that, people must take them first thing on an empty stomach, with a large glass of water, then stay upright for 30 to 60 minutes.

That could make nursing home residents and patients with acid reflux disease, among others, good candidates for the shot.


Reclast is in the same category of osteoporosis drugs, bisphosphonates, as Fosamax from Merck & Co. of Whitehouse Station, N.J.; Actonel by Procter & Gamble Pharmaceuticals of Cincinnati; and Boniva from Hoffmann-La Roche Inc. of Nutley, N.J. Another drug, Forteo from Eli Lilly & Co. of Indianapolis, is a form of human parathyroid hormone and must be injected in the thigh or abdomen daily.

*From Novartis:

In the study, the overall incidence of adverse events experienced with Aclasta were comparable to placebo. The study included a careful examination of key safety parameters, including kidney and jaw safety, which found Aclasta to be comparable to placebo. The most common adverse events associated with intravenous infusion of Aclasta were the following post-dose symptoms: fever, muscle pain, flu-like symptoms, headache and bone pain. The majority of these occurred within the first three days following Aclasta administration and were resolved within the first three days of the event onset. The incidence decreased markedly with subsequent doses of Aclasta.


Aclasta is being studied in a series of multi-national and multi-centre clinical trials called HORIZON - one of the most comprehensive drug evaluation programs ever undertaken in the area of metabolic bone diseases. This clinical development program involves once-yearly dosing with Aclasta for osteoporosis. It also includes studies in the prevention of clinical fractures following a hip fracture in men and women, male osteoporosis, corticosteroid-induced osteoporosis, prevention of osteoporosis, treatment of Paget's disease of the bone, and treatment of osteogenesis imperfecta in children. Approximately 13,000 patients have participated in the ongoing HORIZON program in more than 400 trial centers worldwide.

Aclasta has been approved in approximately 50 countries , including the EU and Canada, for the treatment of Paget's disease. The FDA issued an "approvable letter" for this product, under the proposed trade name Reclast, for the treatment of Paget's disease of the bone in February 2006. The FDA requested additional data from the ongoing clinical trial program in osteoporosis. Novartis is working with the FDA to gain approval for this indication. Zoledronic acid, the active ingredient of Aclasta, is also available under the brand name Zometa for use in other indications.

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At 11:34 PM, Blogger #1 Dinosaur said...

Cool. I suppose it's the logical extension for bisphosphonate treatment (daily -> weekly -> monthly) and if it works I'll be thrilled, as will some patients. Then there are the rest, with whom the annual struggle is to get them to go for the mammogram.

At 6:43 PM, Anonymous Anonymous said...

I want the price of reclasta

At 8:24 AM, Anonymous Anonymous said...

ok this was print in any more new ?
news comments? is anybody try and want to talk about And yes what is the price of it ?
Big stuff more info , more expert opinions , ect...

At 11:50 AM, Anonymous Anonymous said...

A Total fan of this new treatment -well until they say to me in 3 years that it hasn't worked....

Any new development above a weekly tablet that very few of us can tolerate must be a huge advance

But I tell it like it is...........

Just had it - the yearly infusion dose that is - could not take the weekly bisphosphonate dose - well I could take it - just could not live with the hell that followed for 5 days with severe side effects, with one day left of ok'ish life before the next week of hell starts I didn't take it for more than a couple of months...

As a youngish (only just in my 50's) severe osteoporosis patient - I am still coming to terms with the shock that a very severe RTA back in 1987 which necessitated extended hospitalisation and rehabilitation has now caused this problem - my spine is in crumbly bits - Already lost 2" in my height - sadly not my waist! My hips are apparently not in much of a better state too....(I could have told you that with reference to how it takes me to get out of the bath, the car, ec etc...

So in my early 50's I look forward to 5 days out of 7 being hell for the rest of my life, or do I try for something different that may have some side effects - that I might be able to live with, or put up with, for a shorter timescale ... or do I take something that makes me ill...or do I take nothing at all?

(I have to point out that my pain/tolerance threshold is already very well trained/advanced and behaved after a serious RTA that resulted in my existing disabilities)

Well the nothing at all is the nicest immediate option - but not the sensible option.

The weekly option is NOT an option if you are employed in a Senior Management/Director role unless you have a huge insurance or retirement policy already active - I my case I don't have that safety cushion or the finances or even the wish to retire now. It's my bones not my brain cells that are crumbling!

So yearly infusions of Zolendronate could be my saviour - I don't know yet - only had the first one of 3 doses - It will take bone scans in 3 years time to know if it has really worked - this treatment in layman's terms works by blasting the nasty clasts (osteoclasts) and caressing the good guys (the osteoblasts) to allow them to make more bone instead - personally I think they called them the wrong names .... blast should be "get rid of" and clasts should be "make more" ...

I was warned of the side effects - I thought - I REALLY DON'T CARE HOW MUCH IT HURTS........... anything is better than what I have been through already...

Until I had the injection ....

I bravely thought - It's just an injection - I can work from home afterwards ......

Well before I even got home - and it was only 18 miles away - I had to stop driving after 3 miles - severe pain in my ankles - that eventually wore off, and I continued on my journey after an hour - had to stop again in a layby after another 10 miles - desperately tired.... got out the car - walked around it - legs felt like lead ....slept for a while - then got home.....

Tried to work - I answered e mails from colleagues and customers and took phone calls - pretended to be up beat and unaffected - actually was quite effective despite wanting to dive into a duvet -

Gave myself a deadline of 1800 hrs so I could duvet dive and ignore them all ... and dive & die I did for 3 days -

They said.....You might experience SOME side effects..... Bone Pain, Joint Pain, Tiredness, Headache, Nausea, Fever, Vomiting, Thirst, Skin Rash, Itching, Chest Pain, Confusion, Redness & Swelling at Infusion Site .............

WELL I DIDN'T GET...Skin Rash, Itching,Confusion, Redness & Swelling at Infusion Site ... ALL the rest of the side effects I got by the bucketload +....

Will I take it again?

Absolutely YES - just the hope that it might work and the relief of not having to go through a weekly hell has to be an improvement!

At 11:00 PM, Anonymous Anonymous said...

I have had no side affects with Fosomax, Actonel or Evista, but I am still losing bone density. Is it worth while for me to try Aclasta given all the painful side affects mentioned in the previous author's comments?

Maybe I have just been lucky having had no side affects so far.

Why does this treatment scare me while I took the other pills with little thought.

I am a healthy, active 64 year old and do not want to limit my activities such as skiing, curling, skating, golfing and baby sitting with a treatment that will affect me for a year. I have been on these drugs for 13 years now.

Worried... Looking for input...

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