osphos | Horse Racing Free Tips

New Test Can Detect Bisphosphonate Three Years After Administration

A new study may give regulators the key to better regulate bisphosphonate use in racing. Controversy has surrounded bisphosphonate use since the drug became approved by the Food and Drug Administration (FDA) for use in horses. Bisphosphonates are labeled for adult horses battling navicular syndrome and similar chronic conditions that don't respond to other types of treatment.

The FDA has licensed two bisphosphonates, which are sold under the trade names Tildren and Osphos. The Horse reports that there are other, non-licensed versions of bisphosphonates marketed for horses which are not FDA-approved. Those non-approved products are advertised as being more powerful than the two approved versions.

The FDA prohibits the use of bisphosphonates in horses younger than four years old, but some owners and trainers continue to use the product off-label on young horses. Bisphosphonates impact the build-up/breakdown cycle in bone, which veterinarians say could have negative effects on growing animals.

Dr. Christopher Riggs, chief advisor in veterinary science at The Hong Kong Jockey Club, studied 24 Thoroughbreds who had received a single therapeutic dose of tiludronate disodium between one month to three years earlier. The research team then tested blood plasma and urine samples using ultra‐high‐performance liquid chromatography high‐resolution mass spectrometry, a new testing technology. The tests found traces of tiludronate disodium in every sample.

Previously, testing was only able to detect bisphosphonates in equine blood or urine if it had been administered in the last 40 days. Hair testing could detect an administration from months prior, but is limited in its ability to pinpoint the time of administration.

Researchers believe the drug lingers on the surface of bone, occasionally releasing back into the horse's body for months or years, but little is known about how long that effect could go on. The drug may be more detectable in horses that are going through training and rest periods that affect bone remodeling.

Sadler Faces Class 1 Drug Complaint After Flagstaff Tests Positive For Bisphosphonate

The California Horse Racing Board has filed a complaint against trainer John Sadler after graded stakes winner Flagstaff tested positive for clodronic acid, a bisphosphonate sold under the brand name Osphos, following a second-place finish in the Grade 2 Santa Anita Sprint Championship Stakes Sept. 27, 2020, at Santa Anita Park in Arcadia, Calif. A split sample confirmed the presence of the drug.

Flagstaff, a now 7-year-old gelding by Speightstown, is owned by Lane's End Racing and Hronis Racing LLC. He recently scored his first G1 victory in the Churchill Downs Stakes on Kentucky Derby day at Churchill Downs.

Because clodronic acid is not included on the CHRB's current list of prohibited substances, under the regulatory body's rules it automatically falls under the most severe drug category, Class 1. A medication classification proposal working its way through the CHRB's approval process recommends classifying clodronate (clodronic acid) as Class 3, but in the A penalty category.

Proposed amendments for medication violations require a one-year suspension absent mitigating circumstances along with a minimum fine of $10,000 for Category A penalties. Owners face loss of purse and potential placement of a horse on the vet's list for up to 90 days.

Complicating Sadler's status is the fact he is on probation as part of a settlement agreement issued in June 2020 for three medication violations from April and May 2019. Sadler received a 60-day suspension, but 45 days of the ban were stayed provided he have no Class 1, 2 or 3 violations during a probationary period that ends June 28, 2021.

Bisphosphonates are a class of drug approved by the FDA in 2014 and prescribed to prevent bone loss in people and to treat navicular syndrome in horses, a common cause of forelimb lameness. The drug is not approved for horses less than four years old.

Equine surgeon Dr. Larry Bramlage of Rood & Riddle warned about the use of bisphosphonates Osphos and Tildren in young horses during a client education seminar in 2018, saying the drug can have unintended, detrimental side effects. Many racing states moved to ban the drugs.

The CHRB banned bisphosphonates effective July 1, 2020, saying that any horse administered the drug in the previous six months – effectively a cutoff date of Jan. 1, 2020 – was prohibited from stabling on CHRB regulated grounds.

Sadler referred questions to attorney Darrell Vienna, who said Flagstaff was legally treated with Osphos on an unspecified date “late in 2019” when Flagstaff was 5 years old.

Vienna cited the extended half life of Osphos as an explanation for the positive test, saying it can linger in a horse's system for many months or even longer than a year.

Sadler, whose best horses include 3-year-old filly champion Stellar Wind and Horse of the Year Accelerate, is the trainer of this year's G1 Santa Anita Derby winner Rock Your World, a prospective starter in the G1 Belmont Stakes on June 5.

The complaint against Sadler was ordered on April 28 but not published on the CHRB's website until Wednesday, May 26. No hearing date has been set at this time.

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Sadler’s Flagstaff Tests Positive for Biphosphonate

The John Sadler-trained Flagstaff (Speightstown) tested positive for Clodronic Acid, a bisphosphonate otherwise known as Osphos, after finishing second at Santa Anita Sept. 27 last year, according to a California Horse Racing Board (CHRB) complaint.

As per the complaint, dated Mar. 24, an Osphos positive is a Class 1, Category A penalty. A split sample confirmed the original finding, the complaint states.

Sadler is currently on a year's probation in accordance with a settlement agreement and mutual release with the CHRB, as part of which Sadler was fined $15,000 and handed a 60-day suspension–45 days of which were stayed–for three medication violations dating from 2019.

The suspension ran June 29 through June 13 last year. The year-long probation period ends June 28, 2021.

As stated in the agreement, “If John Sadler violates the terms of his probation, the 45 days of stayed suspension shall be imposed following a noticed hearing.”

Sadler referred the TDN to his attorney, Darrell Vienna, who pointed out that Osphos is listed a Class 1 drug because it's unclassified in California at the moment, but is currently going through the administrative process of being classified a Class 3 medication.

Vienna said that it was his understanding Flagstaff was administered Osphos in late 2019, but that due to an extremely slow rate of elimination in a horse's system–sometimes years–Osphos showed up in last year's test.

“I don't think anything in the report shows any evidence of misfeasance or malfeasance by Sadler,” said Vienna. “This isn't him denying the administration. It's a case of the administration being completely legal at the time. The finding is a result of the pharmacology of the substance, not of any wrongdoing.”

Since the settlement agreement was inked last year, Sadler has been fined $1000 and $1500 accordingly for two positive findings related to timed workouts.

The post Sadler’s Flagstaff Tests Positive for Biphosphonate appeared first on TDN | Thoroughbred Daily News | Horse Racing News, Results and Video | Thoroughbred Breeding and Auctions.

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California Horse Racing Board Issues Bisphosphonate Complaint Against Jeff Metz

The California Horse Racing Board issued a complaint against trainer Jeff Metz last week over a finding of bisphosphonates in the Sept. 27, 2020 post-race sample of the gelding Camino De Estrella, reports the Daily Racing Form. The drugs are not yet specifically classified in California, so the positive is being adjudicated under the “prohibited substances” rule with a Class 1, Category A penalty.

However, Metz's attorney Darrell Vienna believes the trainer will be exonerated. Popular at the claim box, Camino de Estrella has been in the care of five different trainers since 2019, including Tim Yakteen, Mark Glatt, Steve Knapp, Metz, and most recently Bill Spawr.

“There is a record of a veterinarian administering the drug when he was not in Mr. Metz's care, in 2019,” Vienna told DRF. “I can say with certainty that Jeff never administered bisphosphonates to that horse. We're confident that the truth will come out, because we think the CHRB already knows the truth.”

Bisphosphonates were approved for equine use in the United States approximately six years ago, to treat horses with symptoms of navicular syndrome, a common, nagging foot pain in older horses. Before the drugs were approved for horses in the U.S., they were used in Europe and veterinarians could legally import them to treat American horses. Having them available to American practitioners who perhaps couldn't previously afford the import process has made a world of difference to mature horses dealing with navicular syndrome – and there are a lot of them. Roughly a third of chronic front leg lamenesses are believed to be related to navicular pain. Generally, bisphosphonates have been safe and effective in the population they're intended for.

Bisphosphonates (sold commercially as Osphos and Tildren) are FDA-approved in horses four years old and up, and are not approved for use in mares who are pregnant or lactating. The reason for those restrictions is unanswered questions about potential side effects. Bisphosphonates do their work by reducing the action of cells called osteoclasts, which clear away damaged bone and make way for osteoblasts to lay down new bone. In a young equine skeleton, this could disrupt the growth cycle.

The CHRB did prohibit the administration of bisphosphonates beginning July 1, 2020, via rule 1867.1, which also prohibits any horse from entering CHRB grounds that has been administered the drug within six months.

Since Camino de Estrella would have been five years old in 2019, administration of a bisphosphonate was legal at that time only if the gelding had a diagnosis of navicular disease.

Vienna argued that “the available science on bisphosphonates clearly demonstrates that the drug can be found more than 2 1/2 years after the drugs have been administered, due to their unique ability to lie dormant in bone but become 'active' in the horse's circulatory system when bone is in need of repair.”