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Tymlos safety with long-term use

Posted by 2024tymloshelp @2024tymloshelp, Jun 28 10:26am

I have been on Tymlos for almost a year . I will have a dexa In September - the 12 month mark to see how things are going.
Questions :
1) Should I expect to see good bone changes after 12 months of Tymlos or does it take longer to have an effect ? ( I know the norm Tymlos duration is 18 mos. )
2) do we have any data about Tymlos risk of osteosarcoma in humans ? I know they say it’s a risk but since it’s a new drug do we know if so far if ANY humans have gotten osteosarcoma from Tymlos?

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njx58 | @njx58 | Jun 28 11:47am

After nine months on Tymlos, I gained 15% bone density, and my T-score went from -3.0 to -2.0 (which is osteopenia.)

My understanding is that some rats who got high doses developed osteosarcoma, but the same has not been seen in humans (who don't get high doses, and are limited to two years max.)

I believe the black box warning was removed a few years ago.

Someone on another site had this explanation (which predates the black box removal):

"Here is the story behind the box warning with Tymlos and Forteo. Both agents are anabolic therapies, that is, they speed up the bone remodeling cycle. In the late 1990’s Lilly was conducting a fracture trial with Forteo vs. placebo in humans. At the same time, Lilly was continuing its research in animal models. The FDA asked Lilly to conduct a study in rats to determine if, at high doses, what are the effects of an anabolic on the risk of osteosarcoma? The results were that Forteo increased the incidence of osteosarcoma in the rat model compared to a control group. When this report was published, the FDA instructed Lilly to stop their fracture trial at month 20 of the 24 month trial. The FDA approved Forteo with the box warning, and a two year limitation of use. When Radius sought approval for Tymlos, the FDA instructed that the same rat model trial be conducted. They did, and got the same results, and the same box warning. Back in the late 1990’s the FDA required Lilly to establish an osteosarcoma registry for any human cases that occurred. None occurred. In 2016 the FDA told Lilly they can shut the registry down. And in 2016, when Tymlos was approved, that no registry was necessary. In 2020 the box warning was removed from the label for Forteo. In time, it will probably be remvoed for Tymlos. There is no evidence that Forteo (or Tymos) cause osteosarcoma in humans."

REPLY
1 reply
2024tymloshelp | @2024tymloshelp | Jun 28 12:41pm
In reply to @njx58 "After nine months on Tymlos, I gained 15% bone density, and my T-score went from -3.0..." + (show)
@njx58

After nine months on Tymlos, I gained 15% bone density, and my T-score went from -3.0 to -2.0 (which is osteopenia.)

My understanding is that some rats who got high doses developed osteosarcoma, but the same has not been seen in humans (who don't get high doses, and are limited to two years max.)

I believe the black box warning was removed a few years ago.

Someone on another site had this explanation (which predates the black box removal):

"Here is the story behind the box warning with Tymlos and Forteo. Both agents are anabolic therapies, that is, they speed up the bone remodeling cycle. In the late 1990’s Lilly was conducting a fracture trial with Forteo vs. placebo in humans. At the same time, Lilly was continuing its research in animal models. The FDA asked Lilly to conduct a study in rats to determine if, at high doses, what are the effects of an anabolic on the risk of osteosarcoma? The results were that Forteo increased the incidence of osteosarcoma in the rat model compared to a control group. When this report was published, the FDA instructed Lilly to stop their fracture trial at month 20 of the 24 month trial. The FDA approved Forteo with the box warning, and a two year limitation of use. When Radius sought approval for Tymlos, the FDA instructed that the same rat model trial be conducted. They did, and got the same results, and the same box warning. Back in the late 1990’s the FDA required Lilly to establish an osteosarcoma registry for any human cases that occurred. None occurred. In 2016 the FDA told Lilly they can shut the registry down. And in 2016, when Tymlos was approved, that no registry was necessary. In 2020 the box warning was removed from the label for Forteo. In time, it will probably be remvoed for Tymlos. There is no evidence that Forteo (or Tymos) cause osteosarcoma in humans."

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Thank you-that’s helpful

REPLY
loriesco | @loriesco | Jun 29 6:54pm

correct - no evidence in humans. It is no longer "new." So there is a lot of research out there. I did my CTX and PNIP annual test and all of my bone markers are heading in the right direction after one year Reclast and one year Tymlos. My DEXA with a TBS analysis is in August! I am looking forward to a good report! if you can, get your Dexa on a machine which has TBS software. It gives a much more accurate assessment from year to year. Dexa's aren't accurate sometimes, so take them with a grain of salt and see a good bone specialist!

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