Began Tymlos 4 wks ago; flying solo till I see Endo in 3wks... advice?

@annie208 at -2.6, with a margin of error of -.5, your femur neck's bone density is not terrible. and is right on the line. It is true that people with osteopenia also fracture, of course, but since your fall was traumatic, it is unclear whether the fracture was due to osteoporosis.

The same thing happened to me in 2006. Horrendous fall on icy steps, landed on my back on the corner of concrete steps and had 3 fractured vertebrae. The excellent endocrinologist told me that the fractures were very likely not due to osteoporosis (I think I was borderline like you) but with a fracture, we qualify for insurance coverage of anabolic drugs.

If you can tolerate 8 clicks all the better. I ramped up but never expected to be entirely without side effects. IF you stay on 8 clicks the issues may resolve- or if they don't, 7 clicks is great!

I barely gave any thought to my bones in your situation. It was only 5 years on cancer meds that made my bones worthy of attention! Other than your femur neck you are in good shape. But you are relatively young so being on top of things the way you are is smart.

I injected in my abdomen because, with a kid with type 1 diabetes, I knew that absorption there is better and faster than any other site. That said I requested thigh for Evenity injections because I had a horrible reaction to the fast absorption in tummy.

A P1NP after one month may not be a baseline. I have no idea how long it takes for Tymlos to raise P1NP. I had my P1NP done at 18 months which seemed to suggest that it was no longer doing much at that point. I continued for 6 more months while I decided what to do next, and both doctors suggested I do that, as did McCormick.

My well-respected endo does not use bone markers and says they do not tell the whole story about what is going on in bones. McCormick says they need to be done properly (CTX early in am, fasting, and at a consistent time). My endo says an entire conference could be held on this question. I have kidney disease which affects CTX. This dilemma seems unresolvable. I sporadically ask my PCP to order bone markers and then talk to McCormick, but I am as skeptical of him as I am of any other provider! (I have talked with McCormick for 18 years and seen my endo for the same period...)

Again, your fracture may or may not be osteoporotic, but since you have a fracture, you can do Tymlos and even Evenity with insurance coverage. You are getting that ho hum reaction from doctors because they see people with multiple non-traumatic fractures (me!) and severe DEXA scores. Hope you are feeling better these days after surgery!

@annie208 Annie, this is such a great "unorthodox-push" story. We should all be so smoothlyaggressive.
You'll have the best idea (even without the prior-to-use bone markers) because the bone markers will indicate that you are losing more than gaining.
The clinical trials were done with endpoints at 18 months. A two year limit was placed on Tymlos because of caution that it could increase osteosarcoma. That limitation has been removed after years of data disproved the fear.
Some endocrinologist are extending the use of Tymlos to a third year.
The remaining concern is that either Tymlos or Forteo aren't as effective after 18 or 24 months, but there is little data given the prior restriction on it's use to 2 years.
You can temper the heart racing by taking a glass of water and something salty before the injection.
Parathyroid hormone vasodilates the blood vessels usually for the first four hours after use. With more space for the blood to flow through the heart beats faster to keep up with the volume to fluid ratio. Fluids will increase the volume and salt will constrict the vessels slowing the heartbeat.
Flying, yes. Well done.

Because you self advocate have you considered hormone replacement with bio-identicals? I realize research says taking estrogen does not effectively build bone, but at your stage you’re wanting to maintain the good bone you have. It is well documented that after menopause a large proportion of women starting losing bone density and hormones play a big part of that.

My suggestion to any 50-65 year old would be to investigate whether hormone replacement is right for them. Today’s research shows it support bone, brain, heart, connective tissue, and the nervous system.

Because of my older sister’s breast cancer, I did not take HRT within the 10 year window they are saying is optimal. My mother and two sisters have never had cancer, yet 2 of them took/take HRT. Only my older sister and I never took it and we both got breast cancer. I’m not suggesting that HRT protected them from cancer, but it certainly didn’t promote any cancer. Our story would skew the statistics on 5 close female relatives and cancer risk.

As AI starts taking over recommendations based on default protocols I think we are going to have to figure out the right question to get AI to consider outside the box. Like asking about research that narrowly missed the significant statistic, and did not become protocol, but may apply to our specific individual circumstances. I’m afraid depending on AI without delving into what data it is using is going to cause denial of service because we don’t all fit into the bell curve.

@gently this has come up before: can you share any info on the two year limit for Tymlos being lifted? It was lifted for Forteo but I have read that for Tymlos, only the osteosarcoma black box warning was lifted, not the two year limit. This is important for me and a lot of us.

I read that Lilly put the money, time and research staff into establishing safety of Forteo for more than two years, but that it is unlikely Radius will do so.

Here is an article on extended use for Forteo (and the lifting of the warning and the time limit)
https://www.ccjm.org/content/88/9/489#:~:text=In%20November%202020%2C%20the%20US%20Food%20and%20Drug,potential%20risk%20of%20osteosarcoma.%201%20The%20lifetime%20limitat
There is a lot of misinformation and outdated information online of course. I would be happy if the time limit was also lifted for Tymlos but I have not seen anything about that.

This is from Radius brochure dated 9/24.

"You should not use TYMLOS for more than 2 years over your lifetime."

windyshores,
I'm not thinking there will ever be such a link. No one will conduct studies.
The FDA approved Tymlos on the basis of one clinical trial. The suspicion of osteosarcoma was directed from the Forteo rats and the two year limit was because of that caution. It remains in the Forteo insert that Forteo should only be given for more than two years in select patients likely to benefit, i.e., those with high fracture risk.
One doctor told me that the third year is similar to off label use, another said that he almost never prescribes medicines as recommended in inserts. He thinks the doses are often too high for women of little weight.

@gently the point is that Forteo is allowed for more than 2 years (Lilly did a study) as described below- but Tymlos isn't.:
2.3 Recommended Treatment Duration
Use of FORTEO for more than 2 years during a patient’s lifetime should only be considered if a patient remains at or has
returned to having a high risk for fracture [see Warnings and Precautions (5.1)].

Again, the two year limit has not been lifted for Tymlos.

If anyone has a doctor prescribing Tymlos for more than two years, I would love to read about it.

@windyshores, I'm curious at your observation of the margin of error on the T-score being .5. I've never seen that reported; I'd like to learn more, can you site a source? .5 is a pretty big margin...

@idlehands so so sorry and thank you for catching that! Here is the correct info. My decimal point was off!

"Small changes in bone mineral density are not significant. Research has shown that at least a 5-6% change on a bone density test is needed to be sure that any change is not simply due to placement on the machine."

I have kept a chart on my DEXA's since 2006 and they jump around wildly. But it should be 5% not .5 !!!!! Apologies to all.

Numbers can mean so many different things 🙂 Glad you shared the info and glad you clarified it. Thx