Fosteum Plus

[Zillogirl]

I've found a great local doc who specializes in treating osteoporosis. I'm 56, in otherwise great health, and am not ready to commit to a lifetime of these meds just yet. We have no accredited DXA team here, so he's looking to send me a few hours away to make sure I get the best reading. I've been thin all my life, small boned, and he agrees that sometimes that's an issue with DXA scans--although he does believe I have osteo. I'll write up a post later to tell a bit more about my story. In the meantime, he's discussed Fosteum with me today. I've looked on two osteo boards and can't seem to find anyone talking about it. Anyone tried it?

[BonesinSeattle]

I’ve never heard of it and will be interested to follow your story!

[RKCnFTX]

Hi, Zillogirl.

I've actually been taking Fosteum Plus since July of 2022. I, too, went looking for information online and was not able to find much. If you have questions, I'll be happy to try and answer them.

[Zillogirl in reply to RKCnFTX]

Oh thanks! I'm 56 with -2.9 lumbar, -3.2 left femoral neck and -3.1 right femoral neck. Early menopause at 42. I tried Actonel (bisphosphonate) for four months, but it had side effects. Flu-like symptoms, general fatigue. So, I'm looking for an alternative that isn't one of the more traditional prescribed bone meds. My new doc has mentioned Fosteum Plus. Have you had DXA since you started it? Did you have any of the side effects (stomach issues)? What about fatigue or sleep disruption?

[avaerly in reply to RKCnFTX]

does your insurance cover it? i’ve been quoted $1800/month

[RKCnFTX in reply to avaerly]

I get a three-month refill for around $140. My insurance is not involved in the transaction. It's through Blink Rx.

[avaerly in reply to RKCnFTX]

thanks

I’ll check it out

[RKCnFTX]

Seems like we’ve got a few things in common.

I’m 56, too. Early menopause, 43, 44-ish. Lumbar is at 3.1 and femoral neck at 2.5.

I was first diagnosed with OP at age 50. Long story short, ran around, saw and consulted with specialists, had labs done looking for the cause, etc. Nothing was ever determined to be a definite cause. The first two doctors wanted to prescribe Forteo. After researching Forteo, I wasn’t interested in doing that, at that point anyway.

Last June, I saw a PA in Fort Worth at The Center for Osteoporosis & Bone Health. He did a DXA and TBS, lab work, including bone markers. CTX (resorption of old bone) was 539 and P1NP (formation of new bone) was 48.

At that point, he suggested Fosteum Plus. He said he has had good results with many patients. I did some research but couldn’t find much. I did look at the manufacturer’s study. In a way, it made me feel better that it wasn’t an RX, but classified as a medical food, a supplement prescribed for a disease. I thought it was worth a try and started taking it in July of 2022. The PA said we could do follow-up bone markers @ the six-month mark to see if anything was happening, and DXA and TBS at the one-year mark.

I had the six-month bone markers in January 2023, and there was a change. CTX had slowed to 424 and P1NP had increased to 55. The numbers still need improvement but seem to be headed in the right direction after only six months.

I have had zero side effects from Fosteum, nothing at all. I’m looking forward to the DXA and TBS in July, hoping and praying for good news.

I hope this helps with your decision. It’s hard to know what to do, so much conflicting information out there. If you have other questions, let me know.

[dcdream in reply to RKCnFTX]

can you keep us posted after your next test results. Also, where did you purchase said med and what is the cost per month?

[RKCnFTX in reply to dcdream]

Yes, I wil post an update here after next DXA and TBS.

It's a prescription, which is filled through a phamacy that the manufacturer of Fosteum Plus works with. I get a three-month refill for around $130. My insurance is not involved in the transaction.

[dcdream in reply to RKCnFTX]

Thanks for the info and I look forward to hearing your new scores.

[Zillogirl in reply to RKCnFTX]

Your story sounds so similar to mine! Unfortunately our area has no bone clinic, but I was able to find a doctor new to the area, working at a senior care group, who specializes in osteoporosis. No one has discussed CTX or P1NP with me. TBS is not offered near me. He has referred me to Wake Forest to get a DXA from an accredited group. Waiting to hear back from them on cost, since this will probably be a cash visit. All of this is a huge frustration for me in dealing with osteoporosis. Docs vary greatly in their in-depth knowledge of it and often go straight to prescribing meds. Additionally, diagnostic resources are so much greater in some areas. I'm in the capital city of South Carolina, with a population of nearly a million and we have no accredited DXA group and probably old DXA machines.

I'm very pleased to hear you had no side effects. Most of the side effects I read about were stomach related. Please do come back to this post and let us know your results in July!

[RKCnFTX in reply to Zillogirl]

I agree about doctors having varying degrees of knowledge. I've tried to do my own research and have traveled near and far to get what I think is important info and tests. I personally think the bone markers are important before starting any treatment. It shows the rate of bone turnover.

The TBS shows bone quality, DXA shows bone density. Unfortunately for me, my quality is not good. I live outside of Houston and travel to Fort Worth, three hours one way, and pay cash. The first appointment with scans was 150 and each appointment after that is 75, including scans. I've traveled there three times since last June and will return in July. After that, it will be a once-a-year trip for DXA/TBS. I've finaly found someone I trust and that has the right equipment in his office to monitor what's going on, which I'm very thankful for.

Doing a quick search, there is a facility in Murrells Inlet, South Carolina, at Waccamaw Hospital that has the TBS. Not sure if that's an option for you. Seems like that's the only facility in SC that has it. It's hard to find because it's very expensive.

I will post again after DXA/TBS in July. Good luck to you!

[Nibuka in reply to RKCnFTX]

Very interesting, thank you for the information!

[Wyaatch in reply to RKCnFTX]

do you mind saying where you are?..I haven’t heard of fosteum—there’s a med called fostamax in the US (sp. not quite right—) Thanks,

[Zillogirl in reply to Wyaatch]

South Carolina! It’s called a prescription medical food. If you google it, you’ll find a website and some other information online.

[Zillogirl in reply to RKCnFTX]

Did you have your DXA in July? What were the results? Looking forward to hearing!

[RKCnFTX in reply to Zillogirl]

So I did have a follow-up. The follow-up is not complete as you'll see below. I was waiting to get the missing piece before I posted. It might be a while, so here's what I do know:

Reminder: I started Fosteum Plus in July of 2022.

In January 2023, they repeated the bone markers and TBS.

P1NP went from 48 to 55. (Moving the RIGHT way)

CTX went from 539 to 424. (Moving the RIGHT way)

Remodeling ratio went from 89 to 129 (Good).

TBS went from 1.123 to 1.114. (Moving the WRONG way)

In July 2023, they repeated the bone markers, TBS, and DXA.

P1NP (Still waiting for the result. Quest has no access to the reagent needed to run PINP)

CTX went from 424 to 602 (Moving the WRONG way)

TBS went from 1.114 to 1.081. (Moving the WRONG way)

DXA spine total stayed the same, -3.1.

So... I am really anxious to get the missing piece, the bone marker (P1NP), to see what's up with that. I'm told it could still be good news, but the P1NP would have to be really high to balance out the remodeling ratio in my favor. Of course, the TBS is a concern. DXA staying the same in my mind is a win as it did not get worse. Quest should provide an update on the reagent around September 4th. So I'm just waiting on that so the bone markers can be repeated.

For now, I'm going to continue on the Fosteum Plus. There's really no reason to stop at this point. I still have zero side effects. I'm still getting it through an online pharmacy, $125 for three months' supply.

[yogalibrarian]

I did extensive research on Fosteum/Genistein several years ago. (Too long a document to share here...)

Fosteum is a prescription medical food, not a medication. (Therefore, no clinical trials... See below for more info on medical foods.)

One Really Important Thing to Consider

In many discussions, the focus is on bone density — increasing bone density. The real concern should be fracture and fracture risk. (Just as in the treatment of high blood pressure, it is not the high BP itself that is the concern, it is the damage -- heart attack, stroke, kidney damage, etc. -- caused by high BP that is the real concern.)

So when considering treatment options focus more on fracture and fracture risk than just on bone density.

Fosteum from the company website

Fosteum Plus is a specially-formulated prescription medical food product consisting of a proprietary blend of calcium, phosphate, genistein (from a fermented, non-soy source) with citrated zinc bisglycinate (a special form of zinc that is absorbed more easily), trans-menaquinone-7 (MK-7), and cholecalciferol (Vitamin D3).

Genistein research

I found very little. Much of it was related to menopausal symptoms and hot flashes. I found very little on bone density and most of that was small studies published in rather obscure journals.

I did find a lot of the info online was from people and organizations wanting to sell you something.

I also found several quotes about the high price, lack of significant results, and side effects. (If you are worried by the side effects of clinically proven and heavily regulated osteoporosis medications, you might NOT want to try unproven and unregulated substitutes.)

Medical Foods Guidance Documents & Regulatory Information

The term medical food, as defined in section 5(b) of the Orphan Drug Act (21 U.S.C. 360ee (b) (3)) is "a food which is formulated to be consumed or administered enterally under the supervision of a physician and which is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation."

FDA doesn’t approve medical foods.

A medical food is used for the dietary management of a disease or health condition that requires special nutrient needs. An example of a medical food is a food for use by persons with phenylketonuria, a genetic disorder. A person with this disorder may need medical foods that are formulated to be free of the amino acid phenylalanine. A medical food is intended for use under the supervision of a physician. It doesn’t include products such as meal replacements or diet shakes, or products for the management of diseases like diabetes, which can be managed through modification of the normal diet.

Medical foods do not have to undergo premarket approval by FDA. But medical food companies must comply with other requirements, such as good manufacturing practices and registration of food facilities. Medical foods do not have to include nutrition information on their labels, and any claims in their labeling must be truthful and not misleading.

[dcdream in reply to yogalibrarian]

Excellent information. I did a quick google search on this and also found some of the side effects and issues you cite above. Lots to consider.

[RKCnFTX in reply to yogalibrarian]

Great recap of information available online.

[Fefcoo in reply to yogalibrarian]

Thanks for that information, everyone!One question:

Wouldn't focusing on & increasing bone density aid in reducing bone fractures? Isn't that the goal?

[Zillogirl in reply to Fefcoo]

Quality of bone is important as well. This is why supplements like strontium are not advised. As yogalibrarian posted, the quality of bone produced by Fosteum/Genistein is unknown. I'm looking forward to reading about RKCnFTX 's results in July!

[Hidden in reply to Fefcoo]

I’ve read recently and come to believe that our bones can actually get too dense, causing them to (sometimes) shatter. This happened to a 90 yo friend of mine who has been on PROLIA for 4 years but continues to have (because of her age & frailty) serious, life threatening fractures.

…something to further complicate this scary health situation.

Best to you.

[yogalibrarian]

One of the things I find myself saying a lot since becoming involved with this work is, "It's complicated."

When I first started trying to figure out the relationships I started taking notes (now up to about 200 pages) on the difference between osteoporosis risk and fracture risk.

At the top of the first page -- Bone density accounts for only about 50%. The rest is made up of other factors including muscle strength, balance, and fall risk.

The fracture risk calculators, such as FRAX, were developed because researchers realized fracture risk was more than just bone density -- and they wanted a way to quantify the other risks.

As a starting point, use one of the fracture risk calculators (FRAX or American Bone Health's FRC) to get a baseline fracture risk to discuss with your healthcare provider.

But there are also fracture risks that do not appear on the calculators because their nuances don't fit well into a calculation tool. So having the fracture risk reviewed by a qualified healthcare provider as part of your overall medical is crucial. The healthcare provider can help determine the weight of factors better than the calculator. (Example: the fracture risk for a young rock climber is probably higher than that of a healthy older woman who walks 2 miles a day.)

Fracture history (your own and your parent's), medical conditions, medications, and lifestyle can all play a part. Some factors such as rheumatoid arthritis operate differently on both the osteoporosis/fracture risk equation.

I subscribe to the concept of "small nibbles." Often, there is not one big solution that fixes "everything." Diet won't fix everything, nor will exercise, or lifestyle, or increasing bone density OR the "magic bullets" and miracle cures I sometimes see advertised online. So pay attention to bone density -- but to the other factors as well.

[Hidden in reply to yogalibrarian]

And bone density doesn't always match bone quality (my bone quality/strength is much worse than my density

[Raleigh59]

Fosteum plus is $2200 per month RX vitamin that has vit d, zinc, and genistein (non-soy)

[Zillogirl in reply to Raleigh59]

it’s covered by my insurance, so thankfully would be far, far less.

[Raleigh59 in reply to Zillogirl]

my insurance is not covering it

[Hidden in reply to Raleigh59]

If you go directly to Fosteum website, they can provide info about cash pay through a pharmacy that delivers to your home I believe. I do not take it as I had multiple fragility fractures in mid-50s and by necessity had to go the RX medication route. I do take D3, K2/MK-7, multiminerals that include magnesium, zinc, calcium.