Treating Osteoporosis: What works for you?

I'm cross-posting this excerpt from an article by an oncologist at the ACSO website so people can know more about the FDA approval process and what to ask their doctors, especially about any new drug. And so people can understand the big difference between known adverse effects (legally-required to be included in the "package insert" given to the customer along with the prescribed drug at the time of receipt) and the 'post-approval' adverse effects later reported. [When you read of a class action lawsuit against a drug manufacturer, the frequent focus is on adverse effects users experienced that were not fully-identified or investigated before the drug was approved.]

There are other factors to consider when taking a new drug. Including whether the prescribing physician is 'incentivized" by the maker or ywhether you might be an inadvertent participant in a drug study without being informed so you can decline.

The FDA's FAERS website is a public-access website where many post-approval adverse effects first show up. But they are thought to represent less than 20% of such incidents as doctors and patients have a low rate of reporting.

Knowledge is power and the basis for confidence in the drugs prescribed. I hope people will be very proactive in understanding drugs recommended to them. And especially diligent about any new drugs. This article highlights that some doctors are legitimately concerned that the FDA is dropping the ball on protecting us when it rubber-stamps drugs that actually failed in the required follow-up testing. [I upper-cased critical words.]
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Raising the Bar: Rethinking the Accelerated Drug Approval Process

"More concerning was the fact that EVEN WHEN confirmatory trials FAILED to show a benefit, we have seen instances where the FDA convenes an advisory committee to decide whether to rescind the drug’s indication. In many cases we looked at, the committee has voted to continue the drug’s market approval, despite the drug having FAILED the confirmatory trial. And in recent years, we have seen an uptick of cases in which the FDA gives FULL approval based on surrogate endpoints without having to undergo further evaluation in confirmatory trials."

'By doing this, we inadvertently lower the bar for approval, which increases the number of drugs in our armamentarium, but it also allows too many drugs with uncertain benefit onto the market."

"This LOWERING of standards for new drug approvals is not a new issue. In fact, in 2014, the ASCO Cancer Research Committee challenged researchers and patients to raise the bar on expectations from novel therapies to significantly advance cancer care. So, we need to continue to press forward and make substantive changes to the system."
https://ascopost.com/news/june-2022/raising-the-bar-rethinking-the-accelerated-drug-approval-process
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I started with two clicks and moved up slowly. After a month I made it to 6 clicks, which my endocrinologist was really happy with. I alternated 6 and 7 for awhile and now do 7 clicks every day. I tried for years to get on to Forteo which is full dose only.

Side effects at first may include headache and dizziness, and brief fast heart beat. I had those when I started at 4-6 clicks. But not when I started lower. I still have some weakness but only maybe 2 days out of 6.

I cannot say that there are no side effects. I can say that even on a day when they are very noticeable, they fade in 3 hours or so.

The thing is, I have several fractures. I would stick with this no matter what. It is harder to feel motivated before fracturing. I wish I had found Tymlos earlier! I has assumed the same problems as I had with Forteo and tried to get into a trial for the Tymlos patch, and fractured in the meantime.

My doc said we would lock in gains with Reclast but maybe 1/4 dose and then I can take a break from all meds as long as I am monitored.

ps I had breast cancer and those meds did cause more bone loss

Thank you for your reply. You have given me a little hope that perhaps I should try Tymlos injections. I have an upcoming appointment with my Endocrinologist next week and will discuss this with him. I'm just wondering, if you are experiencing any side effects from Tymlos. If you so ... what are you feeling and how you are treating them. Also, the injections should only be taken for 2 years. Does this means the bones are stronger and no longer need treatment?

Keith McCormick's book "The Whole Body Approach to Osteoporosis" is a good resource, but know that he did medication before a natural approach. Dr. Lani Simpson is another resource but she also is going on meds at this point.

With a spine of -3.5 have you considered Tymlos, Forteo or Evenity? I started Tymlos at a low dose (2 clicks of the pen out of 8) and moved up. Side effects fade.

I have several spinal fractures which cause pain and disability. Believe me, you do not want to risk fractures.

Hello, my name is Toni. I’m a healthy 75 year old woman with Osteoporosis. My T-score of the spine is -3.5. My Hip is -2.5 and the my Neck is -3.2. I’m also a breast cancer survivor. My Endocrinologist has wanted me on Prolia for several years. Reading and being informed of the side effects of this drug and other drugs for osteoporosis, it tells me I am not a good candidate. I have always taken the natural approach to treat whatever ails me with diet and vitamin supplements. A few years ago I was seeing a Functional Doctor who was wonderful. He is no longer on my Insurance and is quite expensive for me to go out of network in order to see him. At this point, I am not sure I am taking the best vitamins and minerals (and their dosage.) I’d appreciate any feedback and suggestions. Thanks!

Here's an excerpt of the study previously mentioned that noted the need for better prognostic protocol than DEXA reliance.

"However, half of patients with incident fractures have BMD value above the diagnostic threshold of osteoporosis defined as a T-score of -2.5 SD or more below the average value of young healthy women. Clearly there is a need for improvement in the identification of patients at risk for fracture."
https://pubmed.ncbi.nlm.nih.gov/15615078/

NSAIDS caused bisphosphonate failure in one study. Heads up as this might be true with other bisphosphonates. See article and study cited (with links) below. It caught my attention as a friend is on an injected bisphosphonate and, for a different issue, takes a lot of Aleve. The doctor never mentioned a connection though her DEXAs show zero improvement though she's now in year three.

"For women treated with clodronate, the bisphosphonate failed to reduce osteoporotic fracture risk in those who used NSAIDs (HR = 0.95; 95% CI, 0.65-1.41; P = .81), but did reduce the risk in those who did not receive NSAIDs (HR = 0.71; 95% CI, 0.58-0.89; P = .002)."
https://www.healio.com/news/endocrinology/20220616/nsaids-reduce-efficacy-of-clodronate-in-preventing-bone-loss-fractures?utm_source=selligent&utm_medium=email&utm_campaign=topicalert&M_BT=8019573958709
Potential Adverse Effect of Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) on Bisphosphonate Efficacy: An Exploratory Post Hoc Analysis From a Randomized Controlled Trial of Clodronate
https://asbmr.onlinelibrary.wiley.com/doi/10.1002/jbmr.4548

Thanks.

@callalloo, @kilh has a complicated medical situation that makes returning to Tymlos a serious decision one way or the other. No way you would know that but just to explain.

I'm no expert on this stuff but, just thinking, isn't it a good idea to keep with a drug that seems to do what it's supposed to, if one has no side effects? That sounds like the optimal situation - an effective drug, for which the substitutes are problematic, hopefully doing no harm? Buy there might be good other reasons involved in the decision that need consideration too I realize.