Odanacatib

Did anyone here participate in this trial?

http://www.thepharmaletter.com/file/114889/merck-co-closes-odanacatib-trial -early-on-good-results-in-osteoporosis.html

US drug giant Merck & Co (NYSE: MRK) says it is halting a Phase III trial of its investigational osteoporosis drug odanacatib early on the recommendation of the independent Data Monitoring Committee due to robust efficacy and a favorable benefit-risk profile.

Also see http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2951121

20 replies   

Thanks for the post......very interesting! As with any new drug coming on the market, caution is advised. Long term side effects???

"Long-term side effects?"

How long do you have to test a drug to know if it will have long term side effects? 10 years? 20 years? Next generation? How long should it be tested before it is approved for use?
Current patents are for 19 years. It takes 10 years to get a newly patently drug out of the lab for phase 3 trials. If you wait too long, no drug would ever allow it to be sold at a profit to cover the cost of development, and no new drugs wil be produced.

A few years ago I read of a doctor that would not prescribe medications to his family or friends that had not been on the market for 10 years. In my mind ten years after the drug is on the market would give patients the knowledge of the benefits of the drug, and the adverse side effects of the drug. Bisphosphonates comes to mind. Here is an example:http://www.drug-injury.com/druginjurycom/2012/06/bisphosphonate-femur-fract ures-fosamax-cases-medical-diagnosis-difficult-doctors-radiologists-orthope dics-surgeons.html

I am currently taking part in a study for men and osteoporosis. I have less than a year left in the study. I have been taking 50mg of Odanacatib or a placebo once a week, plus 5600iu Vitamin D weekly and 1000mg Calcium daily. I have had no side affects that I can attribute to the study, been on a couple years now. Time flies. I have been waiting for someone to mention this drug. Then I found this article... http://www.huffingtonpost.com/2012/07/12/odanacatib-osteoporosis-drug-fract ure-bone_n_1666631.html

All I know is that I have felt stronger bonewise and healthier since being on this regiment. I refused bisphosphonate drugs that my original doctor prescribed. Called my friend who is a researcher at the University and she set me up. I am so glad, and I changed doctors too. The new drug will probably be expensive and many will not be able to afford, but I am thankful that I was able to be a part of this study that could eventually help someone else in their difficulties with osteo.

Thanks cybertray for sharing. As you know, you and the investigators that are monitoring you do not know if you are on a placebo or the real deal. Thank you for volunteering. IT is very difficult to find treatment naive (never took an osteoporosis drug not the lay definition of "gullible") volunteers anymore to test a new class of medication. You should be commended for not only the possiblity of helping yourself, but of generations of those to come who will benefit from such research.

I've been recently diagnosed with both osteopenia and osteoporosis. I got a stress fracture in my knee which led to the diagnoses. My lumbar spine T score is really bad at -3.88. Yet I have no back pain of any kind. My femoral neck score was -2.36. I'm a 49 yr old guy. There are some thyroid issues in the family. But doctor said my blood tests show nothing wrong with my thyroid. I've been on a crash course of studying up on the meds for Osteoporosis and it has left me rather depressed. This drug sounds promising. If it comes out on the market how soon would it available?

hey ew...do u pay for the pharmaletter? If so, is it worth the cost?

Cybertray thank you for your wonderful contributions on our behalf! I remember your participation in the Forteo for men study & now this one! THANK YOU! I took Forteo & did really well thanks again ♡♥♡

Windblown - I do not subscribe to thepharmaletter, but sometimes articles are available for free for a limited time after they are published.

BMJ6372 - One must find the root cause of their osteoporosis and correct that. Osteoporosis medications do not correct the root cause. In my case, the root causes were insufficient vitamin D and borderline low testosterone. These problems have now been corrected and I feel much better. I am 60, and although I run pretty hard, I have never had any type of fracture.

I take the following "osteoporosis related" daily supplements (NOT ALL AT THE SAME TIME):

Boron (B) - 3 mg (Boron Citrate / Aspartate / Amino Acid Chelate)
Calcium (Ca) - 1065 mg (Calcium Citrate / Malate / Carbonate)
Lactoferrin - 250 mg (Lactoferrin)
Magnesium (Mg) - 546 mg (Magnesium Oxide / Gluconate / Citrate / Glycinate / Malate)
Strontium (Sr) - 680 mg (Strontium Citrate)
Vitamin D3 - 5950 IU (D3 Cholecalciferol)
Vitamin K - 75 mcg (MenaQ7 Menaquinone)

I also have been applying AndroGel (testosterone) since 02/05/2011.

In addition to diet, what about weight bearing exercise? I've recently started going to a Body Pump class (weight lifting).

I think many of us got a bit depressed by the osteo diagnosis. There is a lot of good advice here and if you spend some time here every day, you'll get up to speed.

Ewcollins gave you a good list to follow with respect to supplements. The dairy industry has done a good job of selling milk and dairy products, but treating osteoporosis is so much more than just calcium.

Ew, great idea...fixing what caused it! However, how do you fix genetics and hormone loss? I take hormones but it's not going to turn back the clock and restore my bones. Thanks for sharing!

Latest data presented at ASBMR


http://www.medpagetoday.com/MeetingCoverage/ASBMR/35302

Windblown - I have hormone loss, and that is why I have been applying AndroGel (testosterone) since 02/05/2011.

I was skeptical at first; I thought that once bone was gone, then it was gone forever. All I hoped for was that things would not get any worse. My physician, who is also trained as an endocrinologist, told me that I was mistaken, and that once my testosterone levels stabilized, then of course I would start rebuilding lost bone. They were correct. Although it took 18 months, I notice the difference and I feel MUCH better. My posture has improved and I am now running faster than I did three years ago.

One must select a treatment that they are comfortable with and then patiently stick with it.

EW, that's great NEWS! I'm glad the hormones worked well. Are you going to be running again in a marathon? My bro had osteoporosis and reversed it to osteopenia with hormones. However, he has some trouble with the hormones which I can't get into here ;o)

I've been on hormones, off and on for over 20 years, and I am back at the osteopenia range when I started out with established OP. I guess I found the problem and fixed it. Never really thought about it like that, but I'm glad you mentioned this, because sometimes we need to look at a problem (fixed or not) with a different perspective. Thanks so much for reminding me to do this! You know how we get stuck in the old rut of thinking one way :o(

I hope you continue to improve and are getting ready for another run!!! If so, best of luck... slow and stead wins the race :o)

Windblown - Here I am at a 6-hour run last Sunday - http://rci.rutgers.edu/~mocker/running/photos/glirc_6_hour_run_2012.jpg .

I covered 27.77 miles! This is better than I did at this same race in 2002.

EW, great picture! You are amazing! Keep up the good work, and thanks for being an inspiration to us all.

How fast does the FDA approve drugs like this?

Thanks windblown. For you and many more with this silent ailment, I believe these studies are important and help all of us better understand our framework and our potential frailty. Hopefully there is a cure but also knowledge is a way for us to find ourselves in faith that Divinity has all things in control and is the ultimate cure for every ailment if we only believe. My faith is not in studies, but beyond and far above studies. Living right and eating right will take us further with osteo issues than pills and shots. I like to read about what others are doing with nutrition and minerals. We are all made from different soil types and some components of minerals may be different than others so we all need to look to the One who knows us individually. Doctors practice but knowledge is divine. Not everyone will benefit from the same treatments, but we have hope that what we do in this life matters and it will ultimately help others in some way. Thanks again for your inspiration.

The FDA gives their approval when big pharma's check clears. Ha!

This discussion is closed to replies. We close all discussions after 90 days.

If there's something you'd like to discuss, click below to start a new discussion.

Things you can do

Support NOF

Help the National Osteoporosis Foundation reach its goals and support people like yourself by making a donation today.

Donate to the National Osteoporosis Foundation

Learn more about osteoporosis awareness and prevention

Discussion topics

Links and resources from NOF

OsteoporosisNOF: Please ask your Members of Congress to support the Mother’s Day Centennial Coin Act ( H.R.1905). NOF will be a beneficiary!

OsteoporosisNOF: Check out NOF Board member, Heidi Sklonik, on the Today Show - 6 foods for bone hea... http://t.co/EMF6I2d8Ev.

OsteoporosisNOF: Life After 50: Vitamin D And Calcium -- Confused By Conflicting Reports? You're Not Alone http://t.co/EkLeCBaowd via @HuffPost50

OsteoporosisNOF: NOF is thrilled to welcome Barbara Hannah Grufferman as our first Bone Health Ambassador. Learn more: http://t.co/XTGPTXgU.

OsteoporosisNOF: When eating for bone health, keep it simple & eat whole foods. Read the labels of the foods you eat & only eat those with the least ingre...

Community leaders

Disclaimer

The National Osteoporosis Foundation would like to remind visitors and community members that the views and opinions expressed on this site are not necessarily those of NOF. Please consult your personal healthcare provider regarding any medical information that is shared on this site.