FDA approved clinical trials are a well established way to gain access to medications not yet available to the general public. Most people have heard of individuals taking experimental treatments for cancers or HIV or Ebola on the news. But there is another type of FDA trials to which we now have access.
Osteoporosis medications are first tested and approved for postmenopausal women only. Men are 20-25% of the individuals with osteoporosis. However, approval for men takes a separate clinical trial. Therefore, often men have to wait an additional 3-5 years for access to a medication we know should work but has not yet been officially approved for men.
Participating in the clinical trial for men allows men with osteoporosis access to the new medication years earlier – and at no cost. The anabolic medication Tymlos (abaloparatide) is currrently conducting a national clinical trial for men. The intake process is detailed to be certain that only those men likely to benefit and not be harmed are included.
Cedar Valley Bone Health Institute of Iowa and North-East Iowa Medical Education Foundation are a test site for the clinical trial of Tymlos (abaloparatide) for Men. You may qualify. The qualification testing is all at no cost to the patient.
If you are close enough to Waterloo, IA to come in every 3 months for testing, contact us at 319-233-2663 (Shari) or 319-272-2539 (Kayla) to apply for the clinical trial.
For a bone health evaluation and treatment plan for men or women call 319-233-2663. If you are a man needing anabolic medication we will also proceed to evaluation for the clinical trial.
Jay Ginther, MD
Copy for BTrue Magazine July 2014 Issue
Top 10 reasons to check your Bone Health
10. It’s all downhill after age 30. You reach your maximum bone mass by about age 30. Then you start to lose bone mass every year. After Menopause it is 1 to 2 percent bone loss every year. That adds up fast.
9. You are active and want to stay active. Weak bones can get stress fractures during sports or fun activities like dancing. Don’t get caught doing the wrong knd of break dancing. Strong bones require enough Calcium, Vitamin D, and Protein, as well as regular exercise. See our recommendations at www.BoneDocBlog.com.
8. Fractures “Suck”. A fracture is not fun. You could be in a cast or on crutches for months. That really sucks.
7. Most Iowans are low on Vitamin D. Unless you are taking extra Vitamin D all year long, you are probably too low to absorb calcium well. We can only get Vitamin D from the sun 5 months of the year and then only at mid-day. Find out how much extra you need by testing.
6. “Milk does your body good” Milk is optional. Calcium is not optional. You need about 1200 mg of calcium daily in divided doses with meals. In food is best. Supplements with food also work. Look up foods providing calcium on www.BoneDocBlog.com.
5. Babies steal from your bones. During pregnancy and nursing, your baby comes before your bones. You will steal calcium from your bones to build a healthy baby. Try running after a toddler with weak bones!
4. A fracture is a Bone Attack. It is a warning that you may have problems with bone density or bone quality. Someone with one fracture is 2 to 5 times as likely to have a second fracture. Bummer. A complete bone health evaluation can identify opportunities for improvement. Avoid that second fracture by fixing the problems.
3. A bone density exam (DXA) involves less radiation than a flight to LA and back. DXA is safe and much more comfortable than a mammogram, pelvic or prostate exam. Our machine rotates, so you don’t have to.
2. Osteoporosis is much easier to prevent than treat. Starting to build or preserve your bones while young is relatively easy and does not require medication. Trying to salvage serious osteoporosis after a major fracture is harder for you, and usually requires medication.
1. 60 minutes for a DXA/VFA and Complete Bone Health Evaluation can save you years of misery. Start early to prevent that hip fracture at 70. Or that wrist fracture at 50. Or that foot fracture at 30. They can really cramp your style.
A Complete Bone health Evaluation includes DXA, VFA, FRAX, CBC, CNP, TSH, PTH, 25-hydroxy Vit D level, and a consultation solely focused on bone health. In seven years I have never seen a patient who did not have at least one bone health issue which could be improved.
Jay Ginther, MD
True in the 1960’s – even more true today. We expect to live into our 80’ and 90’s. We expect to enjoy those extra years. We can, with a little planning and action NOW.
If YOU don’t take care of your body, where ARE you going to live? That is the real question. Women start to rapidly lose bone at Menopause. This is totally natural and used to be unavoidable. Without action on your part, you could develop Clinical Osteoporosis and Fractures and wind up in a nursing home. You can avoid these complications of natural aging.
Cedar Valley Bone Health Institute of Iowa offers a Complete Bone Health Evaluation. DXA, VFA, specific blood tests not usually done in annual check-ups, full history, an examination and full consultation usually take 30 minutes focused on bone health alone. We can Prevent Osteoporosis if we start early enough. Prevention is far better than treatment, and ideally should start decades before menopause.
You must be prepared to Take Control of those issues you can control: Calcium, Vitamin D, Protein, Vitamins & Minerals, and Exercises for Balance, Strengthening and Posture. Everyone should do these Natural measures for best results, whether taking Osteoporosis Medications or not. For younger persons and for some individuals over 50, they are enough all by themselves.
Calcium is best absorbed when eaten in foods. You want to consume 400-500 mg in each meal to get 1200 mg every day. If you do not get enough calcium in your diet alone, Calcium Citrate pills are much better absorbed than Calcium Carbonate pills, if you take antacids or are over 50. Adora Premium Chocolates are a delicious way to get 500 mg calcium in only 30 calories.
Your skin can make Vitamin D3 from the Sun at mid-day in the summer. Doing that risks Skin Cancer because you cannot use sun block if you want to make Vitamin D. The sun is high enough above the horizon only 5 months of the year in Iowa. Plus, we lose our ability to make enough Vitamin D as we grow older. Over half of Iowans are low on Vitamin D as summer ends in September. 7 out of 8 Iowans are low by mid April when we can first get a few minutes a day of Vitamin D.
New studies presented at National Osteoporosis Foundation and American Society for Bone & Mineral Research meetings in the last 3 years have shown we need much more Vitamin D than we thought just 3 yers ago. The easiest and safest move is to take extra Vitamin D3. The amount of D3 in your multiple vitamins and minerals, in your calcium supplements, and in your milk combined are rarely enough. Test for 25-hydroxy Vitamin D Level, in order to tell if you are taking enough to get between 40 and 80 ng/ml in your blood.
Bones and muscles are both well over 80% Protein. (Calcium is added for stiffness in bone.) Protein need not be from animals, but getting enough protein in a vegetarian diet takes constant attention. Most people should get 1 gram of protein for every kilogram of their body weight. An easy calculator and advice on where to get protein, as well as calcium and vitamin D3 can be found on my blog site www.BoneDocBlog.com.
Vitamins & Minerals from a diet of many different fresh fruits and vegetables is tedious and difficult. I prefer a Multiple Vitamin & Mineral Supplement as an easy way to be certain I have optimal levels of all those trace nutrients.
Daily Exercises for Balance, Strengthening and Conditioning of your whole body, are important. Include specific Postural Exercises to maintain upright posture of your spine. This decreases the chance of developing “humpback” or kyphosis in later years. A minimum of 20- to 30 minutes daily standing and walking is needed, along with specific exercises for balance.
While women are more likely to have bone health issues and fractures, you are not alone. One-quarter of all Clinical Osteoporosis patients are men. Talk to the men in your life about bone health. Make sure they, and your daughters, are following the guidelines above.
Take Control of your Bone Health. Start today by getting a Complete Bone Health Evaluation. I have never evaluated anyone for bone health and not found at least one detail that we could improve upon. Go to www.BoneDocBlog.com, www.CVBoneHealth.com, or call 319-233-BONE (2663) for further information.
Jay Ginther, MD