How big is the bang from osteoporosis drugs?

From Susan Brown, PhD

Answering the question “how big is the bang from osteoporosis drugs?” can be quite challenging.
One reason is that the statistical calculations are complex and highly manipulated making them difficult to understand. Another is that the subjects included in the drug studies are generally highly-selected and may not represent “real-world” populations.
Recently scientists took an important step to help us separate hype from reality in regard to the benefits of bone drugs.
Researchers asked if “real-world” patients taking bone drugs received the same fracture-reduction benefits seen in the clinical trials. After analysis of hundreds of studies, they found that highly compliant, “real world” patients on osteoporosis drugs experienced a 21% reduction in all clinical fractures. This compares to the 24% overall clinical fracture reduction experienced by subjects in osteoporosis drug clinical trials.
What a different messages than we often hear — such as how bone drugs reduce your chance of fracture by 50%! Or have you ever been told that the fracture reduction on bone drugs is really more like 21-24%? That is — if you use the drug faithfully.
Now compare this 21-24% fracture-reduction benefit from bone drugs to the studies documenting that those taking vitamin D in any dose (much less a therapeutic dose) experience a 23-26% reduction in fractures. It seems to me that the bang from osteoporosis drugs isn’t quite as big as we’ve been led to believe.
As your bone health advocate, I congratulate these researchers on the enormous effort to analyze and synthesize data from hundreds of studies. I also congratulate the drug company which funded this study for clarifying the real fracture/reduction benefit of today’s bone drugs.

References:
Wilkes, et al. 2010. “Bisphosphonates and osteoporotic fractures: a cross-design synthesis of results among compliant/persistent postmenopausal women in clinical practice versus randomized controlled trials.” Osteoporosis International 21:679-688
Bischoff-Ferrari, HA et al. 2005. Fracture prevention with vitamin D supplementation: A meta-analysis of randomized controlled trials. JAMA, 293(18): 2257-2264

The Week in Bone Health | How big is the bang from osteoporosis drugs?

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Selections from Natural Health News

Natural Health News: More about risky drugs and Osteoporosis

Sep 06, 2011

The osteoporosis drug zoledronic acid (Reclast) should not be used in patients with significant renal impairment, and physicians should screen patients for kidney dysfunction before starting them on the drug, the FDA said. ...

http://naturalhealthnews.blogspot.com/

Natural Health News: The Dangers of Osteoporosis Drugs

Aug 16, 2009

Another Big PhARMA fiasco, as all the current osteoporosis drugs seem to be. Of course you don't hear too much about their fluoride content and how this damages the thyroid and bone health, but then how would they mask ...

http://naturalhealthnews.blogspot.com/

Natural Health News: Osteoporosis drug Forteo linked with bone ...

Oct 02, 2009

Osteoporosis drug Forteo linked with bone cancer. BLACK BOX WARNING FOR FORTEO, a gentically engineered pharmaceutical. POTENTIAL RISK OF OSTEOSARCOMA: In male and female rats, teriparatide caused an ...

http://naturalhealthnews.blogspot.com/

Natural Health News: Focus on Bone Health Naturally

Jan 24, 2009

***Just remember that as bone density leads to brittle bones and fracture, so do the prescription osteoporosis drugs. ... Part of this missing link is the bone-damaging impact from many non-osteoporosis drugs. Another is that ...

More about risky drugs and Osteoporosis

UPDATE: 9/10/11
Another new article points to the insanity of the FDA's process of approving drugs that take so long to report data about the risk to bone health.  The other odd consideration is the lack of attention to how to properly label problematic drugs and how to determine just how long someone would take a risky Rx.
FDA advisers wary of time limit on bone drugs

From 9/6/11
Today it was announced that Blythe Danner, actress and mother of Gwyneth Paltrow, has osteoporosis. 

The article states "In order to spread awareness about osteoporosis, Danner is helping launch Act2ReduceFractures.com, an informational Web site on fracture risk jointly sponsored by Amgen, American Bone Health, the Global Healthy Living Foundation, and the Older Women’s League."

This is of course another celebrity pushing drugs and avoiding any discussion of what natural remedies are available to help prevent and treat bone loss. Fluoride based drugs with many serious adverse reactions are the cornerstone along with low level dosing of vitamin D, calcium, and kale chips which are in fact quite good.

Nothing is referenced about the problems with calcium about the form and utilization as well as the need for a full complement of nutrients to keep bones strong and healthy.

No mention of herbs, no mention of homeopathy, no mention of many good natural approaches.
Read complete article

Also consider this - 

Thursday September 01, 2011

Reclast Gets FDA Kidney Failure Warning  The osteoporosis drug zoledronic acid (Reclast) should not be used in patients with significant renal impairment, and physicians should screen patients for kidney dysfunction before starting them on the drug, the FDA said. http://www.medpagetoday.com/ProductAlert/Prescriptions/28320?utm_source=breaking-news&utm_medium=email&utm_campaign=breaking-news Look to Health Forensics for more information

Selections from Natural Health News

Natural Health News: The Dangers of Osteoporosis Drugs

Aug 16, 2009

Osteoporosis involves the thinning of bones, and if some measures are not taken, it can lead to excruciating pain accompanied by fractures and forms of disability. For treatment, one should take proper intake of ...

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Natural Health News: Immune Supression for Osteoporosis?

Aug 12, 2009

FDA staff has expressed concerns that denosumab, the investigational biologic drug for osteoporosis, may increase risk of serious infections through its activity against an important immune system modulator. ...

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Natural Health News: Another healthy drug for women: Osteoporosis ...

Jun 05, 2006

more than just osteoporosis - Further down in this post you will find this paragraph:"Oncologist Julie Gralow, M.D., of the University of Washington and Fred Hutchinson Cancer Center in Seattle said that women should ...

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Natural Health News: Osteoporosis drug Forteo linked with bone ...

Oct 02, 2009

The first case of osteosarcoma associated with Forteo use was published in the Journal of Bone Mineral Research in 2007 (JBMR vol. 22, p. 334), and a second case was published on-line in Osteoporosis International on the ...

Reducing Mortality with Vitamin D

It is very important to understand that mainstream medicine in the US is using doses of vitamin D and 25 OH levels that are too low for achieving the health benefits of vitamin D.

Doubling vitamin D levels most cost effective way to reduce global mortality rates, study

Increasing serum levels of 25-hydroxyvitamin D is the "most cost-effective way to reduce global mortality rates", according to a new study.

The sunshine vitamin: How much is enough?

In a paper assessing the likely impact on mortality rates of doubling serum vitamin D levels from 54 to 110 nmol/l in six regions of the world, Dr William B Grant estimates that this would increase life expectancy by two years across all six regions.

"The predicted reduction in all-cause mortality rates ranges from 7.6 percent for African females to 17.3 percent for European females", claimed Grant, who is a director at the San Franciso-based Sunlight, Nutrition and Health Research Center and the author of several papers on vitamin D.

His latest study, published in the European Journal of Clinical Nutrition, concludes: “Increasing serum 25(OH)D levels is the most cost-effective way to reduce global mortality rates, as the cost of vitamin D is very low and there are few adverse effects from oral intake and/or frequent moderate UVB irradiance with sufficient body surface area exposed.”

Complete article

Selections from Natural Health News (find more than 30 on this topic here)

Natural Health News: More on the Benefits of Vitamin D
Jun 13, 2011
Along with calcium, vitamin D is the nutrient that most people recognize as important for bone health (Holick 2007). But, even today, few people understand the powerful and complex ways that vitamin D acts to promote not ...

Natural Health News: More Benefit from Vitamin D
May 20, 2011
Vitamin D (actually, a hormone) appears to play a wide variety of roles in health and disease. Back in 2007 I reported on a study which found that higher levels of vitamin D were associated with better physical ...

Natural Health News: New Vitamin D Test
Jan 28, 2011
Developed by the diagnostic lab technology company Abbott to detect the amount of 25-hydroxy vitamin D, the ARCHITECT 25-OH Vitamin D is a new diagnostic test to measure levels of vitamin D in blood using an automated ...

Natural Health News: Low Levels of Vitamin D Increase Melanoma Risk
Feb 09, 2011
BYDGOSZCZ, Poland—Results from a recent Polish study found a reduction or absence of vitamin D receptor is linked to progression of melanocytic lesions, and its lack affects survival of melanoma patients, ...

More on the Benefits of Vitamin D

At the simplest level, osteoporosis occurs when more bone is resorbed than formed (Banfi 2010, Chang 2009). There are multiple causes for osteoporosis including suboptimal nutrition, age-related hormonal imbalance, and lack of weight-bearing exercise, to name a few (Body 2011).

Along with calcium, vitamin D is the nutrient that most people recognize as important for bone health (Holick 2007). But, even today, few people understand the powerful and complex ways that vitamin D acts to promote not only bone health, but the way the entire body handles calcium, both in healthy and in undesirable ways (Holick 2007). Vitamin D triggers absorption of calcium from the intestine and deposition of calcium in bone — and also removal of calcium from blood vessel walls. Conversely, insufficient vitamin D intake results in depletion of calcium from bones — and increased deposition of calcium in arterial walls, contributing to atherosclerosis (Celik 2010, Tremollieres 2010).

Vitamin D deficiency (or insufficiency) also causes muscle weakness and neurological deficits, increasing the risk of falling, which of course makes fractures still more likely (Bischoff-Ferrari 2009, Pfeifer 2009, Janssen 2010). The dose of vitamin D required to achieve the neuroprotective and other non-bone related effects are substantially higher than those required simply to achieve good calcium absorption (Bischoff-Ferrari 2007).

Access to high quality Vitamin D and other supplements

http://naturalhealthnews.blogspot.com/2009/09/thank-you-davinci-labs.html

A validated measure of total body vitamin D status in blood is serum 25-hydroxy vitamin D [also known as 25(OH)D, or calcidiol]. Note that this measure is reported in two different units, nmol/L and ng/dL, so it is vital to check which set of units a lab is using. Vitamin D deficiency is defined as a serum 25(OH)D level of less than 50 nmol/L, or less than 20 ng/dL. Experts recommend a higher level of 75 nmol/L, or 30 ng/dL (Bischoff-Ferrari 2007, 2009). To obtain the many health benefits of vitamin D, current scientific evidence suggests a minimum target threshold for optimal health is over 50 ng/ mL or 125 nmol/L (Aloia 2008, Dawson-Hughes 2005, Heaney 2008).

The optimal dose of vitamin D has been hotly debated in recent years. 

Vitamin D dosage as high as 5000 to 8000 IU per day may be required to achieve a minimum target level for optimal health in aging individuals. (Life Extension Magazine® January 2010).

Good Day Sunshine

For as long as I can recall, at least two or three decades, I have been teaching people to take a 20 minute walk at noon, even on cloudy days, to get sun exposure to help maintain vitamin D levels.

Now you know that the "new guidance", like most health discoveries, is actually old data in a new wrapper.

This just happens to be one of the benefits of following a skilled and experienced health care practitioner and educator instead of a glossy on-line tabloid.  Here you get facts.

Sunshine and Vitamin D

You can use our search function to read the many other articles we have posted on vitamin D and sunshine.

 

 

New guidance on vitamin D recommends midday sunshine

By Jane Dreaper Health correspondent, BBC News

 

New health advice recommends short spells in the sun - without suncream and in the middle of the day.

Seven organisations have issued joint advice on vitamin D, which the body gets from natural sunlight.
The nutrient keeps bones strong, and protects against conditions like osteoporosis.
The guidance was drawn up because it is thought fears about skin cancer have made people too cautious about being in the sun.
Cancer Research UK and the National Osteoporosis Society are among the bodies which agree that "little and frequent" spells in summer sunshine several times a week can benefit your health.
The experts now say it is fine to go outside in strong sun in the middle of the day, as long as you cover up or apply sunscreen before your skin goes red.
'Too negative'

A good diet and sensible sun exposure will be adequate for most people to minimise their cancer risk.” Professor Peter Johnson Cancer Research UK

Professor Rona Mackie, from the British Association of Dermatologists, said: "Total sun protection with high factor suncream on all the time is not ideal, in terms of vitamin D levels.

"Even Australia has changed its policy on this. They're now producing charts showing parts of Australia where sun protection may not be required during some parts of the year.
"Some of the messages about sun exposure have been too negative. UK summer sunshine isn't desperately strong. We don't have many days in the year when it is very intense.
"What's changed is that we're now saying that exposure of 10 to 15 minutes to the UK summer sun, without suncream, several times a week is probably a safe balance between adequate vitamin D levels and any risk of skin cancer."
Official government advice already recommends vitamin D supplements for pregnant women and children aged under five.
But the experts who wrote the joint statement say mothers often are not made aware of this recommendation. They suggest women consult their GP.
Winter levels of vitamin D can be helped by a break in the tropical sun - or by eating oily fish, liver and fortified margarine.
'Complex area' Cancer Research UK's chief clinician, Professor Peter Johnson, said: "A good diet and sensible sun exposure will be adequate for the great majority of the UK population to minimise their cancer risk.
"The area of vitamin D and cancer is complex.
"There's some evidence, which is strongest in bowel cancer, that low levels of vitamin D in the blood correlate with the risk of developing cancer.
"But that doesn't mean those low levels cause bowel cancer.
"We think overall that low levels of vitamin D are unlikely to be major contributors to the chances of developing cancer in the UK population."
The joint statement also highlighted questions about vitamin D that warrant further research.
These include finding out the optimal levels of vitamin D, and more detail about the role of dietary sources and supplements.

Nutritional Status and Orthopedic Disturbances

Vitamin D Synthesis http://www.globalrph.com/vitamin_d.htm

Yes, Vitamin D is a very important nutrient.  And we know that the years of non-fat/low-fat diets and staying out of the sun takes a toll on this vital nutrient, and perhaps has become the basis of an epidemic and increased dis-ease states.

While it always seems that the lineal model is favored by so many in healthcare, it can certainly lead to other problems.

I say this because I have not seen the following information in any other the vitamin D data I have reviewed over the past several years.

Vitamin D deficiency can cause rickets.  However, when taking high doses of vitamin D people do need to be cautioned that this too may lead to a deficiency state.

The pro-calcium action of vitamin D can increase absorption and retention of calcium as compared to magnesium.

If you have a magnesium deficiency, as most people these days truly seem to have, high doses of vitamin D can contribute to soft tissue calcium deposits and reduced

• Cortical bone activity
• Muscular contraction
• Recurring vertebral or other joint subluxation

 More to consider -

Vitamin D health warning for the children who shun the sun

Paranoia about sun exposure and indoor lifestyles are causing life-threatening health problems for children due to vitamin D deficiency, a new study claims.

By Richard Alleyne, Science Correspondent
Published: 5:32PM BST 10 Sep 2010

Casualty departments are dealing with dozens of emergency cases where infants are having seizures as a direct result of not getting enough vitamin D, which is essential for healthy teeth and bones.

In one case, a baby suffered brain damage after a fit.

The study said the extreme cases are part of an escalating problem of a deficiency of the vitamin, which the body makes when exposed to sunlight.
The report in the London Journal of Primary Care blames indoor lifestyles and the use of high sun protection factor creams for a health issue unheard of a decade ago.
The findings have prompted experts to call for vitamin D pills to be made more widely available on the NHS, especially for pregnant women.
The study reveals the introduction of schemes offering mothers supplements has been slow. Some areas of London have no vitamin packs available and people are ignorant about the benefits of vitamin D, which is also found in oily fish, liver and eggs.
Colin Michie, a co-author of the study, said vitamin D deficiency was no longer a “poor” problem and the middle classes are just as vulnerable.
The consultant paediatrician, who works at Ealing Hospital and BMI Clementine Churchill, said GPs should be more alert to symptoms such as muscle aches and pains.
He told the Evening Standard: “This is a totally avoidable condition which is now a public health issue. It's affecting middle-class children because they're overprotecting with sunscreen and not going out as much.
SPF is also increasingly in cosmetics used by young women.
“The more dramatic cases tend to be in people who wear traditional clothing and so are covered up.”
However, he added, GPs also see a growing number of low-level cases in other groups.
Warnings over the links between sunburn and skin cancer have prompted some people to shun the sun
The actress Gwyneth Paltrow has revealed recently that she was diagnosed with very poor vitamin D levels after years of keeping her skin covered.
A special investigation is being launched into the extent of emergency admissions for patients with vitamin D deficiency.
The British Paediatric Surveillance Unit will gather data from hospitals from next year.
Mr Michie analysed the cases of 17 babies and infants treated at Ealing Hospital for a severe lack of vitamin D between 2006 and 2008. He found many experienced a delay in walking, a problem last common in Victorian times.
Cancer Research UK is considering changing it guidelines concerning sun exposure because of the problem.
Instead of advising people to stay out the midday sun completely, it may suggest that a few minutes exposure could be healthy.

Yes, you do need more D

It is heartening to see more good coverage about the importance of Vitamin D to health in MSM.
You'll see a comment in this story about D and diabetes.  For decades we have been recommending low dose zinc with vitamin D 3 for Type 1; this combination may help reverse it.

Many people fall short in consumption of vitamin D, studies show
By Michael Hastings, Winston-Salem Journal
August 15, 2010

Vitamin D fortifies a lot of foods, including milk, cereal and orange juice. And it's naturally found in wild-caught oily fish such as salmon and tuna.
That suggests that most people get plenty of Vitamin D.
But that's wrong.
Vitamin D deficiency is a widespread problem.
"Probably 90 percent of my patients are low," said Dr. Victoria Nnadi, a physician at Forsyth Internal Medicine Kernersville, owned by Novant Health.
Dr. Michael F. Holick, a Vitamin D expert at the Boston University School of Medicine, has been quoted as saying that Vitamin D is the most common nutritional deficiency and probably the most common medical problem in the world.
Getting adequate Vitamin D would seem easy. We need to spend only a few minutes a day in the sun.
In general, 5 to 10 minutes a day between 10 a.m. and 3 p.m. with minimal clothing is considered good. But cloud cover, sunscreen, skin pigmentation and even northern latitudes can reduce the penetration of ultraviolet-B rays.
And with sedentary lifestyles and concerns about skin cancer, many people never get enough sun to provide adequate amounts of Vitamin D.
Similarly, most people don't eat enough food with Vitamin D. Kathie Sigler, a registered dietitian with Diabetes and Nutrition Services at Forsyth Medical Center in Winston-Salem, said that someone would have to drink a quart of milk a day to get the 400 IUs (International Units) for people from birth to age 50. This the current amount recommended by the Institute of Medicine, an independent organization.
That leaves supplements as the best alternative. But experts disagree about the optimum level of Vitamin D. The National Institutes of Health currently considers 15 nanograms per millimeter of 25-hydroxyvitamin D in the blood as adequate. But last year, the Institute of Medicine started a 24-month review of current recommendations.
The 2000-2004 National Health and Nutrition Examination Survey, conducted by the federal government, acknowledged the disagreement by publishing results for three different levels of Vitamin D. The survey found that 50 percent to 78 percent of all three groups surveyed (whites, Hispanics and blacks) fell below the highest level (30 ng/ml).
The nonprofit Vitamin D Council says that the level considered good should be 50 ng/ml. And many doctors, including Nnadi, agree.
Nnadi typically sees people with chronic illnesses, and many of them have multiple illnesses. And Vitamin D affects every part of the body. It is associated with the health of bones, the heart, muscles, the immune system and the prevention of cancer.
"I often will see (Vitamin D deficiency) in people who come in all achy, with low-back pain, arm pain or pain all over," Nnadi said.
Sigler said that Vitamin D is involved with the onset of diabetes. "It helps the pancreas make insulin. It helps the cells use that insulin," she said. "If the cells can't use that insulin, if there's not enough Vitamin D there, then diabetes can develop."
Sigler also said that improved Vitamin D can help people manage the complications of diabetes. For instance, the pain of neuropathy, a burning sensation in the feet, can be eased when Vitamin D levels are improved.
Sigler also said that good Vitamin D levels can promote healing after radiation therapy and help with fatigue and mild forms of depression.
It is possible to take too much Vitamin D, but that rarely happens, Nnadi and Sigler said. The NIH currently recommends a maximum of 1,000 IU of Vitamin D for infants and 2,000 IU for anyone age 1 or older.
"I would not start taking supplements (beyond a multivitamin) without getting your blood tested and without talking to your doctor," Sigler said.
Still, studies clearly show that many of us could use more Vitamin D -- and the many health benefits it can provide.
"The take-home message," Nnadi said, "is to get the Vitamin D level checked."

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