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AUSTRALIAN experts have refuted an article published in The BMJ that claims there is a lack of evidence on the benefit of calcium and vitamin D in the treatment of osteoporosis. (1)
In a joint statement to MJA InSight, Professor Peter Ebeling and Dr Greg Lyubomirsky, the medical director and CEO of Osteoporosis Australia, said their organisation acknowledged the ongoing controversy surrounding this issue and would not “shy away” from changing their recommendations in the future.
However, they said The BMJ article failed to present a balanced view of existing evidence, and Osteoporosis Australia would maintain its position that “calcium and vitamin D play a key role in the maintenance of bone health, and adequate intakes and levels are required throughout life for Australians”.
The BMJ analysis included a range of clinical trials that assessed the harms and benefits of vitamin D and calcium use in the treatment of osteoporosis.
The authors wrote that by the end of 2010, 14 large randomised trials of calcium supplements, vitamin D supplements, or a combination, had been published. Of these, three reported a reduction in fracture risk, nine no effect, and two an increased risk of fracture. Among 24 smaller trials that had been conducted, 21 found no effect.
Evidence on harms associated with supplementation had also started to emerge, including gastrointestinal symptoms, kidney stones, falls and adverse cardiovascular outcomes, including myocardial infarction and stroke, they wrote.
Dr Paul Glendenning , a Perth endocrinologist, told MJA InSight that he disagreed with the arguments made by The BMJ authors, saying they had “selectively” quoted research findings.
"The data they quoted were largely their own analyses, and in totality it doesn’t actually establish a convincing case for any increase in cardiovascular risk."
Dr Glendenning said there were also notable randomisation and adjudication biases associated with some of the individual trials which skewed the conclusions.
“If there is an increase in cardiovascular morbidity, why then are we not seeing any change in [the number of cases] or cardiovascular mortality rates?”
However, Dr Glendenning said it was important to bear in mind that supplementation with calcium and vitamin D was just one part of osteoporosis management.
Among patients with a higher fracture risk, “additional antiresorptive treatment in combination with calcium and vitamin D is needed”, he said.
Professor John Eisman, director of clinical translation and advanced education at the Garvan Institute, agreed, telling MJA InSight that the promotion of calcium and vitamin D intake should be grouped into the “healthy lifestyle” advice that doctors gave to their patients with osteoporosis.
The BMJ authors argued that one reason why supplementation continued to be widely recommended despite the lack of efficacy was due to the vested interests of industry, and their influence with advocacy organisations and academia.
"Advocacy organisations and specialist societies should eschew corporate sponsorship, and academics should not engage with advocacy organisations until it is clear that such commercial ties have been severed”, they said.
Professor Eisman said he was disappointed that the authors had framed their argument this way.
“There’s a big difference between doctors recommending calcium and vitamin D intake as part of a healthy lifestyle, and them being in the pockets of Big Pharma.”
Professor Eisman said this argument reflected a broader trend of distrust towards research conducted by pharmaceutical companies, which was akin to “throwing the baby out with the bathwater, especially when we have clear randomised controlled evidence of benefits of pharmacotherapy in osteoporosis”.
However, all experts agreed on the need for additional research into the harms and benefits of vitamin D and calcium supplementation, especially in relation to cardiovascular risk.
Professor Ebeling and Dr Lyubomirsky said that to date, adverse events had not been a major focus of osteoporosis prevention trials, and it was important that adverse outcomes were verified by research.
“[So far], when adverse events are externally verified, most findings suggest that a link between calcium supplementation and cardiovascular events is not clearly established”, they said.
In a written statement to MJA InSight, the Therapeutic Goods Administration said that in the past 12 months, it had not received any complaints regarding the efficacy or adverse events associated with products used in osteoporosis treatment.
Osteoporosis Australia said the current conjecture over supplementation should be addressed through ongoing medical education about safe levels of calcium and serum vitamin D for patients.
(Photo: michaeljung / shutterstock)
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Marcus Navin would not know his foot from his Knee!!!!
As an ex-nurse and now a patient I have been put on Vitamin D3 supplements for low levels 4 times over the past nine years and believe in all of those except the first time I have over a few months of one capsule a day developed moderately severe gastrointestinal symptoms which resolve gradually when I stop the Vitamin D and take a calcium channel blocker prescribed for me by a vascular surgeon after I developed bowel ischaemia following a low flow operation for cancer and the subsequent discovery of a 50% Coeliac Artery stenosis.
I have osteoporosis now despite a healthy lifestyle and have just recently been diagnosed with Coeliac Disease so am now on a gluten free diet but as I have continued this my symptoms became worse until I once again stopped the Vitamin D and took the calcium channel blockers.
My first symptoms of Coeliac Disease only surfaced after a dose of S/C Prolia last September 2014 and I have read that the immune system implications of this drug may be able to do this. Other anti-osteoporotic medications over the years have also led to adverse health effects.
As I have now been told that had I been diagnosed and treated for Coeliac Disease back in the 1980s when I was tested for allergies and found to have a sensitivity to all the cereals, I may never have broken all the ten vertebrae that I now have so I sincerely hope by sharing my story that in the future instead of dangerous drugs and possible side effect-causing Vitamin D and Calcium supplements especially in patients who already have some arterial narrowing, that the doctors will instead start with checking for Coeliac Disease and hopefully recognise that oral Calcium and Vitamin D may indeed be potentially harmful to us all.
The BMJ article clearly indicates not a lack of evidence for Vit D/Calcium efficacy but instead high level statistical evidence for the lack of efficacy and safety of its use.
While I admit this to be counter-intuitive to the scientific mind there are other areas where well-intentioned interventions fail to bring about the intended and seemingly logical change, sometimes even bringing about more harm than good.
What the BMJ is asking us is to review the evidence available and in this article about the response by the Australian ‘authorities’ I sadly cannot see any evidence-based or scientific argumentation, to the contrary. That approach in itself should give us pause because no longer operate in the aforementioned area of ‘common-sense practice’ that simply lacks evidence to support it – we now have strong evidence that tells us what we have done is wrong.
Question is are we brave enough to admit it and adopt change or do we want to wait till patients die because of our well intentioned and as usual pharma-sponsored interventions?
Larry, this wouldn’t be the first case of supplementation being harmful when normal dietary intake is not, and there have been mechanisms proposed to explain this. Leaving aside the issue of cardiovascular risk, in this age group constipation can be problematic and calcium supplements certainly exacerbate this. I think too often patients are advised to take calcium supplements before they are questioned about their dairy intake.
Does this issue reflect yet another area where routine expectations for “preventive therapy” may do more harm than good?
If calcium and vit D supplementation lead to an increase in adverse CV events, why doesn’t calcium in our diet and vit D from the sun?
The BMJ article claims there is currently lack of evidence for the benefit of calcium & vit D in the treatment of osteoporosis. I remind readers that there was a time in general practice when when we were decreasing morbidity/mortality by organising screening FOBT’s & mammography & asthma management plans & aiming to lower glucose levels in patients with diabetes etc etc before the evidence was available. One has to practice sensible medicine until the evidence becomes available. It seems to me that the hard evidence is not yet in and that where appropriate we should aim to maintain “bone health” with weight bearing exercise and adequate calcium & vit D supplementation until proven otherwise. I don’t propose we give calcium supplements to people with nephrolithiasis.
We need to also be cognisant of the fact that Rickets in developing young bones is due to vit D deficiency +/- lack of adequate dietary calcium.
We aim to improve CV health by decreasing dietary fat and more of my patients are on low dairy diets with presumably lower calcium intake.
Kindly excuse the somewhat cynical tone.
The “prescription” most often seen (for Vit D and Calcium) is one given as a result of a blood test demonstrating a low level of Vitamin D. There is often no evidence of (or concern about) osteoporosis, merely a blood test (regularly or repetitively ordered and thereby inevitably taken in the winter months) that raises a concern in a patient. The attentiveness of the practitioner demonstrates the effectiveness of the medical practitioner’s care as seen by the patient. Thus compliance is assured with attendant return visits to the medical practitioner.
Perhaps therein lies the problem, as outlined in the research, as to the the lack of demonstrated benefit in a broad (an indolent?) population?
Your poll needs to include another option – that calcium and vitamin D supplements have neither great benefits for preventing osteoporosis, nor high risk of other problems. As I see it, the problem is that it sounds good in theory to prescribe extra calcium and vitamin D, but so many studies fail to find benefits. On the other hand, claims of risk from these supplements may not be particularly strong.
Unfortunately, claims about calcium and vitamin D have led many people to thinking that swallowing an expensive supplement is all they need to do. It is good to see the comments from Australian experts (above) also stressing the need for lifestyle changes.
A spin-off for those marketing the supplements comes when Recommended Dietary Intakes for calcium are set so high that it is difficult to meet them from a normal healthy diet. Those pushing for these high RDIs have used arguments about providing protection from osteoporosis as a guide. This has created a support system for supplements which ignores the many studies showing no benefits.
Vitamin D has also been subjected to levels set higher than the evidence supports, with no allowance for seasonal changes and the body’s ability to store this nutrient in summer to get the body through winter. Instead, we are told that summer levels are the minimum. This sells supplements, when a short period of (free) skin exposure to sunlight at approriate times of the day would suffice (with exceptions when culture requires covering skin and for the frail aged. Supplements are valuable for these people, but are they the ones buying the expensive supplements? Not in my experience.
This poll could be misleading. I agree with the author of the previous comment. The issue may be calcium supplements rather than vitamin D supplements.
I am convinced that for patients with low vitamin D3 levels, supplementation with vitamin D3 is indicated. I am not convinced about calcium supplementation, as possible adverse cardiovascular events are of concern until proven otherwise. Thus I will not presently advocate e.g.Caltrate by itself or Caltrate-D as supplementation.