Endocrinology Metabolism

Vitamin D in Osteoporotic patients

Are you Sure the Patient with Osteoporosis should take Vitamin D?

Management and Treatment of the Disease

My patient with osteoporosis has a 25-hydroxyvitamin D level of 20 ng/ml. Is that enough?

For the population in general, a 25-hydroxyvitamin D level of 20 ng/ml was considered adequate by the Institute of Medicine. For your patient with osteoporosis a higher target is more appropriate because:

  1. Patients often do not take vitamin D supplements regularly

  2. Some vitamin D assays may overestimate the level

  3. As patients become more obese, the volume of distribution increases, which may lower the level

  4. In one study, to eliminate all evidence of osteomalacia on bone biopsy, a vitamin D level of 30 ng/ml was needed

  5. Some studies show that a vitamin D level of 30 ng/ml is needed for optimal response to bisphosphonate therapy for osteoporosis.

For the osteoporosis patient 30 ng/ml is a reasonable target. There is no evidence that this level is dangerous.

The Institute of Medicine stated that the general population needs 600-800 units daily in diet plus supplements. They also stated that up to 4000 units daily was probably safe.

What is the best way to give my osteoporosis patient vitamin D?

Cholecalciferol (Vitamin D3) is readily available over the counter in 400 international unit, 1000 international unit, and 2000 international unit tablets or capsules. It is inexpensive and can be taken daily. For the osteoporosis patient, the serum 25-hydroxyvitamin D level should be measured and the dose adjusted so that the patient attains a level of 30 ng/ml.

An alternative is to use ergocalciferol (Vitamin D2), which is available by prescription as a 50,000 international unit capsule. To increase the vitamin D level quickly, the patient can take 50,000 units weekly for 4 to 12 weeks and then maintain the level with a monthly capsule. Occasional patients will need 50,000 units every 2 weeks to maintain a level of 30 ng/ml.

Do not give larger doses of vitamin D at one time. There are studies showing that 500,000 units once yearly actually increases risks for falling.

My patient has sarcoidosis. Is vitamin D dangerous in this case?

Some granulomatous diseases, such as sarcoidosis, can produce hypercalciuria and hypercalcemia because the granulomas may contain the 1-alpha hydroxylase that activates 25-hydroxyvitamin D. This unregulated production of calcitriol leads to increased gut absorption of calcium, hypercalciuria and even hypercalcemia. Thus, the patient with active granulomatous disease must be monitored more carefully than the typical patient with osteoporosis. In addition to the 25-hydroxyvitamin D level, a 24-hour urine for calcium and creatinine and serum calcium must be followed as you carefully increase the 25-hydroxyvitamin D level. Other granulomatous disorders that can lead to hypercalcemia include lymphoma and tuberculosis.

Does vitamin D prevent osteoporotic fractures?

In a meta-analysis, vitamin D with calcium had a modest effect in reducing fracture risk. For most patients with osteoporosis, further pharmacologic therapy is necessary. A very recent analysis concluded that at least 800 international units daily were necessary to prevent fractures.

A recent study found a correlation between vitamin D levels and strength of the femoral neck. Nonetheless, there is still controversy about the efficacy of vitamin D to prevent or treat fractures; most studies are of vitamin D plus calcium. For osteoporosis patients now, follow the IOM recommendations as modified by other experts to assure about 1000 to 1200 mg of elemental calcium and a 25-hydroxyvitamin D levels of 30 ng/ml.

My patient wants to take mega-doses of vitamin D to prevent cancer and heart disease. What do I advise?

More is not better. Indeed, just like the patient with sarcoidosis, excess vitamin D ingestion by your patient may lead to hypercalciuria (possibly kidney stones) and hypercalcemia. For the osteoporosis patient, aiming for a 25-hydroxyvitamin D level of 30 ng/ml is reasonable and safe.

There is epidemiologic evidence suggesting that lower levels of vitamin D may be associated with heart disease, cancer, diabetes, and multiple sclerosis. However, such studies generate hypotheses that need to be proven by clinical trials. At this point, there is tantalizing evidence that these associations are important, but little evidence that vitamin D levels beyond 30 ng/ml will prevent disease.

Some large trials are planned or are in progress that we hope will provide definitive answers.

Tell your patient that for now, if she has osteoporosis, 30 ng/ml is a safe target for the 25-hydroxyvitamin D level. She will definitely not be deficient if this is her level. We need more studies to learn the potential benefits and harms of higher target levels.

I have heard that low vitamin D levels are associated with stress fractures in younger people. Is this true?

Studies in military recruits have generally demonstrated that young individuals with the lowest 25-hydroxyvitamin D levels and the poorest physical condition upon starting boot camp have the greatest chance of a stress fracture. A recent study from the UK confirms that low vitamin D levels predict risk of stress fracture in military recruits.

What’s the Evidence?/References

Levels of vitamin D

Ross, A.C., Manson, J.E., Abrams, S.A.. "The 2011 report of dietary reference intakes for calcium and vitamin D from the Institute of Medicine: what clinicians need to know". J Clin Endocrinol Metab. vol. 96. 2011. pp. 53-8.

(In this summary of a very extensive literature review, the authors state that for the general population a vitamin D level of 20 ng/ml is adequate for bone health. For this, most adults will need 600-800 international units daily. However, they also concluded that up to 4000 units daily was probably safe.)

Black, D. M., Rosen, C.J.. "Clinical practice. Postmenopausal osteoporosis". N Engl J Med. vol. 374. 2016. pp. 254-262.

(This practical article includes the Institute of Medicine recommendations in the context of treating older women with osteoporosis.)

Holick, M.F., Binkley, N.C., Bischoff-Ferrari, H.A.. "Evaluation, treatment, and prevention of vitamin D deficiency: an Endocrine Society clinical practice guideline". J Clin Endocrinol Metab. vol. 96. 2011. pp. 1911-1930.

(This clinical guideline differs from the IOM report in that it interprets the literature to show that a level of 30 ng/ml is a better target than 20 ng/ml.)

El Hajj Fuleihan, G., Bouillon, R., Clarke, B.. "Serum 25-hydroxyvitamin D levels: variability, knowledge gaps, and the concept of a desirable range". J Bone Miner Res. vol. 30. 2015. pp. 1119-1133.

(This is a well-written, clinically relevant, and practical approach to choosing a reasonable vitamin D level for your patients.)

Vitamin D and fractures

Chung, M., Lee, J., Terasawa, T.. "Vitamin D with or without calcium supplementation for prevention of cancer and fractures: an updated meta-analysis for the U.S. Preventive Services Task Force". Ann Intern Med. vol. 155. 2011. pp. 827-838.

(This analysis concluded that the combination of calcium and vitamin D provided a small reduction in fracture risk. However, full assessment of potential harms was not possible yet.)

Bischoff-Ferrari, H.A., Wilett, W.C., Orav, E.J.. "A pooled analysis of vitamin D dose requirements for fracture prevention". N Engl J Med. vol. 367. 2012. pp. 40-49.

(This analysis concluded that at least 800 units of vitamin D daily was needed to demonstrate any favorable effect on fracture prevention. Nonetheless, this analysis remains controversial.)

Larocque, S.C., Lerstetter, J.E., Cauley, J.A.. "Dietary protein and vitamin D intake and risk of falls: a secondary analysis of postmenopausal women from the Study of Osteoporotic Fractures". J Nutr Gerontol Geriatr. vol. 34. 2015. pp. 305-318.

(In unadjusted analyses, both low protein intake and low vitamin D levels were associated with falls in postmenopausal women. When other fall risk factors were added, the association was not significant. Still, low protein intake and inadequate vitamin D are often found in older people who have the other risk factors for falls, so the authors still recommend adequate dietary intake of protein and vitamin D.)

Carmel, A.S., Sheih, A., Bang, H.. "The 25-hydroxyvitamin D level needed to maintain a favorable bisphosphonate response is > 33 ng/ml". Osteoporos Int. vol. 23. 2012. pp. 2479-2487.

(This is the latest study that demonstrates the need for adequate vitamin D in osteoporosis patients treated with bisphosphonates.)

Vitamin D and stress fractures

Davey, T., Lanham-New, S.A., Shaw, A.M.. "Low serum 25-hydroxyvitamin D is associated with increased risk of stress fracture during Royal Marine recruit training". Osteoporos Int. vol. 27. 2016. pp. 171-179.

(This study confirms the association of low vitamin D levels and the risk for stress fractures in young people starting the vigorous exercise program at the beginning of military service.)
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