Vitamin D and Bone Health – UK National Osteoporosis Society – April 2013

Vitamin D and Bone Health: A Practical Clinical Guideline for Patient Management

There is growing interest in the importance of vitamin D, not only in the maintenance of bone health but also in terms of its potential role in the prevention of nonskeletal disorders such as auto-immune disease, cancer, mental health problems and cardiovascular disease. Although there is no universal consensus on the criteria for vitamin D deficiency, it is common in the UK, particularly in older people. The awareness that vitamin D deficiency may contribute to the development of osteoporosis and to falls and fractures has resulted in a dramatic increase in requests for serum 25 hydroxyvitamin D (25OHD) measurements. The lack of national guidance on the indications for 25OHD measurements, on the interpretation of the results and on the correction of vitamin D deficiency has resulted in confusion among patients and health-care professionals and in the proliferation of conflicting guidelines and inconsistent practice across the UK. As a result, the National Osteoporosis Society has developed this practical clinical guideline on the management of vitamin D deficiency in adult patients with, or at risk of developing, bone disease. This guideline does not address the management of vitamin D deficiency in childhood, in pregnancy or in patients with severe or end-stage chronic kidney disease (CKD Stages 4-5).
The guideline was developed by a group of clinicians and scientists with expertise in vitamin D and osteoporosis. The group used evidence from the Institute of Medicine (IOM) report in 2010, supplemented by literature reviews to identify papers published subsequently. The IOM report itself sought evidence from two systematic reviews from the Agency for Healthcare Research and Quality (AHRQ), based in Tufts University and Ottawa. Where clear-cut evidence was unavailable to inform the National Osteoporosis Society guideline, the authoring group have offered pragmatic advice, based on a consensus of their own views and experience. It is important to highlight that this is a clinical guideline intended to inform patient management but not to influence public health policy. The latter is the remit of the Department of Health Scientific Advisory Committee on Nutrition (SACN), which is currently reviewing the dietary reference values for vitamin D.

Authors: Prof. Roger Francis (Chair), Dr. Terry Aspray, Prof. William Fraser, Dr. Neil Gittoes,
Dr. Kassim Javaid, Prof. Helen Macdonald, Dr. Sanjeev Patel, Prof. Peter Selby, Dr. Nuttan Tanna,
Dr. Claire Bowring.
Version: 1 Publication date: April 2013; Date for review: April 2016
Funding: The development of this document was funded by the National Osteoporosis Society. We are grateful to the authors for giving their time without charge.
Please send any comments on this practical guide to policyissues at nos.org.uk

Contents

Glossary and abbreviations 4
Conversion factors 4
Key recommendations 5
The role of vitamin D in bone health 6
Vitamin D and parathyroid hormone 6
Vitamin D and bone mineral density 7
Vitamin D, falls and fractures 7
Summary 8
How should we assess Vitamin D status? 9
Introduction 9
Biochemical assessment of Vitamin D status 10
Who should be tested for vitamin D deficiency? 11
Patients with bone diseases (a) that may be improved with vitamin D treatment or (b)
where correcting vitamin D deficiency prior to specific treatment would be appropriate 12
Patients with musculoskeletal symptoms that could be attributed to vitamin D deficiency 12
Asymptomatic individuals at higher risk of vitamin D deficiency 13
Asymptomatic healthy individuals 13
Who do we treat? 14
How do we treat vitamin D deficiency? 14
Vitamin D3 or vitamin D2? 14
Oral or intramuscular administration? 15
Fixed or titrated dosing strategy? 15
Lower daily dose or higher intermittent dose? 15
Calcium supplementation 16
Example regimens 17
Monitoring 17
Assessment of improvement in 25OHD status on replacement therapy 18
Vitamin D toxicity 18
Hypercalcaemia 19
Hypercalciuria and renal stones 19
References 20
Appendix 1: Guidance for treatment of Vitamin D deficiency 25

Key recommendations

• Measurement of serum 25OHD is the best way of estimating vitamin D status.
• Serum 25OHD measurement is recommended for:
  patients with bone diseases that may be improved with vitamin D treatment
  patients with bone diseases, prior to specific treatment where correcting vitamin D deficiency is appropriate
  patients with musculoskeletal symptoms that could be attributed to vitamin D deficiency.
• Routine vitamin D testing may be unnecessary in patients with osteoporosis or fragility fracture, who may be co-prescribed vitamin D supplementation with an oral antiresorptive treatment.
• In agreement with the Institute of Medicine (IOM), we propose that the following vitamin D thresholds are adopted by UK practitioners in respect to bone health:
  serum 25OHD < 30 nmol/L is deficient
  serum 25OHD of 30-50 nmol/L may be inadequate in some people o serum 25OHD > 50 nmol/L is sufficient for almost the whole population.
• Oral vitamin D3 is the treatment of choice in vitamin D deficiency.
• Where rapid correction of vitamin D deficiency is required, such as in patients with symptomatic disease or about to start treatment with a potent antiresorptive agent (zoledronate or denosumab), the recommended treatment regimen is based on fixed loading doses followed by regular maintenance therapy:
  a loading regimen to provide a total of approximately 300,000 IU vitamin D, given either as separate weekly or daily doses over 6 to 10 weeks
  maintenance therapy comprising vitamin D in doses equivalent to 800-2000 IU daily (occasionally up to 4,000 IU daily), given either daily or intermittently at higher doses.
• Where correction of vitamin D deficiency is less urgent and when co-prescribing vitamin D supplements with an oral antiresorptive agent, maintenance therapy may be started without the use of loading doses.
• Adjusted serum calcium should be checked 1 month after completing the loading regimen or after starting vitamin D supplementation in case primary hyperparathyroidism has been unmasked.
• Routine monitoring of serum 25OHD is generally unnecessary but may be appropriate in patients with symptomatic vitamin D deficiency or malabsorption and where poor compliance with medication is suspected.

Appendix 1: Guidance for treatment of Vitamin D

• Treatment of vitamin D deficiency should be effective in terms of assessment and testing, with easy availability of vitamin D formulations, good patient treatment adherence and practical requirements for monitoring a chronic condition.
• Based on current medical consensus, vitamin D3 is recommended as the vitamin D preparation of choice for treatment of vitamin D deficiency. However, D2 should be used in those who cannot take D3 for cultural, dietary or religious reasons because of the animal vs. plant sourcing of vitamin D or the use of gelatine in some preparations.
• The oral supplementation route is recommended in preference to the parenteral route. A titrated treatment approach is likely to be more effective than a fixed approach when treating vitamin D deficiency. However, the complexity of regimens and the paucity of evidence limits this approach.
• The treatment replacement schedule includes a loading phase with high doses of vitamin D3 (or D2) over several weeks and then moves into a maintenance phase with options of daily supplements or less frequent 'top ups' according to individual patient needs.
• There may be sub-groups of patients identified who are unable to maintain adequate vitamin D status. These may require a more aggressive replacement or maintenance schedule provided under specialist supervision in a secondary-care setting.
• As more patients are treated, it is likely that patients with increased sensitivity to vitamin D therapy because of genetic abnormalities in vitamin D metabolism, co-morbidities such as CKD, granuloma-forming diseases or hyperparathyroidism will be identified and require lower subsequent dosing.
• Use of a single mega-dose (300,000 IU or higher) for loading patients, while an attractive option with good adherence, has been shown to be either ineffective 64 or associated with higher rates of falls and fractures 65 In the absence of further studies, such single-loading-dose strategies are not recommended.

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PDF is attached at the bottom of this page

VitaminDWiki sees many problems with this paper - such as:

1. D2 should not be used for any mammals – including humans
2. There are plant sources of vitamin D3
3. It considers vitamin D to be a monotherapy – Fails to consider vital cofactors
4. 20 ng.ml (50 nmol) is not an optimal level of vitamin D
5. Maintenance therapy after loading dose is far too low to maintain even a 20ng blood level
6. There are other sources of vitamin D for those who have poor digestive systems
7. It ignores that too much vitamin A causes bone problems
8. Disagrees with the Osteoporosis Societies in Many other countries - such as Canada and the US

See also VitaminDWiki

• Overview Osteoporosis and vitamin D
• UK Osteoporosis Society (inadequate) guidelines for vitamin D and bone health – Nov 2014
• National Osteoporosis Society of UK declares that 12 ng of vitamin D is enough – June 2013 same group!
• European Osteo group recommends 20-50 ng of vitamin D – Jan 2013
• Is 50 ng of vitamin D too high, just right, or not enough
• Korea proposes vitamin D of 20 ng, but notes 20ng increases osteo by 50 percent – Oct 2012
• Vitamin D, K2, Magnesium, etc increase bone density when taking together– Jan 2012
• 30 to 50 ng of vitamin D is optimal – Central Europe consensus Sept 2013
• Dark Skinned adults need more than 45 minutes of UK summer sun daily – June 2013
• 8X higher Osteoporosis risk if high level of vitamin A, vitamin D important too – Feb 2013
• Overview - Bone Fractures
• Overview: Vitamin D and falling
• Overview Loading of vitamin D loading dose varies by weight as well as current vitamin D blood level.(but not in the paper on this page)
• Overview Rare Allergic reaction to vitamin D since about 1 person in 300 gets an allergic reaction to vitamin D, people should be checked before giving loading doses