POSITION STATEMENTS

Vitamin D supplementation and Fracture Prevention

December 1, 2022

Recommendations from Osteoporosis Canada Rapid Response Team

We are aware of the recent study by Dr. Meryl Leboff that concluded vitamin D3 supplementation of 2000 IU daily does not significantly lower the risk of fractures among generally healthy midlife and older adults. It is important to note that the study’s results and recommendations do not apply to individuals who have osteoporosis, previous fragility fractures or are at risk of severe vitamin D deficiency.

Osteoporosis Canada encourages individuals with osteoporosis to continue taking their current vitamin D supplementation.  Vitamin D helps build stronger bones by increasing the absorption of calcium. It also improves the function of muscles, which can improve your balance and decrease the likelihood of falling and suffering a fracture.

If you have osteoporosis, discuss your vitamin D requirements with your health care professionals before making any changes to your routine.

Vitamin D Supplementation and Fracture Prevention

August 19, 2022

Dr. Adrian Lau, Dr. Rowena Ridout, Dr. Claudia Gagnon, Dr. Zahra Bardai, Dr. Emma Billington and Dr. Wendy Ward.

Recommendations from Osteoporosis Canada Rapid Response Team.

LeBoff and colleagues (1) recently published the results of an ancillary study of the Vitamin D and Omega-3 Trial (VITAL), concluding that Vitamin D3 supplementation of 2000 IU daily did not result in a significantly lower risk of fractures than placebo among generally healthy midlife and older adults.

In an editorial in response to these results, Cummings and Rosen (2) suggest that “providers should stop screening for 25-hydroxyvitamin D levels or recommending vitamin D supplements, and people should stop taking vitamin D supplements to prevent major diseases or extend life”.

These articles have raised concerns in the osteoporosis community, amongst health care professionals, patients, and caregivers.  Should patients with osteoporosis or previous fragility fractures continue their vitamin D3 supplementation?  Should their vitamin D levels be checked?

An individual’s medical risk of conditions in which vitamin D monitoring and supplementation may be of benefit should be carefully evaluated.

It is important to note that the participants in this study were representative of the general American population and thus results and recommendations may or may not be applicable to patients with osteoporosis, previous fractures, or those at risk of severe vitamin D deficiency.  At baseline, only about 10% of the study participants had previous fragility fractures, and less than 5% were on osteoporosis medications.    

About 42% of participants were already on vitamin D supplementation prior to the initiation of the study.  If participants were randomized to the placebo group (as opposed to the vitamin D 2000 IU group), they were allowed to continue their vitamin D supplementation, up to 800 IU daily.  Of note, the baseline 25-hydroxyvitamin D level of participants was 30 ng/ml, or 75 nmol/L, which is in target as per our current guidelines.  While vitamin D was not shown to prevent fractures in this study group, this effect of vitamin D supplementation cannot be generalized to patients with osteoporosis given their higher risk of fractures.

What should we do about Vitamin D testing?

The screening of 25-hydroxyvitamin D levels in the general population is currently not recommended (3).  However, there may be specific situations where vitamin D testing may be of clinical use.  These include patients with co-morbidities which affect vitamin D absorption and metabolism, where testing may help identify significantly low 25-hydroxyvitamin D levels, and facilitate correct dosing of vitamin D supplementation.  These co-morbidities include malabsorptive disease, renal disease, living in institutionalized settings, and taking certain medications which may affect vitamin D metabolism.  Screening lab tests may also be useful prior to the initiation of anti-resorptive agents for osteoporosis, as low 25-hydroxyvitamin D levels may be a risk factor for hypocalcemia.

What should we do about Vitamin D supplementation?

We encourage our patients with osteoporosis to continue with their current vitamin D supplementation, as per the current Osteoporosis Canada Guidelines (4), and according to their personal clinical needs.  As few foods contain vitamin D, Health Canada recommends that all Canadians over age 50 take 400 IU of vitamin D per day (5).  Also, most pharmacotherapy trials provided participants with a minimum of 400 IU of vitamin D per day.  Patients should discuss their vitamin D requirements with their health care professionals before making any changes to their routines.

References

  1. LeBoff MS, Chou SH, Ratliff KA, Cook NR, Khurana B, Kim E, Cawthon PM, Bauer DC, Black D, Gallagher JC, Lee I, Buring JE, Manson JE.  Supplemental Vitamin D and Incident Fractures in Midlife and Older Adults.  New England Journal of Medicine. 2022;387(4):299-309.
  2. Cummings SR and Rosen C. VITAL Findings — A Decisive Verdict on Vitamin D Supplementation.  New England Journal of Medicine.  2022;387(4):368-370.
  3. Lindblad AJ, Garrison S, McCormack J.  Testing vitamin D levels.  Canadian Family Physician. 2014;60(4):351.
  4. Papaioannou A, Morin S, Cheung AM, Atkinson S, Brown JP, Feldman S, David A. Hanley DA, Hodsman A, Jamal SA, Kaiser SM, Kvern B, Siminoski D, Leslie WD.  2010 clinical practice guidelines for the diagnosis and management of osteoporosis in Canada: summary.  CMAJ.  2010;182(17):1864-1873.
  5. https://www.canada.ca/en/health-canada/services/food-nutrition/healthy-eating/vitamins-minerals/vitamin-calcium-updated-dietary-reference-intakes-nutrition.html

COVID-19 Vaccination and Osteoporosis Drug Therapy

April 1, 2021

Dr. Aliya Khan, Dr. Heather Frame, Dr. Claudia Gagnon, Dr. Rowena Ridout, Dr. Lianne Tile and Dr. Sandra Kim

Recommendations from Osteoporosis Canada Rapid Response Team

Osteoporosis is a chronic condition which requires consistent pharmacologic intervention. There is currently no evidence that osteoporosis therapy increases the risk or the severity of COVID-19 infections. With the exception of bisphosphonates, which have long-term skeletal retention, cessation of osteoporosis drug therapy is associated with bone loss and an increased risk of fracture (1, 2). Thus it is important to not stop osteoporosis therapy or delay the dose of medication without consulting your physician.

The COVID -19 vaccine is given intramuscularly and may result in a mild flu like reaction as well as a local injection site reaction. This has been documented with both the adenovirus vector-based vaccine as well as the mRNA-based vaccine (3, 4). Since intravenous zoledronate or injected denosumab or romosozumab medications may also result in a flu like reaction or local injection site reaction, it is advisable that these medications not be administered at the same time as the COVID-19 vaccine. An interval of one week between infusion of the intravenous bisphosphonate zoledronate and COVID-19 vaccination is recommended. An interval of 4-7 days between subcutaneous administration of denosumab or romosozumab and the COVID-19 vaccination is recommended. As teriparatide is administered daily subcutaneously, it can be continued if it is well tolerated and has not resulted in any local injection site reactions. Osteoporosis Canada recommends administration of teriparatide in the abdominal wall or the thigh and not in the same location as the COVID-19 vaccine. Oral bisphosphonates and raloxifene can be continued without any delay in their administration. These recommendations are consistent with the joint recommendations made by the ASMBR, AACE, Endocrine Society, ECTS, IOF and NOF.

Osteoporosis Canada emphasizes the importance of close adherence to the dosing regimens of all osteoporosis medications to ensure optimal skeletal health.

References:

  1. Tsourdi E, Zillikens MC, Meier C, et al. Fracture risk and management of discontinuation of denosumab therapy: a systematic review and position statement by ECTS. J Clin Endocrinol Metab. 2020; doi: 10.1210/clinem/dgaa756 [Epub ahead of print)
  2. Napoli N, Elderkin AL, Kiel DP, Khosla S. Managing fragility fractures during the COVID-19 pandemic. Nat Rev Endocrinol. 2020;16(9):467-8.
  3. Zhu FC, Li YH, Guan XH, et al. Safety, tolerability, and immunogenicity of a recombinant adenovirus type-5 vectored COVID-19 vaccine: a dose-escalation, open-label, non-randomised, first-in-human trial. Lancet. 2020;395(10240):1845-54.
  4. Baden LR, El Sahly HM, Essink B, et al. Efficacy and safety of the mRNA-1273 SARS-CoV-2 vaccine. N Engl J Med. 2021;384(5):403-16.

COVID-19 Vaccination and Osteoporosis Drug Therapy

April 1, 2021

Dr. Aliya Khan, Dr. Heather Frame, Dr. Claudia Gagnon, Dr. Rowena Ridout, Dr. Lianne Tile and Dr. Sandra Kim

Recommendations from Osteoporosis Canada Rapid Response Team

Osteoporosis is a chronic condition that, if you are at high risk of fracture, requires treatment with an osteoporosis medication. There is currently no evidence that osteoporosis medications increase the risk or the severity of COVID-19 infections. With the exception of bisphosphonates, which stay in your bones for a longer time after you stop taking them, stopping osteoporosis drug therapy is associated with bone loss and an increased risk of fracture. Thus it is important to not stop osteoporosis therapy or delay the dose of medication without consulting your physician.

The COVID-19 vaccine may result in a mild flu-like reaction as well as a reaction at the injection site. This is true of all the vaccines available at this time. Since intravenous zoledronate (Aclasta) or injected denosumab (Prolia) or romosozumab (Evenity) medications may also result in a flu-like reaction or local injection site reaction, it is advisable that these medications not be administered at the same time as the COVID-19 vaccine. Although the timing of denosumab (Prolia) can be adjusted to accommodate vaccine timing, it is important to make sure that the denosumab (Prolia) dose is not more than seven months after the previous dose. An interval of one week between infusion of the intravenous bisphosphonate zoledronate (Aclasta) and COVID-19 vaccination is recommended. An interval of 4-7 days between an injection of denosumab (Prolia) or romosozumab (Evenity) and the COVID-19 vaccination is recommended. As teriparatide (Forteo) is administered daily, it can be continued if it is well tolerated and has not resulted in any local injection site reactions. Osteoporosis Canada recommends administration of teriparatide (Forteo) in the abdominal wall or the thigh and not in the same location as the COVID-19 vaccine. Oral bisphosphonates (Actonel, Fosamax, Fosavance) and raloxifene (Evista) can be continued without any delay in their administration. These recommendations are consistent with the joint recommendations made by the American Society of Bone and Mineral Research, the International Osteoporosis Foundation, the National Osteoporosis Foundation and other international organizations.

Osteoporosis Canada emphasizes the importance of following the dosing regimens of all osteoporosis medications to keep your bones healthy. It is also important to keep up with good bone health habits: enough calcium ideally from food, vitamin D supplementation, a balanced diet and appropriate exercise, including weight-bearing and strength training.

Celiac Disease and Bone Health

October 7, 2020

Aliya Khan, Heather Frame,  Claudia Gagnon,  Rowena Ridout , Lianne Tile,  Wendy Ward, Sandra Kim

Recently Duerksen and colleagues published on fracture risk assessment in celiac disease – a registry-based cohort study (1).  This study evaluated the incidence of major osteoporotic fractures (hip, spine, forearm and humerus) in patients with celiac disease confirmed by a positive celiac profile on blood testing, and compared the risk of fracture with those who did not have celiac disease. Individuals with celiac disease had more fractures in comparison to those who did not have celiac disease (HR 1.43 (95% CI 1.11-1.86)) (1).

This study confirms that celiac disease is associated with an increased risk of fracture. This registry-based study supports previous research (2) indicating that celiac disease appeared to be associated with an increased risk of fracture, however previous research was not conclusive as it was not clear if the increased fracture risk was due to the presence of celiac disease. Also, the impact of the gluten-free diet on fracture risk is still not well understood. People with celiac disease benefit from an assessment of bone health and fracture risk.

1. What is celiac disease and how does it affect bone health?

Celiac disease results from an immune reaction to the gluten present in wheat and other foods – ingestion of these foods results in the small bowel lining becoming flat, and affects absorption of nutrients including calcium, phosphate and vitamin D which are essential for bone mineralization and bone health. Also, celiac disease is associated with the release of inflammatory cytokines or proteins which increase the rate of bone loss, and may negatively affect bone formation. 

2. How does FRAX calculate fracture risk in celiac disease?

The FRAX calculation incorporates multiple risk factors for fracture and provides a prediction of future fracture risk over the next 10 years. If the bone mineral density data is entered into the calculator, it does not incorporate the presence of another cause for the osteoporosis (such as celiac disease) in determining the fracture risk. However, if BMD is not provided, it includes the presence of a secondary cause for the osteoporosis in determining fracture risk. This study showed that people with celiac disease had more fractures than expected if the celiac disease had not been present. The FRAX calculation appropriately predicted a higher fracture risk if the presence of celiac disease was considered as a secondary cause, or if BMD data was entered (1).

3. Are there any limitations of this study?

This data may not apply to men  or younger  individuals as the majority of the patients were women and the mean age was 60yrs. . It was also not possible to evaluate the patient’s ability to follow a gluten-free diet – some but not all patients may have followed the diet, and this may have affected the results of the study. Finally, the study was relatively small, with 693 patients with celiac disease and 68,037 patients in the general population.  

4.  How should this information be applied to people with celiac disease? 

People with celiac disease benefit from an assessment of bone health and fracture risk. It is important to ensure that adequate calcium, phosphate and vitamin D are being ingested and absorbed, as malabsorption of these essential nutrients can impair bone quality and strength. (3).  The importance of strict adherence to the gluten-free diet needs to be emphasized  to enhance absorption of key nutrients for optimal  bone quality and strength in those with celiac disease.

References

  1. Duerksen DR, Lix LM, Johansson H, McCloskey EV, Harvey NC, Kanis JA and Leslie WD. Fracture risk assessment in celiac disease: a registry-based cohort study. Osteoporosis International. August 3, 2020
  2. Heikkilä K, Pearce J, Mäki M and Kaukinen K. Celiac disease and bone fractures: A systematic review and meta-analysis. Journal of Clinical Endocrinology & Metabolism, 2015;100(1):25-34.
  3. Fouda MA, Khan AA, Sultan M, Rios LP, McAssey K and Armstrong D. Canadian evaluation and management of skeletal health in celiac disease: Position statement. Canadian Journal of Gastroenterology. 2012;26(11):819-29.

Scientific Advisory Council

Osteoporosis Canada’s rapid response team, made up of members of the Scientific Advisory Council, creates position statements as news breaks regarding osteoporosis. The position statements are used to inform both the healthcare professional and the patient. The Scientific Advisory Council (SAC) is made up of experts in Osteoporosis and bone metabolism and is a volunteer membership.

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