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Meta-analysis of Observational Studies of Risk of Any Fracture or of Hip Fracture Associated With an Increase of 25.0 nmol/L in Blood 25-Hydroxyvitamin D ConcentrationThe size of each square corresponds to the precision of the estimates in each observational study. Degree of adjustment for confounders denoted as , age and sex plus body mass index; , age, sex, and body mass index plus other standard fracture risk factors; and , age, sex, body mass index, and standard fracture risk factors plus markers of season or latitude. To convert 25-hydroxyvitamin D to nanograms per milliliter, divide by 2.496. Identify all potential conflicts of interest that might be relevant to your comment.Conflicts of interest comprise financial interests, activities, and relationships within the past 3 years including but not limited to employment, affiliation, grants or funding, consultancies, honoraria or payment, speaker's bureaus, stock ownership or options, expert testimony, royalties, donation of medical equipment, or patents planned, pending, or issued.Err on the side of full disclosure.If you have no conflicts of interest, check 'No potential conflicts of interest' in the box below.
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Key PointsQuestion What is the available evidence for the efficacy of vitamin D with or without calcium supplementation for reducing the risk of fracture?Findings This systematic review and meta-analysis of randomized clinical trials of vitamin D alone (11 randomized clinical trials with 34 243 participants) showed no significant association with risk of any fracture or of hip fracture. In contrast, daily supplementation with both vitamin D and calcium (6 randomized clinical trials with 49 282 participants) was associated with a 16% reduced risk of hip fracture.Meaning In this study, neither intermittent nor daily dosing with standard doses of vitamin D alone was associated with reduced risk of fracture, but daily treatment with both vitamin D and calcium was a more promising strategy. IntroductionOsteoporosis is characterized by reduced bone mass and fragmentation of bone architecture, resulting in an increased risk of fracture., Approximately 1 in 2 women and 1 in 5 men aged 50 years or older will experience an osteoporotic fracture in their remaining lifetime. Hip fracture is the most serious type of osteoporotic fracture, with an approximate 30% risk of death in the year following hip fracture. The incidence of hip fracture increases exponentially with age, particularly among women 60 years or older and men 70 years or older (eFigure 1 in the ), highlighting the high absolute risks of hip fracture in extreme old age.Vitamin D is essential for optimal musculoskeletal health because it promotes calcium absorption, mineralization of osteoid tissue formation in bone, and maintenance of muscle function. Low vitamin D status causes secondary hyperparathyroidism, bone loss, and muscle weakness. Observational studies, have reported that lower blood concentrations of 25-hydroxyvitamin D (25OHD) are associated with higher risks of falls and fractures.
Meta-analysis of the Observational StudiesWe searched PubMed and EMBASE databases using terms for vitamin D, 25-hydroxyvitamin D, 25(OH)D, 25(OH) vitamin D, cholecalciferol, and fracture to identify published observational studies of 25(OH)D and risk of fracture in English language that were reported until December 31, 2019 (eTable 1 in the ). We restricted studies to those that included at least 200 fracture events (to minimize random error); used a prospective, nested case-control, or case-cohort design; and reported blood 25(OH)D concentrations and risk estimates with 95% CIs for fracture (eAppendix 1 in the ). The risk of bias was assessed by 2 of us (P.Y. And R.C.) using the Risk of Bias in Nonrandomized Studies of Interventions tool.For each study, 2 of us (P.Y. And R.C.) transformed category-specific risk estimates into estimates of rate ratios (RRs) associated with an increase of 10.0 ng/mL (ie, 25.0 nmol/L) in blood 25(OH)D concentration (to convert to nanomoles per liter, multiply by 2.496) using a previously reported method. Subsequently, we pooled the results of individual studies using inverse-variance weighted fixed-effects meta-analysis. Meta-analysis of RCTsRandomized clinical trials were identified by literature searches of the relevant English language reports published before January 1, 2019, through PubMed, EMBASE, Cochrane Central Register of Controlled Trials, and ClinicalTrials.gov, using search terms vitamin D, calcium, randomized trial, and fracture.
Reference lists of studies included in previous systematic reviews were also reviewed to identify any additional RCTs (eTable 1 in the ).Randomized clinical trials of vitamin D alone were eligible for inclusion if they met the following criteria: (1) compared the effects of vitamin D supplementation with a placebo or no treatment, (2) reported at least 10 incident fractures, and (3) included at least 500 participants (to minimize random error and publication bias). Randomized clinical trials of calcium plus vitamin D were selected based on the following inclusion criteria: (1) compared calcium plus vitamin D supplements with a placebo or no treatment group, (2) reported at least 10 incident fractures, and (3) included at least 500 participants. Each RCT was assessed for bias by 2 of us (P.Y. And R.C.) using the Cochrane Collaboration risk of bias tool (eAppendix 2 in the ).Any fracture was defined as a fracture that occurred at any site, but if an RCT only reported hip fracture events, these were also counted as any fracture. The study-specific RRs and 95% CIs were estimated using the Peto 1-step method.
Data from individual RCTs were pooled using inverse variance-weighted fixed-effects meta-analysis. Heterogeneity was assessed using the I 2 statistic, with I 2 greater than 50% considered significant heterogeneity. Contour-enhanced funnel plots were constructed to assess publication bias. Prespecified subgroup analyses included age, residential status, geographic region, open-label RCT design, daily supplementation level, concurrent calcium supplementation, and mean treatment differences in blood 25(OH)D concentrations. R version 3.4.2 (R Project for Statistical Computing) was used for statistical analyses, and a 2-tailed P.
Meta-analysis of the Observational Studies of 25(OH)D Concentration and Risk of FractureWe identified 618 published reports of observational studies of blood 25(OH)D concentrations and risk of fracture (eFigure 2 in the ). After an initial review of titles and abstracts, 59 studies were selected for detailed assessment, yielding 11 eligible observational studies, with 39 141 participants,6278 fractures, and 2367 hip fractures. Of these 11 studies, 5 (45%) were nested case-control or case-cohort studies (8052 participants with 3469 fracture events and 1575 hip fracture events), - and 6 (55%) were prospective studies (31 089 participants with 2809 fracture events and 792 hip fracture events)., Selected characteristics of these 11 observational studies are shown in the - and in eTable 2 in the. The sample size of individual studies varied from 800 to 14 624 individuals, and the mean (range) age was 68.6 (52.6-76.7) years. The weighted mean (range) blood 25(OH)D concentration was 23.7 (21.4-25.2) ng/mL, with the exception of 1 UK study involving much younger adults, who had a mean blood 25(OH)D concentration of 32.5 ng/mL. The results of quality assessments of individual studies are provided in eTable 3 in the. Among the 11 observational studies included in the meta-analysis, 7 (64%) had serious risk of bias, including selection bias (3 27%), missing data (2 18%), or incomplete measurement of outcomes (2 18%), but none had a critical risk of bias.shows that an increase of 10.0 ng/mL in blood 25(OH)D concentration was associated with 7% lower risk of any fracture (RR, 0.93; 95% CI, 0.89-0.96) and 20% lower risk of hip fracture (RR, 0.80; 95% CI, 0.75-0.86).
However, there was significant heterogeneity between the results of individual studies for both fracture outcomes (any fracture: Q = 31.0; df = 9; P. Meta-analysis of RCTs of Vitamin D Alone for Prevention of FractureOf the 1262 published reports identified for initial assessment (eFigure 5 in the ), full texts were retrieved from 52 RCTs, but 36 RCTs were excluded for reasons listed in eTable 4 in the. A total of 11 RCTs of vitamin D - and 6 RCTs of calcium plus vitamin D, - were included in the meta-analysis, and 1 factorial-design RCT was also included in the meta-analysis.Of the 11 RCTs of supplementation with vitamin D alone included in the meta-analysis , the sample size varied from 686 to 9440 participants, and mean age varied from 65.9 to 85.0 years.
Among a total of 34 243 participants, there were 2843 fracture events (8.3%) and 740 hip fracture events (2.2%) during a mean (range) duration of approximately 3 years (9 months to 5 years). Among these 11 RCTs, 9 (82%) had a high risk of bias, 1 (9%) had an uncertain risk of bias, and only 1 (9%) had a low risk of bias (eFigure 6 in the ).
Selected characteristics of the included RCTs of vitamin D and fracture are provided in eTable 5 in the. Among the 11 RCTs, 3 (27%) used daily dosing with vitamin D, but dosing regimens in the 8 other RCTs varied from weekly (1 9%), monthly (1 9%), quarterly (2 18%), every 4 months (2 18%), to annually (2 18%)., Moreover, only 2 of 11 RCTs (18%) assessed the effects of equivalent daily doses of vitamin D greater than 2000 IU., Two RCTs, assessed very high annual doses of vitamin D, which appeared to increase the risk of fractures and falls among those allocated to the vitamin D group.
All RCTs used placebo controls except for 1 (9%) that had an open-label design, and all assessed the effects of either ergocalciferol or cholecalciferol (except for 1 9% that assessed the effects of 5 mL of cod liver oil containing 400 IU of cholecalciferol). Among the 34 243 participants, 20 511 (59.9%) were women, the mean age was 77.1 years, and baseline blood 25(OH)D concentration varied from 10.6 to 26.3 ng/mL. Among 22 803 participants in 6 RCTs, -, 7895 participants (34.6%) reported a history of fracture. A total of 6 RCTs, -, (55%) reported that adherence to supplementation with vitamin D varied between 80% and 99%.shows that supplementation with vitamin D alone was not associated with risk for any fracture (RR, 1.06; 95% CI, 0.98-1.14) or hip fracture (RR, 1.14; 95% CI, 0.98-1.32). There was no significant heterogeneity between RCTs for the associations of treatment with risk of any fracture (Q = 14.5; df = 10; P =.15; I 2 = 31.1%) or hip fracture (Q = 3.0; df = 7; P =.89; I 2 = 0.0%). There was some asymmetry in the contour-enhanced funnel plots of vitamin D for hip fracture, consistent with publication bias (eFigure 7 in the ). Subgroup analyses did not demonstrate any significant differences by age, residential status, geographic region, open-label design, daily supplementation, or duration for any fracture or hip fracture (eFigure 8 in the ).
However, while there was no heterogeneity in the associations of vitamin D with risk of any fracture or hip fracture by baseline 25(OH)D concentrations (. Meta-analysis of RCTs of Vitamin D Plus Calcium for Prevention of FractureA total of 6 RCTs, - compared the effects of allocation to treatment with both vitamin D and calcium vs control (placebo or no treatment) on risk of fracture (; eTable 6 in the ). Among these 6 RCTs, 5 (83%), - had a high risk of bias, and 1 (17%) had a low risk of bias (eFigure 6 in the ). Two RCTs (33%) had an open-label design, and all RCTs used either 800 or 400 IU of vitamin D per day and 1200 or 800 mg of calcium per day.
Participants had a mean age of 66.2 years and a mean treatment duration of 5.9 years. Among a total of 49 282 participants, there were 5449 (11.1%) fracture events and 730 (1.5%) hip fracture events.
Demonstrates that daily supplementation with both vitamin D and calcium (for approximately 6 years) was associated with a 6% reduced risk of any fracture (RR, 0.94; 95% CI, 0.89-0.99) and a 16% reduced rate of hip fracture (RR, 0.84; 95% CI, 0.72-0.97). There was no significant heterogeneity between the RCTs for the associations of calcium plus vitamin D with the risk of any fracture (Q = 7.3; df = 5; P =.20; I 2 = 31.4%) or risk of hip fracture (Q = 6.0; df = 5; P =.31; I 2 = 16.5%). There was also some evidence of asymmetry in the contour-enhanced funnel plots of calcium plus vitamin D for any fracture and for hip fracture (eFigure 10 in the ). Furthermore, eFigure 11 in the shows that the combined supplementation of calcium and vitamin D was associated with more extreme changes in risk of any fracture in the RCTs of older participants (ie, aged ≥80 years) living in an institution than those younger than 80 years living in the community ( P for heterogeneity =.02) and in the RCTs that achieved greater treatment differences in blood 25(OH)D concentrations ( P for heterogeneity =.04). Marginally significant lower risks of hip fracture were also observed in RCTs among older participants living in institutions ( P for heterogeneity =.07) and in those achieving greater treatment differences in 25(OH)D concentration ( P for heterogeneity =.08). Metaregression analysis based on a random sample of participants indicated that each 0.4-ng/mL difference in blood 25(OH)D concentration was associated with an RR of 0.99 (95% CI, 0.98-1.00) for any fracture and 0.98 (95% CI, 0.97-0.99) for hip fracture (eFigure 12 in the ). Overall, the results of RCTs of calcium with vitamin D were consistent with the reported risk reductions associated with differences in 25(OH)D concentrations projected by the observational studies (eFigure 13 in the ).
Ongoing Trials of Vitamin D for Prevention of FractureA total of 7 ongoing large RCTs, involving a total of 62 857 participants, are expected to report the effects of supplementation with higher daily doses of vitamin D on risk of fracture (eTable 7 in the ). DiscussionThe present meta-analysis of the observational studies of blood 25(OH)D concentration and risk of fracture (11 studies with 39 141 participants) demonstrated that higher blood 25(OH)D concentrations were associated with lower risks of any fracture and hip fracture. An increase of 10.0 ng/mL in 25(OH)D concentration was associated with a 7% lower risk of any fracture and a 20% lower risk of hip fracture. In contrast, the present meta-analysis of RCTs of vitamin D alone (11 RCTs with 34 243 participants) demonstrated no beneficial association of supplementation with vitamin D alone with risk of fracture.
However, interpretation of the results of these RCTs is constrained by their small sample size, short treatment duration, high risk of bias (chiefly because of incomplete ascertainment of outcomes), intermittent dosing regimens of vitamin D, and failure to achieve adequate differences in 25(OH)D concentrations. Furthermore, 2 RCTs that assessed very high annual doses of vitamin D both showed an increase in the risk of fractures and falls among those allocated to the vitamin D group, reinforcing the conclusion that intermittent dosing regimens with high doses of vitamin D can cause toxic effects.In contrast, a meta-analysis of the RCTs of daily supplementation with vitamin D and calcium (6 RCTs with 49 282 participants) demonstrated a marginally significant reduction in the risk of any fracture of 6% and hip fracture of 16%. However, the 95% CIs indicated some uncertainty for these estimates. As with the RCTs of vitamin D alone, these RCTs also had a high risk of bias. The risk reductions achieved in the RCTs of calcium plus vitamin D were somewhat greater in RCTs among older participants living in institutions and in RCTs that achieved greater differences in blood 25(OH)D concentrations between the allocated treatment groups.
However, given these uncertainties, further large RCTs of combined treatment with vitamin D and calcium are needed before advocating vitamin D and calcium supplements or fortified foods with vitamin D and calcium for prevention of hip fracture.Previous meta-analyses also reported that vitamin D supplementation alone was not associated with reduction of risks of any fracture or of hip fracture in community-dwelling older adults (14 RCTs with 13 106 participants) or in the general older population (24 RCTs with 39 485 participants). The present meta-analysis differed from previous meta-analyses by excluding small RCTs (ie, 1 month between doses) or those using extreme doses of vitamin D at even longer intervals between doses., One participant-level meta-analysis of RCTs reported effect modification by daily doses of vitamin D for prevention of fracture and highlighted the need to assess the effects of higher daily doses of vitamin D. ConclusionsIn this systematic review and meta-analysis, the available evidence from completed RCTs provided no support for the effects of vitamin D alone on prevention of fracture, but most of these RCTs were constrained by methodological problems. Meta-analyses of ongoing RCTs assessing the effects of higher daily doses of vitamin D on fracture risk are needed before making recommendations on the use of vitamin D for prevention of fracture. Further RCTs are needed to assess the efficacy and safety of higher daily doses of vitamin D with calcium in high-risk individuals for prevention of fracture. Article InformationAccepted for Publication: October 27, 2019.Published: December 20, 2019.
Doi:Open Access: This is an open access article distributed under the terms of the. © 2019 Yao P et al. JAMA Network Open.Corresponding Author: Robert Clarke, FRCP, MD, Clinical Trial Service Unit and Epidemiological Studies Unit, Nuffield Department of Population Health, University of Oxford, Big Data Institute, Old Road Campus, Oxford OX3 7LF, United Kingdom.Author Contributions: Drs Yao and Clarke had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.