Vitamin D and vitamin D analogues for preventing fractures in post-menopausal women and older men - PubMed (original) (raw)

Review

Vitamin D and vitamin D analogues for preventing fractures in post-menopausal women and older men

Alison Avenell et al. Cochrane Database Syst Rev. 2014.

Abstract

Background: Vitamin D and related compounds have been used to prevent osteoporotic fractures in older people. This is the third update of a Cochrane review first published in 1996.

Objectives: To determine the effects of vitamin D or related compounds, with or without calcium, for preventing fractures in post-menopausal women and older men.

Search methods: We searched the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register (to December 2012), the Cochrane Central Register of Controlled Trials (2012, Issue 12), MEDLINE (1966 to November Week 3 2012), EMBASE (1980 to 2012 Week 50), CINAHL (1982 to December 2012), BIOSIS (1985 to 3 January 2013), Current Controlled Trials (December 2012) and reference lists of articles.

Selection criteria: Randomised or quasi-randomised trials that compared vitamin D or related compounds, alone or with calcium, against placebo, no intervention or calcium alone, and that reported fracture outcomes in older people. The primary outcome was hip fracture.

Data collection and analysis: Two authors independently assessed trial risk of selection bias and aspects of methodological quality, and extracted data. Data were pooled, where possible, using the fixed-effect model, or the random-effects model when heterogeneity between studies appeared substantial.

Main results: We included 53 trials with a total of 91,791 participants. Thirty-one trials, with sample sizes ranging from 70 to 36,282 participants, examined vitamin D (including 25-hydroxy vitamin D) with or without calcium in the prevention of fractures in community, nursing home or hospital inpatient populations. Twelve of these 31 trials had participants with a mean or median age of 80 years or over.Another group of 22 smaller trials examined calcitriol or alfacalcidol (1-alphahydroxyvitamin D3), mostly with participants who had established osteoporosis. These trials were carried out in the setting of institutional referral clinics or hospitals.In the assessment of risk of bias for random sequence generation, 21 trials (40%) were deemed to be at low risk, 28 trials (53%) at unclear risk and four trials at high risk (8%). For allocation concealment, 22 trials were at low risk (42%), 29 trials were at unclear risk (55%) and two trials were at high risk (4%).There is high quality evidence that vitamin D alone, in the formats and doses tested, is unlikely to be effective in preventing hip fracture (11 trials, 27,693 participants; risk ratio (RR) 1.12, 95% confidence intervals (CI) 0.98 to 1.29) or any new fracture (15 trials, 28,271 participants; RR 1.03, 95% CI 0.96 to 1.11).There is high quality evidence that vitamin D plus calcium results in a small reduction in hip fracture risk (nine trials, 49,853 participants; RR 0.84, 95% confidence interval (CI) 0.74 to 0.96; P value 0.01). In low-risk populations (residents in the community: with an estimated eight hip fractures per 1000 per year), this equates to one fewer hip fracture per 1000 older adults per year (95% CI 0 to 2). In high risk populations (residents in institutions: with an estimated 54 hip fractures per 1000 per year), this equates to nine fewer hip fractures per 1000 older adults per year (95% CI 2 to 14). There is high quality evidence that vitamin D plus calcium is associated with a statistically significant reduction in incidence of new non-vertebral fractures. However, there is only moderate quality evidence of an absence of a statistically significant preventive effect on clinical vertebral fractures. There is high quality evidence that vitamin D plus calcium reduces the risk of any type of fracture (10 trials, 49,976 participants; RR 0.95, 95% CI 0.90 to 0.99).In terms of the results for adverse effects: mortality was not adversely affected by either vitamin D or vitamin D plus calcium supplementation (29 trials, 71,032 participants, RR 0.97, 95% CI 0.93 to 1.01). Hypercalcaemia, which was usually mild (2.6 to 2.8 mmol/L), was more common in people receiving vitamin D or an analogue, with or without calcium (21 trials, 17,124 participants, RR 2.28, 95% CI 1.57 to 3.31), especially for calcitriol (four trials, 988 participants, RR 4.41, 95% CI 2.14 to 9.09), than in people receiving placebo or control. There was also a small increased risk of gastrointestinal symptoms (15 trials, 47,761 participants, RR 1.04, 95% CI 1.00 to 1.08), especially for calcium plus vitamin D (four trials, 40,524 participants, RR 1.05, 95% CI 1.01 to 1.09), and a significant increase in renal disease (11 trials, 46,548 participants, RR 1.16, 95% CI 1.02 to 1.33). Other systematic reviews have found an increased association of myocardial infarction with supplemental calcium; and evidence of increased myocardial infarction and stroke, but decreased cancer, with supplemental calcium plus vitamin D, without an overall effect on mortality.

Authors' conclusions: Vitamin D alone is unlikely to prevent fractures in the doses and formulations tested so far in older people. Supplements of vitamin D and calcium may prevent hip or any type of fracture. There was a small but significant increase in gastrointestinal symptoms and renal disease associated with vitamin D and calcium. This review found that there was no increased risk of death from taking calcium and vitamin D.

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Conflict of interest statement

Alison Avenell (AA) participated in the RECORD 2005 trial. She was the principal investigator for the Avenell 2004 trial. AA did not carry out data extraction or quality assessment on trials with which she was involved. AA was involved in the meta‐analyses of the effects of calcium (Bolland 2010), and calcium and vitamin D (Bolland 2011b), on cardiovascular disease Jenson CS Mak: nothing to declare Dianne O'Connell: nothing to declare

Figures

1

1

tudy flow diagram for the updated search (December 2012)

2

2

Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies

3

3

Risk of bias summary: review authors' judgements about each risk of bias item for each included study

4

4

Funnel plot of comparison: 1 Vitamin D [D2, D3 or 25(OH)D] versus control or placebo, outcome: 1.1 Persons sustaining new hip fracture

5

5

Funnel plot of comparison: 1 Vitamin D [D2, D3 or 25(OH)D] versus control or placebo, outcome: 1.4 Persons sustaining any new fracture

1.1

1.1. Analysis

Comparison 1: Vitamin D [D2, D3 or 25(OH)D] versus control or placebo, Outcome 1: Persons sustaining new hip fracture

1.2

1.2. Analysis

Comparison 1: Vitamin D [D2, D3 or 25(OH)D] versus control or placebo, Outcome 2: Persons sustaining new non‐vertebral fracture

1.3

1.3. Analysis

Comparison 1: Vitamin D [D2, D3 or 25(OH)D] versus control or placebo, Outcome 3: Persons sustaining new vertebral fracture or deformity

1.4

1.4. Analysis

Comparison 1: Vitamin D [D2, D3 or 25(OH)D] versus control or placebo, Outcome 4: Persons sustaining any new fracture

2.1

2.1. Analysis

Comparison 2: Vitamin D [D2, D3 or 25(OH)D] plus calcium versus calcium, Outcome 1: Persons sustaining new hip fracture

2.2

2.2. Analysis

Comparison 2: Vitamin D [D2, D3 or 25(OH)D] plus calcium versus calcium, Outcome 2: Persons sustaining new non‐vertebral fracture

2.3

2.3. Analysis

Comparison 2: Vitamin D [D2, D3 or 25(OH)D] plus calcium versus calcium, Outcome 3: Persons sustaining new vertebral fracture

2.4

2.4. Analysis

Comparison 2: Vitamin D [D2, D3 or 25(OH)D] plus calcium versus calcium, Outcome 4: Persons sustaining any new fracture

3.1

3.1. Analysis

Comparison 3: Vitamin D [D2, D3 or 25(OH)D] versus calcium, Outcome 1: Persons sustaining new hip fracture

3.2

3.2. Analysis

Comparison 3: Vitamin D [D2, D3 or 25(OH)D] versus calcium, Outcome 2: Persons sustaining new non‐vertebral fracture

3.3

3.3. Analysis

Comparison 3: Vitamin D [D2, D3 or 25(OH)D] versus calcium, Outcome 3: Persons sustaining new vertebral fracture or deformity

3.4

3.4. Analysis

Comparison 3: Vitamin D [D2, D3 or 25(OH)D] versus calcium, Outcome 4: Persons sustaining any new fracture

4.1

4.1. Analysis

Comparison 4: Vitamin D [D2, D3 or 25(OH)D] plus calcium versus control or placebo, Outcome 1: Persons sustaining new hip fracture

4.2

4.2. Analysis

Comparison 4: Vitamin D [D2, D3 or 25(OH)D] plus calcium versus control or placebo, Outcome 2: Persons sustaining new hip fracture: subgroup analysis by residential status (institution vs community)

4.3

4.3. Analysis

Comparison 4: Vitamin D [D2, D3 or 25(OH)D] plus calcium versus control or placebo, Outcome 3: Persons sustaining new non‐vertebral fracture

4.4

4.4. Analysis

Comparison 4: Vitamin D [D2, D3 or 25(OH)D] plus calcium versus control or placebo, Outcome 4: Persons sustaining new vertebral fracture

4.5

4.5. Analysis

Comparison 4: Vitamin D [D2, D3 or 25(OH)D] plus calcium versus control or placebo, Outcome 5: Persons sustaining any new fracture

4.6

4.6. Analysis

Comparison 4: Vitamin D [D2, D3 or 25(OH)D] plus calcium versus control or placebo, Outcome 6: Persons sustaining any new fracture: subgroup analysis by residential status (institution vs community)

5.1

5.1. Analysis

Comparison 5: Alfacalcidol [1‐alpha(OH)D3] versus control or placebo, Outcome 1: Persons sustaining new non‐vertebral fracture

5.2

5.2. Analysis

Comparison 5: Alfacalcidol [1‐alpha(OH)D3] versus control or placebo, Outcome 2: Persons sustaining new vertebral fracture

6.1

6.1. Analysis

Comparison 6: Alfacalcidol [1‐alpha(OH)D3] plus calcium versus calcium, Outcome 1: Persons sustaining new hip fracture

6.2

6.2. Analysis

Comparison 6: Alfacalcidol [1‐alpha(OH)D3] plus calcium versus calcium, Outcome 2: Persons sustaining new vertebral deformity

7.1

7.1. Analysis

Comparison 7: Alfacalcidol [1‐alpha(OH)D3] versus calcium, Outcome 1: Persons sustaining new vertebral deformity

8.1

8.1. Analysis

Comparison 8: Calcitriol [1,25(OH)2D3] versus control or placebo, Outcome 1: Persons sustaining new hip fracture

8.2

8.2. Analysis

Comparison 8: Calcitriol [1,25(OH)2D3] versus control or placebo, Outcome 2: Persons sustaining new non‐vertebral fracture

8.3

8.3. Analysis

Comparison 8: Calcitriol [1,25(OH)2D3] versus control or placebo, Outcome 3: Persons sustaining new vertebral deformity

9.1

9.1. Analysis

Comparison 9: Calcitriol [1,25(OH)2D3] plus calcium versus calcium, Outcome 1: Persons sustaining new non‐vertebral fracture

9.2

9.2. Analysis

Comparison 9: Calcitriol [1,25(OH)2D3] plus calcium versus calcium, Outcome 2: Persons sustaining new vertebral deformity

10.1

10.1. Analysis

Comparison 10: Calcitriol [1,25(OH)2D3] plus vitamin D plus calcium versus vitamin D plus calcium, Outcome 1: Persons sustaining new vertebral deformity

11.1

11.1. Analysis

Comparison 11: Calcitriol [1,25(OH)2D3] versus calcium, Outcome 1: Persons sustaining new non‐vertebral fracture

11.2

11.2. Analysis

Comparison 11: Calcitriol [1,25(OH)2D3] versus calcium, Outcome 2: Persons sustaining new vertebral deformity

11.3

11.3. Analysis

Comparison 11: Calcitriol [1,25(OH)2D3] versus calcium, Outcome 3: Persons sustaining new vertebral deformity in Tilyard study

12.1

12.1. Analysis

Comparison 12: Calcitriol [1,25(OH)2D3] versus vitamin D (with or without calcium in each group), Outcome 1: Persons sustaining new non‐vertebral fracture

12.2

12.2. Analysis

Comparison 12: Calcitriol [1,25(OH)2D3] versus vitamin D (with or without calcium in each group), Outcome 2: Persons sustaining new vertebral deformity

13.1

13.1. Analysis

Comparison 13: Vitamin D [D2, D3 or 25(OH)D] or any analogue with/without calcium: adverse effects, Outcome 1: Deaths

13.2

13.2. Analysis

Comparison 13: Vitamin D [D2, D3 or 25(OH)D] or any analogue with/without calcium: adverse effects, Outcome 2: Persons with hypercalcaemia

13.3

13.3. Analysis

Comparison 13: Vitamin D [D2, D3 or 25(OH)D] or any analogue with/without calcium: adverse effects, Outcome 3: Persons with gastrointestinal effects

13.4

13.4. Analysis

Comparison 13: Vitamin D [D2, D3 or 25(OH)D] or any analogue with/without calcium: adverse effects, Outcome 4: Persons with renal disease (calculi or insufficiency)

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Komulainen 1998 {published and unpublished data}
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    1. Komulainen M, Kroger H, Tuppurainen MT, Keikkinen A-M, Honkanen R, Saarikoski S, et al. Identification of early postmenopausal women with no bone response to HRT: results of a five-year clinical trial. Osteoporosis International 2000;11:211-8. - PubMed
    1. Komulainen MH, Kroger H, Tuppurainen MT, Heikkinen A-M, Alhava E, Honkanen R, et al. HRT and Vit D in prevention of non-vertebral fractures in postmenopausal women; a 5 year randomized trial. Maturitas 1998;31(1):45-54. - PubMed
    1. Komulainen MH. Personal communication 11 November 2004.
Law 2006 {published data only}
    1. Law M, Morris J, Withers H. Cholecalciferol, not ergocalciferol, should be used for vitamin D supplementation [author reply]. Age and Ageing 2006;35(6):645. [MEDLINE: ] - PubMed
    1. Law M, Morris J, Withers H. Vitamin D supplementation and the prevention of fractures and falls. Reply. Age and Ageing 2007;36(2):233. - PubMed
    1. Law M, Morris J, Withers H. Vitamin D supplementation and the prevention of fractures and falls [author reply]. Age and Ageing 2007;36(2):233. [MEDLINE: ] - PubMed
    1. Law M, Withers H, Morris J, Anderson F. Vitamin D supplementation and the prevention of fractures and falls: results of a randomised trial in elderly people in residential accommodation [comment in: Age and Ageing 2006;35(6):645 and Age and Ageing 2007;36(2):232-3]. Age and Ageing 2006;35(5):482-6. - PubMed
Lips 1996 {published data only}
    1. Graafmans WC, Ooms ME, Hofstee HMA, Bezemer PD, Bouter LM, Lips P. Falls in the elderly: a prospective study of risk factors and risk profiles. American Journal of Epidemiology 1996;143(11):1129-36. - PubMed
    1. Lips P, Graafmans WC, Ooms ME, Bezemer PD, Bouter LM. The effect of vitamin D supplementation on the incidence of hip fractures in elderly people. Journal of Bone and Mineral Research 1994;9 Suppl 1:S148.
    1. Lips P, Graafmans WC, Ooms ME, Bezemer PD, Bouter LM. Vitamin D supplementation and fracture incidence in elderly persons. Annals of Internal Medicine 1996;124:400-6. [MEDLINE: ] - PubMed
Lyons 2007 {published data only}
    1. Johansen A, Lyons RA, Stone M, Brophy S, Newcombe RG, Phillips CJ, et al. Preventing fractures among older people living in institutional care: a randomised double blind placebo controlled trial of vitamin D supplementation [abstract]. Age and Ageing 2006;35(Suppl 3):i41. - PubMed
    1. Lyons RA, Johansen A, Brophy S, Newcombe RG, Phillips CJ, Lervy B, et al. Preventing fractures among older people living in institutional care: a pragmatic randomised double blind placebo controlled trial of vitamin D supplementation. Osteoporosis International 2007;18(6):811-8. - PubMed
    1. Lyons RA, Johansen A, Stone MD, Brophy S, Newcombe RG, Philips CJ, et al. Preventing fractures among older people living in institutional care: a randomised double blind placebo controlled trial of vitamin D supplementation [abstract]. Osteoporosis International 2006;17(Suppl 3):372. - PubMed
Menczel 1994 {published data only}
    1. Menczel J, Foldes J, Steinberg R, Leichter I, Shalita B, Bjolah-Abram T, et al. Alfacalcidol (Alpha D3) and calcium in osteoporosis. Clinical Orthopaedics and Related Research 1994;(300):241-7. - PubMed
Meyer 2002 {published data only}
    1. Meyer HE, Falch JA, Kvaavik E, Smedshaug GB, Tverdal A, Pedersen JI. Can vitamin D supplementation reduce the risk of fracture in the elderly? A randomised controlled trial. Osteoporosis International 2000;11(Suppl 2):S114-5. - PubMed
    1. Meyer HE, Smedshaug GB, Kvaavik E, Falch JA, Tverdal A, Pedersen JI. Can vitamin D supplementation reduce the risk of fracture in the elderly? A randomized controlled trial. Journal of Bone and Mineral Research 2002;17(4):709-15. - PubMed
    1. Smedshaug GB, Pedersen JI, Meyer HE. Can vitamin D supplementation improve grip strength in elderly nursing home residents? A double-blinded controlled trial. Scandinavian Journal of Food and Nutrition 2007;51(2):74-8.
Mitri 2011 {published data only}
    1. Mitri J, Dawson-Hughes B, Hu FB, Pittas AG. Effects of vitamin D and calcium supplementation on pancreatic β cell function, insulin sensitivity, and glycemia in adults at high risk of diabetes: the Calcium and Vitamin D for Diabetes Mellitus (CaDDM) randomized controlled trial. American Journal of Clinical Nutrition 2011;94:486-94. - PMC - PubMed
Nakatsuka 1997 {published data only}
    1. Nakatsuka K, Inaba M, Aratani H, Iba K, Sato T, Koike T, et al. Effects of long-term administration of alfacalcidol on bone mass and bone metabolism in patients with primary osteoporosis - comparison with calcium preparations [Japanese]. Nippon Ronen Igakkai Zasshi - Japanese Journal of Geriatrics 1997;34(7):569-76. - PubMed
Ones 2007 {published data only}
    1. Ones K, Schacht E, Dukas L, Caglar N. Effects of combined treatment with alendronate and alfacalcidol on bone mineral density and bone turnover in postmenopausal osteoporosis: a two-years, randomized, multiarm, controlled trial. Internet Journal of Epidemiology 2007;4(1):DOI: 10.5580/1523.
Orimo 1994 {published data only}
    1. Orimo H, Shiraki M, Hayashi Y, Hoshino T, Onaya T, Miyazaki S, et al. Effects of 1-alpha-hydroxyvitamin D3 on lumbar bone mineral density and vertebral fractures in patients with postmenopausal osteoporosis. Calcified Tissue International 1994;54:370-6. - PubMed
OSTPRE‐FPS 2007 {published and unpublished data}
    1. Karkkainen M, Tuppurainen M, Rikkonen T, Salovaara K, Sirola J, Honkanen R, et al. Vitamin-D 800IU/day + calcium 1000mg supplementation decreases the risk of recurrent falling among postmenopausal ambulatory women - a population-based, randomized, 3-year study (OSTPRE-FPS). Osteoporosis International 2008;19(Suppl 1):S17-18.
    1. Karkkainen M, Tuppurainen M, Rikkonen T, Salovaara K, Sirola J, Honkanen R, et al. Vitamin-D 800IU/day + calcium supplementation decreases the risk of falling among postmenopausal ambulatory women - a population-based, randomized 3-year study (OSTPRE-FPS) [abstract]. Journal of Bone and Mineral Research 2007;22(Suppl 1):S131.
    1. Karkkainen M, Tuppurainen M, Salovaara K, Sandini L, Rikkonen T, Sirola J, et al. Effect of calcium and vitamin D supplementation on bone mineral density in women aged 65-71 years: a 3-year randomized population-based trial (OSTPRE-FPS). Osteoporosis International 2010;21:2047-55. - PubMed
    1. Karkkainen MK, Tuppurainen M, Salovaara M, Sandini L, Rikkonen T, Sirola J, et al. Does daily vitamin D 800 IU and calcium 1000 mg supplementation decrease the risk of falling in ambulatory women aged 65-71 years? A 3-year randomized population-based trial (OSTPRE-FPS). Maturitas 2010;65:359-65. - PubMed
    1. Kroger HP, Tuppurainen M. OSTPRE-FPS Prevention of Fractures and Falls in Postmenopausal Women With Calcium and Vitamin-D Supplementation - a Randomised Study. http://www.controlled-trials.com/mrct/trial/405493/OSTPRE.
Ott 1989 {published data only}
    1. Ott SM, Chesnut CH. Calcitriol treatment is not effective in postmenopausal osteoporosis: see comments. Annals of Internal Medicine 1989;110:267-74. - PubMed
Peacock 2000 {published data only}
    1. Peacock M, Liu G, Carey M, McClintock R, Ambrosius W, Hui S, et al. Effect of calcium or 25OH vitamin D3 dietary supplementation on bone loss at the hip in men and women over the age of 60. Journal of Clinical Endocrinology and Metabolism 2000;85:3011-9. - PubMed
Pfeifer 2000 {published data only}
    1. Minne HW, Pfeifer M, Begerow B, Nachtigall D, Hansen C. Vitamin D and calcium supplementation reduces falls in elderly women via improvement of body sway and normalisation of blood pressure; a prospective, randomized, and double-blind study. Osteoporosis International 2000;11(Suppl 2):S115.
    1. Pfeifer M, Begerow B, Minne HW, Abrams C, Nachtigall D, Hansen C. Effects of a short-term vitamin D and calcium supplementation on body sway and secondary hyperparathyroidism in elderly women. Journal of Bone and Mineral Research 2000;15(6):1113-8. - PubMed
    1. Pfeifer M, Begerow B, Nachtigall D, Hansen C. Prevention of falls-related fractures: vitamin D reduces body sway in the elderly - a prospective, randomized, double blind study [abstract]. Bone 1998;23(5 Suppl 1):1110.
Pfeifer 2009 {published data only}
    1. Bolland MJ, Grey A. Different outcomes of meta-analyses and data inconsistency:response to comments by Pfeifer. Archives of Osteoporosis 2015;10:43. - PubMed
    1. Bolland MJ, Grey A. Inconsistent data in text and tables. Osteoporosis International 2015;26:2713. - PubMed
    1. Minne HW, Dobnig H, Pfeifer M, Suppan K. Effects of vitamin D and calcium supplementation on falls and parameters of muscle function: a prospective, randomized, double-blind multicenter study [abstract]. Osteoporosis International 2006;17(Suppl 2):S212. - PubMed
    1. Minne HW, Dobnig H, Pfeifer M, Suppan K. Effects of vitamin D and calcium supplementation on falls and parameters of muscle-function - a prospective, randomized, double-blind multi-center study [abstract]. Osteoporosis International 2006;17(Suppl 1):S21. - PubMed
    1. Pfeifer M, Begerow B, Minne HW, Suppan K, Fahrleitner-Pammer A, Dobnig H. Effects of a long-term vitamin D and calcium supplementation on falls and parameters of muscle function in community-dwelling older individuals. Osteoporosis International 2009;20:315-22. - PubMed
Porthouse 2005 {published and unpublished data}
    1. Dumville JC, Miles JN, Porthouse J, Cockayne ES, Saxon L, King C, et al. Can vitamin D supplementation prevent seasonal affective disorder? A randomised trial among older women. Osteoporosis International 2004;15:S42-3.
    1. Porthouse J, Cockayne S, King C, Saxon L, Steele E, Aspray T, et al. Randomised controlled trial of calcium and supplementation with cholecalciferol (vitamin D3) for prevention of fractures in primary care. BMJ 2005;330(7498):1003-6. - PMC - PubMed
    1. Porthouse J, Cockayne S, King C, Saxon L, Steele E, Aspray T, et al. Randomised controlled trial of calcium and vitamin D supplementation for fracture prevention in primary care. Osteoporosis International 2004;15(Suppl 2):S13.
    1. Porthouse J, Cockayne S, King C, Saxon L, Steele E, Aspray T, et al. Randomised controlled trial of calcium and vitamin D supplementation for fracture prevention in primary care. Osteoporosis International 2005;16:S27. - PMC - PubMed
    1. Puffer S. Calcium and vitamin D in primary care: adherence results from a randomised controlled trial [abstract 6.9.3]. In: RCN International Nursing Conference; 2004 Mar 21-31; Cambridge (UK). London: Royal College of Nursing, 2004.
Prince 2008 {published data only}
    1. Prince RL, Austin N, Devine A, Dick IM, Bruce D, Zhu K. Effects of ergocalciferol added to calcium on the risk of falls in elderly high-risk women. Archives of Internal Medicine 2008;168(1):103-8. - PubMed
    1. Zhu K, Bruce D, Austin N, Devine A, Ebeling PR, Prince RL. Randomized controlled trial of the effects of calcium with or without vitamin D on bone structure and bone-related chemistry in elderly women with vitamin D insufficiency. Journal of Bone and Mineral Research 2008;23(8):1343-8. - PubMed
    1. Zhu K, Devine A, Dick IM, Wilson SG, Prince RL. Effects of calcium and vitamin D supplementation on hip bone mineral density and calcium-related analytes in elderly ambulatory Australian women: a five-year randomized controlled trial. Journal of Clinical Endocrinology and Metabolism 2008;93(3):743-9. - PubMed
RECORD 2005 {published and unpublished data}
    1. Anderson FH, Grant AM, Avenell A, Campbell MK, Cooper C, Donaldson C, et al. The RECORD Trial: an evaluation of calcium and/or vitamin D in the secondary prevention of osteoporotic fractures. Bone 2005;36(Suppl 2):S122-3.
    1. Francis RM, Grant AM and the RECORD trial group. The RECORD trial: a randomised double-blind study of calcium and/or vitamin D in the secondary prevention of low trauma fractures. Age Ageing 2005;34(Suppl 2):ii15.
    1. Grant A, on behalf of the RECORD Trial Group. Prevention of low-trauma fractures in older people [author reply]. Lancet 2005;366(9485):543-4. - PubMed
    1. Grant AM, Anderson FH, for the RECORD Trial Group. The Medical Research Council RECORD Trial: an evaluation of calcium and/or vitamin D in the secondary prevention of osteoporotic fractures. Osteoporosis International 2004;15(Suppl 2):S13.
    1. Grant AM, Anderson FH. The RECORD trial: an evaluation of calcium and/or vitamin D in the secondary prevention of osteoporotic fractures. Osteoporosis International 2005;16(Suppl 3):S4-5.
Shiraki 1996 {published data only}
    1. Shiraki M, Kushida K, Yamazaki K, Nagai T, Inoue T, Orimo H. Effects of 2 years' treatment of osteoporosis with 1alpha-hydroxy vitamin D3 on bone mineral density and incidence of fracture: a placebo-controlled, double-blind prospective study. Endocrine Journal 1996;43(2):211-20. - PubMed
Smith 2007 {published and unpublished data}
    1. Anderson FH, Smith HE, Raphael HM, Cooper C. Intramuscular vitamin D increased serum 1,25-dihydroxycholecalciferol but did not affect 25-hydroxy-cholecalciferol levels in health older adults [abstract]. Journal of Bone and Mineral Research 2000;15(Suppl 1):S315.
    1. Anderson FH, Smith HE, Raphael HM, Crozier SR, Cooper C. Effect of annual intramuscular vitamin D3 supplementation on fracture risk in 9440 community-living older people: the Wessex fracture prevention trial [abstract]. Journal of Bone and Mineral Research 2004;19(Suppl 1):S57.
    1. Arden NK, Crozier S, Smith H, Anderson F, Edwards C, Raphael H, et al. Knee pain, knee osteoarthritis, and the risk of fracture. Arthritis and Rheumatism 2006;55(4):610-5. - PubMed
    1. Cooper C, Crozier S. Personal communication 23 February 2005.
    1. Raphael H, Smith H, Anderson F, Cooper C. Tackling the problems of trial management in primary care - experience from the Wessex research network fracture prevention study of annual vitamin D injection in older people [abstract]. Osteoporosis International 2000;11(Suppl 1):S63-4.
Tilyard 1992 {published data only}
    1. Morrison NA, George PM, Vaughan T, Tilyard MW, Frampton CM, Gilchrist NL. Vitamin D receptor genotypes influence the success of calcitriol therapy for recurrent vertebral fracture in osteoporosis. Pharmacogenetics and Genomics 2005;15(2):127-35. - PubMed
    1. Tilyard M. Low-dose calcitriol versus calcium in established postmenopausal osteoporosis. Metabolism: Clinical & Experimental 1990;39(4 Suppl 1):50-2. - PubMed
    1. Tilyard MW, Spears GF, Thomson J, Dovey S. Treatment of postmenopausal osteoporosis with calcitriol or calcium. New England Journal of Medicine 1992;326(6):357-62. - PubMed
    1. Tilyard MW, Spears GFS, Thomson J, Dovey S. Calcitriol or calcium for postmenopausal osteoporosis. New England Journal of Medicine 1992;327:284. - PubMed
    1. Tilyard MW. 1,25-dihydroxyvitamin D3 (calcitriol) in the treatment of postmenopausal osteoporosis. Aktuelle Rheumatologie 1994;19(Suppl 1):23-6.
Trivedi 2003 {published data only}
    1. Trivedi DP, Doll R, Khaw KT. Effect of four monthly oral vitamin D3 (cholecalciferol) supplementation on fractures and mortality in men and women living in the community: randomised double blind controlled trial. BMJ 2003;326:469. - PMC - PubMed
Ushiroyama 2001 {published data only}
    1. Ushiroyama T, Ikeda A, Sakai M, Higashiyama T, Ueki M. Effects of the combined use of calcitonin and 1alpha-hydroxycholecalciferol on vertebral bone loss and bone turnover in women with postmenopausal osteopenia and osteoporosis: a prospective study of long-term and continuous administration with low dose calcitonin. Maturitas 2001;40:229-38. - PubMed
Vital D {published and unpublished data}
    1. Sanders K, Duque G, Ebeling P, McCorquodale T, Herrmann M, Shore-Lorenti C, et al. The efficacy of high-does oral vitamin D3 administered once a year: increased fracture risk is associated with 1,25 vitamin D level at 3-months post dose. In: ASBMR Annual Meeting; 2012 Oct 12-15; Minneapolis, Minnesota. http://www.asbmr.org/Meetings/AnnualMeeting/AbstractDetail.aspx?aid=6beb.... 2012.
    1. Sanders K, Stuart A, Williamson E, Simpson J, Kotowicz M, Nicholson G. The efficacy of high-dose oral vitamin D3 administered once a year: a randomised, double-blind, placebo-controlled trial (Vital D study) for falls and fractures in older women. Osteoporosis International 2011;22(Suppl 1):S104-5.
    1. Sanders KM, Duque G, McCorquodale T, Stuart AL, Williamson EJ, Kotowicz MA, et al. Annual high-dose oral vitamin D3: is the increased risk of falls attributable to changes in muscle strength? Osteoporosis International 2011;22(Suppl 4):S552.
    1. Sanders KM, Ebeling PR, Stuart AL, Williamson EJ, Kotowicz MA, Nicholson GC. Annual high-dose oral vitamin D3: is increased risk of fractures attributable to changes in bone turnover markers? Osteoporosis International 2011;22(Suppl 4):S589.
    1. Sanders KM, Hayles AL, Kotowicz MA, Nicholson GC. Does vitamin D explain the lower fracture rate in rural communities? Bone 2007;40(6 Suppl 2):S195.
WHI 2006 {published data only}
    1. Cauley J, Wactawski-Wende J, Robbins J, Rodabough R, Chen Z, Johnson K, et al. The Women's Health Initiative (WHI) calcium and vitamin D supplementation trial: health outcomes 5 years after trial completion. ASBMR Annual Meeting; 2012 Oct 12-15; Minneapolis, Minnesota. http://www.asbmr.org/Meetings/AnnualMeeting/AbstractDetail.aspx?aid=6450... (accessed 27 December 2012).
    1. Cauley JA, LaCroix A, Wu L, Lee J, Horowitz M, Bauer D, et al. Serum 25 hydroxy vitamin D 25(OH) and the risk of hip fracture: the Women's Health Initiative (WHI). Journal of Bone and Mineral Research 2007;22(Suppl 1):S57.
    1. Chen Z, Beck TJ, Wright NC, LaCroix AZ, Cauley JA, Lewis CE, et al. The effect of calcium plus vitamin D supplement on hip geometric structures: results from the Women's Health Initiative CaD trial. Journal of Bone and Mineral Research 2007;22(Suppl 1):S59.
    1. Jackson RD, LaCroix AZ, Cauley JA, McGowan J. The Women's Health Initiative Calcium-Vitamin D Trial: overview and baseline characteristics of participants. Annals of Epidemiology 2003;13:S98-106. - PubMed
    1. Jackson RD, LaCroix AZ, Gass M, Wallace RB, Robbins J, Lewis CE, et al. Calcium plus vitamin D supplementation and the risk of fractures [erratum appears in New England Journal of Medicine 9 March 2006;354(10):1102]. New England Journal of Medicine 2006;354(7):669-83. - PubMed
Witham 2010 {published data only}
    1. Witham MD, Crighton LJ, Gillespie ND, Struthers AD, McMurdo ME. The effects of vitamin D supplementation on physical function and quality of life in older patients with heart failure. A randomized controlled trial. Circulation: Heart Failure 2010;3:195-201. - PubMed
Witham 2013 {unpublished data only}ISRCTN92186858
    1. Witham M. Can high-dose vitamin D supplementation reduce blood pressure and markers of cardiovascular risk in older people with isolated systolic hypertension? A randomised, double-blind, parallel group placebo controlled trial. http://www.controlled-trials.com/ISRCTN92186858/ (accessed 3 December 2013).
    1. Witham MD, Price RJ, Struthers AD, Donnan PT, Messow M, Ford I, et al. Vitamin D supplementation to reduce blood pressure in older patients with isolated systolic hypertension (VitDISH) - a randomised controlled trial. Personal communication ahead of publication 15 January 2013.

References to studies excluded from this review

Aguado 2006 {published data only}
    1. Aguado P, Gonzalez-Casaus ML, Cobo T, Campo T, Martinez ME, Martin-Mola E, et al. The efficacy of two dosing regimens (daily colecalciferol versus cyclical calcidiol) for the prevention of bone mass loss in postmenopausal women with vitamin D insufficiency. Journal of Bone and Mineral Research 2006;21(Suppl 1):S306.
ALFA 2006 {published data only}
    1. Bock O, Boerst H, Runge M, Beller G, Touby F, Tuerk J, et al. Effect of alfacalcidol on volumetric bone mineral density measured by pQCT in alendronate-treated postmenopausal women with osteopenia or osteoporosis: 1 year interim analysis of the ALFA study [abstract]. Journal of Bone and Mineral Research 2007;22(Suppl 1):S215.
    1. Bock O, Boerst H, Runge M, Schacht E, Martus P, Felsenberg D. Effect of alfacalcidol on biochemical bone markers in alendronate-treated postmenopausal women with osteopenia or osteoporosis: 1 year interim analysis of the ALFA study [abstract]. Journal of Bone and Mineral Research 2006;21(Suppl 1):S306.
    1. Boerst H, Bock O, Runge M, Degner C, Stephan-Oelkers M, Umrath F, et al. Effects of alfacalcidol on bone markers and bone mineral density in alendronate-treated postmenopausal women with osteopenia or osteoporosis: one year interim analysis of the ALFA study [abstract]. Osteoporosis International 2007;18(Suppl 1):S90-1.
    1. Felsenberg D, Bock O, Borst H, Armbrecht G, Beller G, Degner C, et al. Additive effect of alfacalcidol on bone mineral density and bone strength in alendronate treated postmenopausal women with reduced bone mass. Journal of Musculoskeletal & Neuronal Interactions 2011;11(1):34-45. - PubMed
Aloia 2005 {published data only}
    1. Aloia JF, Talwar SA, Pollack S, Yeh J. A randomized controlled trial of vitamin D3 supplementation in African American women. Archives of Internal Medicine 2005;165(14):1618-23. - PMC - PubMed
    1. Talwar SA, Aloia JF, Pollack S, Yeh J. Oral vitamin D3 supplementation in postmenopausal African American women. Calcified Tissue International 2004;74(Suppl 1):S102.
    1. Talwar SA, Aloia JF, Pollack S, Yeh J. Oral vitamin D3 supplementation in postmenopausal African American women. Journal of Bone and Mineral Research 2004;19(Suppl 1):S324.
Baeksgaard 1998 {published data only}
    1. Baeksgaard L, Andersen KP, Hylstrup L. Calcium and vitamin supplementation increases spinal BMD in healthy, postmenopausal women. Osteoporosis International 1998;8:255-60. - PubMed
Binder 1995 {published data only}
    1. Binder EF. Implementing a structured exercise program for frail nursing home residents with dementia. Journal of Aging and Physical Activity 1995;3:383-95.
Binkley 2007 {published data only}
    1. Binkley N, Recker R, Holst A, Walliser J, Lips P, Pfeifer M. Treatment effects of vitamin D3 8400IU once weekly on elderly subjects with vitamin D insufficiency. Osteoporosis International 2007;18(Suppl 1):S118.
Brazier 2005 {published data only}
    1. Brazier M, Grados F, Kamel S, Mathieu M, Morel A, Maamer M, et al. Clinical and laboratory safety of one year's use of a combination calcium + vitamin D tablet in ambulatory elderly women with vitamin D insufficiency: results of a multicenter, randomized, double-blind, placebo-controlled study. Clinical Therapeutics 2005;27(12):1885-93. - PubMed
Broe 2007 {published data only}
    1. Broe KE, Chen TC, Weinberg J, Bischoff-Ferrari HA, Holick MF, Kiel DP. A higher dose of vitamin D reduces the risk of falls in nursing home residents: a randomized, multiple-dose study. Journal of the American Geriatrics Society 2007;55(2):234-9. - PubMed
    1. Kiel DP, Broe KE, Chen TC, Cupples LA, Bischoff-Ferrari H, Holick MF. A higher dose of vitamin D reduces the risk of falls in nursing home residents: a randomized, placebo-controlled, multiple dose study. Journal of Bone and Mineral Research 2004;19(Suppl 1):S462-3.
Bunout 2006 {published data only}
    1. Bunout D, Barrera G, Leiva L, Gattas V, la Maza MP, Avendano M, et al. Effects of vitamin D supplementation and exercise training on physical performance in Chilean vitamin D deficient elderly subjects. Experimental Gerontology 2006;41(8):747-52. - PubMed
Chen 1997 {published data only}
    1. Chen JT, Shiraki M, Hasumi K, Tanaka N, Katase K, Kato T, et al. 1-alpha-hydroxyvitamin D3 treatment decreases bone turnover and modulates calcium-regulating hormones in early postmenopausal women. Bone 1997;20:557-62. - PubMed
Chevalley 1994 {published data only}
    1. Chevalley T, Rizzoli R, Nydegger V, Slosman D, Rapin C-H, Michel J-P, et al. Effects of calcium supplements on femoral bone mineral density and vertebral fracture rate in vitamin-D-replete elderly patients. Osteoporosis International 1994;4:245-52. - PubMed
Cooper 2003 {published data only}
    1. Cooper L, Clifton-Bligh PB, Nery ML, Figtree G, Twigg S, Hibbert E, et al. Vitamin D supplementation and bone mineral density in early postmenopausal women. American Journal of Clinical Nutrition 2003;77:1324-9. - PubMed
    1. Cooper L, Figtree G, Nery L, Twigg S, Hibbert E, Clifton-Bligh P, et al. Vitamin D supplementation and bone mineral density in early postmenopausal women. Journal of Bone and Mineral Research 1999;14(Suppl 1):S538. - PubMed
Corless 1985 {published data only}
    1. Corless D, Dawson E, Fraser F, Ellis M, Evans SJW, Perry JD, et al. Do vitamin D supplements improve the physical capabilities of elderly hospital patients? Age and Ageing 1985;14:76-84. - PubMed
Daly 2006 {published data only}
    1. Daly RM, Bass S, Nowson C. Long-term effects of calcium-vitamin-D3-fortified milk on bone geometry and strength in older men. Bone 2006;39(4):946-53. - PubMed
    1. Daly RM, Brown M, Bass S, Kukuljan S, Nowson C. Calcium and vitamin D3 fortified milk reduces bone loss at clinically relevant skeletal sites in older men: a 2-year randomised controlled trial. Journal of Bone and Mineral Research 2005;20(Suppl 1):S97. - PubMed
    1. Daly RM, Brown M, Bass S, Kukuljan S, Nowson C. Calcium- and vitamin D3-fortified milk reduces bone loss at clinically relevant skeletal sites in older men: a 2-year randomized controlled trial. Journal of Bone and Mineral Research 2006;21(3):397-405. - PubMed
    1. Kukuljan S, Daly RM, Bass SL, Sanders K, Nicholson GC, Turner CH, et al. Does calcium-vitamin D3 fortified milk enhance the effects of exercise on BMD in older men: an 18 month randomised controlled trial. Journal of Bone and Mineral Research 2006;21(Suppl 1):S184.
Dawson‐Hughes 1991 {published data only}
    1. Dawson-Hughes B, Dallal GE, Krall EA, Harris S, Sokoll LJ, Falconer G. Effect of vitamin D supplementation on wintertime and overall bone loss in healthy postmenopausal women. Annals of Internal Medicine 1991;115:505-12. - PubMed
Dawson‐Hughes 1995 {published data only}
    1. Dawson-Hughes B, Harris SS, Krall EA, Dallal GE, Falconer G, Green CL. Rates of bone loss in postmenopausal women randomly assigned to one of two dosages of vitamin D. American Journal of Clinical Nutrition 1995;61:1140-5. - PubMed
Deroisy 1998 {published data only}
    1. Deroisy R, Collette J, Chevallier T, Breuil V, Reginster JY. Effects of two 1-year calcium and vitamin D3 treatments on bone remodeling markers and femoral bone density in elderly women. Current Therapeutic Research 1998;59:850-62.
Deroisy 2002 {published data only}
    1. Deroisy R, Collette J, Albert A, Jupsin I, Reginster J-Y. Administration of a supplement containing both calcium and vitamin D is more effective than calcium alone to reduce secondary hyperparathyrodism in postmenopausal women with low 25(OH)vitamin D circulating levels. Aging - Clinical and Experimental Research 2002;14:13-7. - PubMed
Dhesi 2004 {published data only}
    1. Dhesi JK, Jackson SHD, Bearne LM, Moniz C, Hurley MV, Swift CG, et al. Vitamin D supplementation improves neuromuscular function in older people who fall. Age and Ageing 2004;33:589-95. - PubMed
Doetsch 2004 {published data only}
    1. Doetsch AM, Faber J, Lynnerup N, Watjen I, Bliddal H, Danneskiold-Samsoe B. The effect of calcium and vitamin D3 supplementation on the healing of the proximal humerus fracture: a randomized placebo-controlled study. Calcified Tissue International 2004;75:183-8. - PubMed
Francis 1996 {published data only}
    1. Francis RM, Boyle IT, Moniz C, Sutcliffe AM, Davis BS, Beastall GH, et al. A comparison of the effects of alfacalcidol treatment and vitamin D2 supplementation on calcium absorption in elderly women with vertebral fractures. Osteoporosis International 1996;6:284-90. - PubMed
Fujita 1989 {published data only}
    1. Fujita T, Inoue T, Orimo H, Kumahara Y, Kurokawa K, Takahashi H, et al. Clinical evaluation of the effect of calcitriol on osteoporosis. Multicenter double-blind study using alfacalcitol as the control drug. Igaku No Ayumi - Journal of Clinical and Experimental Medicine 1989;148:833-57.
Gallagher 1982 {published data only}
    1. Gallagher JC, Jerpbak CM, Jee WS, Johnson KA, DeLuca HF, Riggs BL. 1,25-Dihydroxyvitamin D3: short- and long-term effects on bone and calcium metabolism in patients with postmenopausal osteoporosis. Proceedings of the National Academy of Sciences 1982;79:3325-9. - PMC - PubMed
Gloth 1995 {published data only}
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Grados 2003 {published data only}
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Grady 1991 {published data only}
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Hangartner 1985 {published data only}
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Harju 1989 {published data only}
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Heikinheimo 1992 {published data only}
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Honkanen 1990 {published data only}
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Hunter 2000 {published data only}
    1. Hunter D, Major P, Arden N, Swaminathan R, Andrew T, MacGregor AJ, et al. A randomized controlled trial of vitamin D supplementation on preventing postmenopausal bone loss and modifying bone metabolism using identical twin pairs. Journal of Bone and Mineral Research 2000;15(11):2276-83. - PubMed
Itami 1982 {published data only}
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Iwamoto 1999 {published data only}
    1. Iwamoto I, Kosha S, Noguchi S, Murakami M, Fujino T, Douchi T, et al. A longitudinal study of the effect of vitamin K2 on bone mineral density in postmenopausal women a comparative study with vitamin D3 and estrogen-progestin therapy. Maturitas 1999;31:161-4. - PubMed
Iwamoto 2000 {published data only}
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Jensen 1982 {published data only}
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Jensen 1985 {published data only}
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Johnell 2001 {published and unpublished data}
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Johnson 1980 {published data only}
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Keane 1998 {published data only}
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Kenny 2003 {published data only}
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Krieg 1999 {published data only}
    1. Krieg MA, Jacquet AF, Bremgartner M, Cuttelod S, Thiebaud D, Burckhardt P. Effect of supplementation with vitamin D3 and calcium on quantitative ultrasound of bone in elderly institutionalized women: a longitudinal study. Osteoporosis International 1999;9(6):483-8. - PubMed
Larsen 2004 {published data only}
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Latham 2003 {published data only}
    1. Latham NK, Anderson CS, Lee A, Bennett DA, Moseley A, Cameron ID. A randomized, controlled trial of quadriceps resistance exercise and vitamin D in frail older people: the Frailty Interventions Trial in Elderly Subjects. Journal of the American Geriatrics Society 2003;51:291-9. - PubMed
Meier 2004 {published data only}
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Moschonis 2006 {published data only}
    1. Moschonis G, Manios Y. Skeletal site-dependent response of bone mineral density and quantitative ultrasound parameters following a 12-month dietary intervention using dairy products fortified with calcium and vitamin D: the Postmenopausal Health Study. British Journal of Nutrition 2006;96(6):1140-8. - PubMed
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Ongphiphadhanakul 2000 {published data only}
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Ooms 1995 {published data only}
    1. Ooms ME, Poos JC, Bezemer PD, Vijgh WJ, Bouter LM, Lips P. Prevention of bone loss by vitamin D supplementation in elderly women: a randomized double blind trial. Journal of Clinical Endocrinology and Metabolism 1995;80:1052-8. - PubMed
Orimo 2011 {published data only}
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Orwoll 1989 {published data only}
    1. Orwoll ES, McClung MR, Oviatt SK, Recker RR, Weigel RM. Histomorphometric effects of calcium or calcium plus 25-hydroxyvitamin D3 therapy in senile osteoporosis. Journal of Bone and Mineral Research 1989;4:81-8. - PubMed
Patel 2001 {published data only}
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Pedrosa 2006 {published data only}
    1. Pedrosa MA, Moreira LD, Barros ER, Kunii I, Lazaretti-Castro M. Cholecalciferol supplementation reverts 25-hydroxyvitamin D (25OHD) insufficiency and increases lower limb muscle strength (LLMS) in elderly people living in long-stay geriatric care (LSC). Osteoporosis International 2006;17(Suppl 2):S229-30.
Riera 2003 {published data only}
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References to studies awaiting assessment

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References to ongoing studies

ANVITAD {published data only}
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