BACKGROUND AND METHODS. Osteoporosis is a common problem whose management is controversial. To evaluate the efficacy and safety of calcitriol (1,25-dihydroxyvitamin D3) in the treatment of postmenopausal osteoporosis, we conducted a three-year prospective, multicenter, single-blind study in 622 women who had one or more vertebral compression fractures. The women were randomly assigned to receive treatment with calcitriol (0.25 micrograms twice a day) or supplemental calcium (1 g of elemental calcium daily) for three years. New vertebral fractures were detected by means of lateral roentgenography of the spine each year, and calcium absorption was measured in 392 of the women. RESULTS. The women who received calcitriol had a significant reduction in the rate of new vertebral fractures during the second and third years of treatment, as compared with the women who received calcium (second year, 9.3 vs. 25.0 fractures per 100 patient-years; third year, 9.9 vs. 31.5 fractures per 100 patient-years; P less than 0.001). This effect was evident only in women who had had five or fewer vertebral fractures at base line (second year, 5.2 vs. 25.3 fractures per 100 patient-years; third year, 4.2 vs. 31.0 fractures per 100 patient-years; P less than 0.0001). The groups also differed significantly in the number of peripheral fractures; 11 such fractures occurred in 11 women in the calcitriol group, whereas 24 occurred in 22 women in the calcium group (P less than 0.05). There was no significant difference between the groups in the incidence of side effects requiring withdrawal of treatment (8.6 percent in the calcitriol group vs. 6.5 percent in the calcium group). CONCLUSIONS. Continuous treatment of postmenopausal osteoporosis with calcitriol for three years is safe and significantly reduces the rate of new vertebral fractures in women with this disorder.
Source Information
Department of General Practice, Medical School, University of Otago, Dunedin, New Zealand.
This article has been cited by other articles:
Bischoff-Ferrari, H. A., Willett, W. C., Wong, J. B., Stuck, A. E., Staehelin, H. B., Orav, E. J., Thoma, A., Kiel, D. P., Henschkowski, J.
(2009). Prevention of Nonvertebral Fractures With Oral Vitamin D and Dose Dependency: A Meta-analysis of Randomized Controlled Trials. Arch Intern Med
169: 551-561
[Abstract][Full Text]
MacLaughlin, E. J., Raehl, C. L.
(2008). ASHP Therapeutic Position Statement on the Prevention and Treatment of Osteoporosis in Adults. Am J Health Syst Pharm
65: 343-357
[Full Text]
Mauck, K. F., Clarke, B. L.
(2006). Diagnosis, Screening, Prevention, and Treatment of Osteoporosis. Mayo Clin Proc.
81: 662-672
[Abstract][Full Text]
Nagpal, S., Na, S., Rathnachalam, R.
(2005). Noncalcemic Actions of Vitamin D Receptor Ligands. Endocr. Rev.
26: 662-687
[Abstract][Full Text]
Duque, G., Macoritto, M., Dion, N., Ste-Marie, L.-G., Kremer, R.
(2005). 1,25(OH)2D3 acts as a bone-forming agent in the hormone-independent senescence-accelerated mouse (SAM-P/6). Am. J. Physiol. Endocrinol. Metab.
288: E723-E730
[Abstract][Full Text]
Francis, R.M., Baillie, S.P., Chuck, A.J., Crook, P.R., Dunn, N., Fordham, J.N., Kelly, C., Rodgers, A.
(2004). Acute and long-term management of patients with vertebral fractures. QJM
97: 63-74
[Abstract][Full Text]
Chan, F. K. W., Tiu, S.-C., Choi, K.-L., Choi, C.-H., Kong, A. P. S., Shek, C.-C.
(2003). Increased Bone Mineral Density in Patients with Chronic Hypoparathyroidism. J. Clin. Endocrinol. Metab.
88: 3155-3159
[Abstract][Full Text]
Sutton, A. L. M., MacDonald, P. N.
(2003). Vitamin D: More Than a "Bone-a-Fide" Hormone. Mol. Endocrinol.
17: 777-791
[Abstract][Full Text]
Christodoulou, C, Cooper, C
(2003). What is osteoporosis?. Postgrad. Med. J.
79: 133-138
[Abstract][Full Text]
Shevde, N. K., Plum, L. A., Clagett-Dame, M., Yamamoto, H., Pike, J. W., DeLuca, H. F.
(2002). A potent analog of 1alpha ,25-dihydroxyvitamin D3 selectively induces bone formation. Proc. Natl. Acad. Sci. USA
99: 13487-13491
[Abstract][Full Text]
Papadimitropoulos, E., Wells, G., Shea, B., Gillespie, W., Weaver, B., Zytaruk, N., Cranney, A., Adachi, J., Tugwell, P., Josse, R., Greenwood, C., Guyatt, G.
(2002). VIII: Meta-Analysis of the Efficacy of Vitamin D Treatment in Preventing Osteoporosis in Postmenopausal Women. Endocr. Rev.
23: 560-569
[Full Text]
Jensen, C., Holloway, L., Block, G., Spiller, G., Gildengorin, G., Gunderson, E., Butterfield, G., Marcus, R.
(2002). Long-term effects of nutrient intervention on markers of bone remodeling and calciotropic hormones in late-postmenopausal women. Am. J. Clin. Nutr.
75: 1114-1120
[Abstract][Full Text]
Marcus, R., Wong, M., Heath, H. III, Stock, J. L.
(2002). Antiresorptive Treatment of Postmenopausal Osteoporosis: Comparison of Study Designs and Outcomes in Large Clinical Trials with Fracture as an Endpoint. Endocr. Rev.
23: 16-37
[Abstract][Full Text]
Grossman, J. M., MacLean, C. H.
(2001). Quality Indicators for the Management of Osteoporosis in Vulnerable Elders. ANN INTERN MED
135: 722-730
[Full Text]
Ebeling, P. R., Wark, J. D., Yeung, S., Poon, C., Salehi, N., Nicholson, G. C., Kotowicz, M. A.
(2001). Effects of Calcitriol or Calcium on Bone Mineral Density, Bone Turnover, and Fractures in Men with Primary Osteoporosis: A Two-Year Randomized, Double Blind, Double Placebo Study. J. Clin. Endocrinol. Metab.
86: 4098-4103
[Abstract][Full Text]
Gallagher, J. C., Fowler, S. E., Detter, J. R., Sherman, S. S.
(2001). Combination Treatment with Estrogen and Calcitriol in the Prevention of Age-Related Bone Loss. J. Clin. Endocrinol. Metab.
86: 3618-3628
[Abstract][Full Text]
Neer, R. M., Arnaud, C. D., Zanchetta, J. R., Prince, R., Gaich, G. A., Reginster, J.-Y., Hodsman, A. B., Eriksen, E. F., Ish-Shalom, S., Genant, H. K., Wang, O., Mitlak, B. H., Mellstrom, D., Oefjord, E. S., Marcinowska-Suchowierska, E., Salmi, J., Mulder, H., Halse, J., Sawicki, A. Z.
(2001). Effect of Parathyroid Hormone (1-34) on Fractures and Bone Mineral Density in Postmenopausal Women with Osteoporosis. NEJM
344: 1434-1441
[Abstract][Full Text]
Green, L. A, Dovey, S. M
(2001). Practice based primary care research networks. BMJ
322: 567-568
[Full Text]
Compston, J. E.
(2000). Pharmacological interventions for post-menopausal osteoporosis: an evidence-based approach. Rheumatology (Oxford)
39: 1309-1312
[Full Text]
Sosa, M., Lainez, P., Arbelo, A., Navarro, M. C.
(2000). The effect of 25-dihydroxyvitamin D on the bone mineral metabolism of elderly women with hip fracture. Rheumatology (Oxford)
39: 1263-1268
[Abstract][Full Text]
GARDINER, E. M., BALDOCK, P. A., THOMAS, G. P., SIMS, N. A., HENDERSON, N. K., HOLLIS, B., WHITE, C. P., SUNN, K. L., MORRISON, N. A., WALSH, W. R., EISMAN, J. A.
(2000). Increased formation and decreased resorption of bone in mice with elevated vitamin D receptor in mature cells of the osteoblastic lineage. FASEB J.
14: 1908-1916
[Abstract][Full Text]
Sato, Y., Manabe, S., Kuno, H., Oizumi, K.
(1999). Amelioration of osteopenia and hypovitaminosis D by 1alpha -hydroxyvitamin D3 in elderly patients with Parkinson's disease. J. Neurol. Neurosurg. Psychiatry
66: 64-68
[Abstract][Full Text]
Erben, R. G., Bromm, S., Stangassinger, M.
(1998). Therapeutic Efficacy of 1{alpha},25-Dihydroxyvitamin D3 and Calcium in Osteopenic Ovariectomized Rats: Evidence for a Direct Anabolic Effect of 1{alpha},25-Dihydroxyvitamin D3 on Bone. Endocrinology
139: 4319-4328
[Abstract][Full Text]
JONES, G., STRUGNELL, S. A., DeLUCA, H. F.
(1998). Current Understanding of the Molecular Actions of Vitamin D. Physiol. Rev.
78: 1193-1231
[Abstract][Full Text]
Liu, A. C., Lloyd, M., Eastell, R.
(1998). Treatment of Postmenopausal Osteoporosis. NEJM
339: 202-203
[Full Text]
Masud, T, Mulcahy, B, Thompson, A V, Donnelly, S, Keen, R W, Doyle, D V, Spector, T D
(1998). Effects of cyclical etidronate combined with calcitriol versus cyclical etidronate alone on spine and femoral neck bone mineral density in postmenopausal osteoporotic women. Ann Rheum Dis
57: 346-349
[Abstract][Full Text]
Eastell, R.
(1998). Treatment of Postmenopausal Osteoporosis. NEJM
338: 736-746
[Full Text]
Ensrud, K. E., Black, D. M., Palermo, L., Bauer, D. C., Barrett-Connor, E., Quandt, S. A., Thompson, D. E., Karpf, D. B.
(1997). Trreatment With Alendronate Prevents Fractures in Women at Highest Risk: Results From the Fracture Intervention Trial. Arch Intern Med
157: 2617-2624
[Abstract]
Karpf, D. B., Shapiro, D. R., Seeman, E., Ensrud, K. E., Johnston, C. C. Jr, Adami, S., Harris, S. T., Santora, A. C. II, Hirsch, L. J., Oppenheimer, L., Thompson, D.
(1997). Prevention of Nonvertebral Fractures by Alendronate: A Meta-analysis. JAMA
277: 1159-1164
[Abstract]
LANE, J. M., RILEY, E. H., WIRGANOWICZ, P. Z.
(1996). Instructional Course Lectures, The American Academy of Orthopaedic Surgeons - Osteoporosis: Diagnosis and Treatment*{{dagger}}. JBJS
78: 618-32
[Full Text]
Liberman, U. A., Weiss, S. R., Broll, J., Minne, H. W., Quan, H., Bell, N. H., Rodriguez-Portales, J., Downs, R. W., Dequeker, J., Favus, M., Seeman, E., Recker, R. R., Capizzi, T., Santora, A. C., Lombardi, A., Shah, R. V., Hirsch, L. J., Karpf, D. B., The Alendronate Phase III Osteoporosis Treatment S,
(1995). Effect of Oral Alendronate on Bone Mineral Density and the Incidence of Fractures in Postmenopausal Osteoporosis. NEJM
333: 1437-1444
[Abstract][Full Text]
Sambrook, P. N.
(1995). The Treatment of Postmenopausal Osteoporosis. NEJM
333: 1495-1496
[Full Text]
Windeler, J., Lange, S.
(1995). Events per person year--a dubious concept. BMJ
310: 454-456
[Full Text]
Mets, T, Torgerson, D, Campbell, M
(1994). Calcium, vitamin D, and hip fractures Incidence of falls may have decreased. BMJ
309: 193-193
[Full Text]
Sambrook, P., Birmingham, J., Kelly, P., Kempler, S., Nguyen, T., Pocock, N., Eisman, J.
(1993). Prevention of Corticosteroid Osteoporosis -- A Comparison of Calcium, Calcitriol, and Calcitonin. NEJM
328: 1747-1752
[Abstract][Full Text]
(1992). CALCITRIOL FOR POSTMENOPAUSAL OSTEOPOROSIS. JWatch General
1992: 1-1
[Full Text]
