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Intravenous zoledronic acid in postmenopausal women with low bone mineral density.
N Engl J Med. 2002 Feb 28; 346(9):653-61.NEJM

Abstract

BACKGROUND

Bisphosphonates are effective agents for the management of osteoporosis. Their low bioavailability and low potency necessitate frequent administration on an empty stomach, which may reduce compliance. Gastrointestinal intolerance limits maximal dosing. Although intermittent intravenous treatments have been used, the optimal doses and dosing interval have not been systematically explored.

METHODS

We studied the effects of five regimens of zoledronic acid, the most potent bisphosphonate, on bone turnover and density in 351 postmenopausal women with low bone mineral density in a one-year, randomized, double-blind, placebo-controlled trial. Women received placebo or intravenous zoledronic acid in doses of 0.25 mg, 0.5 mg, or 1 mg at three-month intervals. In addition, one group received a total annual dose of 4 mg as a single dose, and another received two doses of 2 mg each, six months apart. Lumbar-spine bone mineral density was the primary end point.

RESULTS

There were similar increases in bone mineral density in all the zoledronic acid groups to values for the spine that were 4.3 to 5.1 percent higher than those in the placebo group (P<0.001) and values for the femoral neck that were 3.1 to 3.5 percent higher than those in the placebo group (P<0.001). Biochemical markers of bone resorption were significantly suppressed throughout the study in all zoledronic acid groups. Myalgia and pyrexia occurred more commonly in the zoledronic acid groups, but treatment-related dropout rates were similar to that in the placebo group.

CONCLUSIONS

Zoledronic acid infusions given at intervals of up to one year produce effects on bone turnover and bone density as great as those achieved with daily oral dosing with bisphosphonates with proven efficacy against fractures, suggesting that an annual infusion of zoledronic acid might be an effective treatment for postmenopausal osteoporosis.

Authors+Show Affiliations

Department of Medicine, University of Auckland, Auckland, New Zealand. i.reid@auckland.ac.nzNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

11870242

Citation

Reid, Ian R., et al. "Intravenous Zoledronic Acid in Postmenopausal Women With Low Bone Mineral Density." The New England Journal of Medicine, vol. 346, no. 9, 2002, pp. 653-61.
Reid IR, Brown JP, Burckhardt P, et al. Intravenous zoledronic acid in postmenopausal women with low bone mineral density. N Engl J Med. 2002;346(9):653-61.
Reid, I. R., Brown, J. P., Burckhardt, P., Horowitz, Z., Richardson, P., Trechsel, U., Widmer, A., Devogelaer, J. P., Kaufman, J. M., Jaeger, P., Body, J. J., Brandi, M. L., Broell, J., Di Micco, R., Genazzani, A. R., Felsenberg, D., Happ, J., Hooper, M. J., Ittner, J., ... Meunier, P. J. (2002). Intravenous zoledronic acid in postmenopausal women with low bone mineral density. The New England Journal of Medicine, 346(9), 653-61.
Reid IR, et al. Intravenous Zoledronic Acid in Postmenopausal Women With Low Bone Mineral Density. N Engl J Med. 2002 Feb 28;346(9):653-61. PubMed PMID: 11870242.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Intravenous zoledronic acid in postmenopausal women with low bone mineral density. AU - Reid,Ian R, AU - Brown,Jacques P, AU - Burckhardt,Peter, AU - Horowitz,Zebulun, AU - Richardson,Peter, AU - Trechsel,Ulrich, AU - Widmer,Albert, AU - Devogelaer,Jean-Pierre, AU - Kaufman,Jean-Marc, AU - Jaeger,Philippe, AU - Body,Jean-Jacques, AU - Brandi,Maria Luisa, AU - Broell,Johann, AU - Di Micco,Raffaele, AU - Genazzani,Andrea Riccardo, AU - Felsenberg,Dieter, AU - Happ,Joachim, AU - Hooper,Michael J, AU - Ittner,Jochen, AU - Leb,Georg, AU - Mallmin,Hans, AU - Murray,Timothy, AU - Ortolani,Sergio, AU - Rubinacci,Alessandro, AU - Saaf,Maria, AU - Samsioe,Goran, AU - Verbruggen,Leon, AU - Meunier,Pierre J, PY - 2002/3/1/pubmed PY - 2002/3/7/medline PY - 2002/3/1/entrez SP - 653 EP - 61 JF - The New England journal of medicine JO - N Engl J Med VL - 346 IS - 9 N2 - BACKGROUND: Bisphosphonates are effective agents for the management of osteoporosis. Their low bioavailability and low potency necessitate frequent administration on an empty stomach, which may reduce compliance. Gastrointestinal intolerance limits maximal dosing. Although intermittent intravenous treatments have been used, the optimal doses and dosing interval have not been systematically explored. METHODS: We studied the effects of five regimens of zoledronic acid, the most potent bisphosphonate, on bone turnover and density in 351 postmenopausal women with low bone mineral density in a one-year, randomized, double-blind, placebo-controlled trial. Women received placebo or intravenous zoledronic acid in doses of 0.25 mg, 0.5 mg, or 1 mg at three-month intervals. In addition, one group received a total annual dose of 4 mg as a single dose, and another received two doses of 2 mg each, six months apart. Lumbar-spine bone mineral density was the primary end point. RESULTS: There were similar increases in bone mineral density in all the zoledronic acid groups to values for the spine that were 4.3 to 5.1 percent higher than those in the placebo group (P<0.001) and values for the femoral neck that were 3.1 to 3.5 percent higher than those in the placebo group (P<0.001). Biochemical markers of bone resorption were significantly suppressed throughout the study in all zoledronic acid groups. Myalgia and pyrexia occurred more commonly in the zoledronic acid groups, but treatment-related dropout rates were similar to that in the placebo group. CONCLUSIONS: Zoledronic acid infusions given at intervals of up to one year produce effects on bone turnover and bone density as great as those achieved with daily oral dosing with bisphosphonates with proven efficacy against fractures, suggesting that an annual infusion of zoledronic acid might be an effective treatment for postmenopausal osteoporosis. SN - 1533-4406 UR - https://www.unboundmedicine.com/medline/citation/11870242/Intravenous_zoledronic_acid_in_postmenopausal_women_with_low_bone_mineral_density_ L2 - https://www.nejm.org/doi/10.1056/NEJMoa011807?url_ver=Z39.88-2003&amp;rfr_id=ori:rid:crossref.org&amp;rfr_dat=cr_pub=pubmed DB - PRIME DP - Unbound Medicine ER -