Skip to main content
Top
Published in: Current Osteoporosis Reports 1/2012

01-03-2012 | Current Therapeutics (SL Silverman, Section Editor)

Data from Extension Trials: Denosumab and Zoledronic Acid

Author: Robin K. Dore

Published in: Current Osteoporosis Reports | Issue 1/2012

Login to get access

Abstract

Osteoporosis and fractures that occur as a result of this condition pose a huge public health problem to society and result in morbidity and mortality to individuals. Because osteoporosis is often a result of aging, many people are not aware that therapies exist to reduce the risk of fracture. Until recently, the most common therapies used to treat osteoporosis, the oral bisphosphonates, had an inconvenient and cumbersome mode of administration. Within the last 4 years, two new parenteral antiresorptive drugs to treat osteoporosis were approved by the US Food and Drug Administration. As treatment of osteoporosis may extend for many years, the collection of long-term efficacy and safety data is warranted. This paper discusses data from the extension trials of denosumab and zoledronic acid.
Literature
1.
go back to reference Cramer JA, Gold DT, Silverman SL, Lewiecki EM. A systematic review of persistence and compliance with bisphosphonates for osteoporosis. Osteoporos Int. 2007;18:1023–31.PubMedCrossRef Cramer JA, Gold DT, Silverman SL, Lewiecki EM. A systematic review of persistence and compliance with bisphosphonates for osteoporosis. Osteoporos Int. 2007;18:1023–31.PubMedCrossRef
2.
go back to reference Harris ST, Siris E, Abbott T, et al. Reduced osteoporotic fracture risk in patients’ adherence to bisphosphonate therapy; Program & Abstracts of The Endocrine Society’s 87th Annual Meeting; 4–7 June 2005; 2005. pp. 3–382. Harris ST, Siris E, Abbott T, et al. Reduced osteoporotic fracture risk in patients’ adherence to bisphosphonate therapy; Program & Abstracts of The Endocrine Society’s 87th Annual Meeting; 4–7 June 2005; 2005. pp. 3–382.
3.
go back to reference Cummings SR, San Martin J, McClung MR, et al. Denosumab for prevention of fractures in postmenopausal women with osteoporosis. N Engl J Med. 2009;361:756–65.PubMedCrossRef Cummings SR, San Martin J, McClung MR, et al. Denosumab for prevention of fractures in postmenopausal women with osteoporosis. N Engl J Med. 2009;361:756–65.PubMedCrossRef
4.
go back to reference Black DM, Delmas PD, Eastell R, et al. Once yearly zoledronic acid for the treatment of postmenopausal osteoporosis. N Engl J Med. 2007;356:1809–22.PubMedCrossRef Black DM, Delmas PD, Eastell R, et al. Once yearly zoledronic acid for the treatment of postmenopausal osteoporosis. N Engl J Med. 2007;356:1809–22.PubMedCrossRef
5.
go back to reference •• Papapoulos S, Man Z, Mellstrom D et al. Five-Year denosumab treatment of postmenopausal women with osteoporosis: results from the first two years of the FREEDOM trial extension, Osteoporos Int, abstract OC26, ECCEO, Valencia, Spain, March 25, 2011. This is the most recent data presented from the FREEDOM trial extension. •• Papapoulos S, Man Z, Mellstrom D et al. Five-Year denosumab treatment of postmenopausal women with osteoporosis: results from the first two years of the FREEDOM trial extension, Osteoporos Int, abstract OC26, ECCEO, Valencia, Spain, March 25, 2011. This is the most recent data presented from the FREEDOM trial extension.
6.
go back to reference • Seeman E, Libarati C, Austin M et al. The transitory increase in PTH following denosumab administration is associated with reduced intracortical porosity: a distinctive attribute of denosumab therapy, Annual Meeting of the American Society of Bone and Mineral Research, abstract 1064, San Diego CA. September 17, 2011. This is the most plausible explanation for the continued increase in BMD during continuation of denosumab therapy. • Seeman E, Libarati C, Austin M et al. The transitory increase in PTH following denosumab administration is associated with reduced intracortical porosity: a distinctive attribute of denosumab therapy, Annual Meeting of the American Society of Bone and Mineral Research, abstract 1064, San Diego CA. September 17, 2011. This is the most plausible explanation for the continued increase in BMD during continuation of denosumab therapy.
7.
go back to reference Lewiecki EM, Miller PD, McClung MR, et al. Two-year treatment with denosumab (AMH 162) in a randomized phase 2 study of postmenopausal women with low bone mineral density. J Bone Miner Res. 2007;22:1832–41.PubMedCrossRef Lewiecki EM, Miller PD, McClung MR, et al. Two-year treatment with denosumab (AMH 162) in a randomized phase 2 study of postmenopausal women with low bone mineral density. J Bone Miner Res. 2007;22:1832–41.PubMedCrossRef
8.
go back to reference Miller PC, Bolognese MA, Lewiecki EM et al. Effect of denosumab on bone density and turnover in postmenopausal women with low bone mass after long-term continued, discontinued, and restarting of therapy: a randomized blinded phase 2 clinical trial. Bone. 2008;43:222–29. Miller PC, Bolognese MA, Lewiecki EM et al. Effect of denosumab on bone density and turnover in postmenopausal women with low bone mass after long-term continued, discontinued, and restarting of therapy: a randomized blinded phase 2 clinical trial. Bone. 2008;43:222–29.
9.
go back to reference • Miller PD, Wagman RB, Peacock M et al. Effect of denosumab on bone mineral density and biochemical markers of bone turnover: six-year results of a phase 2 clinical trial, J Clin Endocrinol Metab, 2011;96(2):394–402. This is the most recent peer-reviewed publication of denosumab data.PubMedCrossRef • Miller PD, Wagman RB, Peacock M et al. Effect of denosumab on bone mineral density and biochemical markers of bone turnover: six-year results of a phase 2 clinical trial, J Clin Endocrinol Metab, 2011;96(2):394–402. This is the most recent peer-reviewed publication of denosumab data.PubMedCrossRef
10.
go back to reference •• McClung MR, Lewiecki EM, Bolognese MA. Effects of denosumab on bone mineral density and biochemical markers of bone turnover: 8-year results of a phase 2 clinical trial, Annual Meeting of the American Society of Bone Mineral and Research, abstract 1061, San Diego CA, September17, 2011. This is the most recent publication of denosumab long-term safety data. •• McClung MR, Lewiecki EM, Bolognese MA. Effects of denosumab on bone mineral density and biochemical markers of bone turnover: 8-year results of a phase 2 clinical trial, Annual Meeting of the American Society of Bone Mineral and Research, abstract 1061, San Diego CA, September17, 2011. This is the most recent publication of denosumab long-term safety data.
11.
go back to reference •• Black D, Reid I, Cauley J, et al. The effect of 3 versus 6 years of zoledronic acid treatment in osteoporosis: a randomized extension to the HORIZON-Pivotal Fracture Trial (PFT), Annual Meeting of the American Society of Bone Mineral and Research, Abstract 1070 and oral presentation, Toronto, Canada, October 16, 2010. This is the only presentation of ZOL extension trial data not yet published in peer-reviewed literature. •• Black D, Reid I, Cauley J, et al. The effect of 3 versus 6 years of zoledronic acid treatment in osteoporosis: a randomized extension to the HORIZON-Pivotal Fracture Trial (PFT), Annual Meeting of the American Society of Bone Mineral and Research, Abstract 1070 and oral presentation, Toronto, Canada, October 16, 2010. This is the only presentation of ZOL extension trial data not yet published in peer-reviewed literature.
13.
go back to reference Reclast Prescribing Information. East Hanover, NJ: Novartis Pharmaceutical Corp; Jan. 2010. Reclast Prescribing Information. East Hanover, NJ: Novartis Pharmaceutical Corp; Jan. 2010.
Metadata
Title
Data from Extension Trials: Denosumab and Zoledronic Acid
Author
Robin K. Dore
Publication date
01-03-2012
Publisher
Current Science Inc.
Published in
Current Osteoporosis Reports / Issue 1/2012
Print ISSN: 1544-1873
Electronic ISSN: 1544-2241
DOI
https://doi.org/10.1007/s11914-011-0082-z

Other articles of this Issue 1/2012

Current Osteoporosis Reports 1/2012 Go to the issue

Current Therapeutics (SL Silverman, Section Editor)

Vitamin D in the New Millennium

Current Therapeutics (SL Silverman, Section Editor)

Osteoporosis After Transplantation

Future Therapeutics (P Miller, Section Editor)

Sclerostin: Therapeutic Horizons Based Upon Its Actions