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Good clinical endpoints with denosumab in osteoporosis and cancer

Doggrell, Sheila (2009) Good clinical endpoints with denosumab in osteoporosis and cancer. Expert Opinion in Pharmacotherapy, 10(17), pp. 2939-2943.

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Abstract

Background: Bone loss associated with low oestrogen levels in postmenopausal women, and with androgen deprivation therapy in men with hormone-sensitive prostate cancer, result in an increased incidence of fractures. Denosumab has been shown to increase bone mineral density in these two conditions. Objectives/methods: The objective of this evaluation is to review the clinical trials that have studied clinical endpoints in these conditions. Results: FREEDOM (Fracture Reduction Evaluation of Denosumab in Osteoporosis Every 6 Months) was an International Phase III clinical trial that measured the clinical endpoints with denosumab in postmenopausal women with osteoporosis. At 36 months, new vertebral fractures had occurred in 7.2% of subjects in the placebo group and this was lowered to 2.3% of subjects treated with denosumab. HALT (Denosumab Hormone Ablation Bone Loss Trial) studied the clinical endpoints in men with non-metastatic prostate cancer receiving androgen-deprivation therapy. The incidence of vertebral fractures was significantly lower in the denosumab group (1.5%) than in the placebo group (3.9%). The incidence of adverse effects with denosumab in both clinical trials was low. Conclusions: Denosumab reduces the incidence of fractures in postmenopausal women with osteoporosis and in men with non-metastatic prostate cancer receiving androgen-deprivation therapy. Denosumab is well tolerated.

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ID Code: 29672
Item Type: Journal Article
Additional URLs:
Keywords: denosumab, clinical endpoints, men receiving androgen-deprivation therapy, postmenopausal women with osteoporosis, prostate cancer
DOI: 10.1517/14656560903365197
ISSN: 1465-6566
Subjects: Australian and New Zealand Standard Research Classification > MEDICAL AND HEALTH SCIENCES (110000) > PHARMACOLOGY AND PHARMACEUTICAL SCIENCES (111500) > Clinical Pharmacology and Therapeutics (111502)
Divisions: Past > QUT Faculties & Divisions > Faculty of Science and Technology
Copyright Owner: Copyright 2009 Informa Healthcare
Deposited On: 15 Jan 2010 09:05
Last Modified: 19 Jan 2012 15:38

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