[New completion date for HRPC trial in prevention of bone mets (from disclosures at AMGN’s ASCO webcast on 6/7/10).]
The phase-3 denosumab program is one of the largest ever conducted for any drug by any company. All told, there are 22 phase-3 trials (although some are open-label extension trials to assess long-term safety that are effectively phase-4’s). The following table includes the most consequential phase-3 trials; they fall into four main groups: metastatic cancer/treatment of bone mets; metastatic cancer/prevention of bone mets; preservation of bone health in non-metastatic cancer; and postmenopausal osteoporosis.
Primary No. of Completion IndicationComprtrEndpointPatients Date* OutcomeLink
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