Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

Osteoporosis Primary Endpoint Should Remain Fracture Reduction

Executive Summary

FDA's revised osteoporosis drug guidance should use fracture reduction as a primary endpoint, while increases in bone mineral density should remain a surrogate endpoint, FDA's Endocrinologic & Metabolic Drugs Advisory Committee said Sept. 25

You may also be interested in...



Merck Fosamax Study Shows Benefit Vs. Actonel; Aventis/P&G Fault Endpoint

A Merck head-to-head trial showing an efficacy advantage for its osteoporosis agent Fosamax versus Actonel is "misleading" because the claim is based on bone mineral density rather than the preferred fracture risk endpoint, competitors maintain

Merck Fosamax Study Shows Benefit Vs. Actonel; Aventis/P&G Fault Endpoint

A Merck head-to-head trial showing an efficacy advantage for its osteoporosis agent Fosamax versus Actonel is "misleading" because the claim is based on bone mineral density rather than the preferred fracture risk endpoint, competitors maintain

FDA seeks osteoporosis trial design comments

FDA is seeking comments to modify 11994 draft guidance on osteoporosis clinical trial design. FDA's 2notice asks "do fracture endpoint trials need to be three years in duration, or could shorter studies provide adequate evidence of a new osteoporosis drug's effectiveness and safety?" and "is it appropriate to use placebo controls in fracture endpoint trials?" An advisory committee generally agreed that such studies could be conducted ethically among low-risk patients (3"The Pink Sheet" Sept. 30, 2002, p. 17)...

Related Content

UsernamePublicRestriction

Register

PS040549

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel