LIFT study to continue as planned

Editor—The long term intervention on fractures with tibolone (LIFT) study is a randomised trial to determine the effect of treatment with tibolone on risk of vertebral fracture in older osteoporotic postmenopausal women. The average age of the 4538 participants is 68 (SD 5.2) years. They have a bone mineral density t score at the total hip or spine ≤ - 2.5 without a fracture or a t score ≤ - 2.0 with a fracture. Participants were assigned to 1.25 mg tibolone or placebo and followed up periodically for clinical outcomes and safety. The trial started in 2001, and the primary outcome analysis is scheduled for June 2006.

A data safety monitoring board periodically reviews the unblinded results. A steering committee, whose voting members are investigators independent of the sponsor, Organon, oversees scientific issues. The monitoring board notified the sponsor and steering committee of an increased risk of stroke during an average of 2.4 years of the trial. Twenty three cases of stroke occurred during 5399 woman years of observation during and after treatment (4.26/1000 woman years) with tibolone and nine during 5493 woman years with placebo (1.64/1000 woman years), a difference of 2.62 cases per 1000 woman years of treatment (95% confidence interval 0.59 to 4.65 per 1000 woman years) and a relative risk of 2.59 (P = 0.01).

The monitoring board urged the trial to continue as planned in view of a full assessment of current benefits and risks, and because important additional scientific data will be generated. The steering committee concurred with these recommendations. Organon has notified participants and investigators. The LIFT trial is continuing with ongoing monitoring by the data safety monitoring board.