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We wrote to you in October 2005 about the increased risk of stroke in
the LIFT Study (1). Further analysis now indicates a significant benefit
of tibolone on vertebral fracture risk, the primary endpoint of the LIFT
Study. Thus, the LIFT Study is being stopped due to a recommendation by
the Data Safety Monitoring Board that the trial has reached its objectives
and it is unlikely additional follow-up will provide further information
about other adverse events.
LIFT is a randomized clinical trial designed to determine the effect
of treatment with tibolone on risk of vertebral fracture in
postmenopausal osteoporotic women. 4538 postmenopausal women with a bone
mineral density T--score at the total hip or spine equal or lower than -
2.5 without a fracture or a T-score of -2.0 with a fracture were assigned
to 1.25 mg of tibolone or placebo. The average age of participants was 68
years (SD 5.2). They are followed 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 (DSMB) periodically reviews the
unblinded results. A Steering Committee (SC), whose voting members are
investigators independent of the sponsor, Organon, oversees scientific
issues. The DSMB has previously notified the sponsor and steering
committee of an increased risk of stroke during an average of 2,4 years of
the trial with a hazard ratio of 2.591 . The updated results (at 2.75
years) for stroke and the results for vertebral fractures (based on a semi
-quantitative reading of the radiographs) for tibolone and placebo groups
were stroke (ischaemic plus haemorrhagic) 25 (1.11%) and 11 (0.49%),
hazard ratio 2.3 (p=0.02), and vertebral fractures 44 (2.1%) and 85
(4.1%), hazard ratio 0.5 (p=0.0003).
The DSMB has recommend to us that the study be discontinued and that
dispensation to study subjects of all study medications be ended as soon
as practical, and the Steering Committee concurred. We plan to publish a
more detailed report.
Reference
1. Grobbee DE, LIFT Steering Committee. LIFT study to continue as planned.
BMJ 2005;331:843.
Competing interests:
Consultant, and
Research funding from Organon
Competing interests:
No competing interests
27 February 2006
Steven R Cummings
Director
The LIFT Steering Committee: John P. Bilezikian, MD, Claus Christiansen, MD, Steven R. Cummings, MD (Chair), Pierre Delmas, MD, PhD, Richard Eastell, MD, FRCP, Bruce Ettinger, MD, Diederick E. Grobbee, MD, PhD, Susan Johnson, MD, MS, Peter Kenemans, MD, P
California Pacific Medical Center, San Francisco, CA 94105
LIFT Study Discontinued
We wrote to you in October 2005 about the increased risk of stroke in
the LIFT Study (1). Further analysis now indicates a significant benefit
of tibolone on vertebral fracture risk, the primary endpoint of the LIFT
Study. Thus, the LIFT Study is being stopped due to a recommendation by
the Data Safety Monitoring Board that the trial has reached its objectives
and it is unlikely additional follow-up will provide further information
about other adverse events.
LIFT is a randomized clinical trial designed to determine the effect
of treatment with tibolone on risk of vertebral fracture in
postmenopausal osteoporotic women. 4538 postmenopausal women with a bone
mineral density T--score at the total hip or spine equal or lower than -
2.5 without a fracture or a T-score of -2.0 with a fracture were assigned
to 1.25 mg of tibolone or placebo. The average age of participants was 68
years (SD 5.2). They are followed 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 (DSMB) periodically reviews the
unblinded results. A Steering Committee (SC), whose voting members are
investigators independent of the sponsor, Organon, oversees scientific
issues. The DSMB has previously notified the sponsor and steering
committee of an increased risk of stroke during an average of 2,4 years of
the trial with a hazard ratio of 2.591 . The updated results (at 2.75
years) for stroke and the results for vertebral fractures (based on a semi
-quantitative reading of the radiographs) for tibolone and placebo groups
were stroke (ischaemic plus haemorrhagic) 25 (1.11%) and 11 (0.49%),
hazard ratio 2.3 (p=0.02), and vertebral fractures 44 (2.1%) and 85
(4.1%), hazard ratio 0.5 (p=0.0003).
The DSMB has recommend to us that the study be discontinued and that
dispensation to study subjects of all study medications be ended as soon
as practical, and the Steering Committee concurred. We plan to publish a
more detailed report.
Reference
1. Grobbee DE, LIFT Steering Committee. LIFT study to continue as planned.
BMJ 2005;331:843.
Competing interests:
Consultant, and
Research funding from Organon
Competing interests: No competing interests