Therapeutics
Continuing alendronate for an additional 5 years maintained bone mineral density in postmenopausal women
Black DM, Schwartz AV, Ensrud KE, et al. Effects of continuing or stopping alendronate after 5 years of treatment: the Fracture Intervention Trial Long-term Extension (FLEX): a randomized trial. JAMA 2006;296:2927–38.
Q In postmenopausal women with low bone mineral density (BMD) who had been receiving daily alendronate for a mean of 5 years, what is the effect of continuing alendronate treatment for 5 years compared with discontinuing it?
Endocrine Rheumatology Internal medicine Surgery—orthopaedics
Key Words: alendronate • bone density • bone density conservation agents • fractures • bone
| The first 150 words of the full text of this article appear below. |
Design:
randomised placebo controlled trial (Fracture Intervention Trial [FIT] Long-term Extension [FLEX]).
Allocation:
unclear allocation concealment.*
Blinding:
blinded (clinicians, participants, data collectors, and outcome assessors).*
Follow up period:
5 years.
Setting:
10 clinical centres in the US.
Patients:
1099 postmenopausal women (mean age 73 y, 97% white) who had had low femoral neck BMD (<0.68 g/cm2) and had been allocated to alendronate (5 mg/d for 2 y and 10 mg/d thereafter) in FIT. Exclusion criteria were total hip BMD <0.515 g/cm2 (T score <–3.5) or total hip BMD lower than that at FIT baseline.
Intervention:
alendronate, 5 mg/day (n = 329); alendronate, 10 mg/day (n = 333); or placebo (n = 437). All participants received calcium, 500 mg/day, and vitamin D, 250 U/day.
Outcomes:
total hip BMD. Secondary outcomes included BMD at femoral neck, trochanter, lumbar spine, and forearm and of the total body; fracture incidence; and adverse events.
Manitoba Clinic,
Winnipeg, Manitoba, Canada
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Menopause (including HRT)
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