Raloxifene and body composition and muscle strength in postmenopausal women: a randomized, double-blind, placebo-controlled trial.
OBJECTIVE
To compare the effects of raloxifene and placebo on body composition and muscle strength.


METHODS
Randomized, double-blind, placebo-controlled trial involving 198 healthy women aged 70 years or older conducted between July 2003 and January 2008 at the University Medical Centre, Utrecht, The Netherlands.


METHODS
Participants were randomly assigned to receive raloxifene 60 mg or placebo daily for 12 months. Measurements were taken at baseline, 3, 6, and 12 months, and change from baseline was calculated. Main outcome measures were body composition (bioelectrical impedance analysis), muscle strength, and muscle power (maximum voluntary isometric knee extension strength, explosive leg extensor power, and handgrip strength).


RESULTS
At 12 months, the body composition of women taking raloxifene was significantly different from that of women taking placebo: fat-free mass (FFM) had increased by a mean of 0.83 (2.4) kg in the raloxifene group versus 0.03 (1.5) kg in the placebo group (P=0.05), and total body water had increased by a mean of 0.6 (1.8) litres in the raloxifene group versus a decrease of 0.06 (1.1) litres in the placebo group (P=0.02). Muscle strength and power were not significantly different.


CONCLUSIONS
Raloxifene significantly changed body composition (increased FFM; increased water content) compared with placebo in postmenopausal women.
Jacobsen
Didy E
DE
Department of Geriatric Medicine, University Medical Centre Utrecht, Room B05.256, PO Box 85500, 3508 GA Utrecht, The Netherlands.
Samson
Monique M
MM
Emmelot-Vonk
Marielle H
MH
Verhaar
Harald J J
HJ
D000368:Aged; D000369:Aged, 80 and over; D001823:Body Composition / Q000187:drug effects*; D050071:Bone Density Conservation Agents / Q000008:administration & dosage*; D004311:Double-Blind Method; D005260:Female; D018737:Hand Strength; D006801:Humans; D007537:Isometric Contraction / Q000187:drug effects; D053580:Muscle Strength / Q000187:drug effects*; D015663:Osteoporosis, Postmenopausal / Q000517:prevention & control*; D020849:Raloxifene Hydrochloride / Q000008:administration & dosage*; D012111:Residence Characteristics
D050071:Bone Density Conservation Agents; D020849:Raloxifene Hydrochloride