title: The Osteoporosis Prevention and Arterial effects of tiboLone (OPAL) study: design and baseline characteristics.
abstract: The Osteoporosis Prevention and Arterial effects of tiboLone (OPAL) trial is a three-arm, randomized, placebo-controlled, double-blind study to determine the effect of tibolone 2.5 mg (Org OD 14) and continuous combined conjugated equine estrogens plus medroxyprogesterone acetate (0.625 mg/2.5 mg respectively) on progression of intima-media thickness of the carotid arteries and bone mineral density of the lumbar vertebrae and proximal femur in postmenopausal women. A total of 866 healthy postmenopausal women were recruited in six U.S. centers and five European centers. Duplicate carotid ultrasound examinations of the common carotid artery, the carotid bifurcation, and the internal carotid artery were performed at baseline. Single measurements of bone mineral density of the lumbar vertebrae and proximal femur were obtained at baseline. After randomization, ultrasound examinations were repeated every 6 months for 36 months following baseline, with a duplicate examination at the end of the study. Bone mineral density was measured every 12 months throughout the trial. The primary outcome is change in mean common carotid intima-media thickness (CIMT), defined as the average of the intima-media thickness measurements performed circumferentially at predefined angles for the near and far wall of 10-mm segments of the right and left distal common carotid arteries. Unique new features of the OPAL study are the specifically developed OPAL ultrasound protocol, yielding highly reproducible CIMT measurements, and the use of two experienced core laboratories for CIMT readings (one in the United States and one in Europe) with one common quality assurance and control program. The OPAL study is a large, placebo-controlled trial evaluating the effects of tibolone, as well as one of the first large randomized studies to determine the effects of continuous combined estrogen-progestin therapy on carotid atherosclerosis in healthy postmenopausal women. The OPAL study results are expected to complement other studies on atherosclerosis progression in healthy postmenopausal women.
authors.affiliation: Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, The Netherlands. m.l.bots@jc.azu.nl
authors.forename: Michiel L
authors.initials: ML
authors.lastname: Bots
authors.forename: Gregory W
authors.initials: GW
authors.lastname: Evans
authors.forename: Ward
authors.initials: W
authors.lastname: Riley
authors.forename: Rudy
authors.initials: R
authors.lastname: Meijer
authors.forename: Karen H
authors.initials: KH
authors.lastname: McBride
authors.forename: Electra D
authors.initials: ED
authors.lastname: Paskett
authors.forename: Frans A
authors.initials: FA
authors.lastname: Helmond
authors.forename: Diederick E
authors.initials: DE
authors.lastname: Grobbee
mesh_terms: D000368:Aged; D015519:Bone Density / Q000187:drug effects; D002339:Carotid Arteries / Q000000981:diagnostic imaging / Q000187:drug effects; D018450:Disease Progression; D004311:Double-Blind Method; D004966:Estrogens, Conjugated (USP) / Q000494:pharmacology / Q000627:therapeutic use; D005260:Female; D006801:Humans; D008875:Middle Aged; D009652:Norpregnenes / Q000494:pharmacology / Q000627:therapeutic use; D010024:Osteoporosis / Q000473:pathology / Q000517:prevention & control*; D017698:Postmenopause / Q000187:drug effects; D011897:Random Allocation; D016032:Randomized Controlled Trials as Topic / Q000379:methods*; D011795:Surveys and Questionnaires; D014463:Ultrasonography
chemical_list: D004966:Estrogens, Conjugated (USP); D009652:Norpregnenes; C027385:tibolone