Abstract | BACKGROUND: OBJECTIVE: DESIGN: Randomized, controlled trial. SETTING: United States and Europe. PARTICIPANTS: 1609 postmenopausal women 45 to 59 years of age. INTERVENTION: Participants were randomly assigned to receive oral alendronate, 5 mg/d or 2.5 mg/d; placebo; or open-label estrogen- progestin. Women in the alendronate groups received alendronate for the first 2 years of the study. Treatment was then continued without change or replaced with placebo for the last 2 years of the study. MEASUREMENTS: Annual measurement of bone mineral density. RESULTS: By year 4, the bone mineral density of participants in the placebo group had decreased by 1% to 6% (P < 0.001). Four years of treatment with 5 mg of alendronate per day increased bone mineral density at the spine (mean change [+/-SE], 3.8%+/-0.3%), hip (mean, 2.9%+/-0.2%), and total body (mean, 0.9%+/-0.2%) (P < 0.001 overall). By year 4, bone mineral density at most skeletal sites was greater in participants who switched from alendronate to placebo than in those who continuously received placebo. In years 3 and 4, bone loss in participants who switched from alendronate to placebo was similar to that seen during years 1 and 2 in those who continuously received placebo. Compared with 5 mg of alendronate per day, estrogen- medroxyprogesterone acetate produced similar increases in bone mineral density and estradiol- norethisterone acetate produced increases that were substantially greater. CONCLUSIONS:
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Authors | P Ravn, M Bidstrup, R D Wasnich, J W Davis, M R McClung, A Balske, C Coupland, O Sahota, A Kaur, M Daley, G Cizza |
Journal | Annals of internal medicine
(Ann Intern Med)
Vol. 131
Issue 12
Pg. 935-42
(Dec 21 1999)
ISSN: 0003-4819 [Print] United States |
PMID | 10610644
(Publication Type: Clinical Trial, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Estrogens
- Progestins
- Alendronate
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Topics |
- Alendronate
(adverse effects, therapeutic use)
- Bone Density
(drug effects)
- Data Interpretation, Statistical
- Double-Blind Method
- Drug Therapy, Combination
- Estrogens
(adverse effects, therapeutic use)
- Female
- Humans
- Middle Aged
- Osteoporosis, Postmenopausal
(prevention & control)
- Progestins
(adverse effects, therapeutic use)
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