Alendronate and estrogen-progestin in the long-term prevention of bone loss

four-year results from the early postmenopausal intervention cohort study. A randomized, controlled trial

Pernille Ravn, M Bidstrup, R D Wasnich, J W Davis, M R McClung, A Balske, C Coupland, O Sahota, A Kaur, M Daley, G Cizza

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

Resumé

BACKGROUND: Up to 3 years of treatment with alendronate, 5 mg/d, prevents postmenopausal bone loss.

OBJECTIVE: To determine whether the effect of alendronate is sustained at 4 years of treatment and persists after treatment is discontinued.

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: Four years of treatment with alendronate or estrogen-progestin prevented postmenopausal bone loss. A residual effect was seen 2 years after alendronate therapy was stopped; however, continuous alendronate treatment was more effective in preventing postmenopausal bone loss than 2 years of alendronate followed by 2 years of placebo.

OriginalsprogEngelsk
TidsskriftAnnals of Internal Medicine
Vol/bind131
Udgave nummer12
Sider (fra-til)935-42
Antal sider8
ISSN0003-4819
StatusUdgivet - 21. dec. 1999

Fingeraftryk

Alendronate
Progestins
Estrogens
Cohort Studies
Randomized Controlled Trials
Placebos
Bone Density
Postmenopausal Osteoporosis
Medroxyprogesterone Acetate
Hip

Citer dette

Ravn, Pernille ; Bidstrup, M ; Wasnich, R D ; Davis, J W ; McClung, M R ; Balske, A ; Coupland, C ; Sahota, O ; Kaur, A ; Daley, M ; Cizza, G. / Alendronate and estrogen-progestin in the long-term prevention of bone loss : four-year results from the early postmenopausal intervention cohort study. A randomized, controlled trial. I: Annals of Internal Medicine. 1999 ; Bind 131, Nr. 12. s. 935-42.
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title = "Alendronate and estrogen-progestin in the long-term prevention of bone loss: four-year results from the early postmenopausal intervention cohort study. A randomized, controlled trial",
abstract = "BACKGROUND: Up to 3 years of treatment with alendronate, 5 mg/d, prevents postmenopausal bone loss.OBJECTIVE: To determine whether the effect of alendronate is sustained at 4 years of treatment and persists after treatment is discontinued.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: Four years of treatment with alendronate or estrogen-progestin prevented postmenopausal bone loss. A residual effect was seen 2 years after alendronate therapy was stopped; however, continuous alendronate treatment was more effective in preventing postmenopausal bone loss than 2 years of alendronate followed by 2 years of placebo.",
keywords = "Alendronate, Bone Density, Data Interpretation, Statistical, Double-Blind Method, Drug Therapy, Combination, Estrogens, Female, Humans, Middle Aged, Osteoporosis, Postmenopausal, Progestins",
author = "Pernille Ravn and M Bidstrup and Wasnich, {R D} and Davis, {J W} and McClung, {M R} and A Balske and C Coupland and O Sahota and A Kaur and M Daley and G Cizza",
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Ravn, P, Bidstrup, M, Wasnich, RD, Davis, JW, McClung, MR, Balske, A, Coupland, C, Sahota, O, Kaur, A, Daley, M & Cizza, G 1999, 'Alendronate and estrogen-progestin in the long-term prevention of bone loss: four-year results from the early postmenopausal intervention cohort study. A randomized, controlled trial', Annals of Internal Medicine, bind 131, nr. 12, s. 935-42.

Alendronate and estrogen-progestin in the long-term prevention of bone loss : four-year results from the early postmenopausal intervention cohort study. A randomized, controlled trial. / Ravn, Pernille; Bidstrup, M; Wasnich, R D; Davis, J W; McClung, M R; Balske, A; Coupland, C; Sahota, O; Kaur, A; Daley, M; Cizza, G.

I: Annals of Internal Medicine, Bind 131, Nr. 12, 21.12.1999, s. 935-42.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

TY - JOUR

T1 - Alendronate and estrogen-progestin in the long-term prevention of bone loss

T2 - four-year results from the early postmenopausal intervention cohort study. A randomized, controlled trial

AU - Ravn, Pernille

AU - Bidstrup, M

AU - Wasnich, R D

AU - Davis, J W

AU - McClung, M R

AU - Balske, A

AU - Coupland, C

AU - Sahota, O

AU - Kaur, A

AU - Daley, M

AU - Cizza, G

PY - 1999/12/21

Y1 - 1999/12/21

N2 - BACKGROUND: Up to 3 years of treatment with alendronate, 5 mg/d, prevents postmenopausal bone loss.OBJECTIVE: To determine whether the effect of alendronate is sustained at 4 years of treatment and persists after treatment is discontinued.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: Four years of treatment with alendronate or estrogen-progestin prevented postmenopausal bone loss. A residual effect was seen 2 years after alendronate therapy was stopped; however, continuous alendronate treatment was more effective in preventing postmenopausal bone loss than 2 years of alendronate followed by 2 years of placebo.

AB - BACKGROUND: Up to 3 years of treatment with alendronate, 5 mg/d, prevents postmenopausal bone loss.OBJECTIVE: To determine whether the effect of alendronate is sustained at 4 years of treatment and persists after treatment is discontinued.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: Four years of treatment with alendronate or estrogen-progestin prevented postmenopausal bone loss. A residual effect was seen 2 years after alendronate therapy was stopped; however, continuous alendronate treatment was more effective in preventing postmenopausal bone loss than 2 years of alendronate followed by 2 years of placebo.

KW - Alendronate

KW - Bone Density

KW - Data Interpretation, Statistical

KW - Double-Blind Method

KW - Drug Therapy, Combination

KW - Estrogens

KW - Female

KW - Humans

KW - Middle Aged

KW - Osteoporosis, Postmenopausal

KW - Progestins

M3 - Journal article

VL - 131

SP - 935

EP - 942

JO - Annals of Internal Medicine

JF - Annals of Internal Medicine

SN - 0003-4819

IS - 12

ER -