Oral clodronate and reduction in loss of bone mineral density in women with operable primary breast cancer

Women with primary breast cancer who receive systemic therapy may experience ovarian failure or early menopause, leading to a loss of bone mineral density (BMD). Loss of BMD may be reduced by use of bisphosphonates, compounds that inhibit the action of osteoclasts (cells that absorb or remove bone t...

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Veröffentlicht in:JNCI : Journal of the National Cancer Institute 1998-05, Vol.90 (9), p.704-708
Hauptverfasser: POWLES, T. J, MCCLOSKEY, E, PATERSON, A. H. G, ASHLEY, S, TIDY, V. A, NEVANTAUS, A, ROSENQVIST, K, KANIS, J
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container_end_page 708
container_issue 9
container_start_page 704
container_title JNCI : Journal of the National Cancer Institute
container_volume 90
creator POWLES, T. J
MCCLOSKEY, E
PATERSON, A. H. G
ASHLEY, S
TIDY, V. A
NEVANTAUS, A
ROSENQVIST, K
KANIS, J
description Women with primary breast cancer who receive systemic therapy may experience ovarian failure or early menopause, leading to a loss of bone mineral density (BMD). Loss of BMD may be reduced by use of bisphosphonates, compounds that inhibit the action of osteoclasts (cells that absorb or remove bone tissue). We have conducted a double-blind, randomized, two-center trial to evaluate BMD in women with primary breast cancer who were given the bisphosphonate clodronate (1600 mg/day orally) or placebo for 2 years. From August 31, 1990, through March 31, 1996, more than 300 eligible patients had been accrued, randomly assigned to study treatment, given the appropriate primary surgical care and systemic (chemotherapy and/or tamoxifen) therapy, and had completed follow-up for at least 1 year. BMD in the lumbar spine and in the hip, including the trochanteric area, was measured by use of dual-energy x-ray absorptiometry at the beginning of treatment and after 1 and 2 years of treatment. Changes in BMD were calculated as percent changes from the initial readings. Treatment effects for clodronate versus placebo (i.e., mean percent changes in BMD with clodronate minus mean percent changes in BMD with placebo) at 1 and 2 years for individual sites were calculated. After 1 year, the treatment effects for clodronate versus placebo in the lumbar spine, the total hip, and the trochanter, respectively, were as follows: +2.38% (95% confidence interval [CI] = 1.36-3.41), +0.74% (95% CI = -0.13 - 1.60), and +1.29% (95% CI = 0.24-2.34). After 2 years, the corresponding treatment effects were +1.72% (95% CI = 0.12-3.34), +1.85% (95% CI = 0.51-3.20), and +2.30% (95% CI = 0.66-3.94), respectively. Oral clodronate appears to reduce the loss of BMD in patients who receive treatment for primary breast cancer.
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From August 31, 1990, through March 31, 1996, more than 300 eligible patients had been accrued, randomly assigned to study treatment, given the appropriate primary surgical care and systemic (chemotherapy and/or tamoxifen) therapy, and had completed follow-up for at least 1 year. BMD in the lumbar spine and in the hip, including the trochanteric area, was measured by use of dual-energy x-ray absorptiometry at the beginning of treatment and after 1 and 2 years of treatment. Changes in BMD were calculated as percent changes from the initial readings. Treatment effects for clodronate versus placebo (i.e., mean percent changes in BMD with clodronate minus mean percent changes in BMD with placebo) at 1 and 2 years for individual sites were calculated. 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After 1 year, the treatment effects for clodronate versus placebo in the lumbar spine, the total hip, and the trochanter, respectively, were as follows: +2.38% (95% confidence interval [CI] = 1.36-3.41), +0.74% (95% CI = -0.13 - 1.60), and +1.29% (95% CI = 0.24-2.34). After 2 years, the corresponding treatment effects were +1.72% (95% CI = 0.12-3.34), +1.85% (95% CI = 0.51-3.20), and +2.30% (95% CI = 0.66-3.94), respectively. Oral clodronate appears to reduce the loss of BMD in patients who receive treatment for primary breast cancer.</description><subject>Absorptiometry, Photon</subject><subject>Administration, Oral</subject><subject>Adult</subject><subject>Aged</subject><subject>Biological and medical sciences</subject><subject>Bone Density - drug effects</subject><subject>Bones</subject><subject>Breast cancer</subject><subject>Breast Neoplasms - drug therapy</subject><subject>Breast Neoplasms - physiopathology</subject><subject>Breast Neoplasms - surgery</subject><subject>Chemotherapy</subject><subject>Clodronic Acid - administration &amp; dosage</subject><subject>Clodronic Acid - adverse effects</subject><subject>Clodronic Acid - therapeutic use</subject><subject>Double-Blind Method</subject><subject>Female</subject><subject>General and cellular metabolism. Vitamins</subject><subject>Humans</subject><subject>Lumbosacral Region</subject><subject>Medical sciences</subject><subject>Middle Aged</subject><subject>Osteoporosis</subject><subject>Pharmacology. 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We have conducted a double-blind, randomized, two-center trial to evaluate BMD in women with primary breast cancer who were given the bisphosphonate clodronate (1600 mg/day orally) or placebo for 2 years. From August 31, 1990, through March 31, 1996, more than 300 eligible patients had been accrued, randomly assigned to study treatment, given the appropriate primary surgical care and systemic (chemotherapy and/or tamoxifen) therapy, and had completed follow-up for at least 1 year. BMD in the lumbar spine and in the hip, including the trochanteric area, was measured by use of dual-energy x-ray absorptiometry at the beginning of treatment and after 1 and 2 years of treatment. Changes in BMD were calculated as percent changes from the initial readings. Treatment effects for clodronate versus placebo (i.e., mean percent changes in BMD with clodronate minus mean percent changes in BMD with placebo) at 1 and 2 years for individual sites were calculated. After 1 year, the treatment effects for clodronate versus placebo in the lumbar spine, the total hip, and the trochanter, respectively, were as follows: +2.38% (95% confidence interval [CI] = 1.36-3.41), +0.74% (95% CI = -0.13 - 1.60), and +1.29% (95% CI = 0.24-2.34). After 2 years, the corresponding treatment effects were +1.72% (95% CI = 0.12-3.34), +1.85% (95% CI = 0.51-3.20), and +2.30% (95% CI = 0.66-3.94), respectively. Oral clodronate appears to reduce the loss of BMD in patients who receive treatment for primary breast cancer.</abstract><cop>Cary, NC</cop><pub>Oxford University Press</pub><pmid>9586668</pmid><doi>10.1093/jnci/90.9.704</doi><tpages>5</tpages><oa>free_for_read</oa></addata></record>
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subjects Absorptiometry, Photon
Administration, Oral
Adult
Aged
Biological and medical sciences
Bone Density - drug effects
Bones
Breast cancer
Breast Neoplasms - drug therapy
Breast Neoplasms - physiopathology
Breast Neoplasms - surgery
Chemotherapy
Clodronic Acid - administration & dosage
Clodronic Acid - adverse effects
Clodronic Acid - therapeutic use
Double-Blind Method
Female
General and cellular metabolism. Vitamins
Humans
Lumbosacral Region
Medical sciences
Middle Aged
Osteoporosis
Pharmacology. Drug treatments
Side effects
Spine - diagnostic imaging
Spine - drug effects
Spine - physiopathology
Treatment Outcome
title Oral clodronate and reduction in loss of bone mineral density in women with operable primary breast cancer
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