Prevention of breast cancer treatment-induced bone loss in premenopausal women treated with zoledronic acid: Final 5-year results from the randomized, double-blind, placebo-controlled ProBONE II trial

Premenopausal women receiving chemotherapy or endocrine treatment for early breast cancer are at increased risk for cancer treatment induced bone loss (CTIBL). The aim of the randomized, double-blind ProBONE II trial was to investigate whether a 2-year adjuvant treatment with 4 mg intravenous zoledr...

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Bibliographic Details
Published in:Bone (New York, N.Y.) N.Y.), 2018-09, Vol.114, p.109-115
Main Authors: Kyvernitakis, Ioannis, Kann, Peter Herbert, Thomasius, Friederike, Hars, Olaf, Hadji, Peyman
Format: Article
Language:English
Subjects:
Administration, Intravenous
Adult
Antineoplastic Agents - administration & dosage
Antineoplastic Agents - adverse effects
Bone Density Conservation Agents - administration & dosage
Bone mineral density
Bone Resorption - chemically induced
Bone Resorption - diagnostic imaging
Bone Resorption - epidemiology
Bone Resorption - prevention & control
Breast cancer
Breast Neoplasms - diagnostic imaging
Breast Neoplasms - drug therapy
Breast Neoplasms - epidemiology
Double-Blind Method
Drug Therapy, Combination
Female
Follow-Up Studies
Humans
Middle Aged
Osteoporosis
Premenopausal
Premenopause - drug effects
Premenopause - physiology
Prospective Studies
Time Factors
Treatment Outcome
Young Adult
Zoledronic acid
Zoledronic Acid - administration & dosage
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Summary:Premenopausal women receiving chemotherapy or endocrine treatment for early breast cancer are at increased risk for cancer treatment induced bone loss (CTIBL). The aim of the randomized, double-blind ProBONE II trial was to investigate whether a 2-year adjuvant treatment with 4 mg intravenous zoledronic acid (ZOL) every 3 months versus placebo would prevent CTIBL after a five-year period. Thirty-one of the 34 participants in the ZOL arm and thirty-four of the 36 participants in the placebo arm were followed-up to the 5-year visit and completed the study as planned. The changes in Bone Mass Density (BMD) were assessed at baseline and each visit after treatment initiation. After 24 months, BMD at the lumbar spine showed a 2.9% increase in patients treated with ZOL vs. a 7.1% decrease in placebo-treated participants compared to baseline (p 
ISSN:8756-3282
1873-2763
DOI:10.1016/j.bone.2018.06.007