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

• Published in: Bone (New York, N.Y.) Vol. 114; pp. 109 - 115
• Main Authors: Kyvernitakis, Ioannis, Kann, Peter Herbert, Thomasius, Friederike, Hars, Olaf, Hadji, Peyman
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01-09-2018
• 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; Premenopausal; Zoledronic acid; Osteoporosis; Bone mineral density; Breast cancer
• ISSN: 8756-3282; 1873-2763
• DOI: 10.1016/j.bone.2018.06.007

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 < 0.001). Over the 60-month study period, we found a decrease of 2.2% vs. 7.3% in the BMD at the lumbar spine in patients receiving ZOL and placebo respectively (p < 0.001). Over the 60-month study period, BMD in the placebo arm showed a continuous decrease at all sites (p < 0001), whereas patients treated with ZOL reached baseline BMD-values at the femoral neck and total hip.
In ProBone II, a 2-year treatment with ZOL 4 mg intravenous every 3 months prevented cancer treatment induced bone loss in premenopausal women with breast cancer and maintained the BMD up to 3 years post-treatment.
•A 2-year treatment with ZOL prevented cancer treatment induced bone loss in premenopausal women with breast cancer.•ZOL maintained the bone mass density up to 3 years post-treatment.•The placebo group presented with a continuous decrease of BMD at all sites over the entire 5-year observation period.