Bone Loss Treatment From Adjuvant Zoledronate Efficacy

NCT01623908 | Terminated DMC

• 1 other identifier: 20110618GD
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 10

Brief Summary

The main purpose of this study is to observe and assess the impact of adjuvant zoledronate on bone density in breast cancer patients. The second purposes:

• The efficacy of adjuvant zoledronate
• The safety of adjuvant zoledronate
• The bone loss of breast cancer patients in Guangdong
• The correlation between bone loss of breast cancer patients and treatment of disease in Guangdong

Conditions

Breast Neoplasms; Bone Loss

Keywords

Breast neoplasms; Zoledronate; Bone loss

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in Bone Mineral Density

  48 weeks

Secondary Outcomes (2)

• Bone metastasis rate

  From date of randomization until the date of bone metastasis, assessed up to 48 weeks.

• Disease-Free Survival

  From date of randomization until the date of bone metastasis or date of death from any cause, whichever came first, assessed up to 48 weeks

Study Arms (1)

Zoledronate

EXPERIMENTAL

Drug: Zoledronate

Interventions

Zoledronate DRUG

4mg, IV (in the vein) every 6 months. Number of Cycles: up to the researcher or until unacceptable toxicity develops.

Also known as: Zometa

Zoledronate

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female, age \> 18.
• Postoperative breast cancer patients who have finished adjuvant chemotherapy or unwilling to receive chemotherapy.
• T score \< -2.0, or -2.0 \< T score \<-1.0 with any 2 of the following risk factors: T score \< -1.5, age \> 65, BMI \< 20kg/m\^2, family history of hip fractures, age \> 50 with brittle fracture history, oral steroid therapy \> 6 months, receiving aromatase therapy.
• ECOG(Eastern Cooperative Oncology Group) physical state score:0-2.
• Breast cancer stage I-III confirmed by histological or cytological examination.
• Patients received radical surgery with estimated survival time \> 12 months.
• Laboratory tests should be performed 1 week before enrollment and the results should meet the following criteria: neutrophil count ≥ 1.5×10\^9/L, platelet count ≥ 100×10\^9/L, hemoglobin ≥ 80g/L, serum bilirubin ≤ 1.0×ULN, AST and ALT ≤ 1.5×ULN, Serum creatinine ≤ 1.0×ULN.
• Patients who never received intravenous bisphosphonate within 12 months before enrollment and did not receive oral bisphosphonate within 3 weeks before enrollment.
• Informed consents should be signed by the participants or their guardians. All the participants should be aware of the purpose and procedure of this study and willing to participate in this study.
• Contraception required for those reproductive-aged women.

You may not qualify if:

• Pregnant or lactating women.
• Patients who have not signed informed consent.
• Patients received medical treatment which can affect bone metabolism (such as calcitonin, mithramycin or gallium nitrate) within 2 weeks before enrollment.
• Bone metabolic diseases such as Paget's disease, epiphyseal dysplasia and primary or secondary hyperthyroidism diagnosed within 12 months before enrollment.
• Liver function impairment which is defined as 2.5-fold or more increase in ALT or AST levels compared with the upper limit of reference range.
• Refuse appropriate contraception (appropriate contraceptive options include female sterilisation, intrauterine device, oral contraceptives and barrier contraception).
• Active dental diseases including dental infection, mandibular pain and maxillary or mandibular trauma. Patients with mandibular osteonecrosis diagnosed currently or previously, exposed bone or slow healing after oral surgery. Patients who will receive dental or maxillofacial surgery (such as dental extraction and dental implant) in the first 6 weeks after enrollment.
• Patients with dysgnosia or communication disorder who can't well understand our study, cooperate with our staff or operate glucose monitor correctly.
• Combined with major organ dysfunction or other severe diseases such as severe coronary disease, cardiovascular disease, myocardial infarction occurred within 12 months before enrollment, severe neurological or psychiatric diseases, severe infection or active disseminated intravascular coagulation.
• Alcoholics or drug addicts.

Sponsors & Collaborators

• First Affiliated Hospital, Sun Yat-Sen University: lead

Study Sites (10)

Dongguan People's Hospital

Dongguan, Guangdong, 523059, China

Location

General Hospital of Guangzhou Military Command of PLA

Guangzhou, Guangdong, 510010, China

Location

Sun Yat-Sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location

Guangdong General Hospital

Guangzhou, Guangdong, 510080, China

Location

GuangDong Hospital Of Traditional Chinese Medicine

Guangzhou, Guangdong, 510120, China

Location

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510120, China

Location

Guangzhou First Municipal People's Hospital

Guangzhou, Guangdong, 510180, China

Location

Nanfang Hospital

Guangzhou, Guangdong, 510515, China

Location

The First Affiliated Hospital of Jinan University

Guangzhou, Guangdong, 510630, China

Location

Shenzhen Second Municipal People's Hospital

Shenzhen, Guangdong, China

Location

MeSH Terms

Conditions

Breast Neoplasms; Bone Diseases, Metabolic

Interventions

Zoledronic Acid

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Shenming Wang, MD, PhD

  First Affiliated Hospital, Sun Yat-Sen University

  STUDY CHAIR

• Ying Lin, MD, PhD

  First Affiliated Hospital, Sun Yat-Sen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 16, 2012
• First Posted: June 20, 2012
• Study Start: July 1, 2011
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: June 22, 2021

Record last verified: 2021-06

Locations

CN (10)