Role of Zoledronic Acid in Improving Bone Health During Chemotherapy in Women with Breast Cancer

Zoledronic Acid in Preventing Worsening of Bone Health in Postmenopausal Women with Nonmetastatic Carcinoma Breast Receiving Chemotherapy: A multicenter Randomized, Double Blind, Placebo Controlled Study.(ZAPBL STUDY) - ZAPBL STUDY

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/01/079088

Enrollment

370

Registered

2025-01-21

Start date

Unknown

Completion date

Unknown

Last updated

2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C50- Malignant neoplasm of breast

Interventions

Intervention1: Zoledronic Acid: Vial strength:4mg Dose:4mg single dose Method of administration: In 100ml NS over 30 min Control Intervention1: Placebo: 0.9 percentage Normal Saline

Eligibility

Inclusion criteria

Inclusion criteria: Inclusion criteria 1. Post menopausal women with newly diagnosed early and locally advanced breast carcinoma. (Postmenopausal status is defined as spontaneous amenorrhea for at least 12 months. In patients of age less than 50year postmenopausal status will be confirmed with FSH level. If patients undergone hysterectomy, then FSH more than 40mIU/mL is considered as Postmenopausal). 2. Age between 45-70. 3.Planned for adjuvant or neoadjuvant chemotherapy. 4.Patient must provide written informed consent.

Exclusion criteria

Exclusion criteria: Exclusion criteria Previous h/o Malignancy. Exclusion criteria 1. Previous history of Malignancy. 2. Previous history of chemotherapy. 3. Patients with Paget s disease, osteomalacia, Hyperparathyroidism, CKD, Active metabolic bone disease, Bronchial Asthma on steroid medication, Rheumatic arthritis, major surgery or substantial traumatic injury and any conditions deemed to affect vitamin D metabolism. 4. Base line osteoporotic patients (defined by BMD). 5. Creatinine clearance less then 60ml/min. 6. Patients with poor oral hygiene requiring dental intervention (Excluding scaling of tooth) 7. Patient on hormone treatment only. Patients with baseline Vit D level less than 12ng per ml. Thyroid disorder Uncontrolled Diabetes 11. Male breast cancer 12. Renal disorder

Design outcomes

Primary

Measure	Time frame
1. Change in Bone mineral density from baseline to end of chemotherapy and 6 months of follow up 2. Change in Bone related QOL using Qualeffo-31 questionnaire from baseline to end of chemotherapy and, 6 months of follow up Timepoint: 6 months	—

Secondary

Measure	Time frame
1. Reduction in the fracture rates 2. Change in bone formation, resorption and regulatory markers 3. Change in FRAX scores from baseline to end of chemotherapy and follow up Timepoint: 2 Years	—

Countries

India

Contacts

Public ContactDr Biswajit Dubashi

Jawaharlal Institute of Post Graduate Medical Education and Research

drbiswajitdm@gmail.com8056338405

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Sep 19, 2026