Trial to study the role of Zoledronate in the prevention of early bone loss in patients undergoing bone marrow transplant. in prevention of early bone loss in patients undergoing bone marrow transplant.

A Randomized Control Trial of pre-transplant Zoledronate versus observation for the prevention of early bone loss in patients undergoing allogeneic hematopoietic cell transplantation

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2019/04/018764

Enrollment

120

Registered

2019-04-24

Start date

Unknown

Completion date

Unknown

Last updated

2023-09-18

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

Conditions

Health Condition 1: D60-D64- Aplastic and other anemias and other bone marrow failure syndromes Health Condition 2: D613- Idiopathic aplastic anemia Health Condition 3: C95- Leukemia of unspecified cell type Health Condition 4: C95- Leukemia of unspecified cell type Health Condition 5: C91- Lymphoid leukemia Health Condition 6: C93- Monocytic leukemia Health Condition 7: C92- Myeloid leukemia Health Condition 8: C94- Other leukemias of specified celltype Health Condition 9: D56- Thalassemia

Interventions

Intervention1: Zoledronate: 4mg intravenous in 100ml Normal saline over 15 minutes once before the transplant Control Intervention1: Control: Observation only

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age > 18 years. 2. All patients undergoing allogeneic hematopoietic stem cell transplant 3. Able to understand and provide an informed signed consent. 4. Patients with preexisting osteopenia with T scores > -1.5 will be included in the study

Exclusion criteria

Exclusion criteria: 1. Renal failure with eGFR less than 30 ml/min by DTPA method 2. Past history of hypersensitivity to bisphosphonates 3. Dental extraction within past 4 weeks 4. Preexisting metabolic bone disease including those patients with osteoporosis on BMD and those with osteopenia, having T

Design outcomes

Primary

Measure	Time frame
T less than -1.5 at any site (FN or LS) as assessed by DXA on day 100 of transplantTimepoint: day 100 of transplant	—

Secondary

Measure	Time frame
greater than or equal to 5 % decrease in BMD in femoral neck, lumbar spine, at Day 100 T score less than -1.5 at any site ( FN or LS ) at D 365 A greater than or equal to 5 % decrease in BMD in femoral neck, lumbar spine at Day 365 Timepoint: day 100 and day 365 of transplant	—

Countries

India

Contacts

Public ContactNiranjan Khaire

Internal Medicine

deepesh.kem@gmail.com9417770112

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026