Pilot Trial of Zoledronic Acid to Prevent Bone Loss in Hematopoietic Cell Transplant Recipients

Not Applicable

Withdrawn

• Conditions: Hematopoietic Stem Cell Transplant; Bone Marrow Transplant
• Interventions: Drug: Zoledronic acid

• Registration Number: NCT02451462
• Lead Sponsor: Stanford University

Brief Summary

Patients who undergo bone marrow transplant for different types of cancer are exposed to many treatments such as steroids and whole body radiation. These treatments make the transplant possible but also make their bones weaker and more prone to fractures which can be a source of significant disability and decreased quality of life for cancer survivors. Our trial will investigate whether giving one dose of Zoledronic acid (a commonly used drug given to preserve bone mass in osteoporosis) before bone marrow transplant can protect from the bone loss caused by the transplant procedures. The investigators are also interested in studying the complex interactions of bone, muscle and fat which are greatly affected after bone marrow transplant.

Detailed Description

Primary Objective:

To determine whether a single dose of zoledronic acid pre-transplant will prevent HSCT-related bone loss without impeding engraftment, compared with placebo.

Secondary Objectives:

To identify bone and muscle deficits and alterations in fat distribution prior to HSCT, compared with healthy controls.

Study Timeline

• Study First Submitted: 2015-05-15
• Study First Submitted QC: 2015-05-21
• Study First Posted: 2015-05-22
• Study Start: 2015-09
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-25
• Last Update Posted: 2017-07-28
• Primary Completion: 2017-09
• Study Completion: 2018-09

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• First allogeneic HSCT
• Age > 18 years
• Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria

• Current or prior use of bone active medication (bisphosphonates, teriparatide, selective estrogen receptor modulators, or Denosumab)
• Hypo- (Ca < 8.5 mg/dL) or hyper-calcemia (Ca > 10.5 mg/dL)
• Hyperthyroidism (TSH < 0.4 mIU/L and free T4 > 1.6 ng/dL)
• Hyperparathyroidism (PTH > 80 pg/mL)
• Estimated GFR < 35 ml/min/1.73 m2
• Other chronic disease unrelated to HSCT that may impact bone metabolism
• Osteoporosis: patients with a history of fragility fracture, or a Hip or Spine T score of <-2.5 (these patients will be treated with Zoledronic Acid and followed, but excluded from randomization)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Zoledronic acid arm	Zoledronic acid	Zoledronic acid

Primary Outcome Measures

Name	Time	Method
% change in Bone Mineral Density at the Femoral Neck	12 months