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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Bone Marrow Transplant; Hematopoietic Stem Cell Transplant
• Intervention / Treatment: Drug: Zoledronic acid

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 Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Zoledronic acid arm; Zoledronic acid	Drug: Zoledronic acid
No Intervention: placebo arm; placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
% change in Bone Mineral Density at the Femoral Neck	12 months

Collaborators and Investigators

• Sponsor: Stanford University
• Collaborators: National Institutes of Health (NIH)
• Investigators: Principal Investigator: Joy Wu, Stanford University

Study record dates

Study Major Dates

• Study Start: September 1, 2015
• Primary Completion (Anticipated): September 1, 2017
• Study Completion (Anticipated): September 1, 2018

Study Registration Dates

• First Submitted: May 15, 2015
• First Submitted That Met QC Criteria: May 21, 2015
• First Posted (Estimate): May 22, 2015

Study Record Updates

• Last Update Posted (Actual): July 28, 2017
• Last Update Submitted That Met QC Criteria: July 25, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: hematopoietic stem cell transplant; bone marrow transplant
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Bone Density Conservation Agents; Zoledronic Acid
• Other Study ID Numbers: VAR0122-BMT290; 31259