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

NCT ID: NCT02451462

Last Updated: 2017-07-28

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2018-09-30

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.

Conditions

Hematopoietic Stem Cell Transplant; Bone Marrow Transplant

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Zoledronic acid arm

Zoledronic acid

Group Type: EXPERIMENTAL

Zoledronic acid

Intervention Type: DRUG

placebo arm

placebo

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Zoledronic acid

Intervention Type: DRUG

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Joy Wu

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Other Identifiers

31259

Identifier Type: -

Identifier Source: secondary_id

VAR0122-BMT290

Identifier Type: -

Identifier Source: org_study_id