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

Stanford University

Status

Withdrawn

Conditions

Bone Marrow Transplant

Hematopoietic Stem Cell Transplant

Treatments

Drug: Zoledronic acid

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT02451462

31259

VAR0122-BMT290

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)