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

Status

Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02451462

Enrollment

Registered

2015-05-22

Start date

2015-09-30

Completion date

2018-09-30

Last updated

2017-07-28

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

Conditions

Bone Marrow Transplant, Hematopoietic Stem Cell Transplant

Keywords

hematopoietic stem cell transplant, bone marrow transplant

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.

Interventions

DRUGZoledronic acid

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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)

Design outcomes

Primary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026