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

NCT02451462 | Withdrawn

• 2 other identifiers: VAR0122-BMT29031259
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hematopoietic Stem Cell Transplant; Bone Marrow Transplant

Keywords

hematopoietic stem cell transplant; bone marrow transplant

Outcome Measures

Primary Outcomes (1)

• % change in Bone Mineral Density at the Femoral Neck

  12 months

Study Arms (2)

Zoledronic acid arm

EXPERIMENTAL

Zoledronic acid

Drug: Zoledronic acid

placebo arm

NO INTERVENTION

placebo

Interventions

Zoledronic acid DRUG

Zoledronic acid arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Stanford University: lead
• National Institutes of Health (NIH): collaborator

MeSH Terms

Interventions

Zoledronic Acid

Intervention Hierarchy (Ancestors)

Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Joy Wu

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2015
• First Posted: May 22, 2015
• Study Start: September 1, 2015
• Primary Completion: September 1, 2017
• Study Completion: September 1, 2018
• Last Updated: July 28, 2017

Record last verified: 2017-07