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

Hematopoietic Stem Cell Transplant Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02451462
• Other study ID #: VAR0122-BMT290
• Secondary ID: 31259
• Status: Withdrawn
• Phase: N/A
• First received: May 15, 2015
• Last updated: July 25, 2017
• Start date: September 2015
• Est. completion date: September 2018

Study information

• Verified date: July 2017
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2018
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Bone Marrow Transplant
• Hematopoietic Stem Cell Transplant

Intervention

Drug:
• Zoledronic acid

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	National Institutes of Health (NIH)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	% change in Bone Mineral Density at the Femoral Neck		12 months