NCT00352846

Brief Summary

Primary Objective:

  • Evaluate the effect of zoledronate on change in bone mineral density (BMD) at the total lumbar spine and femoral neck. Secondary Objectives:
  • Evaluate the effect of zoledronate on change in BMD at the total hip
  • Evaluate risk factors for developing osteoporosis on chemotherapy
  • Determine correlative markers for response to zoledronate 4. Evaluate zoledronate effect on new bone fractures 5. Evaluate the cost-effectiveness of zoledronic acid (with calcium and vitamin D) versus standard treatment (calcium and vitamin D alone).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
135

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jan 2006

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 13, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 17, 2006

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
1.8 years until next milestone

Results Posted

Study results publicly available

June 20, 2013

Completed
Last Updated

July 2, 2013

Status Verified

June 1, 2013

Enrollment Period

5.7 years

First QC Date

July 13, 2006

Results QC Date

April 30, 2013

Last Update Submit

June 20, 2013

Conditions

Non-Hodgkin's LymphomaLymphoma

Keywords

Non-Hodgkin's LymphomaLymphomaZoledronic AcidZoledronateZometaVitamin DCalcium CarbonateBone Loss

Outcome Measures

Primary Outcomes (1)

  • Percentage Change in Bone Mineral Density (BMD) T-Score From Baseline to 12 Months

    The 12-month change from baseline in BMD at the total lumbar spine. BMD evaluation was performed at baseline and at 12 months after initiation of therapy at the lumbar spine. BMD was measured by dual-energy, x-ray absorptiometry scanners. T-Score is the number of standard deviations above or below the mean. A T-score \>= -1 indicates a normal BMD, while T-scores between -1 and -2.5 indicate osteopenia and T-scores \<= -2.5 indicate osteoporosis.

    From baseline to 12 Months

Study Arms (2)

Vitamin D + Calcium Carbonate

EXPERIMENTAL

Oral Vitamin D 400 mg daily + Calcium 1200 mg daily

Drug: Vitamin DDrug: Calcium Carbonate

Vitamin D + Calcium Carbonate + Zoledronic Acid

EXPERIMENTAL

Oral Vitamin D 400 mg daily and Calcium 1200 mg daily; Zoledronic Acid 4 mg/m\^2 intravenous at baseline and 6 months.

Drug: Zoledronic AcidDrug: Vitamin DDrug: Calcium Carbonate

Interventions

Zoledronic AcidDRUG

4 mg/m\^2 by vein over 30 Minutes at baseline and 6 months.

Also known as: Zometa, Zoledronate
Vitamin D + Calcium Carbonate + Zoledronic Acid
Vitamin DDRUG

400 mg by mouth daily

Vitamin D + Calcium CarbonateVitamin D + Calcium Carbonate + Zoledronic Acid
Calcium CarbonateDRUG

1200 mg by mouth daily

Vitamin D + Calcium CarbonateVitamin D + Calcium Carbonate + Zoledronic Acid

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of Non-Hodgkin's Lymphoma (B- or T-cell) or Hodgkin's lymphoma.
  • Prior Chemotherapy\</= 4 weeks of treatment.
  • Age \>/= 18 years old.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status 0-3.
  • Estimated creatinine clearance \>/= 60 ml/min.
  • Must sign an informed consent form.

You may not qualify if:

  • Radiologic evidence of vertebral or hip fracture.
  • BMD T-score less than (i.e., worse than or more negative than) -2.0 at any of the following sites: lumbar spine, femoral neck, or total hip.
  • Patients with secondary non-lymphomatous cancers metastatic to bone. However, other secondary cancers are allowed.
  • Spinal cord compression due to vertebral collapse.
  • Bisphosphonate treatment in the prior 6 months or steroid use (greater than 35 mg of prednisone equivalent steroids) in the prior 3 months. The use of topical, inhaled, or nasal steroids is allowed.
  • Primary hyperparathyroidism.
  • Active osteomalacia.
  • Untreated hypocalcemia (ionized, iCa), Ionized Ca level must be within normal limits prior to enrollment.
  • Untreated secondary hyperparathyroidism, Patients with abnormal parathyroid hormone (PTH) levels may be enrolled as long as they are being treated.
  • Untreated vitamin D deficiency, Vitamin D level may be abnormal and patient may be enrolled as long as they are being treated.
  • Untreated low testosterone (test in men only), testosterone level may be abnormal and patient may be enrolled as long as they are being treated.
  • Paget's disease.
  • Pregnant or breast-feeding.
  • Radiotherapy involving the mandible.
  • Current active dental problems including infection of the teeth or jawbone (maxilla or mandibular); dental or fixture trauma, or a current or prior diagnosis of osteonecrosis of the jaw (ONJ), or of exposed bone in the mouth, or of slow healing after dental procedures.
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

  • Westin JR, Thompson MA, Cataldo VD, Fayad LE, Fowler N, Fanale MA, Neelapu S, Samaniego F, Romaguera J, Shah J, McLaughlin P, Pro B, Kwak LW, Sanjorjo P, Murphy WA, Jimenez C, Toth B, Dong W, Hagemeister FB. Zoledronic acid for prevention of bone loss in patients receiving primary therapy for lymphomas: a prospective, randomized controlled phase III trial. Clin Lymphoma Myeloma Leuk. 2013 Apr;13(2):99-105. doi: 10.1016/j.clml.2012.11.002. Epub 2012 Dec 29.

    PMID: 23276888DERIVED

Related Links

MeSH Terms

Conditions

Lymphoma, Non-HodgkinLymphomaBone Diseases, Metabolic

Interventions

Zoledronic AcidVitamin DCalcium Carbonate

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

DiphosphonatesOrganophosphonatesOrganophosphorus CompoundsOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsSecosteroidsSteroidsFused-Ring CompoundsPolycyclic CompoundsCalcium CompoundsInorganic ChemicalsCarbonatesCarbonic AcidCarbon Compounds, InorganicMinerals

Results Point of Contact

Title
Fredrick Hagemeister, MD/Professor
Organization
The University of Texas (UT) MD Anderson Cancer Center
psanjorjo@mdanderson.org

Study Officials

  • Fredrick Hagemeister, MD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 13, 2006

First Posted

July 17, 2006

Study Start

January 1, 2006

Primary Completion

September 1, 2011

Study Completion

September 1, 2011

Last Updated

July 2, 2013

Results First Posted

June 20, 2013

Record last verified: 2013-06

Locations

US(1)