Single Dosing of Zoledronic Acid in Cancer Therapy Induced Bone Loss (CTIBL)

NCT00712985 | Completed Phase 3 Results

• 1 other identifier: CZOL446H US113
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research is to establish if a once a year dose of Zoledronic Acid is sufficient to suppress and maintain urine and serum bone density markers (NTx) and serum CTx within normal range at 12 months post-dosing in postmenopausal early breast cancer patients receiving additional treatment with non-steroidal aromatase inhibitors.

Conditions

Breast Cancer

Keywords

Breast cancer; aromatase inhibitors

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Urine and Serum NTx and Serum CTx Within Normal Range at 12 Months

  17 women with early breast cancer receiving adjuvant Aromatase Inhibitor (AI) therapy were treated with a single 5 mg IV dose of zoledronic acid. Urine and serum NTx and serum CTx were measured at baseline and month 12.

  One year

Study Arms (1)

Zometa (Zoledronic Acid) X 1 dose

EXPERIMENTAL

Zometa (Zoledronic Acid) 5 mg IV X 1 dose

Drug: Zometa

Interventions

Zometa DRUG

Zometa (Zoledronic Acid) 5 mg IV over 15 minutes in a one time dose

Also known as: Zoledronic Acid

Zometa (Zoledronic Acid) X 1 dose

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Postmenopausal women with Stage I, II or IIIa breast cancer being treated with a non-steroidal Aromatase Inhibitor (AI) .Negative bone scan (no bone metastases).
• Calculated creatinine clearance \> 40 ml/min
• Documented T score of less than or equal to -1.5 on Dual Energy X-ray Absorptiionmetry (DXA) scan at the lumbar spine or femoral neck within 3 months prior to screening.
• Urine NTx \> 50 nano moles(nM)based on second morning void.
• Signed informed consent.
• Ambulatory patients at least 18 years of age.
• Eastern Cooperative Oncology Group (ECOG)0-2.
• Ability to comply with trial requirements.

You may not qualify if:

• Bone Metastases.
• Any woman of child bearing potential.
• Patients with fractures occurring within three months prior to randomization. - Greater than a 2+ protein on urine dipstick without evidence of contamination or bacteriuria (may be repeated one time, at least a day apart).
• Calculated creatinine clearance less than 30 mL/min at screening.
• Serum calcium \> 2.75 mmol/L (11.0 mg/dL) or \< 2.00 mmol/L (8.0 mg/dL).
• Liver Function tests (LFT)\> 2.0 x upper limit of normal (ULN).
• Serum alkaline phosphatase \> 1.5 x ULN. History of hypersensitivity to bisphosphonates.
• Evidence of vitamin D deficiency (serum 25-(OH) D of less than 15 ng/ml).
• History of uveitis or iritis, except when secondary to trauma, and must have resolved \> 2 years prior to entry.
• A history of invasive malignancy of any organ system, treated or untreated, within the past 12 months prior to screening; excluding, basal cell or squamous cell carcinoma of the skin, colonic polyps with non-invasive malignancy which have been removed, Ductal Carcinoma in-situ (DCIS) that has been surgically removed, and Carcinoma in-situ (CIS) of the uterine cervix that has been surgically removed.
• Previous major solid organ transplant recipient or on a transplant waiting list.
• Treatment with any investigational drug within 30 days prior to randomization.
• History of hyperparathyroidism, hypoparathyroidism, Osteogenesis imperfecta, Paget's disease or any metabolic bone disease other than osteoporosis.
• Any medical condition which would interfere with the action of the study drug or limit life expectancy to less than 6 months.
• Any medical or psychiatric condition which, in the opinion of the investigator, would preclude the participant from adhering to the protocol or completing the trial.

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead
• Novartis: collaborator

Study Sites (1)

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Related Publications (6)

• Baum M, Budzar AU, Cuzick J, Forbes J, Houghton JH, Klijn JG, Sahmoud T; ATAC Trialists' Group. Anastrozole alone or in combination with tamoxifen versus tamoxifen alone for adjuvant treatment of postmenopausal women with early breast cancer: first results of the ATAC randomised trial. Lancet. 2002 Jun 22;359(9324):2131-9. doi: 10.1016/s0140-6736(02)09088-8.

  PMID: 12090977 BACKGROUND

• Goss PE, Ingle JN, Martino S, Robert NJ, Muss HB, Piccart MJ, Castiglione M, Tu D, Shepherd LE, Pritchard KI, Livingston RB, Davidson NE, Norton L, Perez EA, Abrams JS, Therasse P, Palmer MJ, Pater JL. A randomized trial of letrozole in postmenopausal women after five years of tamoxifen therapy for early-stage breast cancer. N Engl J Med. 2003 Nov 6;349(19):1793-802. doi: 10.1056/NEJMoa032312. Epub 2003 Oct 9.

  PMID: 14551341 BACKGROUND

• Coombes RC, Hall E, Gibson LJ, Paridaens R, Jassem J, Delozier T, Jones SE, Alvarez I, Bertelli G, Ortmann O, Coates AS, Bajetta E, Dodwell D, Coleman RE, Fallowfield LJ, Mickiewicz E, Andersen J, Lonning PE, Cocconi G, Stewart A, Stuart N, Snowdon CF, Carpentieri M, Massimini G, Bliss JM, van de Velde C; Intergroup Exemestane Study. A randomized trial of exemestane after two to three years of tamoxifen therapy in postmenopausal women with primary breast cancer. N Engl J Med. 2004 Mar 11;350(11):1081-92. doi: 10.1056/NEJMoa040331.

  PMID: 15014181 BACKGROUND

• BIG 1-98 Collaborative Group. Letrozole versus tamoxifen as adjuvant endocrine therapy for postmenopausal women with receptor-positive breast cancer. BIG 1-98: a prospective randomized double-blind phase III study. Breast. 2005;14:Suppl 1:S3. Abstract.

  BACKGROUND

• Walsh PC. Intravenous zoledronic acid in postmenopausal women with low bone mineral density. J Urol. 2002 Oct;168(4 Pt 1):1643. No abstract available.

  PMID: 12356057 BACKGROUND

• Smith MR, Eastham J, Gleason DM, Shasha D, Tchekmedyian S, Zinner N. Randomized controlled trial of zoledronic acid to prevent bone loss in men receiving androgen deprivation therapy for nonmetastatic prostate cancer. J Urol. 2003 Jun;169(6):2008-12. doi: 10.1097/01.ju.0000063820.94994.95.

  PMID: 12771706 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Zoledronic Acid

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

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

Limitations and Caveats

18 patients were able to be enrolled in this trial \& only 13 were able to be analyzed. This was an insufficient number to analyze/interpret data.

Results Point of Contact

• Title: Allan Lipton, MD
• Organization: Milton S. Hershey Medical Center

alipton@hmc.psu.edu

717-531-5960

Study Officials

• Allan Lipton, MD

  Milton S. Hershey Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: July 9, 2008
• First Posted: July 11, 2008
• Study Start: September 1, 2005
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: April 24, 2014
• Results First Posted: April 24, 2014

Record last verified: 2014-03

Locations

US (1)