Zoledronic Acid in the Prevention of Cancer Treatment Related Bone Loss in Postmenopausal Women Receiving Letrozole for Breast Cancer.
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| ClinicalTrials.gov Identifier: NCT00171340 |
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Recruitment Status :
Completed
First Posted : September 15, 2005
Results First Posted : May 26, 2011
Last Update Posted : April 16, 2012
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Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
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Brief Summary:
Post-menopausal breast cancer patients will receive letrozole 2.5 mg daily for the treatment of breast cancer and will be randomized to a treatment group to receive either upfront zoledronic acid 4 mg IV 15-minute infusion every 6 months or delayed start zoledronic acid 4 mg IV 15-minute infusion every 6 months. Delayed start zoledronic acid will be initiated when either the Bone Mineral Density T-score is below -2 Standard Deviations at either the lumbar spine or hip or any clinical fracture unrelated to trauma or an asymptomatic fracture discovered at the month 36 scheduled visit. Letrozole 2.5 mg will be given daily for 5 years.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Bone Loss Breast Cancer | Drug: Zoledronic acid Drug: Letrozole | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 1065 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | An Open-Label, Randomized, MultiCenter Study to Evaluate the Use of Zolendronic Acid in the Prevention of Cancer Treatment-Related Bone Loss in Postmenopausal Women With Estrogen Positive and/or Progesterone Positive Breast Cancer Receiving Letrozole as Adjuvant Therapy |
| Study Start Date : | May 2003 |
| Actual Primary Completion Date : | February 2010 |
| Actual Study Completion Date : | February 2010 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Breast cancer
| Arm | Intervention/treatment |
|---|---|
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Experimental: Upfront Zoledronic Acid
Zolendronic acid 4 mg Intravenous (IV) 15 minute infusion every 6 months for 5 years beginning on Day 1. All participants took Letrozole tablets 2.5 mg/day for 5 years beginning on Day 1.
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Drug: Zoledronic acid
Zolendronic acid 4 mg Intravenous (IV) 15 minute infusion every 6 months.
Other Names:
Drug: Letrozole Letrozole tablets 2.5 mg/day taken orally for 5 years.
Other Name: Femara® |
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Experimental: Delayed Zoledronic Acid
Zolendronic acid 4 mg Intravenous (IV) 15 minute infusion every 6 months beginning when one of the following occurred: BMD T-score <= -2.0 SD at either the lumbar spine or total hip, any clinical fracture unrelated to trauma or an asymptomatic fracture discovered at the Month 36 visit. All participants took Letrozole tablets 2.5 mg/day for 5 years beginning on Day 1.
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Drug: Zoledronic acid
Zolendronic acid 4 mg Intravenous (IV) 15 minute infusion every 6 months.
Other Names:
Drug: Letrozole Letrozole tablets 2.5 mg/day taken orally for 5 years.
Other Name: Femara® |
Primary Outcome Measures :
- Percentage Change in Bone Mineral Density (BMD) of the Lumbar Spine (L2-L4) at 12 Months of Therapy. [ Time Frame: Baseline, 12 months ]Bone Mineral Density (g/cm^2) of the Lumbar Spine (L2-L4) as measured by energy x-ray absorptiometry (DXA).
Secondary Outcome Measures :
- Percentage Change in Bone Mineral Density (BMD) of the Lumbar Spine (L2-L4) at 2, 3, 4 and 5 Years of Therapy. [ Time Frame: Baseline, 2 years. Baseline, 3 years. Baseline, 4 years. Baseline, 5 years. ]Bone Mineral Density (g/cm^2) of the Lumbar Spine (L2-L4) as measured by dual energy x-ray absorptiometry (DXA)
- Percentage Change in Bone Mineral Density (BMD)of the Lumbar Spine (L1-L4) Over 5 Years of Therapy. [ Time Frame: Baseline, 5 years. ]Bone Mineral Density (g/cm^2) of the Lumbar Spine (L1-L4)as measured by dual energy x-ray absorptiometry (DXA)
- Percentage Change in Bone Mineral Density (BMD) of the Total Hip at 12 Months, 2 Years, 3 Years, 4 Years and 5 Years After Therapy. [ Time Frame: Baseline, 12 months. Baseline, 2 years. Baseline, 3 years. Baseline, 4 years. Baseline, 5 years. ]Bone Mineral Density (g/cm^2) of the Lumbar Spine (L2-L4) as measured by dual energy x-ray absorptiometry (DXA)
- Percentage of Participants With Clinical Fractures at 3 Years of Therapy Which Were Not Present at Baseline [ Time Frame: Baseline,3 years ]At 3 years of therapy the percentage of participants with fractures as detected by X-ray and/ or bone scan.
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| Ages Eligible for Study: | Child, Adult, Older Adult |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Stage I-IIIa breast cancer
- Postmenopausal or recently postmenopausal
- Recent surgery for breast cancer
- Estrogen Receptor positive and/or progesterone receptor positive hormone receptor status
- No prior treatment with letrozole
Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
- Metastatic disease
- Invasive bilateral disease
- Clinical or radiological evidence of existing fracture in spine or hip
- Prior treatment with IV bisphosphonates in the past 12 months
- Current treatment with oral bisphosphonates ( must be discontinued within 3 weeks of baseline evaluation)
- Use of Tibolone within 6 months
- Prior use of parathyroid hormone for more than 1 week
- Previous or concomitant malignancy
- Abnormal renal function
- History of disease effecting bone metabolism
Other protocol-defined exclusion criteria may apply.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00171340
Locations
Show 106 study locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
| Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Novartis Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00171340 |
| Other Study ID Numbers: |
CFEM345D2405 |
| First Posted: | September 15, 2005 Key Record Dates |
| Results First Posted: | May 26, 2011 |
| Last Update Posted: | April 16, 2012 |
| Last Verified: | April 2012 |
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
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Bone Loss Osteopenia Breast cancer |
letrozole zoledronic acid postmenopausal |
Additional relevant MeSH terms:
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Breast Neoplasms Bone Diseases, Metabolic Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Bone Diseases Musculoskeletal Diseases Metabolic Diseases Zoledronic Acid Letrozole |
Antineoplastic Agents Aromatase Inhibitors Steroid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Estrogen Antagonists Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Bone Density Conservation Agents |