Phase 2
N=59
Zoledronic Acid in Aromatase Inhibitor Induced Musculoskeletal Symptoms
Ductal Carcinoma in Situ · Estrogen Receptor-positive Breast Cancer · Progesterone Receptor-positive Breast Cancer · Stage I Breast Cancer · Stage II Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01194440 ↗Enrolled (actual)
59
Serious AEs
0.0%
Results posted
Jan 2017
Primary outcome: Primary: Number of Participants With Aromatase Inhibitor Associated Musculoskeletal Symptoms (AIMSS) — 22 Participants — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- letrozole (Drug); zoledronic acid (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Primary completion
- Jan 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Aromatase Inhibitor Associated Musculoskeletal Symptoms (AIMSS) |
22 | <0.001 sig |
| SECONDARY AIMSS as Determined by Health Assessment Questionnaire Disability Index (HAQ-DI) Score |
0.2; 0.2; 0.1; 0.2; 0.4 | — |
| SECONDARY AIMSS as Determined by Visual Analog Scale (VAS) Score |
0.8; 1; 1.4; 1.2; 1.9 | — |
| SECONDARY Number of Participants Who Discontinue or Change Aromatase Inhibitor (AI) Therapy |
5 | — |
Summary
RATIONALE: Zoledronic acid may prevent bone loss and help prevent or lessen musculoskeletal symptoms in women receiving hormone therapy for breast cancer.
PURPOSE: This phase II trial is studying how well zoledronic acid works in preventing musculoskeletal symptoms in post-menopausal women with stage I, stage II, or stage III breast cancer receiving letrozole.
Eligibility Criteria
Inclusion Criteria
- Patients with histologically proven DCIS or stage I-III invasive carcinoma of the breast that is estrogen and/or progesterone receptor positive by immunohistochemical staining who are considering aromatase inhibitor therapy; women may receive the AI on this study as initial adjuvant hormonal treatment or following tamoxifen; patients must have completed any adjuvant chemotherapy; patients may have received preoperative chemotherapy
- Postmenopausal status, defined as: >= 60 years of age; or = 12 months prior to day 1 if intact uterus/ovaries; or 1 month ago for oral bisphosphonates and/or > 12 months ago for intravenous bisphosphonates, prior to starting study treatment
- Moderate to severe renal impairment (serum creatinine greater than 2 mg/dL or creatinine clearance less than 50 mL/min)
- Hypersensitivity to letrozole or zoledronic acid or any of its excipients
- Concomitant treatment with oral or intravenous corticosteroids
- Current active dental problems including infection or the teeth or jawbone (maxilla or mandibular); dental or fixture trauma, or a current or prior diagnosis of osteonecrosis of the jaw (ONJ), of exposed bone in the mouth, or of slow healing after dental procedures
- Recent (within 6 weeks) or planned dental or jaw surgery (e.g. extraction, implants)
Data sourced from ClinicalTrials.gov (NCT01194440). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.