Clinical trial NCT00375505: The Safety and Efficacy of Zoledronic Acid in the Prevention of Cancer Therapy Induced Bone Loss
Official title: Zoledronic Acid in the Prevention of Cancer Therapy Induced Bone Loss
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Breast Cancer
Keywords: Breast Cancer
Premenopausal
Bone mineral density
Cancer therapy induced bone loss
zoledronic acid
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2006-09-13
Enrollment: 70
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study examines the safety and efficacy of zoledronic acid 4 mg., given every 3 months over 24 months (infusion at month 0, 3, 6, 9, 12, 15, 18 and 21) in improving bone mineral density in premenopausal women with hormone receptor negative breast cancer and adjuvant chemotherapeutic treatment


Eligibility criteria: Inclusion Criteria:

* Female patients with histologically confirmed incident invasive breast cancer (T1-4) with positive hormone receptor status (ER and/or PgR positive) and no evidence of regional lymph node metastasis (N0) or distant metastasis (M0)
* Patient has undergone complete primary tumor resection and axillary lymph node dissection less than 90 days before start of study drug treatment.
* Patient is premenopausal at diagnosis of breast cancer (spontaneous and regular menses with premenopausal estradiol levels (\>10 ng/dL)
* Patient receives adjuvant standard chemoendocrine or endocrine therapy
* Bone density at study entry \> -2.5 T-Score

Exclusion Criteria:

* History of treatment or disease affecting bone metabolism (e.g., Paget's disease, primary hyperparathyroidism), prior treatment with bisphosphonates or treatments for osteoporosis in addition to calcium and vitamin D
* Abnormal renal function
* 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), 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)
* Pregnancy or lactation
* Women of childbearing potential not applying a medically recognized form of contraception (i.e., oral contraceptives or implants, IUD, vaginal diaphragm or sponge, or condom with spermicide)

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Change in Bone Mineral Density (BMD) Measured by Dual (Energy) X-ray Absorptiometry (DXA) at Lumbar Spine (L2-L4) From Baseline to Month 24
timeFrame: baseline, month 24
measure: Change in Bone Mineral Density (BMD) at Lumbar Spine (L2-L4) From Baseline to Month 24 or Last Visit Measure by T-score
timeFrame: baseline, month 24
measure: Change in Bone Mineral Density (BMD) at Lumbar Spine (L2-L4) From Baseline to Month 24 or Last Visit Measure by Z-score
timeFrame: baseline, month 24
measure: Percent Change in Bone Mineral Density for L2-L4 From Baseline to Month 24 or Last Visit
timeFrame: baseline, month 24
Secondary outcomes:
measure: Percentage Change in Bone Mineral Density for Femoral Neck (Right and Left Side) From Baseline to Month 24
timeFrame: baseline, month 24
measure: Percentage Change in Bone Mineral Density for Total Femoral Neck (Right and Left Side) From Baseline to Month 24
timeFrame: baseline, month 24
measure: Change in Bone Mineral Density Os Calcis (Right and Left Side) From Baseline to Month 24 as Measured by Speed of Sound (SOS)
timeFrame: baseline, month 24
measure: Change in Bone Mineral Density Os Calcis (Right and Left Side) From Baseline to Month 24 as Measured by Broadband Ultrasound Attenuation (BUA)
timeFrame: baseline, month 24
measure: Change in Bone Mineral Density Phalanges II, III, IV, and V From Baseline to Month 24 or Last Visit as Measured by Amplitude-dependent Speed of Sound (ADSOS)
timeFrame: baseline, month 24
measure: Change in Serum CTX-carboxy-terminal Collagen Crosslinks From Baseline to Month 24
timeFrame: baseline, month 24
measure: Change in Aminoterminal Propeptide on Type I Procollagen (P1NP) From Baseline to Month 24
timeFrame: baseline, month 24
measure: Change in Estradiol (E2) From Baseline to Month 24
timeFrame: baseline, month 24
measure: Change in Follicle- Stimulating Hormone (FSH) From Baseline to Month 24
timeFrame: baseline, month 24
measure: Change in Testosterone From Baseline to Month 24
timeFrame: baseline, month 24
measure: Change in Sex Hormone Binding Globulin (SHGB) From Baseline to Month 24
timeFrame: baseline, month 24
measure: Change in Parathyroid Hormone (PTH) From Baseline to Month 24
timeFrame: baseline, month 24
measure: Change in Vitamine D From Baseline to Month 24
timeFrame: baseline, month 24
measure: Change in Anti-Mueller Hormone (AMH) From Baseline to Month 24
timeFrame: baseline, month 24
measure: Change in Inhibin A and Inhibin B From Baseline to Month 24
timeFrame: baseline, month 24
Other outcomes:
Locations:
city: Marburg
country: Germany
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
affiliation: Novartis Pharmeceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: