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Completed

NCT Number: NCT00375505

The Safety and Efficacy of Zoledronic Acid in the Prevention of Cancer Therapy Induced Bone Loss

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

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Novartis Investigative Site

Marburg, 35043, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Zoledronic acid

Drug

Other names: ZOL446, zoledronic acid, Zometa

Placebo

Drug

Placebo

Primary outcomes

  1. Change in Bone Mineral Density (BMD) Measured by Dual (Energy) X-ray Absorptiometry (DXA) at Lumbar Spine (L2-L4) From Baseline to Month 24

    Time frame: baseline, month 24

    Bone mineral density (BMD) by DXA at lumbar spine (L2-L4); DXA assessments of the BMD at dual hips. (BMD). Two X-ray beams with different energy levels are aimed at the patient's bones. When soft tissue absorption is subtracted out, the BMD can be determined from the absorption of each beam by bone.

  2. Change in Bone Mineral Density (BMD) at Lumbar Spine (L2-L4) From Baseline to Month 24 or Last Visit Measure by T-score

    Time frame: baseline, month 24

    Bone mineral density (BMD) at lumbar spine (L2-L4) by T-score. Your T-score is the number of units that your bone density is above or below the average. -1 and above-bone density is considered normal; Between -1 and -2.5-is a sign of osteopenia, a condition in which bone density is below normal and may lead to osteoporosis. -2.5 and below-indicates that it is likely osteoporosis.

  3. Change in Bone Mineral Density (BMD) at Lumbar Spine (L2-L4) From Baseline to Month 24 or Last Visit Measure by Z-score

    Time frame: baseline, month 24

    Bone mineral density (BMD) at lumbar spine (L2-L4) measured by Z-score. If Z-score is -2 or lower, it may suggest that something other than aging is causing abnormal bone loss.

  4. Percent Change in Bone Mineral Density for L2-L4 From Baseline to Month 24 or Last Visit

    Time frame: baseline, month 24

    Bone mineral density (BMD) at lumbar spine (L2-L4) measured by using Lunar or Hologic dual-energy X-ray absorptiometry (DXA) Instruments. Measurements were done in the lumbar vertebrae (L2-L4)

Secondary outcomes

  1. Percentage Change in Bone Mineral Density for Femoral Neck (Right and Left Side) From Baseline to Month 24

    Time frame: baseline, month 24

    Bone mineral density (BMD) for femoral neck (right and left side) is measured by using Lunar or Hologic dual-energy X-ray absorptiometry (DXA) Instruments. Measurements were done on femoral neck (right and left side)

  2. Percentage Change in Bone Mineral Density for Total Femoral Neck (Right and Left Side) From Baseline to Month 24

    Time frame: baseline, month 24

    Bone mineral density (BMD) for total femoral neck (right and left side) is measured by using Lunar or Hologic dual-energy X-ray absorptiometry (DXA) Instruments. Measurements were done on femoral neck (right and left side)

  3. Change in Bone Mineral Density Os Calcis (Right and Left Side) From Baseline to Month 24 as Measured by Speed of Sound (SOS)

    Time frame: baseline, month 24

    Bone mineral density (BMD) for Os calcis (right and left side) is measured by SOS; SOS is a Quantitative ultrasonography scanning and measures bone mass and strength and assesses bone microarchitecture by detecting the transmission of high-frequency sound waves through bone.

  4. Change in Bone Mineral Density Os Calcis (Right and Left Side) From Baseline to Month 24 as Measured by Broadband Ultrasound Attenuation (BUA)

    Time frame: baseline, month 24

    Bone mineral density (BMD) for Os calcis (right and left side) is measured by BUA; BUA is a Quantitative ultrasonography scanning and measures bone mass and strength and assesses bone microarchitecture by detecting the transmission of high-frequency sound waves through bone.

  5. 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)

    Time frame: baseline, month 24

    Bone mineral density (BMD) for Phalanges II, III, IV, and V is measured by ADSOS; ADSOS is a Quantitative ultrasonography scanning and measures bone mass and strength and assesses bone microarchitecture by detecting the transmission of high-frequency sound waves through bone.

  6. Change in Serum CTX-carboxy-terminal Collagen Crosslinks From Baseline to Month 24

    Time frame: baseline, month 24

    CTX is a telopeptide that can be used as a biomarker in the serum to measure the rate of bone turnover. The test used to detect the CTX marker is specific to bone resorption.

  7. Change in Aminoterminal Propeptide on Type I Procollagen (P1NP) From Baseline to Month 24

    Time frame: baseline, month 24

    Change in Aminoterminal propeptide on type I procollagen (P1NP) from baseline to month 24. P1NP is a marker for bone formation. It is a specific indicator of type 1 collagen deposition. P1NP is increased in states of high bone turnover

  8. Change in Estradiol (E2) From Baseline to Month 24

    Time frame: baseline, month 24

    Change in Estradiol from baseline to month 24

  9. Change in Follicle- Stimulating Hormone (FSH) From Baseline to Month 24

    Time frame: baseline, month 24

    Change in Follicle- Stimulating Hormone (FSH) from baseline to month 24

  10. Change in Testosterone From Baseline to Month 24

    Time frame: baseline, month 24

    Change in Testosterone from baseline to month 24

  11. Change in Sex Hormone Binding Globulin (SHGB) From Baseline to Month 24

    Time frame: baseline, month 24

    Change in Sex Hormone binding globulin (SHGB) from baseline to month 24

  12. Change in Parathyroid Hormone (PTH) From Baseline to Month 24

    Time frame: baseline, month 24

    Change in Parathyroid Hormone (PTH) from baseline to month 24

  13. Change in Vitamine D From Baseline to Month 24

    Time frame: baseline, month 24

    Change in Vitamine D from baseline to month 24

  14. Change in Anti-Mueller Hormone (AMH) From Baseline to Month 24

    Time frame: baseline, month 24

    Change in anti-Mueller hormone (AMH) from baseline to month 24

  15. Change in Inhibin A and Inhibin B From Baseline to Month 24

    Time frame: baseline, month 24

    Change in Inhibin A and Inhibin B from baseline to month 24

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

Zoledronic Acid in the Prevention of Cancer Therapy Induced Bone Loss

Important dates

Study start
2005
Primary completion
2014
Study completion
2014
First posted
Sep 13, 2006
Registry last updated
Sep 7, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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