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Breast CancerPhase 3NCT00375505

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

A Phase 3 study testing Zoledronic acid in people with Breast Cancer, run by Novartis Pharmaceuticals at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Breast Cancer
What is being tested?
Zoledronic acid
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
70 participants
Where
1 siteGermany
Study dates
Oct 2005to May 2014
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Novartis Investigative Site

    Marburg, 35043

Other trials in Germany

About this study

Official title: 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

Conditions
Breast Cancer
Being tested
Zoledronic acid, Placebo
Keywords
Breast Cancer, Premenopausal, Bone mineral density, Cancer therapy induced bone loss, zoledronic acid
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Zoledronic acidDrug

    Also called ZOL446, zoledronic acid, Zometa

  • PlaceboDrug

    Placebo

Study groups in NCT00375505
Study groupRoleWhat they receive
ZometaExperimentalZoledronic acid 4mg as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
Receives: Drug: Zoledronic acid
PlaceboPlacebo comparatorPlacebo as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    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.

    Measured: baseline, month 24

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

    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.

    Measured: baseline, month 24

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

    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.

    Measured: baseline, month 24

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

    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)

    Measured: baseline, month 24

Secondary outcomes (15)

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

    Measured: baseline, month 24

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

    Measured: baseline, month 24

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

    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.

    Measured: baseline, month 24

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

    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.

    Measured: baseline, month 24

  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)

    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.

    Measured: baseline, month 24

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

    Measured: baseline, month 24

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

    Measured: baseline, month 24

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

    Change in Estradiol from baseline to month 24

    Measured: baseline, month 24

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

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

    Measured: baseline, month 24

  10. Change in Testosterone From Baseline to Month 24

    Change in Testosterone from baseline to month 24

    Measured: baseline, month 24

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

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

    Measured: baseline, month 24

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

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

    Measured: baseline, month 24

  13. Change in Vitamine D From Baseline to Month 24

    Change in Vitamine D from baseline to month 24

    Measured: baseline, month 24

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

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

    Measured: baseline, month 24

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

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

    Measured: baseline, month 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Sep 2006 (estimated)
  2. Study startOct 2005
  3. Primary completionMay 2014
  4. Study completionMay 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
70 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00375505
Sponsor's protocol ID
CZOL446GDE21
Status last verified
Aug 2015
First submitted
11 Sep 2006
Last updated
7 Sep 2015

Publications

  • Adams A, Jakob T, Huth A, Monsef I, Ernst M, Kopp M, Caro-Valenzuela J, Wockel A, Skoetz N. Bone-modifying agents for reducing bone loss in women with early and locally advanced breast cancer: a network meta-analysis. Cochrane Database Syst Rev. 2024 Jul 9;7(7):CD013451. doi: 10.1002/14651858.CD013451.pub2.

    PubMed 38979716

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Zoledronic acid in people with Breast Cancer, run by Novartis Pharmaceuticals at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Sep 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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 (time frame: baseline, month 24). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00375505, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2015.

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