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OsteoporosisPhase 3NCT00332709

Safety/Efficacy of Letrozole Monotherapy or in Combination With Zoledronic Acid as Extended Adjuvant Treatment of Postmenopausal Patients With Primary Breast Cancer

A Phase 3 study testing Letrozole and Zoledronic acid in people with Osteoporosis and Postmenopausal, run by Novartis at 23 sites 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 was a prospective, randomized, open-label, two arm phase III trial designed to evaluate the efficacy and safety of zoledronic acid in preventing bone loss in postmenopausal women with operable breast cancer who had received 4 to 6 years of adjuvant tamoxifen therapy after resection of the tumor. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Osteoporosis, Postmenopausal
What is being tested?
Letrozole and Zoledronic acid
Could I receive a placebo?
No, everyone receives an active treatment
How many people
83 participants
Where
23 sitesGermany
Study dates
Jan 2006to Aug 2010
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
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Compliant postmenopausal women with primary operable breast cancer after 4 to 6 years of therapy with tamoxifen (end of tamoxifen therapy within last 6 months)
  • Performance status 0-2 (Eastern Cooperative Oncology Group)
  • Patients without severe osteoporosis at study entry
  • No evidence of relapse at the time of randomization
  • Adequate function of bone marrow, kidney, and liver

Who cannot join

  • Estrogen- and progesterone-receptor status negative or unknown
  • Completion of adjuvant tamoxifen therapy more than 6 months prior to study start
  • Inflammatory breast cancer
  • Current/active dental problems including infection of the teeth or jawbone, dental or fixture trauma, or a current or prior diagnosis of osteonecrosis of the jaw, of exposed bone in the mouth, or of slow healing after dental procedures.
  • Recent (within 6 weeks) or planned dental or jaw surgery
  • History of diseases with influence on bone metabolism such as Paget's disease and primary overactive parathyroid
Show all 10Show fewer
  • Prior or concomitant therapies: chemotherapy within the last 12 months, intravenous or oral bisphosphonates, systemic corticosteroids, anabolic steroids or growth hormones, Tibolone, parathyroid hormone, systemic sodium fluoride or any drugs known to affect the skeleton (such as calcitonin, mithramycin, or gallium nitrate)
  • Patients with previous or concomitant cancers (not breast cancer) within the past 5 years EXCEPT adequately treated basal or squamous cell skin cancers or in situ cancer of the cervix. Patients with previous other cancer(s) must have been disease-free for at least 5 years.
  • Patients currently receiving oral bisphosphonates must discontinue these at least 3 weeks prior to study start.
  • Additional protocol defined inclusion/exclusion criteria may apply.

Trial locations and contacts

23 sites in 1 country.

23 sites in 1 country

Germany23 sites

  • Novartis Investigative Site

    Cologne

  • Novartis Investigative Site

    Deggendorf

  • Novartis Investigative Site

    Frankfurt am Main

  • Novartis Investigative Site

    Freiburg im Breisgau

  • Novartis Investigative Site

    Georgsmarienhütte

  • Novartis Investigative Site

    Göttingen

  • Novartis Investigative Site

    Halle

  • Novaertis Investigative Site

    Hamein

  • Novartis Investigative Site

    Hanover

  • Novartis Investigative Site

    Höxter

  • Novartis Investigative Site

    Ilsede

  • Novartis Investigative Site

    Jena

  • Novartis Investigative Site

    Karlsruhe

  • Novartis Investigative Site

    Leer

  • Novartis Investigative Site

    Lübeck

  • Novartis Investigative Site

    Mannheim

  • Novartis Investigative Site

    Münster

  • Novartis Investigative Site

    Rostock

  • Novartis Investigative Site

    Salzgitter

  • Novartis Investigative Site

    Schwenningen

  • Novartis Investigative Site

    Stendal

  • Novartis Investigative Site

    Völklingen

  • Novartis Investigative Site

    Witten

Other trials in Germany

About this study

Official title: An Open Phase III Trial With Letrozole Alone or in Combination With Zoledronic Acid as Extended Adjuvant Treatment of Postmenopausal Patients With Primary Breast Cancer

This was a prospective, randomized, open-label, two arm phase III trial designed to evaluate the efficacy and safety of zoledronic acid in preventing bone loss in postmenopausal women with operable breast cancer who had received 4 to 6 years of adjuvant tamoxifen therapy after resection of the tumor. Patients were treated with letrozole 2.5 mg orally per day or letrozole 2.5 mg orally per day in combination with zoledronic acid 4 mg/6 months as an infusion.

This trial did not recruit patients in the United States.

Keywords
Breast cancer, postmenopausal, bone mineral density, Zoledronic acid, Letrozole, extended adjuvant treatment., Postmenopausal women with primary hormone receptor positive breast cancer
Medical subject headings
Osteoporosis, Breast Neoplasms

What participants receive

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

Study groups in NCT00332709
Study groupRoleWhat they receive
LetrozoleExperimentalLetrozole orally 2.5 mg/day for 3 years
Receives: Drug: Letrozole
Letrozole + Zoledronic AcidExperimentalLetrozole orally 2.5mg/day for 3 years; Zoledronic acid 4mg every 6 months by infusion
Receives: Drug: Letrozole; Drug: Zoledronic acid

What is being measured

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

  1. Change in Bone Mineral Density (BMD) From Baseline to Month 36

    Change in bone mineral density (BMD) measured by dual X-ray absorptiometry (DXA) in lumbar spine (L1-L4). Change calculated by (Month 36 BMD-Baseline BMD)/Baseline BMD*100.

    Measured: at 36 months as compared to baseline

  2. Percent Change in Bone Mineral Density (BMD) From Baseline to Month 36

    Bone Mineral Density is measured by dual energy x-ray absorptiometry (DXA) scan.

    ANCOVA model was used in the analysis where: Variable = Baseline, Center, Treatment BMD = (Month 36 BMD-Baseline BMD)/Baseline BMD*100.

    Measured: Baseline, Month 36

  3. Change in T-score From Baseline to Month 36

    BMD measured by DXA (dual energy x-ray absorptiometry) at lumbar spine, L1-L4. The T-Score is a comparison of a patient's BMD to that of a healthy 30 year of the same sex and ethnicity. The criteria of the World Health Organization are Normal is a T-Score of 1.0 or higher. Osteopenia is defined as between - 1.0 and -2.5. Osteoporosis is defined as -2.5 or lower, meaning a bone density that is two and half standard deviations below the mean of a 30 year old man/woman.

    Measured: Baseline and Month 36

  4. Change in Z Score From Baseline to Month 36

    Bone Mineral Density is measured by dual energy x-ray absorptiometry (DXA). The Z-Score is the number of standard deviations a patient's BMD differs from the average BMD of their age, sex and ethnicity. A Z-score of less than minus -1.5 raises concern of factors other than aging as contributing to osteoporosis.

    Measured: Baseline, month 36

Secondary outcomes (5)

  1. Change in Bone Mineral Density From Baseline to 12 Months

    Change in bone mineral density (BMD) measured by dual X-ray absorptiometry (DXA) in lumbar spine (L1-L4). Change calculated by (Month 36 BMD-Baseline BMD)/Baseline BMD*100.

    Measured: Baseline, 12 months

  2. Number of Participants With Any Kind of Fractures, by Visit.

    Number of participants with fractures of any type since the last visit

    Measured: Baseline, Month 6, 12, 18, 24 , 30 and 36

  3. Median Disease Free Survival (DFS)

    Disease Free Survival is measured in days and represents the number of days participants were progression free. Progression free survival is defined as the time from randomization to the date of the first documented progression or recurrence of disease or death from any cause. Median disease free survival is the time when 50% of the patients had a recurrence.

    Measured: 36 months

  4. Change in T-Score From Baseline to Month 12

    BMD measured by DXA (dual energy x-ray absorptiometry) at lumbar spine, L1-L4. The T-Score is a comparison of a patient's BMD to that of a healthy 30 year of the same sex and ethnicity. The criteria of the World Health Organization are Normal is a T-Score of 1.0 or higher. Osteopenia is defined as between - 1.0 and -2.5. Osteoporosis is defined as -2.5 or lower, meaning a bone density that is two and half standard deviations below the mean of a 30 year old man/woman.

    Measured: Baseline, Month 12

  5. Change in Z-Score From Baseline to Month 12

    (DXA). The Z-Score is the number of standard deviations a patient's BMD differs from the average BMD of their age, sex and ethnicity. A Z-score of less than minus -1.5 raises concern of factors other than aging as contributing to osteoporosis

    Measured: Baseline, Month 12

Timeline

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

  1. First posted2 Jun 2006 (estimated)
  2. Study startJan 2006
  3. Primary completionAug 2010
  4. Study completionAug 2010

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
83 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00332709
Sponsor's protocol ID
CFEM345DDE09
Status last verified
Oct 2011
First submitted
31 May 2006
Last updated
16 Nov 2011

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 Letrozole and Zoledronic acid in people with Osteoporosis and Postmenopausal, run by Novartis at 23 sites 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 10 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 16 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 23 sites 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. 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 16 Nov 2011). 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) From Baseline to Month 36 (time frame: at 36 months as compared to baseline). 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 NCT00332709, 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 16 Nov 2011.

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