Bone LossPhase 3NCT00171340

Zoledronic Acid in the Prevention of Cancer Treatment Related Bone Loss in Postmenopausal Women Receiving Letrozole for Breast Cancer.

A Phase 3 study testing Zoledronic acid and Letrozole in people with Bone Loss and Breast Cancer, run by Novartis Pharmaceuticals at 106 sites in 28 countries.

Completed

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

Official record

Search all trials

Trial summary

Who is it for?: Any age, women only
Conditions the study is for: Bone Loss, Breast Cancer
What is being tested?: Zoledronic acid and Letrozole
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,065 participants
Where: 106 sitesin 28 countries
Study dates: May 2003to Feb 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 Any age
Women only
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Stage I-IIIa breast cancer
Postmenopausal or recently postmenopausal
Recent surgery for breast cancer
Estrogen Receptor positive and/or progesterone receptor positive hormone receptor status
No prior treatment with letrozole
Other protocol-defined inclusion criteria may apply.

Who cannot join

Metastatic disease
Invasive bilateral disease
Clinical or radiological evidence of existing fracture in spine or hip
Prior treatment with IV bisphosphonates in the past 12 months
Current treatment with oral bisphosphonates ( must be discontinued within 3 weeks of baseline evaluation)
Use of Tibolone within 6 months

Show all 11Show fewer

Prior use of parathyroid hormone for more than 1 week
Previous or concomitant malignancy
Abnormal renal function
History of disease effecting bone metabolism
Other protocol-defined exclusion criteria may apply.

Trial locations and contacts

106 sites in 28 countries.

Country

City, postcode or hospital

106 sites in 28 countries

Germany18 sites

Novartis Investigative Site
Augsberg
Novartis Investigative Site
Berlin
Novartis Investigative Site
Ebersberg
Novartis Investigative Site
Frankfurt
Novartis Investigative Site
Halberstadt
Novartis Investigative Site
Hamburg
Novartis Investigative Site
Hoyerswerda
Novartis Investigative Site
Kassel
Novartis Investigative Site
Kiel
Novartis Investigative Site
München
Novartis Investigative Site
Munich
Novartis Investigative Site
Neunkirchen
Novartis Investigative Site
Rostock
Novartis Investigative Site
Stadthagen
Novartis Investigative Site
Stendal
Novartis Investigative Site
Trier
Novartis Investigative Site
Tübingen
Novartis Investigative Site
Wiesbaden

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Italy12 sites

Novartis Investigative Site
Ancona
Novartis Investigative Site
Aviano, 33081
Novartis Investigative Site
Bergamo
Novartis Investigative Site
Catanzaro, 88100
Novartis Investigative Site
Florence, 50139
Novartis Investigative Site
Genova
Novartis Investigative Site
Meldola
Novartis Investigative Site
Modena
Novartis Investigative Site
Orbassano Torino
Novartis Investigative Site
Perugia
Novartis Investigative Site
Torino
Novartis Investigative Site
Varese

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Netherlands9 sites

Novartis Investigative Site
Almere Stad
Novartis Investigative Site
Arnhem
Novartis Investigative Site
Ede
Novartis Investigative Site
Eindhoven
Novartis Investigative Site
Hoogeveen
Novartis Investigative Site
Leiden
Novartis Investigative Site
Nijmegen
Novartis Investigative Site
The Hague
Novartis Investigative Site
Utrecht

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United Kingdom8 sites

Novartis Investigative Site
Birmingham
Novartis Investigative Site
Essex
Novartis Investigative Site
Manchester
Novartis Investigative Site
New Castle Upon Tyne
Novartis Investigative Site
Nottingham
Novartis Investigative Site
Plymouth
Novartis Investigative Site
Sheffield
Novartis Investigative Site
Swansea

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Spain6 sites

Novartis Investigative Site
Barcelona
Novartis Investigative Site
Córdoba
Novartis Investigative Site
Gea de Albarracín
Novartis Investigative Site
Ibáñez
Novartis Investigative Site
la Masó
Novartis Investigative Site
Villaroel

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Belgium5 sites

Novartis Investigative Site
Bonheiden
Novartis Investigative Site
Brasschaat
Novartis Investigative Site
Brussels
Novartis Investigative Site
Leuven
Novartis Investigative Site
Wilrijk

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France5 sites

Novartis Investigative Site
Bordeaux
Novartis Investigative Site
Le Havre
Novartis Investigative Site
Montpellier
Novartis Investigative Site
Poitiers
Novartis Investigative Site
Saint-Cloud

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South Korea5 sites

Novartis Investigative Site
Gyeonggi-do
Novartis Investigative Site
Seoul, 110
Novartis Investigative Site
Seoul, 137
Novartis Investigative Site
Seoul, 138
Novartis Investigative Site
Seoul, 139

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Australia4 sites

Novartis Investigative Site
New South Wales
Novartis Investigative Site
Perth
Novartis Investigative Site
South Australia
Novartis Investigative Site
Victoria

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Taiwan4 sites

Novartis Investigative Site
Chang-hua, 500
Novartis Investigative Site
Taipei, 100
Novartis Investigative Site
Taipei, 105
Novartis Investigative Site
Taipei, 112

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Peru3 sites

Novartis Investigative Site
Jesus Maria
Novartis Investigative Site
La Victoria
Novartis Investigative Site
Surquillo

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Switzerland3 sites

Novartis Investigative Site
Bern
Novartis Investigative Site
Locarno
Novartis Investigative Site
Lugano

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Thailand3 sites

Novartis Investigative Site
Bangkok, 10400
Novartis Investigative Site
Bangkok
Ratchathew
Khonkaen, 40002

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Argentina2 sites

Novartis Investigative Site
Buenos Aires
Novartis Investigative Site
Rosario Santa Fe

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Brazil2 sites

Novartis Investigative Site
Porto Alegre
Novartis Investigative Site
São Paulo

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China2 sites

Novartis Investigative Site
Beijing
Novartis Investigative Site
Shanghai

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Finland2 sites

Novartis Investigative Site
Pori
Novartis Investigative Site
Turku

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New Zealand2 sites

Novartis Investigative Site
Hamilton
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Wellington

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Philippines2 sites

Novartis Investigative Site
Cebu City
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Quezon City

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Chile1 site

Novartis Investigative Site
Santiago

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Colombia1 site

Novartis Investigative Site
Medellín

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Czechia1 site

Novartis Investigative Site
Nemocnice

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Egypt1 site

Novartis Investigative Site
Cairo

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Guatemala1 site

Novartis Investigative Site
Guatemala City

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Hong Kong1 site

Novartis Investigative Site
Hong Kong

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Mexico1 site

Novartis Investigative Site
Distrito Federal

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Portugal1 site

Novartis Investigative Site
Coimbra

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Venezuela1 site

Novartis Investigative Site
Caracas

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About this study

Official title: An Open-Label, Randomized, MultiCenter Study to Evaluate the Use of Zolendronic Acid in the Prevention of Cancer Treatment-Related Bone Loss in Postmenopausal Women With Estrogen Positive and/or Progesterone Positive Breast Cancer Receiving Letrozole as Adjuvant Therapy

Post-menopausal breast cancer patients will receive letrozole 2.5 mg daily for the treatment of breast cancer and will be randomized to a treatment group to receive either upfront zoledronic acid 4 mg IV 15-minute infusion every 6 months or delayed start zoledronic acid 4 mg IV 15-minute infusion every 6 months. Delayed start zoledronic acid will be initiated when either the Bone Mineral Density T-score is below -2 Standard Deviations at either the lumbar spine or hip or any clinical fracture unrelated to trauma or an asymptomatic fracture discovered at the month 36 scheduled visit. Letrozole 2.5 mg will be given daily for 5 years.

Conditions: Bone Loss, Breast Cancer
Being tested: Zoledronic acid, Letrozole
Keywords: Bone Loss, Osteopenia, Breast cancer, letrozole, zoledronic acid, postmenopausal
Medical subject headings: Bone Diseases, Metabolic, 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, Zometa®
Zolendronic acid 4 mg Intravenous (IV) 15 minute infusion every 6 months.
LetrozoleDrug
Also called Femara®
Letrozole tablets 2.5 mg/day taken orally for 5 years.

Study groups in NCT00171340
Study group	Role	What they receive
Upfront Zoledronic Acid	Experimental	Zolendronic acid 4 mg Intravenous (IV) 15 minute infusion every 6 months for 5 years beginning on Day 1. All participants took Letrozole tablets 2.5 mg/day for 5 years beginning on Day 1. Receives: Drug: Zoledronic acid; Drug: Letrozole
Delayed Zoledronic Acid	Experimental	Zolendronic acid 4 mg Intravenous (IV) 15 minute infusion every 6 months beginning when one of the following occurred: BMD T-score <= -2.0 SD at either the lumbar spine or total hip, any clinical fracture unrelated to trauma or an asymptomatic fracture discovered at the Month 36 visit. All participants took Letrozole tablets 2.5 mg/day for 5 years beginning on Day 1. Receives: Drug: Zoledronic acid; Drug: Letrozole

What is being measured

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

Percentage Change in Bone Mineral Density (BMD) of the Lumbar Spine (L2-L4) at 12 Months of Therapy.
Bone Mineral Density (g/cm^2) of the Lumbar Spine (L2-L4) as measured by energy x-ray absorptiometry (DXA).
Measured: Baseline, 12 months

Secondary outcomes (4)

Percentage Change in Bone Mineral Density (BMD) of the Lumbar Spine (L2-L4) at 2, 3, 4 and 5 Years of Therapy.
Bone Mineral Density (g/cm^2) of the Lumbar Spine (L2-L4) as measured by dual energy x-ray absorptiometry (DXA)
Measured: Baseline, 2 years. Baseline, 3 years. Baseline, 4 years. Baseline, 5 years.
Percentage Change in Bone Mineral Density (BMD)of the Lumbar Spine (L1-L4) Over 5 Years of Therapy.
Bone Mineral Density (g/cm^2) of the Lumbar Spine (L1-L4)as measured by dual energy x-ray absorptiometry (DXA)
Measured: Baseline, 5 years.
Percentage Change in Bone Mineral Density (BMD) of the Total Hip at 12 Months, 2 Years, 3 Years, 4 Years and 5 Years After Therapy.
Bone Mineral Density (g/cm^2) of the Lumbar Spine (L2-L4) as measured by dual energy x-ray absorptiometry (DXA)
Measured: Baseline, 12 months. Baseline, 2 years. Baseline, 3 years. Baseline, 4 years. Baseline, 5 years.
Percentage of Participants With Clinical Fractures at 3 Years of Therapy Which Were Not Present at Baseline
At 3 years of therapy the percentage of participants with fractures as detected by X-ray and/ or bone scan.
Measured: Baseline,3 years

Timeline

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

May 2003Feb 2010

First posted15 Sep 2005 (estimated)
Study startMay 2003
Primary completionFeb 2010
Study completionFeb 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Bone LossStudies of the same condition, open and under way.
More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: 1,065 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00171340
Sponsor's protocol ID: CFEM345D2405
Status last verified: Apr 2012
First submitted: 12 Sep 2005
Last updated: 16 Apr 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

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
Coleman R, de Boer R, Eidtmann H, Llombart A, Davidson N, Neven P, von Minckwitz G, Sleeboom HP, Forbes J, Barrios C, Frassoldati A, Campbell I, Paija O, Martin N, Modi A, Bundred N. Zoledronic acid (zoledronate) for postmenopausal women with early breast cancer receiving adjuvant letrozole (ZO-FAST study): final 60-month results. Ann Oncol. 2013 Feb;24(2):398-405. doi: 10.1093/annonc/mds277. Epub 2012 Oct 9.
PubMed 23047045

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 16 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-Label, Randomized, MultiCenter Study to Evaluate the Use of Zolendronic Acid in the Prevention of Cancer Treatment-Related Bone Loss in Postmenopausal Women With Estrogen Positive and/or Progesterone Positive Breast Cancer Receiving Letrozole as Adjuvant Therapy
ClinicalTrials.gov ID: NCT00171340
Acronym / sponsor ID: CFEM345D2405
Conditions: Bone Loss, Breast Cancer
Keywords: Bone Loss, Osteopenia, Breast cancer, letrozole, zoledronic acid, postmenopausal
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,065 participants (actual)
Lead sponsor: Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: May 2003
Primary completion: Feb 2010 (actual)
Study completion: Feb 2010 (actual)
First posted: 15 Sep 2005 (estimated)
Results: Posted 26 May 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Upfront Zoledronic Acid	Experimental	Drug: Zoledronic acid, Drug: LetrozoleZolendronic acid 4 mg Intravenous (IV) 15 minute infusion every 6 months for 5 years beginning on Day 1. All participants took Letrozole tablets 2.5 mg/day for 5 years beginning on Day 1.
Delayed Zoledronic Acid	Experimental	Drug: Zoledronic acid, Drug: LetrozoleZolendronic acid 4 mg Intravenous (IV) 15 minute infusion every 6 months beginning when one of the following occurred: BMD T-score <= -2.0 SD at either the lumbar spine or total hip, any clinical fracture unrelated to trauma or an asymptomatic fracture discovered at the Month 36 visit. All participants took Letrozole tablets 2.5 mg/day for 5 years beginning on Day 1.

Who may qualify

Sex: Female only
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (6 listed)

Stage I-IIIa breast cancer
Postmenopausal or recently postmenopausal
Recent surgery for breast cancer
Estrogen Receptor positive and/or progesterone receptor positive hormone receptor status
No prior treatment with letrozole

Key exclusion criteria (11 listed)

Metastatic disease
Invasive bilateral disease
Clinical or radiological evidence of existing fracture in spine or hip
Prior treatment with IV bisphosphonates in the past 12 months
Current treatment with oral bisphosphonates ( must be discontinued within 3 weeks of baseline evaluation)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Zoledronic acidAlso: ZOL446, Zometa®Zolendronic acid 4 mg Intravenous (IV) 15 minute infusion every 6 months.	Drug	Delayed Zoledronic Acid, Upfront Zoledronic Acid
LetrozoleAlso: Femara®Letrozole tablets 2.5 mg/day taken orally for 5 years.	Drug	Delayed Zoledronic Acid, Upfront Zoledronic Acid

Primary outcome

Percentage Change in Bone Mineral Density (BMD) of the Lumbar Spine (L2-L4) at 12 Months of Therapy.
Time frame: Baseline, 12 months
Bone Mineral Density (g/cm^2) of the Lumbar Spine (L2-L4) as measured by energy x-ray absorptiometry (DXA).

4 secondary outcomes

Percentage Change in Bone Mineral Density (BMD) of the Lumbar Spine (L2-L4) at 2, 3, 4 and 5 Years of Therapy.
Time frame: Baseline, 2 years. Baseline, 3 years. Baseline, 4 years. Baseline, 5 years.
Percentage Change in Bone Mineral Density (BMD)of the Lumbar Spine (L1-L4) Over 5 Years of Therapy.
Time frame: Baseline, 5 years.
Percentage Change in Bone Mineral Density (BMD) of the Total Hip at 12 Months, 2 Years, 3 Years, 4 Years and 5 Years After Therapy.
Time frame: Baseline, 12 months. Baseline, 2 years. Baseline, 3 years. Baseline, 4 years. Baseline, 5 years.
Percentage of Participants With Clinical Fractures at 3 Years of Therapy Which Were Not Present at Baseline
Time frame: Baseline,3 years

Results and safety

Results posted to the registry on 26 May 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Zoledronic Acid 4 mg Upfront	532	408
Zoledronic Acid 4 mg Delayed	533	398

Primary outcome: Percentage Change in Bone Mineral Density (BMD) of the Lumbar Spine (L2-L4) at 12 Months of Therapy.

Time frame: Baseline, 12 months. Mean (Standard Deviation). Unit: Percentage change in BMD

Measure	Zoledronic Acid 4 mg Upfront n = 423	Zoledronic Acid 4 mg Delayed n = 418
Value	2.208 (3.4194)	-3.617 (4.2151)

Population analysed: The Safety Population consists of all Randomized Patients who received at least 1 dose of study medication.

4 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Zoledronic Acid 4mg Upfront	133 of 525 (25.3%)	477 of 525 (90.9%)	Not reported
Zolendronic Acid 4mg Delayed	124 of 535 (23.2%)	486 of 535 (90.8%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 38979716Adams 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.
Derived from this study: PubMed 23047045Coleman R, de Boer R, Eidtmann H, Llombart A, Davidson N, Neven P, von Minckwitz G, Sleeboom HP, Forbes J, Barrios C, Frassoldati A, Campbell I, Paija O, Martin N, Modi A, Bundred N. Zoledronic acid (zoledronate) for postmenopausal women with early breast cancer receiving adjuvant letrozole (ZO-FAST study): final 60-month results. Ann Oncol. 2013 Feb;24(2):398-405. doi: 10.1093/annonc/mds277. Epub 2012 Oct 9.

Related trials for Bone Loss

Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
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Melatonin in Posterior Mandible Extraction Socket
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CFTR Modulator Effects on Bone and Muscle in Adults With Cystic Fibrosis
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Novartis Pharmaceuticals study director

Novartis Pharmaceuticals

106 sites in 28 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Zoledronic acid and Letrozole in people with Bone Loss and Breast Cancer, run by Novartis Pharmaceuticals at 106 sites in 28 countries.

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 6 inclusion and 11 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 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 106 sites in Germany, Italy, Netherlands, United Kingdom, Spain and 23 more countries. 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 26 May 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?

Percentage Change in Bone Mineral Density (BMD) of the Lumbar Spine (L2-L4) at 12 Months of Therapy. (time frame: Baseline, 12 months). 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 NCT00171340, which also lists 2 linked publications.

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 Apr 2012.