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Could fewer injections protect bones just as well? major trial tests every-12-week denosumab

NCT ID NCT02051218

Disease control Sponsor: Swiss Cancer Institute Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 3 trial tests whether giving denosumab every 12 weeks instead of every 4 weeks can still prevent bone complications (like fractures or spinal cord compression) in people with metastatic breast or prostate cancer. About 1,380 participants with bone metastases will be randomly assigned to one of the two schedules. The goal is to see if the less frequent dosing is just as effective, with fewer clinic visits and lower side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

1,380 people

The number who actually took part.

Started

Jul 2014

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Patient has given written informed consent. * Histologically confirmed diagnosis of breast or prostate cancer before randomization. * Patient has metastatic breast cancer (stage IV, all subtypes allowed) or prostate cancer (stage IV) and bone metastases and is planned to receive or is receiving antineoplastic treatment. * Patients with prostate cancer must have evidence of disease progression on continuous androgen deprivation therapy (CRPC). * Patients must have ≥ 3 bone metastases (lytic or blastic or mixed). The lesions must be documented by radiological evaluation within 12 weeks before randomization (by X-Ray, CT scan, PET-CT, MRI scan or bone scintigraphy). * WHO performance status 0-2 * Age ≥ 18 years. * Corrected serum calcium ≥ 2 mmol/l and ≤ 3 mmol/l (medical treatments to obtain serum calcium levels in the normal range are allowed, as far as no denosumab is used. Maximally 1 dose of bisphosphonates in the case of hypercalcemia is allowed, if the bisphosphonate was applied at least 3 weeks before the first dose of denosumab). * Liver transaminases not more than 1.5 x ULN or not more than 3 x ULN with liver metastases. Serum total bilirubin ≤ 1.5 x ULN (≤ 2.0 x ULN in case of known Gilbert's disease) * Women are not breastfeeding. Women with child-bearing potential are using effective contraception, are not pregnant and agree not to become pregnant during participation in the trial and during the 12 months thereafter. A negative pregnancy test before inclusion (within 7 days) into the trial is required for all women with child-bearing potential. * Men agree not to father a child during participation in the trial and during 12 months thereafter. Exclusion Criteria: * Definite contraindication for denosumab (e.g. hypocalcaemia \[Albumin-corrected serum calcium \< 2.0 mmol/l\]). * History or current evidence of osteonecrosis of the jaw. * Non-healed mucosa in oral cavity (by surgery or as a side effect of any other treatment). * Jaw or dental conditions that require oral surgery or if surgery or invasive dental procedures are planned. * Prior use of denosumab for bone metastases (dose 120 mg every 4 weeks) or bisphosphonates to treat bone metastases. Patients treated with denosumab or bisphosphonates against osteopenia or osteoporosis are allowed to enter the trial if the last dose was more than 28 days before randomization. * Patients with known osteoporosis (T-score ≤ -2.5) at study entry (since fractures from osteoporosis are difficult to be discriminated from fractures through bone metastases). * Radiotherapy or surgery to the bone within the last two weeks before randomization or planned within 6 weeks after randomization. * Presence or history of CNS metastases or leptomeningeal disease. A MRI evaluation within 12 weeks before randomization must be performed in case of suspicious symptoms. * Psychiatric disorder precluding understanding of information on trial related topics, giving informed consent, filling out QoL forms. * Concurrent treatment in a clinical trial with SSE or SRE as primary endpoint. * Known hypersensitivity to trial drug or hypersensitivity to any other component of the trial drug (e.g. fructose). * Any concomitant drugs contraindicated for use with the trial drugs according to the approved product information. * Any psychological, familial, sociological or geographical condition potentially hampering compliance with the trial protocol.

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Conditions

The condition(s) this trial relates to.

breast carcinoma breast neoplasm metastatic carcinoma in the bone metastatic prostate carcinoma prostate cancer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Bone metastases Metastatic breast cancer Metastatic prostate cancer

Contacts and locations

Locations

  • Brustzentrum Basel - Praxis für ambulante Tumortherapie

    Basel, 4052, Switzerland

  • Brustzentrum-Zürich

    Zurich, 8005, Switzerland

  • Bürgerspital Solothurn - Zentrum für Onkologie und Hämatologie

    Solothurn, 4500, Switzerland

  • CCAC Lausanne

    Lausanne, 1004, Switzerland

  • CHUV

    Lausanne, 1011, Switzerland

  • Centre du Sein de Genève, Clinique des Grangettes

    Chêne-Bougeries, 1224, Switzerland

  • Clinique De Genolier

    Genolier, 1272, Switzerland

  • Fondazione Oncologia / Oncologia ematologia

    Locarno, 6600, Switzerland

  • Hirslanden Klinik Aarau

    Aarau, CH-5001, Switzerland

  • Hirslanden Klinik St. Anna Luzern

    Lucerne, 6006, Switzerland

  • Hopital Fribourgeois

    Fribourg, 1708, Switzerland

  • Hopitaux Universitaires de Geneve

    Geneva, 1211, Switzerland

  • Hôpital du Valais Sion

    Sion, 1951, Switzerland

  • Hôpital neuchâtelois

    La Chaux-de-Fonds, 2300, Switzerland

  • Inselspital, Bern

    Bern, CH-3010, Switzerland

  • Istituto Oncologico della Svizzera Italiana - Ospedale Regionale Bellinzona e Valli

    Bellinzona, 6500, Switzerland

  • Kantonspital Aarau

    Aarau, CH-5001, Switzerland

  • Kantonsspital Baden

    Baden, CH-5404, Switzerland

  • Kantonsspital Frauenfeld - Brustzentrum

    Frauenfeld, 8501, Switzerland

  • Kantonsspital Graubünden

    Chur, 7000, Switzerland

  • Kantonsspital Liestal

    Liestal, CH-4410, Switzerland

  • Kantonsspital Muensterlingen

    Münsterlingen, 8596, Switzerland

  • Kantonsspital Olten

    Olten, 4600, Switzerland

  • Kantonsspital St. Gallen

    Sankt Gallen, CH-9007, Switzerland

  • Kantonsspital Winterthur

    Winterthur, 8401, Switzerland

  • Klinik Engeried / Praxis Oncocare

    Bern, 3012, Switzerland

  • Klinik für Hämatologie und Onkologie Hirslanden Zürich AG

    Zurich, 8032, Switzerland

  • Klinikum Wels-Grieskrichen GmbH

    Wels, 4600, Austria

  • Landeskrankenhaus Feldkirch

    Feldkirch, 6800, Austria

  • Luzerner Kantonsspital

    Lucerne, 6000, Switzerland

  • Oncologia Varini & Calderoni & Christinat

    Lugano, 6900, Switzerland

  • Onkologie Bellevue

    Zurich, 8001, Switzerland

  • Onkologie Zentrum Spital Männedorf

    Männedorf, 8708, Switzerland

  • Onkozentrum Klinik im Park

    Zurich, 8038, Switzerland

  • Rundum Onkologie am Bahnhofpark

    Sargans, 7320, Switzerland

  • Spital Limmattal

    Schlieren, 8952, Switzerland

  • Spital STS AG

    Thun, 3600, Switzerland

  • Spitalzentrum Biel

    Biel, CH-2501, Switzerland

  • Spitalzentrum Oberwallis

    Brig, 3900, Switzerland

  • St. Claraspital AG

    Basel, CH-4016, Switzerland

  • Stadtspital Zürich Triemli

    Zurich, CH-8063, Switzerland

  • Tumor and Brustzentrum Ostschweiz TBZO

    Sankt Gallen, 9016, Switzerland

  • Tumor and Brustzentrum Ostschweiz TBZO

    Sankt Gallen, CH-9006, Switzerland

  • Uniklinik Düsseldorf, Urologische Klinik

    Düsseldorf, 40225, Germany

  • Universitaetsspital Basel

    Basel, 4031, Switzerland

  • Universitäts-Frauenklinik Ulm

    Ulm, 89075, Germany

  • Universitätsklinikum Düsseldorf, Frauenheilkunde/Geburtshilfe

    Düsseldorf, 40225, Germany

  • Universitätsklinikum Schleswig-Holstein

    Lübeck, 23538, Germany

  • Universitätsmedizin Göttingen

    Göttingen, 37075, Germany

  • Universitätsspital Zürich

    Zurich, 8091, Switzerland

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