Osteoporosis, PostmenopausalEURODECNCT05575167
Single or Repeat Zoledronate Versus Alendronate Following Denosumab (EUROpean Denosumab Effects Consolidation Study)
An observational study of Osteoporosis, Postmenopausal, run by 424 General Military Hospital at 9 sites in 3 countries.
Trial summary
A 24-month prospective, open-label, randomized, multicenter, multinational, non-inferiority pragmatic clinical trial evaluating zoledronate single or double infusion versus oral alendronate following denosumab Read more about this study
- Who is it for?
- Ages 50 to 85 years, women only
- Conditions the study is for
- Osteoporosis, Postmenopausal
- What is being tested?
- Zoledronate or Alendronate
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 122 participants
- Where
- 9 sitesin 3 countries
- Study dates
- 28 Nov 2023to Nov 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 50 to 85 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Postmenopausal women treated with denosumab
Who may be able to join
- Postmenopausal women treated with denosumab for 3 or more years who will reach osteopenia
Who cannot join
- a bone disease other than postmenopausal osteoporosis
- use of medications other than bisphosphonates or SERMS affecting bone metabolism during the last 12 months before entering the study
- creatinine clearance <60 mL/min/1.73 m2
- liver failure
- any type of cancer
- uncontrolled endocrine diseases
- serum 25-hydroxy vitamin D (25-OHD) concentrations lower than 20 ng/mL (50 nmol/L)
Trial locations and contacts
9 sites in 3 countries.
9 sites in 3 countries
Greece4 sites
251 Hellenic Airforce and VA General Hospital
Athens, 11525
First Department of Propaedeutic and Internal Medicine, Medical School, National and Kapodistrian University of Athens
Athens, 11527
, KAT General Hospital
Athens, 14561
424 General Military Hospital
Thessaloniki, 56429
Italy4 sites
Fondazione IRCCS Cà Granda-Ospedale Maggiore Policlinico
Milan
Campus Bio-Medico University
Roma, 00128
Department of Medicine, Surgery and Neurosciences, University of Siena
Siena, 53100
University-Hospital S. Maria della Misericordia
Udine
About this study
Official title: The Effectiveness of Single or Repeat Zoledronate Infusion Versus Oral Alendronate in Consolidating the Bone Accrual Achieved With Denosumab: a Study Organised by the European Calcified Tissue Society
A 24-month prospective, open-label, randomized, multicenter, multinational, non-inferiority pragmatic clinical trial evaluating zoledronate single or double infusion versus oral alendronate following denosumab
Read the detailed description
125 postmenopausal women treated with Dmab for 3 or more years who will reach osteopenia with denosumab will be randomized into three groups: i) zoledronate infusion (5mg) at 6 months after last Dmab dose (single Zol group) ii) zoledronate infusion (5mg) at 6 and 12 months after last Dmab dose (double Zol group) iii) alendronate 70mg orally weekly for 12 months (ALN group) All women will receive no further treatment during the 2nd year of the study.
Participating centers: ECTS affiliated bone centers
Endpoints: Primary: BMD changes at the lumbar spine at 12 months. Secondary: i) BMD changes at the lumbar spine at 24 months; ii) BMD changes at the non-dominant femoral neck and total hip at 12 and 24 months; iii) changes at levels of bone turnover markers throughout the study; iv) incident fractures: vertebral (clinical and morphometric identified on VFA scans) and non-vertebral; v) clinical parameters: height change, VAS for back pain, and use of analgesics
- Conditions
- Osteoporosis, Postmenopausal
- Being tested
- Zoledronate or Alendronate
- Medical subject headings
- Osteoporosis, Postmenopausal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zoledronate or AlendronateDrug
Also called Calcium and vitamin D supplementation
infusion (for zoledronate) or oral digestion (for alendronate)
| Study group | Role | What they receive |
|---|---|---|
| single Zol group | postmenopausal women treated with denosumab for 3 or more years who will reach osteopenia with denosumab and will receive a single zoledronate infusion (5mg) at 6 months after the last denosumab dose Receives: Drug: Zoledronate or Alendronate | |
| double Zol group | postmenopausal women treated with denosumab for 3 or more years who will reach osteopenia with denosumab and will receive two zoledronate infusions (5mg) at 6 and 12 months after the last denosumab dose Receives: Drug: Zoledronate or Alendronate | |
| ALN group | postmenopausal women treated with denosumab for 3 or more years who will reach osteopenia with denosumab and will receive alendronate 70mg orally weekly for 12 months Receives: Drug: Zoledronate or Alendronate |
What is being measured
The primary outcome is the main question the study is designed to answer.
lumbar spine BMD
BMD changes at the lumbar spine at 12 and 24 months
Measured: 24 months
Secondary outcomes (5)
femoral neck BMD
BMD changes at the non-dominant femoral neck and total hip at 12 and 24 months
Measured: 24 months
P1NP
bone turnover (formation) marker
Measured: baseline, 3 months, 6 months, 12 months, 18 months, 24 months
CTx
bone turnover (resorption) marker
Measured: 24 months
fracture
incident fractures: vertebral (clinical and morphometric identified on VFA scans) and non-vertebral
Measured: 24 months
height
loss of height
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2022
- Study start28 Nov 2023
- Primary completionJul 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoporosis, PostmenopausalStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- 424 General Military Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Laikο General Hospital, Athens, 251 Hellenic Air Force & VA General Hospital, Campus Bio-Medico University
- Responsible party
- Principal investigator, Athanasios D. Anastasilakis, 424 General Military Hospital
- Investigators
- Willem Lems, Prof, Principal investigator, ECTS Clinical Action Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05575167
- Sponsor's protocol ID
- EURODEC
- Acronym
- EURODEC
- Status last verified
- Jul 2026
- First submitted
- 7 Oct 2022
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Single or Repeat Zoledronate Infusion Versus Oral Alendronate in Consolidating the Bone Accrual Achieved With Denosumab: a Study Organised by the European Calcified Tissue Society
- ClinicalTrials.gov ID
- NCT05575167
- Acronym / sponsor ID
- EURODEC / EURODEC
- Conditions
- Osteoporosis, Postmenopausal
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 122 participants (actual)
- Lead sponsor
- 424 General Military HospitalUniversity, hospital or other
- Collaborators
- Laikο General Hospital, Athens, 251 Hellenic Air Force & VA General Hospital, Campus Bio-Medico University
- Study start
- 28 Nov 2023 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 12 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A 24-month prospective, open-label, randomized, multicenter, multinational, non-inferiority pragmatic clinical trial evaluating zoledronate single or double infusion versus oral alendronate following denosumab
Detailed description
125 postmenopausal women treated with Dmab for 3 or more years who will reach osteopenia with denosumab will be randomized into three groups: i) zoledronate infusion (5mg) at 6 months after last Dmab dose (single Zol group) ii) zoledronate infusion (5mg) at 6 and 12 months after last Dmab dose (double Zol group) iii) alendronate 70mg orally weekly for 12 months (ALN group) All women will receive no further treatment during the 2nd year of the study.
Participating centers: ECTS affiliated bone centers
Endpoints: Primary: BMD changes at the lumbar spine at 12 months. Secondary: i) BMD changes at the lumbar spine at 24 months; ii) BMD changes at the non-dominant femoral neck and total hip at 12 and 24 months; iii) changes at levels of bone turnover markers throughout the study; iv) incident fractures: vertebral (clinical and morphometric identified on VFA scans) and non-vertebral; v) clinical parameters: height change, VAS for back pain, and use of analgesics
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| single Zol group | – | Drug: Zoledronate or Alendronatepostmenopausal women treated with denosumab for 3 or more years who will reach osteopenia with denosumab and will receive a single zoledronate infusion (5mg) at 6 months after the last denosumab dose |
| double Zol group | – | Drug: Zoledronate or Alendronatepostmenopausal women treated with denosumab for 3 or more years who will reach osteopenia with denosumab and will receive two zoledronate infusions (5mg) at 6 and 12 months after the last denosumab dose |
| ALN group | – | Drug: Zoledronate or Alendronatepostmenopausal women treated with denosumab for 3 or more years who will reach osteopenia with denosumab and will receive alendronate 70mg orally weekly for 12 months |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Postmenopausal women treated with denosumab
Key inclusion criteria (1 listed)
- Postmenopausal women treated with denosumab for 3 or more years who will reach osteopenia
Key exclusion criteria (7 listed)
- a bone disease other than postmenopausal osteoporosis
- use of medications other than bisphosphonates or SERMS affecting bone metabolism during the last 12 months before entering the study
- creatinine clearance <60 mL/min/1.73 m2
- liver failure
- any type of cancer
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 |
|---|---|---|
| Zoledronate or AlendronateAlso: Calcium and vitamin D supplementationinfusion (for zoledronate) or oral digestion (for alendronate) | Drug | ALN group, double Zol group, single Zol group |
Primary outcome
lumbar spine BMD
Time frame: 24 months
BMD changes at the lumbar spine at 12 and 24 months
5 secondary outcomes
femoral neck BMD
Time frame: 24 months
P1NP
Time frame: baseline, 3 months, 6 months, 12 months, 18 months, 24 months
CTx
Time frame: 24 months
fracture
Time frame: 24 months
height
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2026.
- Individual participant dataSharing planned: Undecided
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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.
Willem Lems, Prof principal investigator
ECTS Clinical Action Group
9 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoporosis, Postmenopausal, run by 424 General Military Hospital at 9 sites in 3 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 1 inclusion and 7 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: under way, not looking for participants, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Greece, Italy, France. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
lumbar spine BMD (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Jul 2026.