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
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