NCT05575167

Brief 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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
125

participants targeted

Target at P50-P75 for all trials

Timeline
18mo left

Started Nov 2023

Longer than P75 for all trials

Geographic Reach
3 countries

9 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress62%
Nov 2023Nov 2027

First Submitted

Initial submission to the registry

October 7, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 12, 2022

Completed
1.1 years until next milestone

Study Start

First participant enrolled

November 28, 2023

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2027

Last Updated

April 27, 2025

Status Verified

April 1, 2025

Enrollment Period

3.9 years

First QC Date

October 7, 2022

Last Update Submit

April 24, 2025

Conditions

Osteoporosis, Postmenopausal

Outcome Measures

Primary Outcomes (1)

  • lumbar spine BMD

    BMD changes at the lumbar spine at 12 and 24 months

    24 months

Secondary Outcomes (5)

  • femoral neck BMD

    24 months

  • P1NP

    baseline, 3 months, 6 months, 12 months, 18 months, 24 months

  • CTx

    24 months

  • fracture

    24 months

  • height

    24 months

Study Arms (3)

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

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

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

Drug: Zoledronate or Alendronate

Interventions

Zoledronate or AlendronateDRUG

infusion (for zoledronate) or oral digestion (for alendronate)

Also known as: Calcium and vitamin D supplementation
ALN groupdouble Zol groupsingle Zol group

Eligibility Criteria

Age50 Years - 85 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailspostmenopausal women
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Postmenopausal women treated with denosumab

You may qualify if:

  • Postmenopausal women treated with denosumab for 3 or more years who will reach osteopenia

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Univ. Lille, CHU Lille

Lille, France

RECRUITING

251 Hellenic Airforce and VA General Hospital

Athens, 11525, Greece

RECRUITING

First Department of Propaedeutic and Internal Medicine, Medical School, National and Kapodistrian University of Athens

Athens, 11527, Greece

RECRUITING

, KAT General Hospital

Athens, 14561, Greece

RECRUITING

424 General Military Hospital

Thessaloniki, 56429, Greece

RECRUITING

Fondazione IRCCS Cà Granda-Ospedale Maggiore Policlinico

Milan, Italy

NOT YET RECRUITING

Campus Bio-Medico University

Roma, 00128, Italy

NOT YET RECRUITING

Department of Medicine, Surgery and Neurosciences, University of Siena

Siena, 53100, Italy

NOT YET RECRUITING

University-Hospital S. Maria della Misericordia

Udine, Italy

NOT YET RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum samples for bone markers measurements

MeSH Terms

Conditions

Osteoporosis, Postmenopausal

Interventions

Zoledronic AcidAlendronateCalcium

Condition Hierarchy (Ancestors)

OsteoporosisBone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

DiphosphonatesOrganophosphonatesOrganophosphorus CompoundsOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsMetals, Alkaline EarthElementsInorganic ChemicalsMetalsBlood Coagulation FactorsBiological Factors

Study Officials

  • Willem Lems, Prof

    ECTS Clinical Action Group

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Athanasios D Anastasilakis, MD

CONTACT

2310381431a.anastasilakis@gmail.com

John Carey, MD

CONTACT

john.j.carey@universityofgalway.ie

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant of endocrinology; in charge of the Department of Metabolic Bone Diseases

Study Record Dates

First Submitted

October 7, 2022

First Posted

October 12, 2022

Study Start

November 28, 2023

Primary Completion (Estimated)

November 1, 2027

Study Completion (Estimated)

November 1, 2027

Last Updated

April 27, 2025

Record last verified: 2025-04

Locations

IT(4)GR(4)FR(1)