Comparing Zoledronate and Alendronate for Osteoporosis Treatment After Denosumab

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

This study is testing whether one or two infusions of zoledronate work better than weekly oral alendronate to improve bone health in postmenopausal women who have been on denosumab for a while.

Quick facts

• Study type: Observational
• Enrollment: 125 (estimated)
• Ages: 50 Years to 85 Years
• Sex: Female
• Sponsor: 424 General Military Hospital (Academic / other)
• Drugs / interventions: denosumab
• Locations: 9 sites (Lille and 8 other locations)
• Trial ID: NCT05575167 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of single or double infusions of zoledronate compared to weekly oral alendronate in postmenopausal women who have been treated with denosumab for three or more years and are transitioning to osteopenia. A total of 125 participants will be randomized into three groups: one receiving a single infusion of zoledronate, another receiving two infusions, and the third receiving oral alendronate. The primary endpoint is the change in bone mineral density (BMD) at the lumbar spine after 12 months, with secondary endpoints including BMD changes at 24 months and various clinical parameters. The study will take place over 24 months with no further treatment in the second year.

Who should consider this trial

Good fit: Ideal candidates are postmenopausal women who have been treated with denosumab for at least three years and are transitioning to osteopenia.

Not a fit: Patients with other bone diseases, certain cancers, or those with significant renal or liver issues may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a more effective treatment option for postmenopausal women at risk of osteoporosis after denosumab therapy.

How similar studies have performed: Previous studies have shown promising results with bisphosphonates in osteoporosis management, suggesting potential success for this approach.

Eligibility criteria

Inclusion Criteria:

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

Exclusion Criteria:

* 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)

Where this trial is running

Lille and 8 other locations

• Univ. Lille, CHU Lille — Lille, France (Recruiting)
• 251 Hellenic Airforce and VA General Hospital — Athens, Greece (Recruiting)
• First Department of Propaedeutic and Internal Medicine, Medical School, National and Kapodistrian University of Athens — Athens, Greece (Recruiting)
• , KAT General Hospital — Athens, Greece (Recruiting)
• 424 General Military Hospital — Thessaloniki, Greece (Recruiting)
• Fondazione IRCCS Cà Granda-Ospedale Maggiore Policlinico — Milan, Italy (Not_yet_recruiting)
• Campus Bio-Medico University — Roma, Italy (Not_yet_recruiting)
• Department of Medicine, Surgery and Neurosciences, University of Siena — Siena, Italy (Not_yet_recruiting)
• University-Hospital S. Maria della Misericordia — Udine, Italy (Not_yet_recruiting)

Study contacts

• Principal investigator: Willem Lems, Prof — ECTS Clinical Action Group
• Study coordinator: Athanasios D Anastasilakis, MD

Conditions Osteoporosis, Postmenopausal