Single or Repeat Zoledronate Versus Alendronate Following Denosumab (EUROpean Denosumab Effects Consolidation Study)

Recruiting

• Conditions: Osteoporosis, Postmenopausal
• Interventions: Drug: Zoledronate or Alendronate

• Registration Number: NCT05575167
• Lead Sponsor: 424 General Military Hospital

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

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 Timeline

• Study First Submitted: 2022-10-07
• Study First Submitted QC: 2022-10-08
• Study First Posted: 2022-10-12
• Study Start: 2023-11-28
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-24
• Last Update Posted: 2025-04-27
• Primary Completion: 2027-11
• Study Completion: 2027-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 125

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
double Zol group	Zoledronate or Alendronate	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
single Zol group	Zoledronate or Alendronate	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
ALN group	Zoledronate or Alendronate	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

Primary Outcome Measures

Name	Time	Method
lumbar spine BMD	24 months	BMD changes at the lumbar spine at 12 and 24 months

Secondary Outcome Measures

Name	Time	Method
fracture	24 months	incident fractures: vertebral (clinical and morphometric identified on VFA scans) and non-vertebral
height	24 months	loss of height
P1NP	baseline, 3 months, 6 months, 12 months, 18 months, 24 months	bone turnover (formation) marker
CTx	24 months	bone turnover (resorption) marker
femoral neck BMD	24 months	BMD changes at the non-dominant femoral neck and total hip at 12 and 24 months

Trial Locations

Locations (9)

Univ. Lille, CHU Lille; 🇫🇷 Lille, France

, KAT General Hospital; 🇬🇷 Athens, Greece

251 Hellenic Airforce and VA General Hospital; 🇬🇷 Athens, Greece

First Department of Propaedeutic and Internal Medicine, Medical School, National and Kapodistrian University of Athens; 🇬🇷 Athens, Greece

424 General Military Hospital; 🇬🇷 Thessaloniki, Greece

Fondazione IRCCS Cà Granda-Ospedale Maggiore Policlinico; 🇮🇹 Milan, Italy

Campus Bio-Medico University; 🇮🇹 Roma, Italy

Department of Medicine, Surgery and Neurosciences, University of Siena; 🇮🇹 Siena, Italy

University-Hospital S. Maria della Misericordia; 🇮🇹 Udine, Italy