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

Osteoporosis, Postmenopausal Clinical Trial

— EURODEC  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05575167
• Other study ID #: EURODEC
• Status: Recruiting
• Start date: November 28, 2023
• Est. completion date: November 2026

Study information

• Verified date: November 2023
• Source: 424 General Military Hospital
• Contact: Athanasios D Anastasilakis, MD
• Phone: 2310381431
• Email: a.anastasilakis[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 125
• Est. completion date: November 2026
• Est. primary completion date: November 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 50 Years to 85 Years

Eligibility

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)

Related Conditions & MeSH terms

• Osteoporosis
• Osteoporosis, Postmenopausal

Intervention

Drug:
• Zoledronate or Alendronate
infusion (for zoledronate) or oral digestion (for alendronate)

Locations

Country	Name	City	State
France	Univ. Lille, CHU Lille	Lille
Germany	Department of Medicine III and Center for Healthy Aging, Technische Universität Dresden	Dresden
Greece	, 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
Italy	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

Sponsors (1)

Lead Sponsor	Collaborator
424 General Military Hospital

Countries where clinical trial is conducted

France,  Germany,  Greece,  Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	lumbar spine BMD	BMD changes at the lumbar spine at 12 and 24 months	24 months
Secondary	femoral neck BMD	BMD changes at the non-dominant femoral neck and total hip at 12 and 24 months	24 months
Secondary	P1NP	bone turnover (formation) marker	baseline, 3 months, 6 months, 12 months, 18 months, 24 months
Secondary	CTx	bone turnover (resorption) marker	24 months
Secondary	fracture	incident fractures: vertebral (clinical and morphometric identified on VFA scans) and non-vertebral	24 months
Secondary	height	loss of height	24 months