Clinical trial NCT05575167: Single or Repeat Zoledronate Versus Alendronate Following Denosumab (EUROpean Denosumab Effects Consolidation 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Osteoporosis, Postmenopausal
Lead sponsor: 424 General Military Hospital
Sponsor class: OTHER
First posted: 2022-10-12
Enrollment: 125
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Postmenopausal women treated with denosumab

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

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)

Primary outcomes:
measure: lumbar spine BMD
timeFrame: 24 months
Secondary outcomes:
measure: femoral neck BMD
timeFrame: 24 months
measure: P1NP
timeFrame: baseline, 3 months, 6 months, 12 months, 18 months, 24 months
measure: CTx
timeFrame: 24 months
measure: fracture
timeFrame: 24 months
measure: height
timeFrame: 24 months
Other outcomes:
Locations:
city: Lille
country: France
facility: Univ. Lille, CHU Lille
city: Athens
country: Greece
facility: 251 Hellenic Airforce and VA General Hospital
city: Athens
country: Greece
facility: First Department of Propaedeutic and Internal Medicine, Medical School, National and Kapodistrian University of Athens
city: Athens
country: Greece
facility: , KAT General Hospital
city: Thessaloniki
country: Greece
facility: 424 General Military Hospital
city: Milan
country: Italy
facility: Fondazione IRCCS Cà Granda-Ospedale Maggiore Policlinico
city: Roma
country: Italy
facility: Campus Bio-Medico University
city: Siena
country: Italy
facility: Department of Medicine, Surgery and Neurosciences, University of Siena
city: Udine
country: Italy
facility: University-Hospital S. Maria della Misericordia
Study officials:
affiliation: ECTS Clinical Action Group
name: Willem Lems, Prof
role: PRINCIPAL_INVESTIGATOR
References: