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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05575167

Acronym

EURODEC

Enrollment

122

Registered

2022-10-12

Start date

2023-11-28

Completion date

2027-11-01

Last updated

2026-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoporosis, Postmenopausal

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

Interventions

DRUGZoledronate or Alendronate

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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

50 Years to 85 Years

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame	Description
lumbar spine BMD	24 months	BMD changes at the lumbar spine at 12 and 24 months

Secondary

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

Countries

France, Greece, Italy

Contacts

PRINCIPAL_INVESTIGATORWillem Lems, Prof

ECTS Clinical Action Group

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 23, 2026