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

424 General Military Hospital

Status: Enrolling

Conditions: Osteoporosis, Postmenopausal

Treatments: Drug: Zoledronate or Alendronate

Study type: Observational

Funder types: Other

Identifiers

NCT05575167

EURODEC

Details and patient eligibility

About

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

Full 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

Enrollment: 125 estimated patients

Sex: Female

Ages: 50 to 85 years old

Volunteers: No 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)

Trial design

125 participants in 3 patient groups

single Zol group

Description:

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

Treatment:

Drug: Zoledronate or Alendronate

double Zol group

Description:

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

Treatment:

Drug: Zoledronate or Alendronate

ALN group

Description:

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

Treatment:

Drug: Zoledronate or Alendronate