Health TrialsbyHealthPanel

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

ConditionOsteoporosis, Postmenopausal
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age50-85
Sponsor424 General Military Hospital

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

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

Trial population

Postmenopausal women treated with denosumab

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Zoledronate or Alendronate

    Drug

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

Treatment groups

125 Participants
are divided into 3 treatment groups
Group A: single Zol group1 intervention
Group B: double Zol group1 intervention
Group C: ALN group1 intervention

Trial outcomes

Primary outcomes

1

lumbar spine BMD

BMD changes at the lumbar spine at 12 and 24 months

Time frame
24 months

Secondary outcomes

1

femoral neck BMD

BMD changes at the non-dominant femoral neck and total hip at 12 and 24 months

Time frame
24 months
2

P1NP

bone turnover (formation) marker

Time frame
baseline, 3 months, 6 months, 12 months, 18 months, 24 months
3

CTx

bone turnover (resorption) marker

Time frame
24 months
4

fracture

incident fractures: vertebral (clinical and morphometric identified on VFA scans) and non-vertebral

Time frame
24 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

424 General Military Hospital

Lead sponsor

Source ClinicalTrials.gov
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