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Clinical Trials/EUCTR2016-000852-91-NL
EUCTR2016-000852-91-NL
Active, not recruiting
Phase 1

Zoledronic Acid to Maintain Bone Mass After Denosumab Discontinuation: AfterDmab - After Dmab

eiden University Medical Center0 sites75 target enrollmentMarch 30, 2016
DrugsAclasta

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Not specified
Sponsor
eiden University Medical Center
Enrollment
75
Status
Active, not recruiting
Last Updated
4 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
March 30, 2016
End Date
February 1, 2020
Last Updated
4 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
Female

Investigators

Sponsor
eiden University Medical Center

Eligibility Criteria

Inclusion Criteria

  • Postmenopausal women with osteoporosis (T\-score \<\-2\.5\) who reached a T score of \>\-2\.5 on the LS spine and/or Fn Neck while on treatment with denosumab attending the outpatient clinic and willing to participate.
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1\.2 Adults (18\-64 years) yes
  • F.1\.2\.1 Number of subjects for this age range 15
  • F.1\.3 Elderly (\>\=65 years) yes
  • F.1\.3\.1 Number of subjects for this age range 15

Exclusion Criteria

  • A potential subject who meets any of the following criteria will be excluded from participation in this study:
  • i) secondary osteoporosis; ii) diseases that could affect bone metabolism other then osteoporosis; iii) medications that could affect bone metabolism; iv) history of any antiosteoporotic treatment other than denosumab prior to randomization.

Outcomes

Primary Outcomes

Not specified

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