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.
Investigators
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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