Zoledronic Acid to Maintain Bone Mass After Denosumab Discontinuation: AfterDmab
Completed
- Conditions
- Osteoporosis
- Registration Number
- NL-OMON43199
- Lead Sponsor
- eids Universitair Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 30
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Lumbar spine and hip BMD at 24 months ( 12 months after discontinuation)</p><br>
- Secondary Outcome Measures
Name Time Method <p>- Markers of bone turonover at T= 6 months, 12 months, 15 months, 18 months and<br /><br>24 months<br /><br>- Number of fractures at T=24 months</p><br>