Status:
COMPLETED
Alendronate in an Weekly Effervescent Tablet Formulation Following Denosumab Discontinuation
Lead Sponsor:
251 Hellenic Air Force & VA General Hospital
Collaborating Sponsors:
Laikο General Hospital, Athens
424 General Military Hospital
Conditions:
Postmenopausal Osteoporosis
Eligibility:
FEMALE
Up to 90 years
Brief Summary
Discontinuation of denosumab results in a rebound response of bone turnover markers, which rise above baseline at 3 months and remain elevated until reaching again baseline levels approximately 30 mon...
Detailed Description
Denosumab, a monoclonal antibody against the receptor activator of nuclear factor κ-Β ligand (RANKL), is a potent antiresorptive agent commonly prescribed in patients with postmenopausal osteoporosis....
Eligibility Criteria
Inclusion
- i) osteopenic postmenopausal Caucasian women following Dmab treatment ii) assignment to treatment with alendronate in an effervescent tablet formulation following Dmab discontinuation
Exclusion
- i) secondary osteoporosis; ii) diseases that could affect bone metabolism iii) medications that could affect bone metabolism iv) chronic kidney disease (stage \>3b) and/or liver failure v) neoplastic disease vi) hypersensitivity to alendronate or to any of the excipients vii) abnormalities of the esophagus and other factors which delay esophageal emptying such as stricture or achalasia viii) inability to stand or sit upright for at least 30 minutes ix) hypocalcaemia x) confirmed esophagitis
Key Trial Info
Start Date :
April 1 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 1 2024
Estimated Enrollment :
92 Patients enrolled
Trial Details
Trial ID
NCT04338529
Start Date
April 1 2020
End Date
November 1 2024
Last Update
December 2 2024
Active Locations (1)
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1
251 Hellenic Air Force & VA General Hospital
Athens, Attica, Greece, 11525