NCT04338529Completed
Alendronate in an Weekly Effervescent Tablet Formulation Following Denosumab Discontinuation
Alendronate in an Weekly Effervescent Tablet Formulation for Preservation of Bone Mass After Denosumab Discontinuation in Postmenopausal Women with Low Bone Mass. an Observational Study (Binosto After Denosumab - the BAD Study)
Source: ClinicalTrials.gov · Last updated 2 Dec 2024
Brief summary (registry, in English)
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 months after the last dose. Bone mineral density (BMD) gains are also lost and BMD values reach original baseline values after 1-2 years off-treatment.For the above reasons, current literature recommends that patients who discontinue denosumab should continue to receive either intravenous (iv) or oral (peros) bisphosphonate therapy for some time. The study aims to investigate changes in the BMD of the lumbar spine 12 months after transitioning from denosumab to oral alendronate 70 mg in a weekly effervescent tablet formulation
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 92 (actual)
- First submitted
- 4 Apr 2020
- Start date
- Apr 2020
- Primary completion date
- Sept 2024
- Lead sponsor
- 251 Hellenic Air Force & VA General Hospital
- Diseases
- Osteoporosis
- NCT number
- NCT04338529
What you commit to
- Study type: Observational
- Participants enrolled: 92
- From Apr 2020 to the primary completion date, Sept 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
Who the study is looking for
- osteopenic postmenopausal Caucasian women following Dmab treatment ii) assignment to treatment with alendronate in an effervescent tablet formulation following Dmab discontinuation
Age in the registry: - to 90 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| 251 Hellenic Air Force & VA General Hospital Coordinator of this site? Confirm its status | Athens | Greece | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.