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Effervescent and Buffered Alendronate vs Conventional Alendronate in Postmenopausal Women
NCT05325515Phase 4
Key facts
- Status
- Completed
- Start
- Oct 2021
- Primary completion
- Sep 2022
- Countries
- 1
- Sponsor
- Aarhus University Hospital
- Modality
- Small Molecules
- Drugs
- alendronate
- Conditions
- osteopeniaosteoporosis
01
Overview
Phase 4, randomised, open-label trial of alendronate in osteopenia and osteoporosis (2 arms), sponsored by Aarhus University Hospital. Primary endpoint: Carboxy-terminal collagen crosslinks at 16 weeks. Started Oct 2021; status: completed.
02
Design
2 arms- Study design
- RandomizedOpen-label
Fosamax (conventional alendronate)
Conventional alendronate 70mg weekly for 16 weeks
Binosto (effervescent and buffered alendronate)
Effervescent and buffered alendronate 70mg weekly for 16 weeks
03
Who it enrols
Postmenopausal women (2 years since last menstrual bleeding) with a bone mineral density T-score < -1 at either lumbar spine or hip, CTx > 0.42 µg/L, and no prior treatment for osteoporosis.
04
Endpoints
Primary
Carboxy-terminal collagen crosslinks
Secondary
Propeptide of type 1 procollagen
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