NCT05325515

The Effect of Effervescent Alendronate on Bone Turnover

The Effect of Effervescent and Buffered Alendronate on Bone Turnover Compared to Conventional Alendronate: A Randomized Non-inferiority Study

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Aarhus University Hospital · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

Summary

64 postmenopausal women are randomized to treatment with either effervescent and buffered alendronate or conventional alendronate -both 70mg weekly for 16 weeks to see if bone turnover is suppressed to the same extent as in the conventional formulation with the effervescent form.

Detailed description

Alendronate is mainstay in the treatment of osteoporosis but is often discontinued due to gastro-intestinal side-effects. These side effects are believed to be caused by a low gastric pH induced by the drug. Effervescent and buffered alendronate is a new formulation that increases gastric pH and thereby decreases risk of side effects but the clinical effect of the drug is not fully elucidated. In the present study 64 postmenopausal women with a bone mineral density T-score \< -1 are randomized 1:1 to open label treatment with effervescent and buffered alendronate or conventional alendronate 70 mg weekly for 16 weeks. The primary end-point is change in the bone resorption marker "carboxy-terminal collagen crosslinks" from baseline to 16 weeks. The decrease in the two groups is compared using non-inferiority statistics. Secondary end-points include change in the bone formation marker "propeptide of type 1 procollagen", rate of change in the two bone markers and occurence of side effects.

Conditions

• Osteopenia or Osteoporosis

Interventions

Type	Name	Description
DRUG	Conventional alendronate	Conventional alendronate 70mg weekly
DRUG	Effervescent and buffered alendronate	Effervescent and buffered alendronate 70mg weekly

Timeline

• Start date: 2021-10-01
• Primary completion: 2022-09-01
• Completion: 2022-12-01
• First posted: 2022-04-13
• Last updated: 2023-02-08

Locations

1 site across 1 country: Denmark