NCT05902078

Eldecalcitol and Calcitriol in Postmenopausal Women With Low Bone Mineral Density or Mild Osteoporosis

Comparison of the Efficacy and Safety With Eldecalcitol and Calcitriol in Postmenopausal Women With Low Bone Mineral Density or Mild Osteoporosis

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Shanghai Jiao Tong University Affiliated Sixth People's Hospital · Academic / Other
• Sex: Female
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

To investigate the efficacy and safety of eldecalcitol in postmenopausal women with low bone mineral density (BMD) or mild osteoporosis through a randomized, open-label, parallel controlled trial with calcitriol as the control.

Detailed description

Postmenopausal women with low bone mineral density (BMD) or mild osteoporosis will be randomized in a 1:1 ratio to receive open-label oral 0.75μg eldecalcit daily or open-label oral 0.5μg calcitriol daily for 12 months.

Conditions

• Low Bone Mineral Density
• Postmenopausal Osteoporosis

Interventions

Type	Name	Description
DRUG	Eldecalcitol capsules	Oral eldecalcitol 0.75μg daily
DRUG	Calcitriol capsules	Oral calcitriol 0.5μg daily

Timeline

• Start date: 2023-09-27
• Primary completion: 2025-06-01
• Completion: 2025-12-01
• First posted: 2023-06-13
• Last updated: 2024-05-16

Locations

21 sites across 1 country: China