NCT01350934

A Study to Evaluate Alendronate Sodium /Vitamin D3 Combination Tablets(FOSAMAX PLUS) Versus Calcitriol in the Treatment of Osteoporosis in Postmenopausal Women in China (MK-0217A-264)

A 6-Month, Randomized, Open-Label, Active-Comparator Controlled, Parallel-Group Study With a 6-Month Extension to Evaluate the Safety and Efficacy of Alendronate Sodium 70 mg/Vitamin D3 5600 I.U. Combination Tablets Versus Calcitriol in the Treatment of Osteoporosis in Postmenopausal Women in China

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 219 (actual)
• Sponsor: Organon and Co · Industry
• Sex: Female
• Age: 56 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate whether the once weekly administration of the combination tablet alendronate/vitamin D3 (FOSAMAX PLUS) will increase lumbar spine bone mineral density (BMD) more than the daily use of calcitriol.

Detailed description

This was a 6-month, randomized, open-label, active-comparator controlled, parallel-group study with a 6-month extension to evaluate the safety and efficacy of alendronate sodium 70 mg plus vitamin D3 5600 IU combination tablets versus calcitriol in the treatment of osteoporosis in postmenopausal women in China. Participants were randomly assigned to receive alendronate 70 mg plus vitamin D3 5600 IU combination tablet once weekly orally or calcitriol 0.25 μg daily orally.

Conditions

• Osteoporosis, Postmenopausal

Interventions

Type	Name	Description
DRUG	alendronate 70-mg/vitamin D3 5600 IU combination tablet (Fosamax Plus)	one combination tablet once weekly
DRUG	Calcitriol	0.25 μg once daily orally
DIETARY_SUPPLEMENT	Calcium 500 mg	one 500 mg tablet once daily

Timeline

• Start date: 2011-06-19
• Primary completion: 2013-01-10
• Completion: 2013-01-10
• First posted: 2011-05-10
• Last updated: 2024-06-20
• Results posted: 2014-07-22