NCT00692913

A Study to Test the Effect of MK0217A on Vitamin D Inadequacy in Postmenopausal Women With Osteoporosis (0217A-262)

A Phase III (Phase V Program), Open-Label, Randomized, Referred-Care-Controlled, Clinical Trial to Evaluate the Efficacy and Safety of MK -0217A/Alendronate Sodium-70 mg/Vitamin D3 5600 I.U. Combination Tablet on Vitamin D Inadequacy in the Treatment of Osteoporosis in Postmenopausal Women

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 515 (actual)
• Sponsor: Organon and Co · Industry
• Sex: Female
• Age: 65 Years
• Healthy volunteers: Not accepted

Summary

A study designed to see if the study drug will increase blood levels of vitamin D, bone mineral density (BMD), improve biochemical markers of bone turnover, and reduce the number of falls as compared to women receiving standard care for osteoporosis.

Conditions

• Osteoporosis

Interventions

Type	Name	Description
DRUG	FOSAVANCE 5600 (Alendronate Sodium (+) cholecalciferol)	FOSAVANCE 5600 international units (IU)(Alendronate Sodium 70 mg/Vitamin D 5600 IU) combination tablet once weekly for 6 months (Week 26) during the base period and an additional 6-month extension period (Week 52).
DIETARY_SUPPLEMENT	Calcium Supplement 500 mg	Calcium supplied locally by the investigator (containing 500 mg calcium supplement) daily for 52 weeks (unless the patient's dietary intake of calcium exceeds 1000 mg per day).
OTHER	Referred-Care Model	Usual treatment for osteoporosis chosen and prescribed by patients' own physicians for 6 months (Week 26) during the base period and an additional 6-month extension period (Week 52).

Timeline

• Start date: 2008-06-01
• Primary completion: 2010-07-01
• Completion: 2010-07-01
• First posted: 2008-06-06
• Last updated: 2024-05-09
• Results posted: 2011-08-15