NCT00092053

Study of Investigational Drug in Osteoporosis (MK-0217-908)

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Persistence of the Effect of Oral Monthly Ibandronate on Bone Reception in Postmenopausal Women in Osteoporosis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 203 (actual)
• Sponsor: Organon and Co · Industry
• Sex: Female
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy and safety of an investigational drug in postmenopausal women with osteoporosis. The primary hypothesis of this study is that in postmenopausal women with osteoporosis, oral monthly ibandronate, at doses of 100 mg and 150 mg, does not achieve persistence in reduction of bone resorption throughout the monthly dosing interval, as demonstrated by a larger change in the serum carboxyterminal crosslinked telopeptide of Type I collagen (CTX-I) log-transformed fraction from baseline four weeks post dose compared to one week post dose, during the third month of treatment, in the participants taking ibandronate than in the participants taking placebo.

Conditions

• Postmenopausal Osteoporosis

Interventions

Type	Name	Description
DRUG	Placebo	tablets
DRUG	ibandronate	50 mg tablets

Timeline

• Start date: 2004-12-01
• Primary completion: 2005-07-01
• Completion: 2005-07-01
• First posted: 2004-09-24
• Last updated: 2022-02-02