NCT00271713

Impact of Oral Ibandronate 150 mg Monthly on Structural Properties of Bone in Postmenopausal Osteoporosis (SPIMOS-3D)

Randomized Double-Blind Placebo-Controlled and Parallel Group Study to Evaluate the Impact of One Year Therapy With Monthly Oral Ibandronate 150 mg on Structural Properties of Bone in Postmenopausal Osteoporosis Without Vertebral Fractures

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Charite University, Berlin, Germany · Academic / Other
• Sex: Female
• Age: 60 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Efficacy: To investigate changes of structural bone properties in vivo using 3DpQCT ("Xtreme" CT, Scanco) in monthly oral ibandronate therapy for women with postmenopausal osteoporosis. Major structural bone parameters which determine bone strength and predict fracture risk earlier and more precisely are measurable in vivo by 3DpQCT. Safety: To assess the tolerability and safety of ibandronate therapy

Conditions

• Osteoporosis, Postmenopausal

Interventions

Type	Name	Description
DRUG	ibandronate, calcium and vitamin D	1: 150 mg ibandronate monthly plus 500mg calcium and 800 UI vitamin D daily or
DRUG	placebo,calcium and vitamin D	2: placebo monthly plus 500mg calcium and 800 UI vitamin D daily

Timeline

• Start date: 2006-03-01
• Primary completion: 2007-09-01
• Completion: 2007-09-01
• First posted: 2006-01-04
• Last updated: 2009-01-28

Locations

1 site across 1 country: Germany