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

NCT00271713 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2009-01-28

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Charite University, Berlin, Germany

    lead OTHER

Principal Investigators

  • Dieter Felsenberg, Prof. Dr. · Centre for Muscle and Bone Research, Charité - Campus Benjamin Franklin, Berlin, 12200, Germany

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-03-31
Primary Completion
2007-09-30
Completion
2007-09-30

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00271713 on ClinicalTrials.gov