Skip to main content
OpenTrials
Completed

NCT Number: NCT00447915

Phase II/III Clinical Study of R484iv (Ibandronic Acid) for Primary Osteoporosis

To evaluate the efficacy and safety of R484iv by intravenous intermittent administration to patients with primary osteoporosis in comparison with sodium risedronate hydrate (RIS) by oral administration every day. To evaluate also the dose response of R484iv.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Primary Osteoporosis

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Chubu/Kansai region, Chubu/Kansai, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with fragile bone fracture
  • Patients in whom either of study site analysis value of bone density of lumbar spine, proximal part of femur or neck of femur is less than 80% of young adult mean (YAM).
  • Patients with 1 - 5 bone fractures in 4th thoracic spine (Th4) - 4th lumbar spine (L4)
  • Ambulatory

Exclusion criteria

  • Patients with disease lowering bone volume secondarily (secondary osteoporosis)
  • Patients receiving at least one time of of oral bisphosphonate preparations within 6 months before the start of administration of the study drug
  • Patient with disorder delaying the passage of food through esophagus

Treatment and study plan

ibandronic acid 0.5mg

Drug

0.5mg(i.v.)/month for 35 months

RIS placebo

Drug

0 mg(p.o.)/day for 36 months

1.0mg ibandronic acid

Drug

1.0mg(i.v.)/month for 35 months

ibandronic acid placebo

Drug

0mg(i.v.)/month for 35 months

2.5mg RIS

Drug

2.5 mg(p.o.)/day for 36 months

Calcium and Vitamine D3

Dietary Supplement

Calcium 305 mg and Vitamine D3 200IU(p.o.)/day for 36 months

Primary outcomes

  1. Incidence of vertebral fracture

    Time frame: 36 months

Secondary outcomes

  1. Change of bone density of lumbar spine and proximal part of femur from baseline

    Time frame: 36 months

  2. Change of bone absorption marker from baseline

    Time frame: 36 months

  3. Change of bone formation marker from baseline

    Time frame: 36 months

Sponsors and collaborators

Lead sponsor

Chugai Pharmaceutical

Industry

Registry information

Official study title

Phase II/III Clinical Study of R484iv (Ibandronic Acid) for Primary Osteoporosis - Comparative Study With Sodium Risedronate Hydrate(RIS) With Vertebral Fracture as an Index -

Important dates

Study start
2007
Primary completion
2011
Study completion
2011
First posted
Mar 15, 2007
Registry last updated
Aug 2, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.