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

Information source: Chugai Pharmaceutical
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Primary Osteoporosis

Intervention: ibandronic acid 0.5mg (Drug); RIS placebo (Drug); 1.0mg ibandronic acid (Drug); ibandronic acid placebo (Drug); 2.5mg RIS (Drug); Calcium and Vitamine D3 (Dietary Supplement)

Phase: Phase 3

Status: Completed

Sponsored by: Chugai Pharmaceutical

Official(s) and/or principal investigator(s):
Toshitaka Nakamura, Study Chair, Affiliation: University of Occupational and Environment Health

Summary

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.

Clinical Details

Official 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 -

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Incidence of vertebral fracture

Secondary outcome:

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

Change of bone absorption marker from baseline

Change of bone formation marker from baseline

Eligibility

Minimum age: 60 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

Chubu/Kansai region, Chubu/Kansai, Japan

Chugoku/Kyusyu region, Chugoku/Kyusyu, Japan

Hokkaido/Tohoku region, Hokkaido/Tohoku, Japan

Kanto/Koshinetsu region, Kanto/Koshinetsu, Japan

Additional Information

Starting date: March 2007
Last updated: July 31, 2012

Page last updated: August 23, 2015

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