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

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: Recruiting

Sponsored by: Chugai Pharmaceutical

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

Overall contact:
Masayuki Matsunaga, Email: clinical-trials@chugai-pharm.co.jp

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.

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: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study

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

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

Masayuki Matsunaga, Email: clinical-trials@chugai-pharm.co.jp

Hokkaido/Tohoku region, Hokkaido/Tohoku, Japan; Recruiting
Masayuki Matsunaga, Email: clinical-trials@chugai-pharm.co.jp

Kanto/Koshinetsu region, Kanto/Koshinetsu, Japan; Recruiting
Masayuki Matsunaga, Email: clinical-trials@chugai-pharm.co.jp

Chubu/Kansai region, Chubu/Kansai, Japan; Recruiting
Masayuki Matsunaga, Email: clinical-trials@chugai-pharm.co.jp

Chugoku/Kyusyu region, Chugoku/Kyusyu, Japan; Recruiting
Masayuki Matsunaga, Email: clinical-trials@chugai-pharm.co.jp

Starting date: March 2007
Last updated: February 13, 2008