NCT00447915 is a Phase 3 clinical trial of ibandronic acid 0.5mg in Primary Osteoporosis, sponsored by Chugai Pharmaceutical.

Who is sponsoring NCT00447915?

NCT00447915 is sponsored by Chugai Pharmaceutical.

What drugs are being tested in NCT00447915?

Interventions in NCT00447915: ibandronic acid 0.5mg, RIS placebo, 1.0mg ibandronic acid, ibandronic acid placebo, 2.5mg RIS, Calcium and Vitamine D3.

What condition does NCT00447915 study?

NCT00447915 studies Primary Osteoporosis.

Is NCT00447915 still recruiting?

NCT00447915 is currently completed. Last updated 31 July 2012.

Last reviewed 2012-07-31 · How we verify

NCT00447915

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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 -

Completed Phase 3 Last updated 31 July 2012

What this trial tests

Phase 3 trial testing ibandronic acid 0.5mg in Primary Osteoporosis in 1,265 participants. Completed in 1 December 2011.

Timeline

1 March 2007

Primary endpoint
1 August 2011

1 December 2011

Quick facts

Lead sponsor	Chugai Pharmaceutical
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	1,265
Start date	1 March 2007
Primary completion	1 August 2011
Estimated completion	1 December 2011
Sites	4 locations across Japan

Drugs / interventions tested

ibandronic acid 0.5mg — full drug profile →
RIS placebo — full drug profile →
1.0mg ibandronic acid — full drug profile →
ibandronic acid placebo — full drug profile →
2.5mg RIS — full drug profile →
Calcium and Vitamine D3

Conditions studied

Primary Osteoporosis — all drugs for Primary Osteoporosis →

Sponsor

Chugai Pharmaceutical — full company profile →

Who can join

60 and older, any sex, with Primary Osteoporosis. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Incidence of vertebral fracture
Time frame: 36 months

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Clinical efficacy on fracture risk and safety of 0.5 mg or 1 mg/month intravenous ibandronate versus 2.5 mg/day oral risedronate in patients with primary osteoporosis.
Nakamura T, Nakano T, Ito M, Hagino H, et al · · 2013 · cited 45× · PMID 23644930 · DOI 10.1007/s00223-013-9734-6

Verify or expand the search:

Other recruiting trials for Primary Osteoporosis

Currently open trials in the same condition.

NCT07296471 — Vitamin D Status and Multi-Omics Profiles in Primary Osteoporosis · recruiting
NCT07506538 — Community Smart Aging Model - Resistance Training · NA · active not recruiting

Other Chugai Pharmaceutical trials

Trials by the same sponsor.

NCT07239336 — Study of DONQ52 in Active Celiac Disease · Phase 2 · recruiting
NCT07107490 — A PHASE I STUDY OF ALPS12 IN PATIENTS WITH EXTENSIVE STAGE SMALL CELL LUNG CANCER · Phase 1 · recruiting
NCT07030959 — Study of AUBE00 in Patients With Solid Tumors · Phase 1 · recruiting
NCT06723106 — Phase 1b Long-term Extension Trial of RAY121 in Immunological Diseases (RAINBOW-LTE Trial) · Phase 1 · enrolling by invitation
NCT06371417 — Phase 1b Trial of RAY121 in Immunological Diseases (RAINBOW Trial) · Phase 1 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00447915 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Chugai Pharmaceutical
Last refreshed: 31 July 2012

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00447915.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing