Controlled Study of ONO-5920 in Patients With Involutional Osteoporosis in Japan

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ono Pharmaceutical Co. Ltd
ClinicalTrials.gov Identifier:
NCT00212719
First received: September 13, 2005
Last updated: October 10, 2012
Last verified: October 2012

September 13, 2005
October 10, 2012
May 2003
April 2006   (final data collection date for primary outcome measure)
Mean bone mineral density of the lumbar spine (L2-4 BMD)
Same as current
Complete list of historical versions of study NCT00212719 on ClinicalTrials.gov Archive Site
Bone mineral density at femur, fragility fractures, biochemical markers of bone turnover, lower back pain
Same as current
Not Provided
Not Provided
 
Controlled Study of ONO-5920 in Patients With Involutional Osteoporosis in Japan
Controlled Study of ONO-5920 in Patients With Involutional Osteoporosis in Japan

The purpose of this study is to evaluate the efficacy and safety of ONO-5920 in patients with involutional osteoporosis.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Involutional Osteoporosis
Drug: ONO-5920
Not Provided
Hagino H, Nishizawa Y, Sone T, Morii H, Taketani Y, Nakamura T, Itabashi A, Mizunuma H, Ohashi Y, Shiraki M, Minamide T, Matsumoto T. A double-blinded head-to-head trial of minodronate and alendronate in women with postmenopausal osteoporosis. Bone. 2009 Jun;44(6):1078-84. Epub 2009 Mar 2.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
250
Not Provided
April 2006   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. A diagnosis in accordance with Criteria for the Diagnosis of Primary Osteoporosis.
  2. Other inclusion criteria as specified in the study protocol.

Exclusion Criteria:

  1. Patients having secondary osteoporosis or another condition that presents low bone mass.
  2. Patients having findings that affect measurement of lumbar spinal bone mineral density by DXA
  3. Patients that have been administered bisphosphonate derivatives.
  4. Other exclusion criteria as specified in the study protocol.
Female
45 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00212719
ONO-5920-03
Not Provided
Ono Pharmaceutical Co. Ltd
Ono Pharmaceutical Co. Ltd
Not Provided
Study Director: Project Leader, ` Development Planning Ono Pharmaceutical Co. Ltd
Ono Pharmaceutical Co. Ltd
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP