36-month Special Drug Use Surveillance on Frequency of Bone Fractures With Sodium Risedronate 75 mg Tablets

36-month Special Drug Use Surveillance on Frequency of Bone Fractures With Benet 75 mg Tablets

The purpose of this survey is to evaluate the effectiveness (endpoints: frequency of bone fractures, percent change in bone density, etc.) and safety of administration of sodium risedronate tablets 75 mg for 36 months in osteoporosis patients in daily medical practice.

Study Overview

• Status: Completed
• Conditions: Osteoporosis
• Intervention / Treatment: Drug: Sodium risedronate

Detailed Description

This special drug use surveillance was designed to evaluate the effectiveness (endpoints: frequency of bone fractures, percent change from baseline in bone density, etc.) and safety of sodium risedronate 75 mg tablets in osteoporosis patients in daily medical practice.

The usual dosage for adult is 75 mg of sodium risedronate administered orally with a sufficient volume (approximately 180 mL) of water once monthly after waking.

• Study Type: Observational
• Enrollment (Actual): 579

Contacts and Locations

Study Locations

• Japan
  • Osaka, Japan
  • Tokyo, Japan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Osteoporosis

Description

Inclusion Criteria:

Osteoporosis patients who meet all the following criteria:

1. Patients with 1 to 4 confirmed vertebral body fractures in the T4-L4 region by thoracic and lumbar spine X-ray examination at screening (within 3 months before the start of administration of sodium risedronate 75 mg tablets)
2. Male and postmenopausal female patients aged 50 years or older
3. Ambulatory outpatients

Exclusion Criteria:

-

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Sodium Risedronate 75 mg; 75 mg of sodium risedronate is administered orally with a sufficient volume (approximately 180 mL) of water once monthly after waking. Participants receive sodium risedronate 75 mg as part of routine medical care.	Drug: Sodium risedronate; Sodium risedronate tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cumulative Percentage of Participants With New or Worsening Vertebral Body Fractures	The cumulative data was collected between baseline and Month 36, and reported for the following time points: baseline, Months 6, 12, 18, 24, 30, and 36.	From baseline up to Month 36

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cumulative Percentage of Participants With Non-Vertebral Body Fractures	The cumulative data was collected between baseline and Month 36, and reported for the following time points: baseline, Months 6, 12, 18, 24, 30, and 36.	From baseline up to Month 36
Cumulative Percentage of Participants With Femur Fractures	The cumulative data was collected between baseline and Month 36, and reported for the following time points: baseline, Months 6, 12, 18, 24, 30, and 36.	From baseline up to Month 36
Percent Change From Baseline in Mean Lumbar Spine (L2-L4) Bone Mineral Density (BMD) at Final Assessment (up to Month 36)	BMD was measured by dual-energy X-ray absorptiometry.	Baseline and final assessment (up to Month 36)
Percent Change From Baseline in Femur Neck BMD at Final Assessment (up to Month 36)	BMD was measured by dual-energy X-ray absorptiometry.	Baseline and final assessment (up to Month 36)
Percent Change From Baseline in Total Proximal Femur BMD at Final Assessment (up to Month 36)	BMD was measured by dual-energy X-ray absorptiometry.	Baseline and final assessment (up to Month 36)
Percent Change From Baseline in Radius BMD at Final Assessment (up to Month 36)	BMD was measured by dual-energy X-ray absorptiometry.	Baseline and final assessment (up to Month 36)
Percent Change From Baseline in Bone Metabolism Markers Serum Type 1 Collagen Cross-linked N-telopeptide (NTX) at Final Assessment (up to Month 36)		Baseline and final assessment (up to Month 36)
Percent Change From Baseline in Bone Metabolism Markers Serum Tartrate-resistant Acid Phosphatase 5b (TRACP-5b) at Final Assessment (up to Month 36)		Baseline and final assessment (up to Month 36)
Percent Change From Baseline in Bone Metabolism Markers Serum Bone-type Alkaline Phosphatase (BAP) at Final Assessment (up to Month 36)		Baseline and final assessment (up to Month 36)
Percent Change From Baseline in Bone Metabolism Markers Serum Procollagen 1 N-terminal Peptide (P1NP) at Final Assessment (up to Month 36)		Baseline and final assessment (up to Month 36)
Percent Change From Baseline in Bone Metabolism Markers Urinary Type 1 Collagen Cross-linked N-telopeptide (NTX) at Final Assessment (up to Month 36)		Baseline and final assessment (up to Month 36)
Change From Baseline in Height at Final Assessment (up to Month 36)		Baseline and final assessment (up to Month 36)
Number of Participants Who Had Lumbar Backache at Final Assessment (up to Month 36)		Final assessment (up to Month 36)
Number of Participants Who Had One or More Adverse Drug Reactions	Adverse drug reaction refers to adverse events related to the administered drug.	Up to Month 36

Collaborators and Investigators

• Sponsor: Takeda

Study record dates

Study Major Dates

• Study Start (Actual): May 13, 2013
• Primary Completion (Actual): April 30, 2018
• Study Completion (Actual): April 30, 2018

Study Registration Dates

• First Submitted: April 3, 2014
• First Submitted That Met QC Criteria: April 3, 2014
• First Posted (Estimate): April 8, 2014

Study Record Updates

• Last Update Posted (Actual): July 30, 2019
• Last Update Submitted That Met QC Criteria: July 18, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: Pharmacological therapy
• Additional Relevant MeSH Terms: Metabolic Diseases; Wounds and Injuries; Musculoskeletal Diseases; Bone Diseases; Bone Diseases, Metabolic; Fractures, Bone; Osteoporosis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Membrane Transport Modulators; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Risedronic Acid
• Other Study ID Numbers: 178-002; JapicCTI-142479 (Registry Identifier: JapicCTI)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Takeda makes patient-level, de-identified data sets and associated documents available for all interventional studies after applicable marketing approvals and commercial availability have been received (or program is completely terminated), an opportunity for the primary publication of the research and final report development has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No