Special Drug Use Surveillance on Long-term Use of Sodium Risedronate Tablets (Benet 75 mg Tablets) (12-month Treatment Survey)

NCT02089997 | Completed Results

• 3 other identifiers: 178-001JapicCTI-142463JapicCTI-R171017
• Study Type: observational
• Target: 3,304
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of sodium risedronate tablets (Benet 75 mg Tablets) in osteoporosis patients in daily medical practice, as well as to examine "the status of treatment compliance" - i.e., whether sodium risedronate tablets are taken properly in accordance with the prescribed once-monthly regimen

Conditions

Osteoporosis

Keywords

Pharmacological therapy

Outcome Measures

Primary Outcomes (1)

• Number of Participants Who Experience at Least One Adverse Drug Reactions (ADRs)

  Adverse drug reactions are defined as adverse events (AEs) which are in the investigator's opinion of causal relationship to the study treatment. AEs are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with administration of sodium risedronate, whether or not it was considered related to the treatment.

  Up to Month 12

Secondary Outcomes (11)

• Percent Change From Baseline in Mean Lumbar Spine (L2-L4) Bone Mineral Density (BMD) at Final Assessment

  Baseline and final assessment (up to Month 12)

• Percent Change From Baseline in Femur (Neck Region) BMD at Final Assessment

  Baseline and final assessment (up to Month 12)

• Percent Change From Baseline in Femur (Total Proximal Femur) BMD at Final Assessment

  Baseline and final assessment (up to Month 12)

• Percent Change From Baseline in Radius BMD at Final Assessment

  Baseline and final assessment (up to Month 12)

• Percent Change From Baseline in Bone Metabolism Markers Serum Type 1 Collagen Cross-linked N-telopeptide (NTX) at Final Assessment

  Baseline and final assessment (up to Month 12)

Study Arms (1)

75 mg of sodium risedronate

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

Drug: Sodium Risedronate

Interventions

Sodium Risedronate DRUG

Sodium risedronate tablets

Also known as: Benet 75mg Tablets

75 mg of sodium risedronate

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Osteoporosis

You may qualify if:

• Osteoporosis patients

You may not qualify if:

• None

Sponsors & Collaborators

• Takeda: lead

Study Sites (2)

Unknown Facility

Osaka, Japan

Location

Unknown Facility

Tokyo, Japan

Location

MeSH Terms

Conditions

Osteoporosis

Interventions

Risedronic Acid

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Medical Director
• Organization: Takeda

trialdisclosures@takeda.com

+1-877-825-3327

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2014
• First Posted: March 18, 2014
• Study Start: May 27, 2013
• Primary Completion: April 30, 2016
• Study Completion: April 30, 2016
• Last Updated: October 19, 2018
• Results First Posted: October 19, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

JP (2)