Sodium Risedronate Tablets - Special Drug Use Surveillance in Patients With Osseous Paget's Disease (All-case Surveillance) -48-week Surveillance -

NCT02106455 | Completed Results

• 2 other identifiers: 067-211JapicCTI-142480
• Study Type: observational
• Target: 315
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of sodium risedronate tablets administered once daily (one tablet per dose) in patients with osseous Paget's disease for 48 weeks from baseline in daily medical practice.

Conditions

Osseous Paget's Disease

Keywords

Pharmacological theapy

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Who Had One or More Adverse Drug Reactions

  Adverse drug reaction refers to adverse events related to administered drug.

  Up to 48 weeks

Secondary Outcomes (10)

• Percentage of Changes From Baseline in Excess Serum Alkaline Phosphatase (ALP) Level at Final Assessment Point

  Baseline and final assessment point (Up to 48 weeks)

• Percentage of Changes From Baseline in Serum ALP Level at Final Assessment Point

  Baseline and final assessment point (Up to 48 weeks)

• Number of Participants Stratified by Comparison of Pain Scale Associated With Osseous Paget's Disease Between Baseline and Final Assessment Point

  Baseline and final assessment point (Up to 48 weeks)

• Number of Participants Stratified by Assessment of Image Findings of Bone Morphogenic Abnormalities at Final Assessment Point Compared With Baseline

  Baseline and final assessment point (Up to 48 weeks)

• Number of Participants Stratified by Assessment of Image Findings of Trabecular Bone Structural Abnormalities at Final Assessment Point Compared With Baseline

  Baseline and final assessment point (Up to 48 weeks)

Study Arms (1)

17.5 mg of sodium risedronate

17.5 mg of sodium risedronate is administered orally with a sufficient volume (approximately 180 mL) of water once daily after waking for 8 consecutive weeks.

Drug: Sodium risedronate

Interventions

Sodium risedronate DRUG

Sodium risedronate tablets

Also known as: Benet 17.5mg Tablets, Actonel 17.5mg Tablets

17.5 mg of sodium risedronate

Eligibility Criteria

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

Study Population

Osseous Paget's disease

You may qualify if:

• Osseous Paget's disease patients treated with sodium risedronate tablets 17.5 mg

Sponsors & Collaborators

• Takeda: lead

Study Sites (2)

Unknown Facility

Osaka, Japan

Location

Unknown Facility

Tokyo, Japan

Location

MeSH Terms

Conditions

Osteitis Deformans

Interventions

Risedronic Acid

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal 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: April 3, 2014
• First Posted: April 8, 2014
• Study Start: August 1, 2008
• Primary Completion: October 24, 2017
• Study Completion: October 24, 2017
• Last Updated: June 3, 2019
• Results First Posted: June 3, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

JP (2)