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

Osteoporosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02106442
• Other study ID #: 178-002
• Secondary ID: JapicCTI-142479
• Status: Completed
• Start date: May 13, 2013
• Est. completion date: April 30, 2018

Study information

• Verified date: July 2019
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 579
• Est. completion date: April 30, 2018
• Est. primary completion date: April 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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:

-

Related Conditions & MeSH terms

• Fractures, Bone
• Osteoporosis

Intervention

Drug:
• Sodium risedronate
Sodium risedronate tablets

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Takeda

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	Change From Baseline in Height at Final Assessment (up to Month 36)		Baseline and final assessment (up to Month 36)
Secondary	Number of Participants Who Had Lumbar Backache at Final Assessment (up to Month 36)		Final assessment (up to Month 36)
Secondary	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