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

Completed

• Conditions: Osteoporosis
• Interventions: Drug: Sodium risedronate

• Registration Number: NCT02106442
• Lead Sponsor: Takeda

Brief 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.

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 Timeline

• Study Start: 2013-05-13
• Study First Submitted: 2014-04-03
• Study First Submitted QC: 2014-04-03
• Study First Posted: 2014-04-08
• Primary Completion: 2018-04-30
• Study Completion: 2018-04-30
• Results First Submitted: 2019-04-23
• Results First Submitted QC: 2019-04-23
• Status Verified: 2019-07
• Results First Posted: 2019-07-17
• Last Update Submitted: 2019-07-18
• Last Update Posted: 2019-07-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 579

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

Read More

Exclusion Criteria

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Sodium Risedronate 75 mg	Sodium risedronate	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.

Primary Outcome Measures

Name	Time	Method
Cumulative Percentage of Participants With New or Worsening Vertebral Body Fractures	From baseline up to Month 36	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.

Secondary Outcome Measures

Name	Time	Method
Cumulative Percentage of Participants With Non-Vertebral Body Fractures	From baseline up to Month 36	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.
Cumulative Percentage of Participants With Femur Fractures	From baseline up to Month 36	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.
Percent Change From Baseline in Mean Lumbar Spine (L2-L4) Bone Mineral Density (BMD) at Final Assessment (up to Month 36)	Baseline and final assessment (up to Month 36)	BMD was measured by dual-energy X-ray absorptiometry.
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 Femur Neck BMD at Final Assessment (up to Month 36)	Baseline and final assessment (up to Month 36)	BMD was measured by dual-energy X-ray absorptiometry.
Percent Change From Baseline in Total Proximal Femur BMD at Final Assessment (up to Month 36)	Baseline and final assessment (up to Month 36)	BMD was measured by dual-energy X-ray absorptiometry.
Percent Change From Baseline in Radius BMD at Final Assessment (up to Month 36)	Baseline and final assessment (up to Month 36)	BMD was measured by dual-energy X-ray absorptiometry.
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	Up to Month 36	Adverse drug reaction refers to adverse events related to the administered drug.
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)