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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-jRCT1080222429

Enrollment

579

Registered

2014-03-18

Start date

2013-05-13

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoporosis

Interventions

investigational material(s) Generic name etc : Sodium risedronate 75 mg INN of investigational material : Risedronic acid Therapeutic category code : 399 Agents affecting metabolism, n.e.c. Dosage and

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria: -

Design outcomes

Primary

Measure	Time frame
efficacy Cumulative Percentage of Participants with New or Worsening Vertebral Body Fractures Timeframe: From baseline up to Month 36	—

Secondary

Measure	Time frame
efficacy Cumulative Percentage of Participants with Non-Vertebral Body Fractures Timeframe: From baseline up to Month 36 efficacy Cumulative Percentage of Participants with Femur Fractures Timeframe: From baseline up to Month 36 efficacy Percent Change from Baseline in Mean Lumbar Spine (L2-L4) Bone Mineral Density (BMD) at Final Assessment (up to Month 36) Timeframe: Baseline and final assessment (up to Month 36) BMD was measured by Dual-energy X-ray Absorptiometry. efficacy Percent Change from Baseline in Femur Neck BMD at Final Assessment (up to Month 36) Timeframe: Baseline and final assessment (up to Month 36) BMD was measured by Dual-energy X-ray Absorptiometry. efficacy Percent Change from Baseline in Total Proximal Femur BMD at Final Assessment (up to Month 36) Timeframe: Baseline and final assessment (up to Month 36) BMD was measured by Dual-energy X-ray Absorptiometry. efficacy Percent Change from Baseline in Radius BMD at Final Assessment (up to Month 36) Timeframe: Baseline and final assessment (up to Month 36) BMD was measured by Dual-energy X-ray Absorptiometry. efficacy Percent Change from Baseline in Bone Metabolism Markers Serum Type 1 Collagen Cross-linked N-telopeptide (NTX) at Final Assessment (up to Month 36) Timeframe: Baseline and final assessment (up to Month 36) efficacy Percent Change from Baseline in Bone Metabolism Markers Serum Tartrate-resistant Acid Phosphatase 5b (TRACP-5b) at Final Assessment (up to Month 36) Timeframe: Baseline and final assessment (up to Month 36) efficacy Percent Change from Baseline in Bone Metabolism Markers Serum Bone-type Alkaline Phosphatase (BAP) at Final Assessment (up to Month 36) Timeframe: Baseline and final assessment (up to Month 36) efficacy Percent Change from Baseline in Bone Metabolism Markers Serum Procollagen 1 N-terminal Peptide (P1NP) at Final Assessment (up to Month 36) Timeframe: Baseline and final assessment (up to Month 36) efficacy Percent Change from Baseline in Bone Metabolism Markers Ur	—

Measure

Time frame

efficacy Cumulative Percentage of Participants with Non-Vertebral Body Fractures Timeframe: From baseline up to Month 36 efficacy Cumulative Percentage of Participants with Femur Fractures Timeframe: From baseline up to Month 36 efficacy Percent Change from Baseline in Mean Lumbar Spine (L2-L4) Bone Mineral Density (BMD) at Final Assessment (up to Month 36) Timeframe: Baseline and final assessment (up to Month 36) BMD was measured by Dual-energy X-ray Absorptiometry. efficacy Percent Change from Baseline in Femur Neck BMD at Final Assessment (up to Month 36) Timeframe: Baseline and final assessment (up to Month 36) BMD was measured by Dual-energy X-ray Absorptiometry. efficacy Percent Change from Baseline in Total Proximal Femur BMD at Final Assessment (up to Month 36) Timeframe: Baseline and final assessment (up to Month 36) BMD was measured by Dual-energy X-ray Absorptiometry. efficacy Percent Change from Baseline in Radius BMD at Final Assessment (up to Month 36) Timeframe: Baseline and final assessment (up to Month 36) BMD was measured by Dual-energy X-ray Absorptiometry. efficacy Percent Change from Baseline in Bone Metabolism Markers Serum Type 1 Collagen Cross-linked N-telopeptide (NTX) at Final Assessment (up to Month 36) Timeframe: Baseline and final assessment (up to Month 36) efficacy Percent Change from Baseline in Bone Metabolism Markers Serum Tartrate-resistant Acid Phosphatase 5b (TRACP-5b) at Final Assessment (up to Month 36) Timeframe: Baseline and final assessment (up to Month 36) efficacy Percent Change from Baseline in Bone Metabolism Markers Serum Bone-type Alkaline Phosphatase (BAP) at Final Assessment (up to Month 36) Timeframe: Baseline and final assessment (up to Month 36) efficacy Percent Change from Baseline in Bone Metabolism Markers Serum Procollagen 1 N-terminal Peptide (P1NP) at Final Assessment (up to Month 36) Timeframe: Baseline and final assessment (up to Month 36) efficacy Percent Change from Baseline in Bone Metabolism Markers Ur

—

Countries

Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026