Clinical trial NCT02106442: 36-month Special Drug Use Surveillance on Frequency of Bone Fractures With Sodium Risedronate 75 mg Tablets
Official title: 36-month Special Drug Use Surveillance on Frequency of Bone Fractures With Benet 75 mg Tablets
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoporosis
Keywords: Pharmacological therapy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2014-04-08
Enrollment: 579
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Osteoporosis

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.

Eligibility 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:

-

Primary outcomes:
measure: Cumulative Percentage of Participants With New or Worsening Vertebral Body Fractures
timeFrame: From baseline up to Month 36
Secondary outcomes:
measure: Cumulative Percentage of Participants With Non-Vertebral Body Fractures
timeFrame: From baseline up to Month 36
measure: Cumulative Percentage of Participants With Femur Fractures
timeFrame: From baseline up to Month 36
measure: 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)
measure: Percent Change From Baseline in Femur Neck BMD at Final Assessment (up to Month 36)
timeFrame: Baseline and final assessment (up to Month 36)
measure: 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)
measure: Percent Change From Baseline in Radius BMD at Final Assessment (up to Month 36)
timeFrame: Baseline and final assessment (up to Month 36)
measure: 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)
measure: 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)
measure: 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)
measure: 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)
measure: Percent Change From Baseline in Bone Metabolism Markers Urinary Type 1 Collagen Cross-linked N-telopeptide (NTX) at Final Assessment (up to Month 36)
timeFrame: Baseline and final assessment (up to Month 36)
measure: Change From Baseline in Height at Final Assessment (up to Month 36)
timeFrame: Baseline and final assessment (up to Month 36)
measure: Number of Participants Who Had Lumbar Backache at Final Assessment (up to Month 36)
timeFrame: Final assessment (up to Month 36)
measure: Number of Participants Who Had One or More Adverse Drug Reactions
timeFrame: Up to Month 36
Other outcomes:
Locations:
city: Osaka
country: Japan
city: Tokyo
country: Japan
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References: