Clinical trial NCT02089997: Special Drug Use Surveillance on Long-term Use of Sodium Risedronate Tablets (Benet 75 mg Tablets) (12-month Treatment Survey)
Official title: Benet 75 mg Tablets Special Drug Use Surveillance: Long-term Use (12-month Treatment Survey)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoporosis
Keywords: Pharmacological therapy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2014-03-18
Enrollment: 3304
Sex: ALL
Standard ages: CHILD
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 study is to evaluate the safety and efficacy of sodium risedronate tablets (Benet 75 mg Tablets) in osteoporosis patients in daily medical practice, as well as to examine "the status of treatment compliance" - i.e., whether sodium risedronate tablets are taken properly in accordance with the prescribed once-monthly regimen

Detailed description: This surveillance was designed to evaluate the safety and efficacy of sodium risedronate tablets (Benet 75 mg Tablets) as well as to evaluate the status of treatment compliance 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. For at least 30 minutes after administration, patients should avoid lying in a supine position and should avoid taking food, drink (except for water) or other oral drugs. For more details, see the "Precautions related to dosage and administration" section of the package insert.

Eligibility criteria: Inclusion Criteria:

* Osteoporosis patients

Exclusion Criteria:

* None

Primary outcomes:
measure: Number of Participants Who Experience at Least One Adverse Drug Reactions (ADRs)
timeFrame: Up to Month 12
Secondary outcomes:
measure: Percent Change From Baseline in Mean Lumbar Spine (L2-L4) Bone Mineral Density (BMD) at Final Assessment
timeFrame: Baseline and final assessment (up to Month 12)
measure: Percent Change From Baseline in Femur (Neck Region) BMD at Final Assessment
timeFrame: Baseline and final assessment (up to Month 12)
measure: Percent Change From Baseline in Femur (Total Proximal Femur) BMD at Final Assessment
timeFrame: Baseline and final assessment (up to Month 12)
measure: Percent Change From Baseline in Radius BMD at Final Assessment
timeFrame: Baseline and final assessment (up to Month 12)
measure: Percent Change From Baseline in Bone Metabolism Markers Serum Type 1 Collagen Cross-linked N-telopeptide (NTX) at Final Assessment
timeFrame: Baseline and final assessment (up to Month 12)
measure: Percent Change From Baseline in Bone Metabolism Markers Serum Tartrate-resistant Acid Phosphatase 5b (TRACP-5b) at Final Assessment
timeFrame: Baseline and final assessment (up to Month 12)
measure: Percent Change From Baseline in Bone Metabolism Markers Serum Bone-type Alkaline Phosphatase (BAP) at Final Assessment
timeFrame: Baseline and final assessment (up to Month 12)
measure: Percent Change From Baseline in Bone Metabolism Markers Serum Procollagen 1 N-terminal Peptide (P1NP) at Final Assessment
timeFrame: Baseline and final assessment (up to Month 12)
measure: Percent Change From Baseline in Bone Metabolism Markers Urinary Type 1 Collagen Cross-linked N-telopeptide (NTX) at Final Assessment
timeFrame: Baseline and final assessment (up to Month 12)
measure: Change From Baseline in Height
timeFrame: Baseline and final assessment (up to Month 12)
measure: Number of Participants Who Had Lumbar Backache at Final Assessment
timeFrame: Final assessment (Month 12)
Other outcomes:
Locations:
city: Osaka
country: Japan
city: Tokyo
country: Japan
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References: