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Completed

NCT Number: NCT02089997

Special Drug Use Surveillance on Long-term Use of Sodium Risedronate Tablets (Benet 75 mg Tablets) (12-month Treatment Survey)

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

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Key information

Conditions

Osteoporosis Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Osaka, Japan

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Osteoporosis patients

Exclusion criteria

  • None

Treatment and study plan

Sodium risedronate

Drug

Sodium risedronate tablets

Other names: Benet 75mg Tablets

Primary outcomes

  1. Number of Participants Who Experience at Least One Adverse Drug Reactions (ADRs)

    Time frame: Up to Month 12

    Adverse drug reactions are defined as adverse events (AEs) which are in the investigator's opinion of causal relationship to the study treatment. AEs are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with administration of sodium risedronate, whether or not it was considered related to the treatment.

Secondary outcomes

  1. Percent Change From Baseline in Mean Lumbar Spine (L2-L4) Bone Mineral Density (BMD) at Final Assessment

    Time frame: Baseline and final assessment (up to Month 12)

    BMD was measured with Dual-energy X-ray Absorptiometry. Reporting data are the change in BMD in the second to the fourth lumbar vertebrae, L2 to L4, and the averages of L2 to L4 at end of study relative to baseline.

  2. Percent Change From Baseline in Femur (Neck Region) BMD at Final Assessment

    Time frame: Baseline and final assessment (up to Month 12)

    BMD was measured with Dual-energy X-ray Absorptiometry. Reporting data are the change in BMD in the femur (neck region) at end of study relative to baseline.

  3. Percent Change From Baseline in Femur (Total Proximal Femur) BMD at Final Assessment

    Time frame: Baseline and final assessment (up to Month 12)

    BMD was measured with Dual-energy X-ray Absorptiometry. Reporting data are the change in BMD in the total proximal femur (whole bone, trochanteric region, and neck region) at end of study relative to baseline.

  4. Percent Change From Baseline in Radius BMD at Final Assessment

    Time frame: Baseline and final assessment (up to Month 12)

    BMD was measured with Dual-energy X-ray Absorptiometry. Reporting data are the change in BMD in the radius at end of study relative to baseline.

  5. Percent Change From Baseline in Bone Metabolism Markers Serum Type 1 Collagen Cross-linked N-telopeptide (NTX) at Final Assessment

    Time frame: Baseline and final assessment (up to Month 12)

    Blood samples for serum bone turnover markers were collected at specified visits according to the study schedule.

  6. Percent Change From Baseline in Bone Metabolism Markers Serum Tartrate-resistant Acid Phosphatase 5b (TRACP-5b) at Final Assessment

    Time frame: Baseline and final assessment (up to Month 12)

    Blood samples for serum bone turnover markers were collected at specified visits according to the study schedule.

  7. Percent Change From Baseline in Bone Metabolism Markers Serum Bone-type Alkaline Phosphatase (BAP) at Final Assessment

    Time frame: Baseline and final assessment (up to Month 12)

    Blood samples for serum bone turnover markers were collected at specified visits according to the study schedule.

  8. Percent Change From Baseline in Bone Metabolism Markers Serum Procollagen 1 N-terminal Peptide (P1NP) at Final Assessment

    Time frame: Baseline and final assessment (up to Month 12)

    Blood samples for serum bone turnover markers were collected at specified visits according to the study schedule.

  9. Percent Change From Baseline in Bone Metabolism Markers Urinary Type 1 Collagen Cross-linked N-telopeptide (NTX) at Final Assessment

    Time frame: Baseline and final assessment (up to Month 12)

    Urine samples for urinary bone turnover markers were collected at specified visits according to the study schedule.

  10. Change From Baseline in Height

    Time frame: Baseline and final assessment (up to Month 12)

  11. Number of Participants Who Had Lumbar Backache at Final Assessment

    Time frame: Final assessment (Month 12)

Sponsors and collaborators

Lead sponsor

Takeda

Industry

Registry information

Official study title

Benet 75 mg Tablets Special Drug Use Surveillance: Long-term Use (12-month Treatment Survey)

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Mar 18, 2014
Registry last updated
Oct 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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