NCT02089997

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

Completed Results posted Last updated 19 October 2018

What this trial tests

trial testing Sodium Risedronate in Osteoporosis in 3,304 participants. Completed in 30 April 2016.

Timeline

27 May 2013

Primary endpoint
30 April 2016

30 April 2016

Quick facts

Lead sponsor	Takeda
Status	Completed
Study type	OBSERVATIONAL
Enrollment	3,304
Start date	27 May 2013
Primary completion	30 April 2016
Estimated completion	30 April 2016
Sites	2 locations across Japan

Drugs / interventions tested

• Sodium Risedronate

Conditions studied

• Osteoporosis — all drugs for Osteoporosis →

Sponsor

Takeda — full company profile →

Who can join

Eligibility, any sex, with Osteoporosis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

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

Group	Value	95% CI
Sodium Risedronate 75 mg	231

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

Group	Value	95% CI
Sodium Risedronate 75 mg	4.700	± 12.118

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

Group	Value	95% CI
Sodium Risedronate 75 mg	1.008	± 5.473

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

Group	Value	95% CI
Sodium Risedronate 75 mg	1.745	± 5.180

Percent Change From Baseline in Radius BMD at Final Assessment Secondary · 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.

Group	Value	95% CI
Sodium Risedronate 75 mg	1.173	± 6.909

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

Group	Value	95% CI
Sodium Risedronate 75 mg	-14.024	± 27.863

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

Group	Value	95% CI
Sodium Risedronate 75 mg	-32.016	± 30.219

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

Group	Value	95% CI
Sodium Risedronate 75 mg	-19.449	± 28.058

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

Group	Value	95% CI
Sodium Risedronate 75 mg	-46.302	± 30.482

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

Group	Value	95% CI
Sodium Risedronate 75 mg	-22.010	± 60.634

Change From Baseline in Height Secondary · Baseline and final assessment (up to Month 12)

Group	Value	95% CI
Sodium Risedronate 75 mg	-0.37	± 1.10

Number of Participants Who Had Lumbar Backache at Final Assessment Secondary · Final assessment (Month 12)

Group	Value	95% CI
Sodium Risedronate 75 mg	663

Adverse events — posted to ClinicalTrials.gov

Time frame: Baseline up to Month 12. Reporting threshold: 0.5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Sodium Risedronate 75 mg

Serious: 15/3058 (0%)

Deaths: —

Serious adverse events (12 terms)

Reaction	System	Sodium Risedronate 75 mg
Cerebral haemorrhage	Nervous system disorders	—
Death	General disorders	—
Pneumonia	Infections and infestations	—
Cardiac hypertrophy	Cardiac disorders	—
Aortic valve stenosis	Cardiac disorders	—
Hypertension	Vascular disorders	—
Back pain	Musculoskeletal and connective tissue disorders	—
Collagen disorder	Musculoskeletal and connective tissue disorders	—
Renal impairment	Renal and urinary disorders	—
Malaise	General disorders	—
Pyrexia	General disorders	—
Femoral neck fracture	Injury, poisoning and procedural complications	—

Other adverse events (3 terms — click to expand)

Reaction	System	Sodium Risedronate 75 mg
Nausea	Gastrointestinal disorders	—
Pyrexia	General disorders	—
Diarrhoea	Gastrointestinal disorders	—

Most-reported serious reactions: Cerebral haemorrhage, Death, Pneumonia, Cardiac hypertrophy, Aortic valve stenosis, Hypertension, Back pain, Collagen disorder.

Data from ClinicalTrials.gov NCT02089997 adverse events section.

Sponsor's own description

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

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.