NCT02106442 is a clinical trial of Sodium risedronate in Osteoporosis, sponsored by Takeda.

Who is sponsoring NCT02106442?

NCT02106442 is sponsored by Takeda.

What drugs are being tested in NCT02106442?

Interventions in NCT02106442: Sodium risedronate.

What condition does NCT02106442 study?

NCT02106442 studies Osteoporosis.

Is NCT02106442 still recruiting?

NCT02106442 is currently completed. Last updated 30 July 2019.

Are results published for NCT02106442?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2019-07-30 · How we verify

NCT02106442

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

36-month Special Drug Use Surveillance on Frequency of Bone Fractures With Sodium Risedronate 75 mg Tablets

Completed Results posted Last updated 30 July 2019

What this trial tests

trial testing Sodium risedronate in Osteoporosis in 579 participants. Completed in 30 April 2018.

Timeline

13 May 2013

Primary endpoint
30 April 2018

30 April 2018

Quick facts

Lead sponsor	Takeda
Status	Completed
Study type	OBSERVATIONAL
Enrollment	579
Start date	13 May 2013
Primary completion	30 April 2018
Estimated completion	30 April 2018
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

50 and older, 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.

Cumulative Percentage of Participants With New or Worsening Vertebral Body Fractures Primary · From baseline up to Month 36

The cumulative data was collected between baseline and Month 36, and reported for the following time points: baseline, Months 6, 12, 18, 24, 30, and 36.

Month 6

Group	Value	95% CI
Sodium Risedronate 75 mg	5.43	3.36 – 8.72

Month 12

Group	Value	95% CI
Sodium Risedronate 75 mg	7.35	4.85 – 11.06

Month 18

Group	Value	95% CI
Sodium Risedronate 75 mg	7.80	5.20 – 11.64

Month 24

Group	Value	95% CI
Sodium Risedronate 75 mg	8.82	5.97 – 12.93

Month 30

Group	Value	95% CI
Sodium Risedronate 75 mg	9.97	6.84 – 14.43

Month 36

Group	Value	95% CI
Sodium Risedronate 75 mg	12.58	8.61 – 18.18

Cumulative Percentage of Participants With Non-Vertebral Body Fractures Secondary · From baseline up to Month 36

The cumulative data was collected between baseline and Month 36, and reported for the following time points: baseline, Months 6, 12, 18, 24, 30, and 36.

Month 6

Group	Value	95% CI
Sodium Risedronate 75 mg	1.72	0.86 – 3.41

Month 12

Group	Value	95% CI
Sodium Risedronate 75 mg	2.78	1.58 – 4.86

Month 18

Group	Value	95% CI
Sodium Risedronate 75 mg	3.40	2.01 – 5.71

Month 24

Group	Value	95% CI
Sodium Risedronate 75 mg	4.11	2.51 – 6.69

Month 30

Group	Value	95% CI
Sodium Risedronate 75 mg	6.15	3.99 – 9.43

Month 36

Group	Value	95% CI
Sodium Risedronate 75 mg	6.59	4.31 – 10.01

Cumulative Percentage of Participants With Femur Fractures Secondary · From baseline up to Month 36

The cumulative data was collected between baseline and Month 36, and reported for the following time points: baseline, Months 6, 12, 18, 24, 30, and 36.

Month 6

Group	Value	95% CI
Sodium Risedronate 75 mg	0.19	0.03 – 1.35

Month 12

Group	Value	95% CI
Sodium Risedronate 75 mg	0.46	0.11 – 1.84

Month 18

Group	Value	95% CI
Sodium Risedronate 75 mg	0.78	0.25 – 2.46

Month 24

Group	Value	95% CI
Sodium Risedronate 75 mg	1.14	0.42 – 3.08

Month 30

Group	Value	95% CI
Sodium Risedronate 75 mg	1.14	0.42 – 3.08

Month 36

Group	Value	95% CI
Sodium Risedronate 75 mg	1.58	0.64 – 3.88

Percent Change From Baseline in Mean Lumbar Spine (L2-L4) Bone Mineral Density (BMD) at Final Assessment (up to Month 36) Secondary · Baseline and final assessment (up to Month 36)

BMD was measured by dual-energy X-ray absorptiometry.

Group	Value	95% CI
Sodium Risedronate 75 mg	6.848	± 8.971

Percent Change From Baseline in Femur Neck BMD at Final Assessment (up to Month 36) Secondary · Baseline and final assessment (up to Month 36)

BMD was measured by dual-energy X-ray absorptiometry.

Group	Value	95% CI
Sodium Risedronate 75 mg	1.067	± 6.757

Percent Change From Baseline in Total Proximal Femur BMD at Final Assessment (up to Month 36) Secondary · Baseline and final assessment (up to Month 36)

BMD was measured by dual-energy X-ray absorptiometry.

Group	Value	95% CI
Sodium Risedronate 75 mg	1.496	± 6.841

Percent Change From Baseline in Radius BMD at Final Assessment (up to Month 36) Secondary · Baseline and final assessment (up to Month 36)

BMD was measured by dual-energy X-ray absorptiometry.

Group	Value	95% CI
Sodium Risedronate 75 mg	3.498	± 10.608

Percent Change From Baseline in Bone Metabolism Markers Serum Type 1 Collagen Cross-linked N-telopeptide (NTX) at Final Assessment (up to Month 36) Secondary · Baseline and final assessment (up to Month 36)

Group	Value	95% CI
Sodium Risedronate 75 mg	-15.756	± 26.386

Percent Change From Baseline in Bone Metabolism Markers Serum Tartrate-resistant Acid Phosphatase 5b (TRACP-5b) at Final Assessment (up to Month 36) Secondary · Baseline and final assessment (up to Month 36)

Group	Value	95% CI
Sodium Risedronate 75 mg	-15.539	± 130.961

Percent Change From Baseline in Bone Metabolism Markers Serum Bone-type Alkaline Phosphatase (BAP) at Final Assessment (up to Month 36) Secondary · Baseline and final assessment (up to Month 36)

Group	Value	95% CI
Sodium Risedronate 75 mg	-20.023	± 23.160

Percent Change From Baseline in Bone Metabolism Markers Serum Procollagen 1 N-terminal Peptide (P1NP) at Final Assessment (up to Month 36) Secondary · Baseline and final assessment (up to Month 36)

Group	Value	95% CI
Sodium Risedronate 75 mg	-40.838	± 40.776

Percent Change From Baseline in Bone Metabolism Markers Urinary Type 1 Collagen Cross-linked N-telopeptide (NTX) at Final Assessment (up to Month 36) Secondary · Baseline and final assessment (up to Month 36)

Group	Value	95% CI
Sodium Risedronate 75 mg	-25.285	± 62.112

Adverse events — posted to ClinicalTrials.gov

Time frame: Up to Month 36. Reporting threshold: 1%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Sodium Risedronate 75 mg

Serious: 4/542 (1%)

Deaths: 0/542

Serious adverse events (4 terms)

Reaction	System	Sodium Risedronate 75 mg
Toothache	Gastrointestinal disorders	—
Osteonecrosis	Musculoskeletal and connective tissue disorders	—
Femur fracture	Injury, poisoning and procedural complications	—
Hospitalisation	Surgical and medical procedures	—

Other adverse events (1 terms — click to expand)

Reaction	System	Sodium Risedronate 75 mg
Nausea	Gastrointestinal disorders	—

Most-reported serious reactions: Toothache, Osteonecrosis, Femur fracture, Hospitalisation.

Data from ClinicalTrials.gov NCT02106442 adverse events section.

Sponsor's own description

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.

Publications & conference data

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

Verify or expand the search:

Other trials of Sodium risedronate

Trials testing the same drug.

NCT02106455 — Sodium Risedronate Tablets - Special Drug Use Surveillance in Patients With Osseous Paget's Disease (All-case Surveillan · completed

Other recruiting trials for Osteoporosis

Currently open trials in the same condition.

NCT07027306 — The Osteoporotic Fracture Classification-based Scoring System for Treatment Decision in Thoracolumbar Osteoporotic Fract · recruiting
NCT07367776 — Patient Education in Osteoporosis (RCT-PATOS) · NA · recruiting
NCT06731608 — OsteoPorotic fracTure preventION System (OPTIONS) Research Study · NA · recruiting
NCT07281586 — Step-down Therapy After Long-term Osteoporosis Treatment · Phase 4 · recruiting
NCT07083557 — Routine Validation and Reproducibility Testing of Laboratory Assays and Research Techniques Used for Endocrine, Cardiome · recruiting

Other Takeda trials

Trials by the same sponsor.

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NCT07293364 — A Study to Learn About the C1-Inhibitor Function as Diagnosis for Hereditary Angioedema · NA · not yet recruiting
NCT07218393 — A Study About the Diagnosis and Management of Hereditary Angioedema (HAE) in Egypt · not yet recruiting
NCT07445087 — A Study of Takhzyro in Teenagers and Adults With Hereditary Angioedema (HAE) in South Korea · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02106442 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Takeda
Last refreshed: 30 July 2019

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02106442.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT02106442

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Serious adverse events (4 terms)

Sponsor's own description

Publications & conference data

Related trials

Other trials of Sodium risedronate

Other recruiting trials for Osteoporosis

Other Takeda trials

Verify against primary sources