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

An observational study of Osteoporosis, run by Takeda at 2 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 50 years and older
Conditions the study is for: Osteoporosis
What is being tested?: Sodium risedronate
Type of treatment: Pill or oral medicine
How many people: 579 participants
Where: 2 sitesJapan
Study dates: 13 May 2013to 30 Apr 2018
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 50 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: Osteoporosis

Who may be able to join

Osteoporosis patients who meet all the following criteria:
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)
Male and postmenopausal female patients aged 50 years or older
Ambulatory outpatients

Who cannot join

Trial locations and contacts

2 sites in 1 country.

Japan2 sites

Study site
Osaka
Study site
Tokyo

Other trials in Japan

About this study

Official title: 36-month Special Drug Use Surveillance on Frequency of Bone Fractures With Benet 75 mg Tablets

Read the 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.

Conditions: Osteoporosis
Being tested: Sodium risedronate
Keywords: Pharmacological therapy
Medical subject headings: Osteoporosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Sodium risedronateDrug
Sodium risedronate tablets

Study groups in NCT02106442
Study group	Role	What they receive
Sodium Risedronate 75 mg		75 mg of sodium risedronate is administered orally with a sufficient volume (approximately 180 mL) of water once monthly after waking. Participants receive sodium risedronate 75 mg as part of routine medical care. Receives: Drug: Sodium risedronate

What is being measured

The primary outcome is the main question the study is designed to answer.

Cumulative Percentage of Participants With New or Worsening Vertebral Body Fractures
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.
Measured: From baseline up to Month 36

Secondary outcomes (14)

Cumulative Percentage of Participants With Non-Vertebral Body Fractures
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.
Measured: From baseline up to Month 36
Cumulative Percentage of Participants With Femur Fractures
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.
Measured: From baseline up to Month 36
Percent Change From Baseline in Mean Lumbar Spine (L2-L4) Bone Mineral Density (BMD) at Final Assessment (up to Month 36)
BMD was measured by dual-energy X-ray absorptiometry.
Measured: Baseline and final assessment (up to Month 36)
Percent Change From Baseline in Femur Neck BMD at Final Assessment (up to Month 36)
BMD was measured by dual-energy X-ray absorptiometry.
Measured: Baseline and final assessment (up to Month 36)
Percent Change From Baseline in Total Proximal Femur BMD at Final Assessment (up to Month 36)
BMD was measured by dual-energy X-ray absorptiometry.
Measured: Baseline and final assessment (up to Month 36)
Percent Change From Baseline in Radius BMD at Final Assessment (up to Month 36)
BMD was measured by dual-energy X-ray absorptiometry.
Measured: Baseline and final assessment (up to Month 36)
Percent Change From Baseline in Bone Metabolism Markers Serum Type 1 Collagen Cross-linked N-telopeptide (NTX) at Final Assessment (up to Month 36)
Measured: Baseline and final assessment (up to Month 36)
Percent Change From Baseline in Bone Metabolism Markers Serum Tartrate-resistant Acid Phosphatase 5b (TRACP-5b) at Final Assessment (up to Month 36)
Measured: Baseline and final assessment (up to Month 36)
Percent Change From Baseline in Bone Metabolism Markers Serum Bone-type Alkaline Phosphatase (BAP) at Final Assessment (up to Month 36)
Measured: Baseline and final assessment (up to Month 36)
Percent Change From Baseline in Bone Metabolism Markers Serum Procollagen 1 N-terminal Peptide (P1NP) at Final Assessment (up to Month 36)
Measured: Baseline and final assessment (up to Month 36)
Percent Change From Baseline in Bone Metabolism Markers Urinary Type 1 Collagen Cross-linked N-telopeptide (NTX) at Final Assessment (up to Month 36)
Measured: Baseline and final assessment (up to Month 36)
Change From Baseline in Height at Final Assessment (up to Month 36)
Measured: Baseline and final assessment (up to Month 36)
Number of Participants Who Had Lumbar Backache at Final Assessment (up to Month 36)
Measured: Final assessment (up to Month 36)
Number of Participants Who Had One or More Adverse Drug Reactions
Adverse drug reaction refers to adverse events related to the administered drug.
Measured: Up to Month 36

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 May 201330 Apr 2018

First posted8 Apr 2014 (estimated)
Study start13 May 2013
Primary completion30 Apr 2018
Study completion30 Apr 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for OsteoporosisStudies of the same condition, open and under way.
More trials run by TakedaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 579 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02106442
Sponsor's protocol ID: 178-002
Other IDs: JapicCTI-142479
Status last verified: Jul 2019
First submitted: 3 Apr 2014
Last updated: 30 Jul 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: Takeda makes patient-level, de-identified data sets and associated documents available for all interventional studies after applicable marketing approvals and commercial availability have been received (or program is completely terminated), an opportunity for the primary publication of the research and final report development has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
A Clinical Study to Collect Real-wordt Data on Safety and Clinical Performance of the VCFix Spinal System for Treatment of Vertebral Compression Fractures of (Suspected) Osteoporotic Origin.
Vertebra Compression Fracture
Active, not recruitingObservational study
The Impact of Osteosarcopenia on Falls, Kinesiophobia, and Quality of Life in Postmenopausal Women
Osteosarcopenia, Sarcopenia
Active, not recruitingPhase 2
TCM Formula vs. HMB in Pre-Frail Elders: Muscle Strength and Bone Status
Pre-Frailty, Sarcopenia
Not yet recruitingPhase 4
Romosozumab and Denosumab Combination Therapy for Osteoporosis
Postmenopausal Osteoporosis
RecruitingObservational study
Assessment and Comparison of Osteoporosis Risk Factors After Stroke
Stroke, Osteoporosis

All Osteoporosis trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 36-month Special Drug Use Surveillance on Frequency of Bone Fractures With Benet 75 mg Tablets
ClinicalTrials.gov ID: NCT02106442
Acronym / sponsor ID: 178-002
Conditions: Osteoporosis
Keywords: Pharmacological therapy
Study type: Observational
Recruitment status: Completed
Enrolment: 579 participants (actual)
Lead sponsor: TakedaIndustry (pharma, biotech, devices)
Study start: 13 May 2013 (actual)
Primary completion: 30 Apr 2018 (actual)
Study completion: 30 Apr 2018 (actual)
First posted: 8 Apr 2014 (estimated)
Results: Posted 17 Jul 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Sodium Risedronate 75 mg	–	Drug: Sodium risedronate75 mg of sodium risedronate is administered orally with a sufficient volume (approximately 180 mL) of water once monthly after waking. Participants receive sodium risedronate 75 mg as part of routine medical care.

Who may qualify

Ages: 50 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Osteoporosis

Key inclusion criteria (4 listed)

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)
Male and postmenopausal female patients aged 50 years or older
Ambulatory outpatients

Key exclusion criteria (1 listed)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Sodium risedronateSodium risedronate tablets	Drug	Sodium Risedronate 75 mg

Primary outcome

Cumulative Percentage of Participants With New or Worsening Vertebral Body Fractures
Time frame: 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.

14 secondary outcomes

Cumulative Percentage of Participants With Non-Vertebral Body Fractures
Time frame: From baseline up to Month 36
Cumulative Percentage of Participants With Femur Fractures
Time frame: From baseline up to Month 36
Percent Change From Baseline in Mean Lumbar Spine (L2-L4) Bone Mineral Density (BMD) at Final Assessment (up to Month 36)
Time frame: Baseline and final assessment (up to Month 36)
Percent Change From Baseline in Femur Neck BMD at Final Assessment (up to Month 36)
Time frame: Baseline and final assessment (up to Month 36)
Percent Change From Baseline in Total Proximal Femur BMD at Final Assessment (up to Month 36)
Time frame: Baseline and final assessment (up to Month 36)
Percent Change From Baseline in Radius BMD at Final Assessment (up to Month 36)
Time frame: Baseline and final assessment (up to Month 36)
Percent Change From Baseline in Bone Metabolism Markers Serum Type 1 Collagen Cross-linked N-telopeptide (NTX) at Final Assessment (up to Month 36)
Time frame: Baseline and final assessment (up to Month 36)
Percent Change From Baseline in Bone Metabolism Markers Serum Tartrate-resistant Acid Phosphatase 5b (TRACP-5b) at Final Assessment (up to Month 36)
Time frame: Baseline and final assessment (up to Month 36)
Percent Change From Baseline in Bone Metabolism Markers Serum Bone-type Alkaline Phosphatase (BAP) at Final Assessment (up to Month 36)
Time frame: Baseline and final assessment (up to Month 36)
Percent Change From Baseline in Bone Metabolism Markers Serum Procollagen 1 N-terminal Peptide (P1NP) at Final Assessment (up to Month 36)
Time frame: Baseline and final assessment (up to Month 36)
Percent Change From Baseline in Bone Metabolism Markers Urinary Type 1 Collagen Cross-linked N-telopeptide (NTX) at Final Assessment (up to Month 36)
Time frame: Baseline and final assessment (up to Month 36)
Change From Baseline in Height at Final Assessment (up to Month 36)
Time frame: Baseline and final assessment (up to Month 36)
Number of Participants Who Had Lumbar Backache at Final Assessment (up to Month 36)
Time frame: Final assessment (up to Month 36)
Number of Participants Who Had One or More Adverse Drug Reactions
Time frame: Up to Month 36

Results and safety

Results posted to the registry on 17 Jul 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Sodium Risedronate 75 mg	579	542

Primary outcome: Cumulative Percentage of Participants With New or Worsening Vertebral Body Fractures

Time frame: From baseline up to Month 36. Number (95% Confidence Interval). Unit: Percentage of Participants

Measure	Sodium Risedronate 75 mg n = 328
Month 6	5.43 (3.36 to 8.72)
Month 12	7.35 (4.85 to 11.06)
Month 18	7.80 (5.20 to 11.64)
Month 24	8.82 (5.97 to 12.93)
Month 30	9.97 (6.84 to 14.43)
Month 36	12.58 (8.61 to 18.18)

Population analysed: Vertebral fractures assessment population; The vertebral fractures assessment population was defined as participants who completed the survey and had evaluable vertebral fractures data at baseline and post-baseline time points. Number analyzed is the number of participants who were evaluable at each time point.

14 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to Month 36. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Sodium Risedronate 75 mg	4 of 542 (0.7%)	7 of 542 (1.3%)	0 of 542

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No. Takeda makes patient-level, de-identified data sets and associated documents available for all interventional studies after applicable marketing approvals and commercial availability have been received (or program is completely terminated), an opportunity for the primary publication of the research and final report development has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.

Related trials for Osteoporosis

RecruitingObservational study
A Clinical Study to Collect Real-wordt Data on Safety and Clinical Performance of the VCFix Spinal System for Treatment of Vertebral Compression Fractures of (Suspected) Osteoporotic Origin.
Vertebra Compression Fracture
Active, not recruitingObservational study
The Impact of Osteosarcopenia on Falls, Kinesiophobia, and Quality of Life in Postmenopausal Women
Osteosarcopenia, Sarcopenia
Active, not recruitingPhase 2
TCM Formula vs. HMB in Pre-Frail Elders: Muscle Strength and Bone Status
Pre-Frailty, Sarcopenia
Not yet recruitingPhase 4
Romosozumab and Denosumab Combination Therapy for Osteoporosis
Postmenopausal Osteoporosis
RecruitingObservational study
Assessment and Comparison of Osteoporosis Risk Factors After Stroke
Stroke, Osteoporosis

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Study Director study director

Takeda

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Osteoporosis, run by Takeda at 2 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cumulative Percentage of Participants With New or Worsening Vertebral Body Fractures (time frame: From baseline up to Month 36). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02106442.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2019.