Postmenopausal Women OsteoporosisPhase 3NCT01806792
Post-menopausal Women Osteoporosis(Phase III)
A Phase 3 study testing risedronate combine and Risedronate in people with Postmenopausal Women Osteoporosis, run by Hanlim Pharm. Co., Ltd. at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate the efficacy and the safety of Risedronate, cholecalciferol combination tablet in patients with Osteoporosis Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Postmenopausal Women Osteoporosis
- What is being tested?
- risedronate combine and Risedronate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteSouth Korea
- Study dates
- Nov 2009to Mar 2011
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- women osteoporosis
- patients with a diagnosis of Postmenopausal over 6 Months if they had a bone mineral density T-score of < -2.5 at the mean lumbar spine (L1-4), femoral neck, or total, or a T-score of < -1.0 with radiologic evidence of at least one vertebral fracture. Menopause was defined as no natural menses for at least 1 year and a serum FSH level > 40 IU/L, with a reported hysterectomy
- low levels of 25(OH)D > 9 ng/mL
- patients who give written consent of agreement to voluntarily participate in the clinical study
- patients who can read and understand written instructions
Who cannot join
- patients who had contraindications to oral bisphosphonates, such as esophageal strictures
- ALT, AST ≥ 2×UNL and Serum Creatinine ≥ 1.5×UNL
- low levels of 25(OH)D (less than 9 ng/mL).
- Previous use of oral bisphosphonates and vitamin D were allowed, but a washout period was needed, depending on the duration of treatment. Two-year washout periods were needed for bisphosphonate users and 3-6-month periods were required for vitamin D users of > 200 IU.
- drug administration after diagnosing as alcoholic or psychical disease
- patients whom the investigators judge as improper to participate in this clinical trial 7)13.patients who have experience to participate in other clinical trial within 30 days prior to study participation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: For 4 Months, the Multi Center, Double Blinded, Randomized, Active Controlled, Comparative Clinical Study to Assess the Efficacy and the Safety to Improvement Effect of Vit.D of Risenex Plus M Tablet in Patients With In Post-menopausal Women Osteoporosis
The purpose of this study is to evaluate the efficacy and the safety of Risedronate, cholecalciferol combination tablet in patients with Osteoporosis
Read the detailed description
The purpose of this study is to evaluate the efficacy and the safety of Monthly Risedronate with cholecalciferol on 25 Hydroxyvitamin D level and bone markers patients with osteoporosis.
- Conditions
- Postmenopausal Women Osteoporosis
- Being tested
- risedronate combine, Risedronate, Placebo(for Risedronate), Placebo(for risedronate combine)
- Keywords
- Osteoporosis
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
risedronate combineDrug
Also called - Other name : Risenex M(risedronate 150mg and cholecalciferol 30,000 IU combined)
RisedronateDrug
Also called Other name : Actonel(Risedronate 150mg)
Placebo(for Risedronate)Drug
Also called once a month
Placebo(for risedronate combine)Drug
Also called once a month
| Study group | Role | What they receive |
|---|---|---|
| Risendronate and Cholecalciferol combination | Experimental | risedronate 150mg and cholecalciferol 30,000 IU 1 tablet + Placebo(for risedronate 150mg) 1 tablet by once a month. Receives: Drug: risedronate combine; Drug: Placebo(for Risedronate) |
| Risedronate | Active comparator | risedronate 150mg 1 tablet + Placebo(for risedronate 150mg and cholecalciferol 30,000 IU) 1 tablet by once a month. Receives: Drug: Risedronate; Drug: Placebo(for risedronate combine) |
What is being measured
The primary outcome is the main question the study is designed to answer.
proportion of patients with 25(OH)D level < 20 ng/mL at 16 weeks.
Measured: 16 weeks form first drug adminstration.
Secondary outcomes (1)
proportion of patients with 25(OH)D level < 9 ng/mL at 16 weeks, change of 25(OH)D level and Bone Markers.
Secondary end point is :
- proportion of patients with 25(OH)D level < 9 ng/mL at 16 weeks
- change of 25(OH)D level
- change of BSAP
- change of CTX
- change of Ca
- change of phosphorous
- change of PTH
- change of 8-foot walking test, Sit-To-Stand test
Measured: 16 weeks form first drug administration.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2013 (estimated)
- Study startNov 2009
- Primary completionAug 2010
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postmenopausal Women OsteoporosisStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hanlim Pharm. Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hyoung-Moo Park, MD, Principal investigator, Chung-Ang University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01806792
- Sponsor's protocol ID
- HL_RSNPM_301
- Status last verified
- Mar 2013
- First submitted
- 5 Mar 2013
- Last updated
- 7 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- For 4 Months, the Multi Center, Double Blinded, Randomized, Active Controlled, Comparative Clinical Study to Assess the Efficacy and the Safety to Improvement Effect of Vit.D of Risenex Plus M Tablet in Patients With In Post-menopausal Women Osteoporosis
- ClinicalTrials.gov ID
- NCT01806792
- Acronym / sponsor ID
- HL_RSNPM_301
- Conditions
- Postmenopausal Women Osteoporosis
- Keywords
- Osteoporosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Hanlim Pharm. Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Nov 2009
- Primary completion
- Aug 2010 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 7 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the efficacy and the safety of Risedronate, cholecalciferol combination tablet in patients with Osteoporosis
Detailed description
The purpose of this study is to evaluate the efficacy and the safety of Monthly Risedronate with cholecalciferol on 25 Hydroxyvitamin D level and bone markers patients with osteoporosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Risendronate and Cholecalciferol combination | Experimental | Drug: risedronate combine, Drug: Placebo(for Risedronate)risedronate 150mg and cholecalciferol 30,000 IU 1 tablet + Placebo(for risedronate 150mg) 1 tablet by once a month. |
| Risedronate | Active comparator | Drug: Risedronate, Drug: Placebo(for risedronate combine)risedronate 150mg 1 tablet + Placebo(for risedronate 150mg and cholecalciferol 30,000 IU) 1 tablet by once a month. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- women osteoporosis
- patients with a diagnosis of Postmenopausal over 6 Months if they had a bone mineral density T-score of < -2.5 at the mean lumbar spine (L1-4), femoral neck, or total, or a T-score of < -1.0 with radiologic evidence of at least one vertebral fracture. Menopause was defined as no natural menses for at least 1 year and a serum FSH level > 40 IU/L, with a reported hysterectomy
- low levels of 25(OH)D > 9 ng/mL
- patients who give written consent of agreement to voluntarily participate in the clinical study
- patients who can read and understand written instructions
Key exclusion criteria (6 listed)
- patients who had contraindications to oral bisphosphonates, such as esophageal strictures
- ALT, AST ≥ 2×UNL and Serum Creatinine ≥ 1.5×UNL
- low levels of 25(OH)D (less than 9 ng/mL).
- Previous use of oral bisphosphonates and vitamin D were allowed, but a washout period was needed, depending on the duration of treatment. Two-year washout periods were needed for bisphosphonate users and 3-6-month periods were required for vitamin D users of > 200 IU.
- drug administration after diagnosing as alcoholic or psychical disease
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 |
|---|---|---|
| risedronate combineAlso: - Other name : Risenex M(risedronate 150mg and cholecalciferol 30,000 IU combined) | Drug | Risendronate and Cholecalciferol combination |
| RisedronateAlso: Other name : Actonel(Risedronate 150mg) | Drug | Risedronate |
| Placebo(for Risedronate)Also: once a month | Drug | Risendronate and Cholecalciferol combination |
| Placebo(for risedronate combine)Also: once a month | Drug | Risedronate |
Primary outcome
proportion of patients with 25(OH)D level < 20 ng/mL at 16 weeks.
Time frame: 16 weeks form first drug adminstration.
1 secondary outcome
proportion of patients with 25(OH)D level < 9 ng/mL at 16 weeks, change of 25(OH)D level and Bone Markers.
Time frame: 16 weeks form first drug administration.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2013.
Related trials for Postmenopausal Women Osteoporosis
Active, not recruitingObservational study
The Impact of Osteosarcopenia on Falls, Kinesiophobia, and Quality of Life in Postmenopausal Women
Osteosarcopenia, Sarcopenia
Not yet recruiting
Effects of Sensorimotor Balance Training vs Digitally Augmented Core Stabilization in Women With Osteoporosis
Postmenopausal Osteoporosis
Not yet recruitingPhase 2
Study of TST002 Injection in Postmenopausal Women With Osteoporosis or Low Bone Mass
Postmenopausal Osteoporosis, Low Bone Mass
Not yet recruiting
Effect of Postural Correction Exercises on Pelvic Floor Dysfunction in Postmenopausal Osteoporotic Women
Osteoporosis, Postmenopausal
Not yet recruitingPhase 4
Sequential Treatment With Romosozumab Followed by Denosumab vs. Zoledronic Acid for Gains in HIP BMD
Osteoporosis in Post-menopausal Women
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.
Hyoung-Moo Park, MD principal investigator
Chung-Ang University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing risedronate combine and Risedronate in people with Postmenopausal Women Osteoporosis, run by Hanlim Pharm. Co., Ltd. at 1 site in South Korea.
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 5 inclusion and 6 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 7 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
proportion of patients with 25(OH)D level < 20 ng/mL at 16 weeks. (time frame: 16 weeks form first drug adminstration.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Mar 2013.