Postmenopausal OsteoporosisPhase 4NCT05630768
Efficacy and Safety of Actonel® After Denosumab Discontinuation in Postmenopausal Osteoporosis Women
A Phase 4 study testing Risedronate Sodium 35 MG [Actonel] and Calcium Vitamin D combination in people with Postmenopausal Osteoporosis, run by Dong-A ST Co., Ltd. at 1 site in South Korea.
Trial summary
To evaluate the effect of 1 year of risedronate treatment on the prevention of bone loss after denosumab discontinuation in denosumab-treated post-menopausal osteoporosis for a year Read more about this study
- Who is it for?
- Ages 50 to 80 years, women only
- Conditions the study is for
- Postmenopausal Osteoporosis
- What is being tested?
- Risedronate Sodium 35 MG [Actonel] and Calcium Vitamin D combination
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 149 participants
- Where
- 1 siteSouth Korea
- Study dates
- 3 Jan 2023to 23 Jul 2025
- Phase
- Phase 4
- 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 50 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Main Inclusion Criteria:
- Postmenopausal women
- Patients diagnosed with postmenopausal osteoporosis and administered denosumab for 1 year
Main Exclusion Criteria:
- Any contraindication to risedronate
- Those evaluated as inappropriate at the discretion of the investigator
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter, Open-label, Single-arm Clinical Trial to Evaluate the Efficacy and Safety of Actonel® After Denosumab Discontinuation in Postmenopausal Osteoporosis Women
To evaluate the effect of 1 year of risedronate treatment on the prevention of bone loss after denosumab discontinuation in denosumab-treated post-menopausal osteoporosis for a year
- Conditions
- Postmenopausal Osteoporosis
- Being tested
- Risedronate Sodium 35 MG [Actonel], Calcium Vitamin D combination
- Medical subject headings
- Osteoporosis, Postmenopausal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Risedronate Sodium 35 MG [Actonel]Drug
Risendronate Sodium Tab. 35mg, orally, once weekly
Calcium Vitamin D combinationDrug
orally, once daily for concomitant drug
| Study group | Role | What they receive |
|---|---|---|
| Actonel® | Experimental | Risedronate Sodium 35mg Receives: Drug: Risedronate Sodium 35 MG [Actonel]; Drug: Calcium Vitamin D combination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent change from baseline in lumbar spine bone mineral density (LS BMD) at 1 year (%)
Percent change from baseline in lumbar spine bone mineral density (LS BMD) at 1 year (%)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2022
- Study start3 Jan 2023
- Primary completion23 Jul 2025
- Study completion23 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postmenopausal 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 4
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 149 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dong-A ST Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05630768
- Sponsor's protocol ID
- ATN_PMO_IV
- Status last verified
- Dec 2024
- First submitted
- 18 Nov 2022
- Last updated
- 24 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-label, Single-arm Clinical Trial to Evaluate the Efficacy and Safety of Actonel® After Denosumab Discontinuation in Postmenopausal Osteoporosis Women
- ClinicalTrials.gov ID
- NCT05630768
- Acronym / sponsor ID
- ATN_PMO_IV
- Conditions
- Postmenopausal Osteoporosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 149 participants (actual)
- Lead sponsor
- Dong-A ST Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 3 Jan 2023 (actual)
- Primary completion
- 23 Jul 2025 (actual)
- Study completion
- 23 Jul 2025 (actual)
- First posted
- 30 Nov 2022 (actual)
- 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.
To evaluate the effect of 1 year of risedronate treatment on the prevention of bone loss after denosumab discontinuation in denosumab-treated post-menopausal osteoporosis for a year
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Actonel® | Experimental | Drug: Risedronate Sodium 35 MG [Actonel], Drug: Calcium Vitamin D combinationRisedronate Sodium 35mg |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 Sodium 35 MG [Actonel]Risendronate Sodium Tab. 35mg, orally, once weekly | Drug | Actonel® |
| Calcium Vitamin D combinationorally, once daily for concomitant drug | Drug | Actonel® |
Primary outcome
Percent change from baseline in lumbar spine bone mineral density (LS BMD) at 1 year (%)
Time frame: 1 year
Percent change from baseline in lumbar spine bone mineral density (LS BMD) at 1 year (%)
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 24 Aug 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Risedronate Sodium 35 MG [Actonel] and Calcium Vitamin D combination in people with Postmenopausal Osteoporosis, run by Dong-A ST 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?
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 24 Aug 2025. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Percent change from baseline in lumbar spine bone mineral density (LS BMD) at 1 year (%) (time frame: 1 year). 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 24 Aug 2025.