OsteoporosisPhase 4NCT05091086
The Optimal Long Term Treatment Strategy of Anti-resorptive Medications
A Phase 4 study testing Continuous Denosumab and Administer zoledronate and denosumab on an alternating schedule in people with Osteoporosis and Bone Mineral Density, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
This study is to investigate whether the alternating use of Prolia (Denosumab) and Aclasta (Zoledronic acid) can continue to increase bone density. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Osteoporosis, Bone Mineral Density
- What is being tested?
- Continuous Denosumab and Administer zoledronate and denosumab on an alternating schedule
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 20 Nov 2021to 31 Dec 2030
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Postmenopausal women or men over 50 years old with osteoporosis or osteopenia leading to fractures.
- Denosumab treatment for at least two years and less than three years (up to maximum of five doses).
Who cannot join
- Secondary osteoporosis.
- Metabolic bone diseases.
- Malignancy.
- Continuous steroid treatment, hormone therapy or other medical treatment affecting bone metabolism.
- Patients had ever used antiosteoporosis medications other than Dmab
- Estimated glomerular filtration rate < 35 mL/min.
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- Allergy to Zoledronate.
- Any other contraindications to Zoledronate use.
- History of diagnosed hypocalcemia.
- Age greater than 80 years.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
National Taiwan University Hospital, Yunlin branch
Douliu, Yunlin county, 640
About this study
This study is to investigate whether the alternating use of Prolia (Denosumab) and Aclasta (Zoledronic acid) can continue to increase bone density.
Read the detailed description
This study intends to use a randomized trial to test whether the long-term treatment of Denosumab and Zoledronic acid can achieve sustained bone density progress and avoid the risk of rapid bone loss after the withdrawal of Denosumab.
- Conditions
- Osteoporosis, Bone Mineral Density
- Being tested
- Continuous Denosumab, Administer zoledronate and denosumab on an alternating schedule
- Keywords
- Osteoporosis, denosumab, zoledronic acid
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous DenosumabDrug
Active comparator: persistent treatment of denosumab.
Administer zoledronate and denosumab on an alternating scheduleDrug
In the experimental group, zoledronic acid was administered for one year, followed by two years of denosumab. This cycle was repeated, with the regimen concluding with one year of zoledronic acid.
| Study group | Role | What they receive |
|---|---|---|
| Persistent treatment of Denosumab: | Active comparator | persistent denosumab for 7 years Receives: Drug: Continuous Denosumab |
| Alternating treatment of Denosumab and Zoledronic acid | Experimental | Alternating treatment with denosumab and zoledronic acid over a 7-year period: after entering the trial, patients received one year of zoledronic acid, followed by two years of denosumab, then switched back to zoledronic acid for one year, followed by another two years of denosumab, and finally received one more year of zoledronic acid. Receives: Drug: Administer zoledronate and denosumab on an alternating schedule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in lumbar spine bone mineral density
Measured: From enrollment to the end of treatment at 3 years
Secondary outcomes (7)
Change in total hip bone mineral density
Measured: From enrollment to the end of treatment at 3 years and 7 years
Change in femoral neck bone mineral density
Measured: From enrollment to the end of treatment at 3 years and 7 years
Change in lumbar spine bone mineral density
Measured: From enrollment to the end of treatment at 7 years
Change in C-terminal telopeptide of type 1 collagen
Measured: From enrollment to the end of treatment at 3 years and 7 years
Change in Procollagen type 1 N-terminal propeptide
Measured: From enrollment to the end of treatment at 3 years and 7 years
Fractures
Number of Participants with clinical fractures and radiographic vertebral fractures
Measured: 3 & 7 years
Change in quality of life
Measured: From enrollment to the end of treatment at 3 years and 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2021
- Study start20 Nov 2021
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two parallel group would be selected. One group of participants keep their denosumab treatment for 7 years. Another group of participants accept two cycles of treatment (one year of zoledronate and two years of denosumab) and complete with one year of zoledronate.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, National Taiwan University Clinical Trial Center, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05091086
- Sponsor's protocol ID
- 202107164MINC
- Status last verified
- Jan 2025
- First submitted
- 11 Oct 2021
- Last updated
- 22 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: After application
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Optimal Long Term Treatment Strategy of Anti-resorptive Medications
- ClinicalTrials.gov ID
- NCT05091086
- Acronym / sponsor ID
- 202107164MINC
- Conditions
- Osteoporosis, Bone Mineral Density
- Keywords
- Osteoporosis, denosumab, zoledronic acid
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 20 Nov 2021 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 25 Oct 2021 (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.
This study is to investigate whether the alternating use of Prolia (Denosumab) and Aclasta (Zoledronic acid) can continue to increase bone density.
Detailed description
This study intends to use a randomized trial to test whether the long-term treatment of Denosumab and Zoledronic acid can achieve sustained bone density progress and avoid the risk of rapid bone loss after the withdrawal of Denosumab.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Two parallel group would be selected. One group of participants keep their denosumab treatment for 7 years. Another group of participants accept two cycles of treatment (one year of zoledronate and two years of denosumab) and complete with one year of zoledronate.
| Arm | Type | Receives |
|---|---|---|
| Persistent treatment of Denosumab: | Active comparator | Drug: Continuous Denosumabpersistent denosumab for 7 years |
| Alternating treatment of Denosumab and Zoledronic acid | Experimental | Drug: Administer zoledronate and denosumab on an alternating scheduleAlternating treatment with denosumab and zoledronic acid over a 7-year period: after entering the trial, patients received one year of zoledronic acid, followed by two years of denosumab, then switched back to zoledronic acid for one year, followed by another two years of denosumab, and finally received one more year of zoledronic acid. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Postmenopausal women or men over 50 years old with osteoporosis or osteopenia leading to fractures.
- Denosumab treatment for at least two years and less than three years (up to maximum of five doses).
Key exclusion criteria (10 listed)
- Secondary osteoporosis.
- Metabolic bone diseases.
- Malignancy.
- Continuous steroid treatment, hormone therapy or other medical treatment affecting bone metabolism.
- Patients had ever used antiosteoporosis medications other than Dmab
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 |
|---|---|---|
| Continuous DenosumabActive comparator: persistent treatment of denosumab. | Drug | Persistent treatment of Denosumab: |
| Administer zoledronate and denosumab on an alternating scheduleIn the experimental group, zoledronic acid was administered for one year, followed by two years of denosumab. This cycle was repeated, with the regimen concluding with one year of zoledronic acid. | Drug | Alternating treatment of Denosumab and Zoledronic acid |
Primary outcome
Change in lumbar spine bone mineral density
Time frame: From enrollment to the end of treatment at 3 years
7 secondary outcomes
Change in total hip bone mineral density
Time frame: From enrollment to the end of treatment at 3 years and 7 years
Change in femoral neck bone mineral density
Time frame: From enrollment to the end of treatment at 3 years and 7 years
Change in lumbar spine bone mineral density
Time frame: From enrollment to the end of treatment at 7 years
Change in C-terminal telopeptide of type 1 collagen
Time frame: From enrollment to the end of treatment at 3 years and 7 years
Change in Procollagen type 1 N-terminal propeptide
Time frame: From enrollment to the end of treatment at 3 years and 7 years
Fractures
Time frame: 3 & 7 years
Change in quality of life
Time frame: From enrollment to the end of treatment at 3 years and 7 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2025.
- Individual participant dataSharing planned: Undecided. After application
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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 Continuous Denosumab and Administer zoledronate and denosumab on an alternating schedule in people with Osteoporosis and Bone Mineral Density, run by National Taiwan University Hospital at 1 site in Taiwan.
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 2 inclusion and 10 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: under way, not looking for participants, as of the sponsor's last update on 22 May 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 Taiwan. 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?
This study is still under way. Results are not available in the source record yet.
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?
Change in lumbar spine bone mineral density (time frame: From enrollment to the end of treatment at 3 years). 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 22 May 2025.