OsteoporosisPhase 4NCT05091099
The Optimal Sequential Therapy After Long Term Denosumab Treatment
A Phase 4 study testing zoledronate and Alendronate and Zoledronate in people with Osteoporosis, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
This study intends to investigate whether Alendronate and Zoledronate can prevent bone mineral density loss after long-term treatment with Denosumab. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Osteoporosis
- What is being tested?
- zoledronate and Alendronate and Zoledronate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteTaiwan
- Study dates
- 10 Jan 2022to 14 Nov 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Postmenopausal women or men over 50 years old
- Continuous Denosumab treatment for at least three years (up to six doses).
Who cannot join
- Secondary osteoporosis
- Metabolic bone diseases
- Active or prior malignancy
- Ongoing systemic glucocorticoid therapy
- Current use of hormone replacement therapy
- Current use of any medication known to affect bone metabolism
Show all 14Show fewer
- Prior use of any osteoporosis medication other than denosumab
- Estimated glomerular filtration rate (eGFR) < 40 mL/min
- Known hypersensitivity to zoledronic acid
- Hypocalcemia
- Any other contraindication to zoledronic acid
- Age > 85 years
- Esophageal abnormalities that delay esophageal emptying (e.g., esophageal stricture, achalasia)
- Inability to stand or sit upright for at least 30 minutes
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 intends to investigate whether Alendronate and Zoledronate can prevent bone mineral density loss after long-term treatment with Denosumab.
Read the detailed description
This study intends to use a randomized trial to test whether Alendronate and Zoledronate can avoid the risk of rapid bone loss after the withdrawal of Denosumab.
- Conditions
- Osteoporosis
- Being tested
- zoledronate, Alendronate and Zoledronate
- Keywords
- Osteoporosis, denosumab, alendronate, 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.
zoledronateDrug
Also called Zoledronic acid
On time Zoledronate: Zoledronate would be given (one dose for one year) after the completiong of denosumab on time
Alendronate and ZoledronateDrug
Alendronate and Zoledronate: Alendronate would be given one month before the the completiong of denosumab and the following 3 months (Total four months). After the completion of Alendronate, Zoledronate would be given (one dose).
| Study group | Role | What they receive |
|---|---|---|
| On time Zoledronate | Active comparator | Zoledronate would be given (one dose for one year) after the completiong of denosumab on time Receives: Drug: zoledronate |
| Alendronate and Zoledronate | Experimental | Alendronate would be given one month before the the completiong of denosumab and the following 3 months (Total four months). After the completion of Alendronate, Zoledronate would be given (one dose). Receives: Drug: Alendronate and Zoledronate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone mineral density of lumbar spine
Bone mineral density of lumbar spine
Measured: one year
Secondary outcomes (4)
Bone mineral density of femoral neck
Bone mineral density of femoral neck
Measured: one year
Bone mineral density of total hip
Bone mineral density of total hip
Measured: one year
bone turnover markers
Changes of C-terminal telopeptide of type I collagen (CTX) and propeptide of procollagen type I (P1NP)
Measured: 13 months
clinical osteoporotic fracture
any incidence of clinical osteoporotic fracture
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 posted25 Oct 2021
- Study start10 Jan 2022
- Primary completion14 Nov 2025
- Study completion14 Nov 2025
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
- One arm accept on time zoledronic acid after long-tearm denosumab. Another arm accept alendronate for 4 months and then zoledronic acid after long-tearm denosumab.
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05091099
- Sponsor's protocol ID
- 202108044MINA
- Status last verified
- Nov 2025
- First submitted
- 11 Oct 2021
- Last updated
- 19 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: after application
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Optimal Sequential Therapy After Long Term Denosumab Treatment
- ClinicalTrials.gov ID
- NCT05091099
- Acronym / sponsor ID
- 202108044MINA
- Conditions
- Osteoporosis
- Keywords
- Osteoporosis, denosumab, alendronate, zoledronic acid
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 10 Jan 2022 (actual)
- Primary completion
- 14 Nov 2025 (actual)
- Study completion
- 14 Nov 2025 (actual)
- 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 intends to investigate whether Alendronate and Zoledronate can prevent bone mineral density loss after long-term treatment with Denosumab.
Detailed description
This study intends to use a randomized trial to test whether Alendronate and Zoledronate can avoid the risk of rapid bone loss after the withdrawal of Denosumab.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- One arm accept on time zoledronic acid after long-tearm denosumab. Another arm accept alendronate for 4 months and then zoledronic acid after long-tearm denosumab.
| Arm | Type | Receives |
|---|---|---|
| On time Zoledronate | Active comparator | Drug: zoledronateZoledronate would be given (one dose for one year) after the completiong of denosumab on time |
| Alendronate and Zoledronate | Experimental | Drug: Alendronate and ZoledronateAlendronate would be given one month before the the completiong of denosumab and the following 3 months (Total four months). After the completion of Alendronate, Zoledronate would be given (one dose). |
Who may qualify
- Ages
- 50 to 85 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
- Continuous Denosumab treatment for at least three years (up to six doses).
Key exclusion criteria (14 listed)
- Secondary osteoporosis
- Metabolic bone diseases
- Active or prior malignancy
- Ongoing systemic glucocorticoid therapy
- Current use of hormone replacement therapy
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 |
|---|---|---|
| zoledronateAlso: Zoledronic acidOn time Zoledronate: Zoledronate would be given (one dose for one year) after the completiong of denosumab on time | Drug | On time Zoledronate |
| Alendronate and ZoledronateAlendronate and Zoledronate: Alendronate would be given one month before the the completiong of denosumab and the following 3 months (Total four months). After the completion of Alendronate, Zoledronate would be given (one dose). | Drug | Alendronate and Zoledronate |
Primary outcome
Bone mineral density of lumbar spine
Time frame: one year
Bone mineral density of lumbar spine
4 secondary outcomes
Bone mineral density of femoral neck
Time frame: one year
Bone mineral density of total hip
Time frame: one year
bone turnover markers
Time frame: 13 months
clinical osteoporotic fracture
Time frame: 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 19 Nov 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 zoledronate and Alendronate and Zoledronate in people with Osteoporosis, 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 14 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 19 Nov 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?
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?
Bone mineral density of lumbar spine (time frame: one 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 19 Nov 2025; AzTrials last refreshed its copy on 27 Oct 2026.