Osteoporosis in Post-menopausal WomenPhase 4ALEXISNCT06864130
A Clinical Study on the Effect of Discontinuing Alendronate in Postmenopausal Women With Osteoporosis After a Treatment Period Without Fractures
A Phase 4 study testing Alendronate 70mg weekly in people with Osteoporosis in Post-menopausal Women, run by Odense University Hospital at 7 sites in Denmark.
Trial summary
The goal of this clinical trial is to study the effects of discontinuation of Alendronate treatment for three years. The participants are postmenopausal women with osteoporosis, who have had a treatment period without fractures. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Osteoporosis in Post-menopausal Women
- What is being tested?
- Alendronate 70mg weekly
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,400 participants
- Where
- 7 sitesDenmark
- Study dates
- 21 Feb 2025to 15 Sep 2029
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Female
- Postmenopausal
- Current treatment with Alendronate
- Alendronate treatment >3 år AND no fracture OR
- Alendronate treatment >5 år AND latest low energy fracture > 3 years ago
Who cannot join
- T-score < - 3,5 in hip (total hip or femoral neck) or lumbar spine
- Treatment with systemic glucocorticoids, ongoing or within 12 months
- Uncontrolled inflammatory disease
- Active malignancy
- eGFR < 40 mL/min
- Atypical femur fracture (ever)
- OsteoNecrosis of the Jaw (active)
- Unable to give inform consent
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
Denmark7 sites, 7 recruiting
- Not yet recruiting
Aalborg University Hospital
Aalborg, 9000
Peter Vestergaard, +4597660000, p.vestergaard@rn.dk
- Not yet recruiting
Bispebjerg Hospital
Copenhagen, 2400
Pia Eiken, +4525889530, pia.eiken.01@regionh.dk
- Not yet recruiting
Esbjerg Og Grindsted Sygehus
Esbjerg, 6700
Jeppe Gram, +4521338706, svs-forskning@rsyd.dk
- Not yet recruiting
Copenhagen University Hospital (Herlev)
Herlev, 2730
Jakob Praest Holm, +4538683868, jakob.praest.holm.01@regionh.dk
- Not yet recruiting
Nordsjaellands Hospital (Hillerød)
Hillerød, 3400
Louise Tjelum, +4520485162, louise.tjelum@regionh.dk
- Not yet recruiting
Hvidovre Hospital
Hvidovre, 2650
Jens-Erik Bech Jensen, +4540427592, jens-erik.beck-jensen@regionh.dk
- Recruiting
Odense University Hospital
Odense, 5000
Pernille Hermann, MD, PhD., +4523602366, pernille.hermann@rsyd.dk
Freja Gram, MD
About this study
Official title: The Alendronate Discontinuation Study
The goal of this clinical trial is to study the effects of discontinuation of Alendronate treatment for three years. The participants are postmenopausal women with osteoporosis, who have had a treatment period without fractures. The study will answer:
- What is the rate of fragility fractures during the study? The hypothesis is that discontinuation of Alendronate after a fracture-free period does not raise the 3-year fracture risk.
- Are there predictors of significant bone loss after discontinuation of Alendronate? The hypothesis is that clinical, biochemical, cellular, or molecular characteristics can predict bone loss.
Read more
Researchers will compare the outcomes of discontinuation of Alendronate with continuing treatment. Participants will be randomly assigned to a group.
Participants will:
- Either take alendronate once weekly for three years OR discontinue their treatment
- Visit the clinic at 6 and 18 months for blood samples
- Visit the clinic at the start of the study and after 1, 2, and 3 years for bone scans and blood samples.
- Conditions
- Osteoporosis in Post-menopausal Women
- Being tested
- Alendronate 70mg weekly
- Keywords
- Alendronate, Discontinuation, Osteoporosis, Bone mineral density, post-menopausal
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alendronate 70mg weeklyDrug
The intervention is discontinuation of Alendronate
| Study group | Role | What they receive |
|---|---|---|
| Discontinuation of Alendronate | Experimental | Discontinuation of Alendronate treatment Receives: Drug: Alendronate 70mg weekly |
| Control group | No intervention | The control group will continue Alendronate treatment, but shift to project-sponsored product (70 mg Alendronate weekly) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fragility fractures
Incidence of fragility fractures during the study period
Measured: From enrollment to the end of the 3 year study period.
Secondary outcomes (5)
Changes in bone mineral density (BMD)
Changes in lumbar spine and total hip BMD measured by dual energy X-ray arbsorptiometry. The three follow-up scans will be analyzed by a technician blinded to participant allocation, ie this person will not meet the patient and the patient will not be able see the results of the scans until the final study visit.
Measured: Baseline, 12, 24 and 36 months
Bone turn over marker (CTX)
Fasting blood samples will be performed during the study period to analyze changes in carboxy-terminal collagen crosslinks (CTX).
Measured: Blood samples are performed at baseline, 6, 12, 18, 24, and 36 months.
Bone turn over marker (P1NP)
Fasting blood samples will be performed during the study period to analyze changes in procollagen type I N-terminal propeptide (PINP).
Measured: Blood samples are performed at baseline, 6, 12, 18, 24, and 36 months.
Restart Criteria
The proportion of participants meeting restart criteria during the study period. Restart criteria is defined as: Participants experiencing boneloss exceeding 10% from baseline in any region, one clinical vertebral fracture, two low energy fractures (including morphometric vertebral fracture but excluding fractures of scull, fingers or toes) are withdrawn from the study and offered treatment with alendronate or zoledronic acid after new diagnostic work-up.
Measured: From enrollment to the end of the study period at 3 years
Adverse Events
At baseline a thoroughly physical examination of the participants and questioning concerning any conditions or diseases will take place. This way the investigators will be able to evaluate possible changes throughout the study. Patients will be interviewed about the occurrence of AEs at each visit from the first trial related activity after the subject has signed the informed consent. Subjects that experience adverse events or develop a disease during the trial period will be managed until the condition is cured or stationary. If this is not the case at the end of the study, subjects will be referred to a relevant physician, e.g. the general practitioner or a specialist, to be followed up.
Measured: From enrollment to the end of the 3 year study period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2025
- Study start21 Feb 2025
- Primary completion1 Mar 2029 (estimated)
- Study completion15 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoporosis in Post-menopausal WomenStudies of the same condition, open and under way.
- More trials run by Odense 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pernille Hermann, MD, PhD., Principal investigator, Odense Universitetshospital / Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06864130
- Sponsor's protocol ID
- CT 2023-510042-24
- Other IDs
- 2023-510042-24-01, 2023
- Acronym
- ALEXIS
- Status last verified
- Feb 2025
- First submitted
- 10 Feb 2025
- Last updated
- 7 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Alendronate Discontinuation Study
- ClinicalTrials.gov ID
- NCT06864130
- Acronym / sponsor ID
- ALEXIS / CT 2023-510042-24
- Conditions
- Osteoporosis in Post-menopausal Women
- Keywords
- Alendronate, Discontinuation, Osteoporosis, Bone mineral density, post-menopausal
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,400 participants (estimated)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Study start
- 21 Feb 2025 (actual)
- Primary completion
- 1 Mar 2029 (estimated)
- Study completion
- 15 Sep 2029 (estimated)
- First posted
- 7 Mar 2025 (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.
The goal of this clinical trial is to study the effects of discontinuation of Alendronate treatment for three years. The participants are postmenopausal women with osteoporosis, who have had a treatment period without fractures. The study will answer:
- What is the rate of fragility fractures during the study? The hypothesis is that discontinuation of Alendronate after a fracture-free period does not raise the 3-year fracture risk.
- Are there predictors of significant bone loss after discontinuation of Alendronate? The hypothesis is that clinical, biochemical, cellular, or molecular characteristics can predict bone loss.
Researchers will compare the outcomes of discontinuation of Alendronate with continuing treatment. Participants will be randomly assigned to a group.
Participants will:
- Either take alendronate once weekly for three years OR discontinue their treatment
- Visit the clinic at 6 and 18 months for blood samples
- Visit the clinic at the start of the study and after 1, 2, and 3 years for bone scans and blood samples.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Discontinuation of Alendronate | Experimental | Drug: Alendronate 70mg weeklyDiscontinuation of Alendronate treatment |
| Control group | No intervention | –The control group will continue Alendronate treatment, but shift to project-sponsored product (70 mg Alendronate weekly) |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Female
- Postmenopausal
- Current treatment with Alendronate
- Alendronate treatment >3 år AND no fracture OR
- Alendronate treatment >5 år AND latest low energy fracture > 3 years ago
Key exclusion criteria (8 listed)
- T-score < - 3,5 in hip (total hip or femoral neck) or lumbar spine
- Treatment with systemic glucocorticoids, ongoing or within 12 months
- Uncontrolled inflammatory disease
- Active malignancy
- eGFR < 40 mL/min
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 |
|---|---|---|
| Alendronate 70mg weeklyThe intervention is discontinuation of Alendronate | Drug | Discontinuation of Alendronate |
Primary outcome
Fragility fractures
Time frame: From enrollment to the end of the 3 year study period.
Incidence of fragility fractures during the study period
5 secondary outcomes
Changes in bone mineral density (BMD)
Time frame: Baseline, 12, 24 and 36 months
Bone turn over marker (CTX)
Time frame: Blood samples are performed at baseline, 6, 12, 18, 24, and 36 months.
Bone turn over marker (P1NP)
Time frame: Blood samples are performed at baseline, 6, 12, 18, 24, and 36 months.
Restart Criteria
Time frame: From enrollment to the end of the study period at 3 years
Adverse Events
Time frame: From enrollment to the end of the 3 year study period.
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 7 Mar 2025.
- Individual participant dataSharing planned: No
Related trials for Osteoporosis in Post-menopausal Women
Not yet recruitingPhase 4
Sequential Treatment With Romosozumab Followed by Denosumab vs. Zoledronic Acid for Gains in HIP BMD
Osteoporosis in Post-menopausal Women
Active, not recruitingPhase 1
Intravenous Infusion of Human Mesenchymal Stem Cells (HMM910 ) in Postmenopausal Women With Osteoporosis at High Risk of Fracture
Osteoporosis in Post-menopausal Women, Osteoporosis
Not yet recruiting
Bone Health in Postmenopausal Women: The Effect of Exercise With or Without Medication for Osteoporosis
Osteoporosis in Post-menopausal Women
Not yet recruiting
Monitoring Combined Effect of Balance and Strengthening Exercises on Static and Dynamic Balance in Elderly Populations
Geriatrics Balance Disturbance With High Risk Falling, Osteoporosis, Vestibular Age Related Changes, Female Post-menopausal Based on History
Not yet recruitingPhase 4
Efficacy of Romosozumab and Denosumab Combined Treatment in Postmenopausal Osteoporosis Patients with Multiple Fragility Fractures
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.
Pernille Hermann, MD, PhD. principal investigator
Odense Universitetshospital / Odense University Hospital
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Alendronate 70mg weekly in people with Osteoporosis in Post-menopausal Women, run by Odense University Hospital at 7 sites in Denmark.
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 8 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: looking for participants now, as of the sponsor's last update on 7 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Denmark. 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?
Contact Pernille Hermann, MD, PhD. (+4523602366, pernille.herman@rsyd.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fragility fractures (time frame: From enrollment to the end of the 3 year study period.). 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 2025.