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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-510042-24-01 | EU Trial (CTIS) Number |
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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:
Researchers will compare the outcomes of discontinuation of Alendronate with continuing treatment. Participants will be randomly assigned to a group.
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Discontinuation of Alendronate | Experimental | Discontinuation of Alendronate treatment |
|
| Control group | No Intervention | The control group will continue Alendronate treatment, but shift to project-sponsored product (70 mg Alendronate weekly) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alendronate 70mg weekly | Drug | The intervention is discontinuation of Alendronate |
|
| Measure | Description | Time Frame |
|---|---|---|
| Fragility fractures | Incidence of fragility fractures during the study period | From enrollment to the end of the 3 year study period. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, 12, 24 and 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| Osteoclastassay | Osteoclasts differentiation, formation, activity and response to Alendronate in cultures derived from peripheal blood at baseline and 12 months, from a subgroup of 35 from each arm (70 participants in total). | Baseline and 12 months |
| Molecular bone histology |
Inclusion Criteria:
Exclusion Criteria:
Only biological females will be enrolled.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pernille Hermann, MD, PhD. | Contact | +4523602366 | pernille.herman@rsyd.dk | |
| Lars Folkestad, MD, PhD. | Contact | +4529648537 | lars.folkestad@rsyd.dk |
| Name | Affiliation | Role |
|---|---|---|
| Pernille Hermann, MD, PhD. | Odense Universitetshospital / Odense University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aalborg University Hospital | Not yet recruiting | Aalborg | 9000 | Denmark |
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| Bone turn over marker (CTX) | Fasting blood samples will be performed during the study period to analyze changes in carboxy-terminal collagen crosslinks (CTX). | 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). | 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. | 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. | From enrollment to the end of the 3 year study period. |
Iliac crest bone biopsy specimens will be obtained to evaluate the effect of discontinuation of alendronate on cortical and trabecular bone resorption and formation by histomorphometry. These results will be compared with results of bone turnover markers. Biopsies will be obtained of maximum 35 from each treatment group at 12 and 36 months (in totalt 140 participants). |
| 12 and 36 months |
| Epigenetic analysis | Epigenetic analysis of peripheal blood with focus on the degree of methylation. | Baseline |
| Bispebjerg Hospital | Not yet recruiting | Copenhagen | 2400 | Denmark |
|
| Esbjerg Og Grindsted Sygehus | Not yet recruiting | Esbjerg | 6700 | Denmark |
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| Copenhagen University Hospital (Herlev) | Not yet recruiting | Herlev | 2730 | Denmark |
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| Nordsjaellands Hospital (Hillerød) | Not yet recruiting | Hillerød | 3400 | Denmark |
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| Hvidovre Hospital | Not yet recruiting | Hvidovre | 2650 | Denmark |
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| Odense University Hospital | Recruiting | Odense | 5000 | Denmark |
|
| ID | Term |
|---|---|
| D010024 | Osteoporosis |
| ID | Term |
|---|---|
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D019386 | Alendronate |
| ID | Term |
|---|---|
| D004164 | Diphosphonates |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
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