Osteopenia or OsteoporosisPhase 4NCT05325515
The Effect of Effervescent Alendronate on Bone Turnover
A Phase 4 study testing Conventional alendronate and Effervescent and buffered alendronate in people with Osteopenia or Osteoporosis, run by Aarhus University Hospital at 1 site in Denmark.
Trial summary
64 postmenopausal women are randomized to treatment with either effervescent and buffered alendronate or conventional alendronate -both 70mg weekly for 16 weeks to see if bone turnover is suppressed to the same extent as in the conventional formulation with the effervescent form. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Osteopenia or Osteoporosis
- What is being tested?
- Conventional alendronate and Effervescent and buffered alendronate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Oct 2021to 1 Dec 2022
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 2 years since last menstrual bleeding
- Bone mineral density T-score < -1 at either lumbar spine or hip
- CTx > 0.42 µg/L
Who cannot join
- Ever treatment for osteoporosis
- Indication for teriparatide treatment
- Treatment with oral systemic glucocorticoids within last 12 months
- Rheumatoid arthritis
- Inflammatory bowel disease
- Untreated thyroid disease
Show all 15Show fewer
- Primary hyperparathyroidism
- Diabetes mellitus
- eGFR < 60 mL/min
- Cancer within last 2 years except basal cell carcinoma of the skin
- Hormone therapy
- Unstable liver disease
- Contraindications for alendronate
- Major gastrointestinal disease within 12 months (eg. esophagitis, ulcer, major surgery).
- Vitamin D < 50nmol/L
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Effervescent and Buffered Alendronate on Bone Turnover Compared to Conventional Alendronate: A Randomized Non-inferiority Study
64 postmenopausal women are randomized to treatment with either effervescent and buffered alendronate or conventional alendronate -both 70mg weekly for 16 weeks to see if bone turnover is suppressed to the same extent as in the conventional formulation with the effervescent form.
Read the detailed description
Alendronate is mainstay in the treatment of osteoporosis but is often discontinued due to gastro-intestinal side-effects. These side effects are believed to be caused by a low gastric pH induced by the drug. Effervescent and buffered alendronate is a new formulation that increases gastric pH and thereby decreases risk of side effects but the clinical effect of the drug is not fully elucidated. In the present study 64 postmenopausal women with a bone mineral density T-score < -1 are randomized 1:1 to open label treatment with effervescent and buffered alendronate or conventional alendronate 70 mg weekly for 16 weeks. The primary end-point is change in the bone resorption marker "carboxy-terminal collagen crosslinks" from baseline to 16 weeks. The decrease in the two groups is compared using non-inferiority statistics. Secondary end-points include change in the bone formation marker "propeptide of type 1 procollagen", rate of change in the two bone markers and occurence of side effects.
- Conditions
- Osteopenia or Osteoporosis
- Being tested
- Conventional alendronate, Effervescent and buffered alendronate
- Medical subject headings
- Bone Diseases, Metabolic, Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional alendronateDrug
Conventional alendronate 70mg weekly
Effervescent and buffered alendronateDrug
Effervescent and buffered alendronate 70mg weekly
| Study group | Role | What they receive |
|---|---|---|
| Fosamax (conventional alendronate) | Active comparator | Conventional alendronate 70mg weekly for 16 weeks Receives: Drug: Conventional alendronate |
| Binosto (effervescent and buffered alendronate) | Experimental | Effervescent and buffered alendronate70mg weekly for 16 weeks Receives: Drug: Effervescent and buffered alendronate |
What is being measured
The primary outcome is the main question the study is designed to answer.
CTx
Change in the bone resorption marker CTx
Measured: baseline to week 16
Secondary outcomes (1)
P1NP
Change in the bone resorption marker P1NP
Measured: baseline to week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2022
- Study start1 Oct 2021
- Primary completion1 Sep 2022
- Study completion1 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteopenia or OsteoporosisStudies of the same condition, open and under way.
- More trials run by Aarhus 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
- 2 study arms in which participants are allocated by randomization 1:1. Randomixation is performed in 8 blocks of 8.
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Torben Harsløf, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05325515
- Sponsor's protocol ID
- Binosto_1
- Status last verified
- Feb 2023
- First submitted
- 5 Apr 2022
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Effervescent and Buffered Alendronate on Bone Turnover Compared to Conventional Alendronate: A Randomized Non-inferiority Study
- ClinicalTrials.gov ID
- NCT05325515
- Acronym / sponsor ID
- Binosto_1
- Conditions
- Osteopenia or Osteoporosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Aarhus University HospitalUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 1 Sep 2022 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 13 Apr 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.
64 postmenopausal women are randomized to treatment with either effervescent and buffered alendronate or conventional alendronate -both 70mg weekly for 16 weeks to see if bone turnover is suppressed to the same extent as in the conventional formulation with the effervescent form.
Detailed description
Alendronate is mainstay in the treatment of osteoporosis but is often discontinued due to gastro-intestinal side-effects. These side effects are believed to be caused by a low gastric pH induced by the drug. Effervescent and buffered alendronate is a new formulation that increases gastric pH and thereby decreases risk of side effects but the clinical effect of the drug is not fully elucidated. In the present study 64 postmenopausal women with a bone mineral density T-score < -1 are randomized 1:1 to open label treatment with effervescent and buffered alendronate or conventional alendronate 70 mg weekly for 16 weeks. The primary end-point is change in the bone resorption marker "carboxy-terminal collagen crosslinks" from baseline to 16 weeks. The decrease in the two groups is compared using non-inferiority statistics. Secondary end-points include change in the bone formation marker "propeptide of type 1 procollagen", rate of change in the two bone markers and occurence of side effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 2 study arms in which participants are allocated by randomization 1:1. Randomixation is performed in 8 blocks of 8.
| Arm | Type | Receives |
|---|---|---|
| Fosamax (conventional alendronate) | Active comparator | Drug: Conventional alendronateConventional alendronate 70mg weekly for 16 weeks |
| Binosto (effervescent and buffered alendronate) | Experimental | Drug: Effervescent and buffered alendronateEffervescent and buffered alendronate70mg weekly for 16 weeks |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 2 years since last menstrual bleeding
- Bone mineral density T-score < -1 at either lumbar spine or hip
- CTx > 0.42 µg/L
Key exclusion criteria (15 listed)
- Ever treatment for osteoporosis
- Indication for teriparatide treatment
- Treatment with oral systemic glucocorticoids within last 12 months
- Rheumatoid arthritis
- Inflammatory bowel disease
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 |
|---|---|---|
| Conventional alendronateConventional alendronate 70mg weekly | Drug | Fosamax (conventional alendronate) |
| Effervescent and buffered alendronateEffervescent and buffered alendronate 70mg weekly | Drug | Binosto (effervescent and buffered alendronate) |
Primary outcome
CTx
Time frame: baseline to week 16
Change in the bone resorption marker CTx
1 secondary outcome
P1NP
Time frame: baseline to week 16
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 8 Feb 2023.
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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 Conventional alendronate and Effervescent and buffered alendronate in people with Osteopenia or Osteoporosis, run by Aarhus University Hospital at 1 site 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 3 inclusion and 15 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 8 Feb 2023. 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 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?
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?
CTx (time frame: baseline to week 16). 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 8 Feb 2023.