Osteoporosis, PostmenopausalNCT03435094
Effect of Alendronate 70mg Formulation on Bone Turnover Markers and Patient Reported Outcomes
An observational study of Osteoporosis, Postmenopausal, run by Labatec Pharma SA at 2 sites in Switzerland.
Trial summary
Compare the data obtained with two formulations of alendronate 70 mg (tablets vs effervescent tablet for buffered solution) on the change in bone turnover markers, on gastric tolerance and on treatment adherence (including compliance and persistence). Read more about this study
- Who is it for?
- Ages 55 to 90 years, women only
- Conditions the study is for
- Osteoporosis, Postmenopausal
- What is being tested?
- Binosto 70Mg Effervescent Tablet and Fosamax 70Mg Tablet
- Type of treatment
- Pill or oral medicine
- How many people
- 80 participants
- Where
- 2 sitesSwitzerland
- Study dates
- 25 Feb 2018to 1 Dec 2022
- Phase
- Observational
- 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 55 to 90 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Post-menopausal women with osteoporosis, on treatment with Fosamax® or Binosto® for 6-8 months and who will be continued to be treated for a minimum of 12 months, with available BTMs, biochemistry and DXA at the initiation are to be offered participation in the study at the discretion of the treating physician.
Who may be able to join
- Post-menopausal women (at least 5 years after natural / surgical menopause).
- Patients on treatment with alendronate 70mg tablets or alendronate 70mg effervescent tablets for 6-8 months and who will be continued to be treated for a minimum of 12 months.
- Available BTMs (s-CTX), biochemistry (calcium, phosphate, 25-OH vit D, PTH, creatinine) and DXA (lumbar spine, total hip and femoral neck) at the initiation of the treatment.
- Ability to sign an informed patient consent
Who cannot join
- Patients who had received a prior osteoporosis treatment with anti-resorptive drugs (bisphosphonate or denosumab) or teriparatide before starting alendronate 70 mg.
- Any secondary cause of osteoporosis including current treatment with glucocorticoids or aromatase inhibitors, inflammatory disorders, malabsorption
- Metabolic or cancer bone disease
- Contra-indications to bisphosphonates according to product labelling
- Known or suspected allergy to study product(s) or related products
- Inability to sign an informed consent
- Previous participation in this study
Trial locations and contacts
2 sites in 1 country.
Switzerland2 sites, 2 recruiting
- Recruiting
Endokrinologische Praxis & Labor
Basel, Canton of Basel-City, 4055
Christian Meier, Prof
- Recruiting
Hôpital Universitaire de Genève, Service des maladies osseuses
Geneva, Canton of Geneva, 1211
Serge Ferrari, Prof
About this study
Official title: A Non-interventional Two-arm Two-centre, Retrospective/Prospective Study to Compare the Effect of Alendronate 70mg Formulation (Tablet vs Effervescent Tablet) on Bone Turnover Markers and Patient Reported Outcomes
Compare the data obtained with two formulations of alendronate 70 mg (tablets vs effervescent tablet for buffered solution) on the change in bone turnover markers, on gastric tolerance and on treatment adherence (including compliance and persistence).
- Conditions
- Osteoporosis, Postmenopausal
- Being tested
- Binosto 70Mg Effervescent Tablet, Fosamax 70Mg Tablet
- Medical subject headings
- Osteoporosis, Postmenopausal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Binosto 70Mg Effervescent TabletDrug
Assess the effect of alendronate 70mg effervescent tablet on bone turnover markers and patient reported outcomes.
Fosamax 70Mg TabletDrug
Assess the effect of alendronate 70mg tablet on bone turnover markers and patient reported outcomes.
| Study group | Role | What they receive |
|---|---|---|
| Fosamax® | 1 group will be treated with alendronate 70 mg tablets (Fosamax®) Receives: Drug: Fosamax 70Mg Tablet | |
| Binosto® | 1 group will be treated with alendronate 70 mg effervescent tablets for buffered solution (Binosto®) Receives: Drug: Binosto 70Mg Effervescent Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
s-CTX
Decrease in the rate of the bone resorption marker s-CTX
Measured: Change at 6 months, 12 months, 18 months after treatment start
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2018
- Study start25 Feb 2018
- Primary completion31 Mar 2022 (estimated)
- Study completion1 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoporosis, PostmenopausalStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Labatec Pharma SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Aurélie TIREFORD, PharmD, Study director, Labatec Pharma SA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03435094
- Sponsor's protocol ID
- LAB-BIN-001
- Status last verified
- Dec 2020
- First submitted
- 1 Feb 2018
- Last updated
- 3 Dec 2020
- 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 3 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-interventional Two-arm Two-centre, Retrospective/Prospective Study to Compare the Effect of Alendronate 70mg Formulation (Tablet vs Effervescent Tablet) on Bone Turnover Markers and Patient Reported Outcomes
- ClinicalTrials.gov ID
- NCT03435094
- Acronym / sponsor ID
- LAB-BIN-001
- Conditions
- Osteoporosis, Postmenopausal
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Labatec Pharma SAIndustry (pharma, biotech, devices)
- Study start
- 25 Feb 2018 (actual)
- Primary completion
- 31 Mar 2022 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 15 Feb 2018 (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.
Compare the data obtained with two formulations of alendronate 70 mg (tablets vs effervescent tablet for buffered solution) on the change in bone turnover markers, on gastric tolerance and on treatment adherence (including compliance and persistence).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fosamax® | – | Drug: Fosamax 70Mg Tablet1 group will be treated with alendronate 70 mg tablets (Fosamax®) |
| Binosto® | – | Drug: Binosto 70Mg Effervescent Tablet1 group will be treated with alendronate 70 mg effervescent tablets for buffered solution (Binosto®) |
Who may qualify
- Ages
- 55 to 90 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Post-menopausal women with osteoporosis, on treatment with Fosamax® or Binosto® for 6-8 months and who will be continued to be treated for a minimum of 12 months, with available BTMs, biochemistry and DXA at the initiation are to be offered participation in the study at the discretion of the treating physician.
Key inclusion criteria (4 listed)
- Post-menopausal women (at least 5 years after natural / surgical menopause).
- Patients on treatment with alendronate 70mg tablets or alendronate 70mg effervescent tablets for 6-8 months and who will be continued to be treated for a minimum of 12 months.
- Available BTMs (s-CTX), biochemistry (calcium, phosphate, 25-OH vit D, PTH, creatinine) and DXA (lumbar spine, total hip and femoral neck) at the initiation of the treatment.
- Ability to sign an informed patient consent
Key exclusion criteria (7 listed)
- Patients who had received a prior osteoporosis treatment with anti-resorptive drugs (bisphosphonate or denosumab) or teriparatide before starting alendronate 70 mg.
- Any secondary cause of osteoporosis including current treatment with glucocorticoids or aromatase inhibitors, inflammatory disorders, malabsorption
- Metabolic or cancer bone disease
- Contra-indications to bisphosphonates according to product labelling
- Known or suspected allergy to study product(s) or related products
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 |
|---|---|---|
| Binosto 70Mg Effervescent TabletAssess the effect of alendronate 70mg effervescent tablet on bone turnover markers and patient reported outcomes. | Drug | Binosto® |
| Fosamax 70Mg TabletAssess the effect of alendronate 70mg tablet on bone turnover markers and patient reported outcomes. | Drug | Fosamax® |
Primary outcome
s-CTX
Time frame: Change at 6 months, 12 months, 18 months after treatment start
Decrease in the rate of the bone resorption marker s-CTX
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2020.
- Individual participant dataSharing planned: No
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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.
Aurélie TIREFORD, PharmD study director
Labatec Pharma SA
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoporosis, Postmenopausal, run by Labatec Pharma SA at 2 sites in Switzerland.
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 4 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 3 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aurélie TIREFORD, PharmD (+41 22 593 78 54, aurelie.tireford@labatec.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
s-CTX (time frame: Change at 6 months, 12 months, 18 months after treatment start). 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 3 Dec 2020.