MedDataX Logo

Effect of Alendronate 70mg Formulation on Bone Turnover Markers and Patient Reported Outcomes

NCT ID: NCT03435094

Last Updated: 2020-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-02-25

Study Completion Date

2022-12-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Osteoporosis, Postmenopausal

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Fosamax®

1 group will be treated with alendronate 70 mg tablets (Fosamax®)

Fosamax 70Mg Tablet

Intervention Type DRUG

Assess the effect of alendronate 70mg tablet on bone turnover markers and patient reported outcomes.

Binosto®

1 group will be treated with alendronate 70 mg effervescent tablets for buffered solution (Binosto®)

Binosto 70Mg Effervescent Tablet

Intervention Type DRUG

Assess the effect of alendronate 70mg effervescent tablet on bone turnover markers and patient reported outcomes.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Binosto 70Mg Effervescent Tablet

Assess the effect of alendronate 70mg effervescent tablet on bone turnover markers and patient reported outcomes.

Intervention Type DRUG

Fosamax 70Mg Tablet

Assess the effect of alendronate 70mg tablet on bone turnover markers and patient reported outcomes.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

55 Years

Maximum Eligible Age

90 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Labatec Pharma SA

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Aurélie TIREFORD, PharmD

Role: STUDY_DIRECTOR

Labatec Pharma SA

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Endokrinologische Praxis & Labor

Basel, Canton of Basel-City, Switzerland

Site Status RECRUITING

Hôpital Universitaire de Genève, Service des maladies osseuses

Geneva, Canton of Geneva, Switzerland

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Switzerland

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Aurélie TIREFORD, PharmD

Role: CONTACT

Phone: +41 22 593 78 54

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Christian Meier, Prof

Role: primary

Serge Ferrari, Prof

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

LAB-BIN-001

Identifier Type: -

Identifier Source: org_study_id