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Effect of Alendronate 70mg Formulation on Bone Turnover Markers and Patient Reported Outcomes | Clinical Trials | Clareo Health

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

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

NCT03435094•Labatec Pharma SA

View on ClinicalTrials.gov

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).

Eligibility

Age

55 - 90 years

Sex

FEMALE

Healthy Volunteers

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

Locations (2)

Endokrinologische Praxis & Labor

Basel, Canton of Basel-City, Switzerland

Hôpital Universitaire de Genève, Service des maladies osseuses

Geneva, Canton of Geneva, Switzerland

Key Dates

Start Date

February 25, 2018

Primary Completion Date

March 31, 2022

Completion Date

December 1, 2022

Last Updated

December 3, 2020

Enrollment

ESTIMATED participants

Conditions

Osteoporosis, Postmenopausal

Interventions

Binosto 70Mg Effervescent Tablet

DRUG

Fosamax 70Mg Tablet

DRUG

Contacts

Aurélie TIREFORD, PharmD

CONTACT

+41 22 593 78 54 aurelie.tireford@labatec.com

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RECRUITINGNA

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 3, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Single or Repeat Zoledronate Versus Alendronate Following Denosumab (EUROpean Denosumab Effects Consolidation Study)

Vascular Function, Sarcopenia and Pain in Postmenopausal Osteoporosis

Effect of Mechanical Loading With PTH on Cortical Bone

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A Study to Evaluate Alendronate Sodium /Vitamin D3 Combination Tablets(FOSAMAX PLUS) Versus Calcitriol in the Treatment of Osteoporosis in Postmenopausal Women in China (MK-0217A-264)

Efficacy and Safety of MW031 in PMO Subjects